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1. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Bril, V., Breiner, A., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentssch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I.N., Eftimov, F., Notermans, N.C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Alberti Aguiló, M., Gamez, J., Figueras, M., Marquez Infante, C., Benitez Rivero, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Chi-Ho Lai, E., Dimachkie, M., Barohn, R.J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, and Merkies, Ingemar S J

Published
2018
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3. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

Merkies, Ingemar S. J., van Schaik, Ivo N., Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Masson, G. Le, Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Infante, C. Marquez, Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., Macdonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., De Bleecker, J. L., Robberecht, W., Franques, J., Léger, J. -M., Morales, R. Juntas, Nguento, A., Schrey, Ch., Kamienowski, J., Stelmasiak, Z., Zwolińska, G., Neurology, AII - Infectious diseases, ANS - Neuroinfection & -inflammation, CSL Behring, Neurologian yksikkö, Clinicum, Department of Food and Nutrition, and HUS Neurocenter

Subjects
Research Report, Male, Outcome Assessment, efficacy, Medizin, Chronic inflammatory demyelinating polyneuropathy, CIDP, IVIG, PATH, PRIMA, Neuroscience (all), Neurology (clinical), INFLAMMATORY DEMYELINATING POLYNEUROPATHY, 3124 Neurology and psychiatry, law.invention, Grip strength, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, hemic and lymphatic diseases, Outcome Assessment, Health Care, 80 and over, Medicine and Health Sciences, Prospective Studies, Chronic Inflammatory Demyelinating, Prospective cohort study, Aged, 80 and over, education.field_of_study, General Neuroscience, Immunoglobulins, Intravenous, Middle Aged, OPEN-LABEL, humanities, 3. Good health, PREVALENCE, Europe, 030220 oncology & carcinogenesis, Cohort, POLYRADICULONEUROPATHY, Female, Intravenous, Polyneuropathy, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, Efficacy, Neuroscience(all), Population, Clinical Neurology, Immunoglobulins, MAINTENANCE TREATMENT, 03 medical and health sciences, Young Adult, Double-Blind Method, Internal medicine, medicine, Journal Article, Humans, Immunologic Factors, INTRAVENOUS IMMUNOGLOBULIN, Aged, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, education, Science & Technology, business.industry, Neurosciences, 3112 Neurosciences, Research Reports, medicine.disease, PHASE-III, Health Care, cidp, ivig, path, prima, Neurosciences & Neurology, business, 030217 neurology & neurosurgery
Abstract

PRIMA Trial Investigators and the PATH Study Group., Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open‐label, single‐arm study of IVIG in immunoglobulin (Ig)‐naïve or IVIG pre‐treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double‐blind, randomized study including an open‐label, single‐arm IVIG phase in IVIG pre‐treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre‐treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was −1.0 (interquartile range −2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA‐approved IVIG for CIDP, in a population of mainly pre‐treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Published
2019

4. Efficacy and tolerability of adjuvant perampanel: an Australian multicenter real-world observational study in refractory focal and generalized epilepsy syndromes.

Author

Sagar P., Wawryk O., Vogrin S., Whitham E., Kiley M., Frasca J., Carne R., Seneviratne U., Cook M.J., Lawn N., Nikpour A., D'Souza W.J., Sagar P., Wawryk O., Vogrin S., Whitham E., Kiley M., Frasca J., Carne R., Seneviratne U., Cook M.J., Lawn N., Nikpour A., and D'Souza W.J.

Abstract

Purpose: To explore the efficacy and tolerability of adjuvant perampanel (PER) and their associated risk factors in late add-on drug-resistant epilepsy. Method(s): Retrospective multicenter 'real-world' observational study. Consecutively identified patients commenced on PER, with mixed epilepsy syndromes, from nine Australian epilepsy centers. Primary efficacy endpoints were at least 50% reduction in seizure frequency (responders), seizure freedom, and retention at 6 and 12 months, following a 3-month titration period. Tolerability endpoints were cessation of PER for any reason, cessation of PER due to treatment-emergent adverse events (TEAE), or cessation due to inefficacy. Outcomes were assessed for a-priori risk factors associated with efficacy and tolerability. Result(s): Three-hundred and eighty seven adults were identified and followed up for a median of 12.1 months (IQR 7.0-25.2). Focal epilepsy accounted for 79.6% (FE), idiopathic generalized epilepsy (IGE), 10.3% and developmental epileptic encephalopathy (DEE) 10.1%, of the cohort. All patients had drug-resistant epilepsy, 71.6% had never experienced six months of seizure freedom, and the mean number of antiepileptic medications (AEDs) prior to starting PER was six. At 12 months, with missing cases classified as treatment failure, retention was 40.0%, responder 21.7%, and seizure freedom 9.0%, whereas, using last outcome carried forward (LOCF), responder and seizure freedom rates were 41.3% and 14.7%, respectively. Older age of epilepsy onset was associated with a marginal increase in the likelihood of seizure freedom at 12-month maintenance (OR 1.04, 95% CI 1.02, 1.06). Male sex (adjusted OR [aOR] 2.06 95% CI 1.33, 3.19), lower number of prior AEDs (aOR 0.84, 95% CI 0.74, 0.96) and no previous seizure-free period of at least 6-month duration (aOR 2.04 95% CI 1.21, 3.47) were associated with retention. Perampanel combined with a GABA receptor AED was associated with a lower responder rate at 12 months but

Published
2021

5. Long-term mood, quality of life, and seizure freedom in intracranial EEG epilepsy surgery.

Author

Swarup O., Waxmann A., Chu J., Vogrin S., Lai A., Laing J., Barker J., Seiderer L., Ignatiadis S., Plummer C., Carne R., Seneviratne U., Cook M., Murphy M., D'Souza W., Swarup O., Waxmann A., Chu J., Vogrin S., Lai A., Laing J., Barker J., Seiderer L., Ignatiadis S., Plummer C., Carne R., Seneviratne U., Cook M., Murphy M., and D'Souza W.

Abstract

Objectives: To determine the long-term outcomes in patients undergoing intracranial EEG (iEEG) evaluation for epilepsy surgery in terms of seizure freedom, mood, and quality of life at St. Vincent's Hospital, Melbourne. Method(s): Patients who underwent iEEG between 1999 and 2016 were identified. Patients were retrospectively assessed between 2014 and 2017 by specialist clinic record review and telephone survey with standardized validated questionnaires for: 1) seizure freedom using the Engel classification; 2) Mood using the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E); 3) Quality-of-life outcomes using the QOLIE-10 questionnaire. Summary statistics and univariate analysis were performed to investigate variables for significance. Result(s): Seventy one patients underwent iEEG surgery: 49 Subdural, 14 Depths, 8 Combination with 62/68 (91.9%) of those still alive, available at last follow-up by telephone survey or medical record review (median of 8.2 years). The estimated epileptogenic zone was 62% temporal and 38% extra-temporal. At last follow-up, 69.4% (43/62) were Engel Class I and 30.6% (19/62) were Engel Class II-IV. Further, a depressive episode (NDDI-E > 15) was observed in 34% (16/47), while a 'better quality of life' (QOLIE-10 score < 25) was noted in 74% (31/42). Quality of life (p < 0.001) but not mood (p = 0.24) was associated with seizure freedom. Significance: Long-term seizure freedom can be observed in patients undergoing complex epilepsy surgery with iEEG evaluation and is associated with good quality of life.Copyright © 2021 Elsevier Inc.

Published
2021

8. Improved irritability, mood, and quality of life following introduction of perampanel as late adjunctive treatment for epilepsy.

Author

Dharan A., Ignatiadis S., Carne R., D'Souza W.J., Cook M.J., Seneviratne U., Moraes J.S., Hepworth G., Dharan A., Ignatiadis S., Carne R., D'Souza W.J., Cook M.J., Seneviratne U., Moraes J.S., and Hepworth G.

Abstract

Objective: The objective of this study was to evaluate the efficacy and tolerability of perampanel (PER) in late adjunctive treatment of focal epilepsy. We assessed outcomes 1) according to patients' clinical profiles and the broad mechanism of action (MoA) of concomitant antiepileptic drugs (AEDs) and 2) the effects of PER on adverse events, irritability, mood, and quality of life (QOL). Method(s): Consecutive patients commenced on PER at two epilepsy centers in Melbourne, Australia were identified. A nested cohort underwent detailed prospective assessment, while the remainder were retrospectively analyzed. Six- and 12-month efficacy endpoints were at least a 50% reduction in seizure frequency (responders) and complete seizure freedom. The prospective cohort underwent standardized validated questionnaires at 0, 1, 3, 6, and 12 months using the modified semi-structured seizure interview (SSI), Liverpool Adverse Events Profile (LAEP), Quality of Life in Epilepsy-Patient-Weighted (QOLIE-10-P), Neurological Disorders Depression Inventory Epilepsy (NDDI-E), and an Irritability Questionnaire. Result(s): One hundred sixty patients were followed for a median of 6 months: the mean number of prior AEDs was 6, 99% had drug-resistant epilepsy, and 72% had never experienced a prior seizure-free period of at least 6 months (= continuously refractory epilepsy). Perampanel was associated with responder and seizure freedom rates of 30.6% and 9.4% at 6 months and 19.4% and 4.4% (5.6% adjusted for the titration period) at 12 months. Having "continuously refractory epilepsy" was associated with a reduced likelihood of seizure freedom at 6 months (5% vs. 30%; p = 0.001) and 12 months (3% vs. 13%; p = 0.058). Quality of Life in Epilepsy-Patient-Weighted, irritability, and NDDI-E showed mean improvement at 6 months from baseline. Significance: Even when used as late add-on adjunctive therapy in patients with highly refractory focal epilepsy, PER can result in 12-month seizure freedom of

Published
2020

10. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study

Author

van Schaik, Ivo N, Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L, Cornblath, David R, Merkies, Ingemar SJ, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Bril, V, Breiner, A, Kunc, P, Michal, V, Sussova, J, Tomas, K, Talab, R, Michal, B, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschumtszsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, van Schaik, IN, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, E Chi-Ho, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Hagenacker, Tim (Beitragende*r), HUS Neurocenter, Neurologian yksikkö, Clinicum, Department of Neurosciences, Academic Medical Center, and CSL Behring

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Injections, Subcutaneous, Medizin, Chronic inflammatory demyelinating polyneuropathy, Subcutaneous immunoglobulin, INFLAMMATORY DEMYELINATING POLYNEUROPATHY, Gastroenterology, 3124 Neurology and psychiatry, law.invention, 03 medical and health sciences, MUSCLE STRENGTH, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Humans, Medicine, Prospective Studies, Dosing, Adverse effect, Prospective cohort study, Aged, 030304 developmental biology, 0303 health sciences, MMN, business.industry, Extension study, 3112 Neurosciences, Immunoglobulins, Intravenous, Polyradiculoneuropathy, Middle Aged, medicine.disease, 3. Good health, Treatment Outcome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Neurology, Immunoglobulin G, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

PATH study group., [Objective] To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP)., [Methods] In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and—if clinically stable—switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score., [Results] Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg–treated patients and 48% in 0.2 g/kg–treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs., [Conclusions] Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious., This study was supported by CSL Behring.

Published
2019
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11. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., and Gable, K.

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Published
2019

12. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP PATH extension study

Author

van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., Merkies, Ingemar S. J., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Bril, V, Breiner, A., Kunc, P., Michal, V, Sussova, J., Tomas, K., Talab, R., Michal, B., Toomsoo, T., Rubanovits, I, Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschumtszsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V, Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I, Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., Merkies, Ingemar S. J., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Bril, V, Breiner, A., Kunc, P., Michal, V, Sussova, J., Tomas, K., Talab, R., Michal, B., Toomsoo, T., Rubanovits, I, Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschumtszsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V, Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I, Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., and Gable, K.

Abstract

Objective To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP). Methods In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and-if clinically stable-switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score. Results Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg-treated patients and 48% in 0.2 g/kg-treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs. Conclusions Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.

Published
2019

13. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

Merkies, ISJ, van Schaik, IN, Leger, J-M, Bril, V, van Geloven, N, Hartung, H-P, Lewis, RA, Sobue, G, Lawo, J-P, Durn, BL, Cornblath, DR, De Bleecker, JL, Sommer, C, Robberecht, W, Saarela, M, Kamienowski, J, Stelmasiak, Z, Tackenberg, B, Mielke, O, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Franques, J, Morales, RJ, Nguento, A, Schrey, C, Zwolinska, G, Merkies, ISJ, van Schaik, IN, Leger, J-M, Bril, V, van Geloven, N, Hartung, H-P, Lewis, RA, Sobue, G, Lawo, J-P, Durn, BL, Cornblath, DR, De Bleecker, JL, Sommer, C, Robberecht, W, Saarela, M, Kamienowski, J, Stelmasiak, Z, Tackenberg, B, Mielke, O, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Franques, J, Morales, RJ, Nguento, A, Schrey, C, and Zwolinska, G

Abstract

Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Published
2019

14. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

Mielke, O, Bril, V, Cornblath, DR, Lawo, J-P, van Geloven, N, Hartung, H-P, Lewis, RA, Merkies, ISJ, Sobue, G, Durn, B, Shebl, A, van Schaik, IN, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Mielke, O, Bril, V, Cornblath, DR, Lawo, J-P, van Geloven, N, Hartung, H-P, Lewis, RA, Merkies, ISJ, Sobue, G, Durn, B, Shebl, A, van Schaik, IN, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, and Gable, K

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Published
2019

15. Placebo effect in chronic inflammatory demyelinating polyneuropathy: The PATH study and a systematic review.

Author

Lewis, Richard A., Cornblath, David R., Hartung, Hans‐Peter, Sobue, Gens, Lawo, John‐Philip, Mielke, Orell, Durn, Billie L., Bril, Vera, Merkies, Ingemar S. J., Bassett, Paul, Cleasby, Alexa, Schaik, Ivo N., Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, and Demeestere, J

Subjects
THERAPEUTIC use of immunoglobulins, DEMYELINATION, IMMUNOGLOBULINS, META-analysis, PLACEBOS, GUILLAIN-Barre syndrome, STATISTICS, SYSTEMATIC reviews, DISEASE relapse, DATA analysis
Abstract

The Polyneuropathy And Treatment with Hizentra (PATH) study required subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) to show dependency on immunoglobulin G (IgG) and then be restabilized on IgG before being randomized to placebo or one of two doses of subcutaneous immunoglobulin (SCIG). Nineteen of the 51 subjects (37%) randomized to placebo did not relapse over the next 24 weeks. This article explores the reasons for this effect. A post‐hoc analysis of the PATH placebo group was undertaken. A literature search identified other placebo‐controlled CIDP trials for review and comparison. In PATH, subjects randomized to placebo who did not relapse were significantly older, had more severe disease, and took longer to deteriorate in the IgG dependency period compared with those who relapsed. Published trials in CIDP, whose primary endpoint was stability or deterioration, had a mean non‐deterioration (placebo effect) of 43%, while trials with a primary endpoint of improvement had a placebo response of only 11%. Placebo is an important variable in the design of CIDP trials. Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration. [ABSTRACT FROM AUTHOR]

Published
2020
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16. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

van Schaik, Ivo N, primary, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A, additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Praus, Michaela, additional, Mielke, Orell, additional, Durn, Billie L, additional, Cornblath, David R, additional, Merkies, Ingemar S J, additional, Sabet, A., additional, George, K., additional, Roberts, L., additional, Carne, R., additional, Blum, S., additional, Henderson, R., additional, Van Damme, P., additional, Demeestere, J., additional, Larue, S., additional, D'Amour, C., additional, Bril, V., additional, Breiner, A., additional, Kunc, P., additional, Valis, M., additional, Sussova, J., additional, Kalous, T., additional, Talab, R., additional, Bednar, M., additional, Toomsoo, T., additional, Rubanovits, I., additional, Gross-Paju, K., additional, Sorro, U., additional, Saarela, M., additional, Auranen, M., additional, Pouget, J., additional, Attarian, S., additional, Le Masson, G., additional, Wielanek-Bachelet, A., additional, Desnuelle, C., additional, Delmont, E., additional, Clavelou, P., additional, Aufauvre, D., additional, Schmidt, J., additional, Zschuentssch, J., additional, Sommer, C., additional, Kramer, D., additional, Hoffmann, O., additional, Goerlitz, C., additional, Haas, J., additional, Chatzopoulos, M., additional, Yoon, R., additional, Gold, R., additional, Berlit, P., additional, Jaspert-Grehl, A., additional, Liebetanz, D., additional, Kutschenko, A., additional, Stangel, M., additional, Trebst, C., additional, Baum, P., additional, Bergh, F., additional, Klehmet, J., additional, Meisel, A., additional, Klostermann, F., additional, Oechtering, J., additional, Lehmann, H., additional, Schroeter, M., additional, Hagenacker, T., additional, Mueller, D., additional, Sperfeld, A., additional, Bethke, F., additional, Drory, V., additional, Algom, A., additional, Yarnitsky, D., additional, Murinson, B., additional, Di Muzio, A., additional, Ciccocioppo, F., additional, Sorbi, S., additional, Mata, S., additional, Schenone, A., additional, Grandis, M., additional, Lauria, G., additional, Cazzato, D., additional, Antonini, G., additional, Morino, S., additional, Cocito, D., additional, Zibetti, M., additional, Yokota, T., additional, Ohkubo, T., additional, Kanda, T., additional, Kawai, M., additional, Kaida, K., additional, Onoue, H., additional, Kuwabara, S., additional, Mori, M., additional, Iijima, M., additional, Ohyama, K., additional, Baba, M., additional, Tomiyama, M., additional, Nishiyama, K., additional, Akutsu, T., additional, Yokoyama, K., additional, Kanai, K., additional, van Schaik, I.N., additional, Eftimov, F., additional, Notermans, N.C., additional, Visser, N., additional, Faber, C., additional, Hoeijmakers, J., additional, Rejdak, K., additional, Chyrchel-Paszkiewicz, U., additional, Casanovas Pons, C., additional, Alberti Aguiló, M., additional, Gamez, J., additional, Figueras, M., additional, Marquez Infante, C., additional, Benitez Rivero, S., additional, Lunn, M., additional, Morrow, J., additional, Gosal, D., additional, Lavin, T., additional, Melamed, I., additional, Testori, A., additional, Ajroud-Driss, S., additional, Menichella, D., additional, Simpson, E., additional, Chi-Ho Lai, E., additional, Dimachkie, M., additional, Barohn, R.J., additional, Beydoun, S., additional, Johl, H., additional, Lange, D., additional, Shtilbans, A., additional, Muley, S., additional, Ladha, S., additional, Freimer, M., additional, Kissel, J., additional, Latov, N., additional, Chin, R., additional, Ubogu, E., additional, Mumfrey, S., additional, Rao, T., additional, MacDonald, P., additional, Sharma, K., additional, Gonzalez, G., additional, Allen, J., additional, Walk, D., additional, Hobson-Webb, L., additional, and Gable, K., additional

Published
2018
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17. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post‐Hoc Analysis of the GISSI‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) Trial

Author

Dauriz, Marco, primary, Targher, Giovanni, additional, Temporelli, Pier Luigi, additional, Lucci, Donata, additional, Gonzini, Lucio, additional, Nicolosi, Gian Luigi, additional, Marchioli, Roberto, additional, Tognoni, Gianni, additional, Latini, Roberto, additional, Cosmi, Franco, additional, Tavazzi, Luigi, additional, Maggioni, Aldo Pietro, additional, Barlera, Simona, additional, Franzosi, Maria Grazia, additional, Maggioni, Aldo P., additional, Porcu, Maurizio, additional, Yusuf, Salim, additional, Camerini, Fulvio, additional, Cohn, Jay N., additional, Decarli, Adriano, additional, Pitt, Bertram, additional, Sleight, Peter, additional, Poole‐Wilson, Philip A., additional, Geraci, Enrico, additional, Scherillo, Marino, additional, Fabbri, Gianna, additional, Bartolomei, Barbara, additional, Bertoli, Daniele, additional, Cobelli, Franco, additional, Fresco, Claudio, additional, Ledda, Antonietta, additional, Levantesi, Giacomo, additional, Opasich, Cristina, additional, Rusconi, Franco, additional, Sinagra, Gianfranco, additional, Turazza, Fabio, additional, Volpi, Alberto, additional, Ceseri, Martina, additional, Alongi, Gianluca, additional, Atzori, Antonio, additional, Bambi, Filippo, additional, Bastarolo, Desiree, additional, Bianchini, Francesca, additional, Cangioli, Iacopo, additional, Canu, Vittoriana, additional, Caporusso, Concetta, additional, Cenni, Gabriele, additional, Cintelli, Laura, additional, Cocchio, Michele, additional, Confente, Alessia, additional, Fenicia, Eva, additional, Friso, Giorgio, additional, Gianfriddo, Marco, additional, Grilli, Gianluca, additional, Lazzaro, Beatrice, additional, Lonardo, Giuseppe, additional, Luise, Alessia, additional, Nota, Rachele, additional, Orlando, Mariaelena, additional, Petrolo, Rosaria, additional, Pierattini, Chiara, additional, Pierota, Valeria, additional, Provenzani, Alessandro, additional, Quartuccio, Velia, additional, Ragno, Anna, additional, Serio, Chiara, additional, Spolaor, Alvise, additional, Tafi, Arianna, additional, Tellaroli, Elisa, additional, Ghio, Stefano, additional, Ghizzardi, Elisa, additional, Masson, Serge, additional, Crociati, Lella, additional, La Rovere, Maria Teresa, additional, Corrà, Ugo, additional, Finzi, Andrea, additional, Gorini, Marco, additional, Milani, Valentina, additional, Orsini, Giampietro, additional, Bianchini, Elisa, additional, Cabiddu, Silvia, additional, Cangioli, Ilaria, additional, Cipressa, Laura, additional, Cipressa, Maria Lucia, additional, Di Bitetto, Giuseppina, additional, Ferri, Barbara, additional, Galbiati, Luisa, additional, Lorimer, Andrea, additional, Pera, Carla, additional, Priami, Paola, additional, Vasamì, Antonella, additional, Moccetti, T., additional, Rossi, M.G., additional, Pasotti, E., additional, Vaghi, F., additional, Roncarolo, P., additional, Zunino, M.T., additional, Matta, F., additional, Perinetto, E. Actis, additional, Gaita, F., additional, Azzaro, G., additional, Zanetta, M., additional, Paino, A.M., additional, Parravicini, U., additional, Vegis, D., additional, Conte, R., additional, Ferraro, P., additional, De Bernardi, A., additional, Morelloni, S., additional, Fagnani, M., additional, Lucchina, P. Greco, additional, Montagna, L., additional, Bellone, E., additional, Sappè, D., additional, Ferraro, F., additional, Delucchi, M., additional, Reynaud, S.G., additional, Dore, M., additional, La Brocca, A., additional, Massobrio, N., additional, Bo, L., additional, Trinchero, R., additional, Imazio, M., additional, Brocchi, G., additional, Nejrotti, A., additional, Rissone, L., additional, Gabasio, S., additional, Zocchi, C., additional, Randazzo, S., additional, Crenna, A., additional, Giannuzzi, P., additional, Bonanomi, E., additional, Mezzani, A., additional, De Marchi, M., additional, Begliuomini, G., additional, Gianonatti, C.A., additional, Gavazzi, A., additional, Grosu, A., additional, Dei Cas, L., additional, Nodari, S., additional, Garyfallidis, P., additional, Bertoletti, A., additional, Bonifazi, C., additional, Arisi, S., additional, Mascaro, F., additional, Fraccarollo, M., additional, Dell'Orto, S., additional, Sfolcini, M., additional, Bortolini, F., additional, Raccagni, D., additional, Turelli, A., additional, Santarone, M., additional, Miglierina, E., additional, Sormani, L., additional, Jemoli, R., additional, Tettamanti, F., additional, Pirelli, S., additional, Bianchi, C., additional, Verde, S., additional, Mariani, M., additional, Ziacchi, V., additional, Ferrazza, A., additional, Russo, A., additional, Bortolotti, M., additional, Pasini, G.F., additional, Volpi, A., additional, Jones, K.N., additional, Cuzzucrea, D., additional, Gullace, G., additional, Carbone, C., additional, Granata, A., additional, De Servi, S., additional, Del Rosso, G., additional, Inserra, C., additional, Renaldini, E., additional, Zappa, C., additional, Moretti, M., additional, Zanini, R., additional, Ferrari, M., additional, Moroni, E., additional, Cei, A., additional, Lissi, C., additional, Dovico, E., additional, Fiorentini, C., additional, Palermo, P., additional, Brusoni, B., additional, Negrini, M., additional, Heyman, J., additional, Danzi, G.B., additional, Finzi, A., additional, Frigerio, M., additional, Turazza, F., additional, Beretta, L., additional, Sachero, A., additional, Casazza, F., additional, Squadroni, L., additional, Lombardi, F., additional, Marano, L., additional, Margonato, A., additional, Fragasso, G., additional, Febo, O.C., additional, Aiolfi, E., additional, Olmetti, F., additional, Grieco, A., additional, Antonazzo, V., additional, Specchia, G., additional, Mortara, A., additional, Robustelli, F., additional, Songini, M.G., additional, Schweiger, C., additional, Frisinghelli, A., additional, Palvarini, M., additional, Campana, C., additional, Scelsi, L., additional, Ajmone Marsan, N., additional, Cobelli, F., additional, Gualco, A., additional, Opasich, C., additional, De Feo, S., additional, Mazzucco, R., additional, Iannone, M.A., additional, Diaco, T., additional, Zaniboni, D., additional, Milanesi, G., additional, Nassiacos, D., additional, Meloni, S., additional, Giani, P., additional, Nicoli, T., additional, Malinverni, C., additional, Gusmini, A., additional, Pozzoni, L., additional, Bisiani, G., additional, Margaroli, P., additional, Schizzarotto, A., additional, Daverio, A., additional, Occhi, G., additional, Partesana, N., additional, Bandini, P., additional, Rosella, M.G., additional, Giustiniani, S., additional, Cucchi, G., additional, Pedretti, R., additional, Raimondo, R., additional, Vaninetti, R., additional, Fedele, A., additional, Ghezzi, I., additional, Rezzonico, E., additional, Salerno Uriarte, J.A., additional, Morandi, F., additional, Salvucci, F., additional, Valenti, C., additional, Graziano, G., additional, Romanò, M., additional, Cimminiello, C., additional, Mangone, I., additional, Lombardo, M., additional, Quorso, P., additional, Marinoni, G., additional, Breghi, M., additional, Erckert, M., additional, Dienstl, A., additional, Mirante Marini, G., additional, Stefenelli, C., additional, Cioffi, G., additional, Buczkowska, E., additional, Bonanome, A., additional, Bazzanini, F., additional, Parissenti, L., additional, Serafini, C., additional, Catania, G., additional, Tarantini, L., additional, Rigatelli, G., additional, Boni, S., additional, Pasini, A., additional, Masini, E., additional, Zampiero, A.A., additional, Zanchetta, M., additional, Franceschetto, L., additional, Delise, P., additional, Marcon, C., additional, Sacchetta, A., additional, Borgese, L., additional, Artusi, L., additional, Casolino, P., additional, Corbara, F., additional, Banzato, A., additional, Barbiero, M., additional, Aldegheri, M.P., additional, Bazzucco, R., additional, Crivellenti, G., additional, Raviele, A., additional, Zanella, C., additional, Pascotto, P., additional, Sarto, P., additional, Milan, S., additional, Barbieri, E., additional, Girardi, P., additional, Dalla Villa, W., additional, Dalle Mule, J., additional, Di Sipio, M.L., additional, Cazzin, R., additional, Milan, D., additional, Zonzin, P., additional, Carraro, M., additional, Rossi, R., additional, Carbonieri, E., additional, Rossi, I., additional, Stritoni, P., additional, Meneghetti, P., additional, Risica, G., additional, Tenderini, P.L., additional, Vassanelli, C., additional, Zanolla, L., additional, Perini, G., additional, Brighetti, G., additional, Chiozza, R., additional, Giuliano, G., additional, Gortan, R., additional, Cesanelli, R., additional, Nicolosi, G.L., additional, Piazza, R., additional, Mos, L., additional, Vriz, O., additional, Pavan, D., additional, Pascottini, G., additional, Alberti, E., additional, Werren, M., additional, Solinas, L., additional, Sinagra, G., additional, Longaro, F., additional, Fioretti, P., additional, Albanese, M.C., additional, Miani, D., additional, Gianrossi, R., additional, Pende, A., additional, Rubartelli, P., additional, Magaia, O., additional, Domenicucci, S., additional, Caruso, D., additional, Faraguti, A.S., additional, Magliani, L., additional, Miccoli, F., additional, Guglielmino, G., additional, Bertoli, D., additional, Cantarelli, A., additional, Orlandi, S., additional, Vallebona, A., additional, Pozzati, A., additional, Brega, G., additional, Pancaldi, L.G., additional, Vandelli, R., additional, Urbinati, S., additional, Poci, M.G., additional, Zoli, M., additional, Costa, G.M., additional, Guiducci, U., additional, Zobbi, G., additional, Tartagni, F., additional, Tisselli, A., additional, Gentili, A., additional, Pieri, P., additional, Cagnetta, E., additional, Bendinelli, S., additional, Barbieri, A., additional, Conti, R., additional, Ferrari, R., additional, Merlini, F., additional, Fucili, A., additional, Moruzzi, P., additional, Buia, E., additional, Galvani, M., additional, Ferrini, D., additional, Baggioni, G., additional, Yiannacopulu, P., additional, Canè, G., additional, Bonfiglioli, A., additional, Zandomeneghi, R., additional, Brugioni, L., additional, Giannini, A., additional, Di Ruvo, R., additional, Giuliani, M., additional, Rusconi, L., additional, Del Corso, P., additional, Piovaccari, G., additional, Bologna, F., additional, Venturi, P., additional, Melandri, F., additional, Bagni, E., additional, Bolognese, L., additional, Perticucci, R., additional, Zuppiroli, A., additional, Nannini, M., additional, Consoli, N., additional, Petrone, P., additional, Pipitò, C., additional, Colombi, L., additional, Bernardi, D., additional, Mariani, P.R., additional, Testa, R., additional, Mazzinghi, F., additional, Cosmi, F., additional, Cosmi, D., additional, Zipoli, A., additional, Cecchi, A., additional, Castelli, G., additional, Ciaccheri, M., additional, Mori, F., additional, Pieri, F., additional, Valoti, P., additional, Chiarantini, D., additional, Santoro, G.M., additional, Minneci, C., additional, Marchi, F., additional, Milli, M., additional, Zambaldi, G., additional, Brandinelli Geri, A.A., additional, Cipriani, M., additional, Alessandri, M., additional, Severi, S., additional, Stefanelli, S., additional, Comella, A., additional, Poddighe, R., additional, Digiorgio, A., additional, Carluccio, M., additional, Berti, S., additional, Rizza, A., additional, Bonatti, V., additional, Molendi, V., additional, Brancato, A., additional, D'Aprile, N., additional, Giappichini, G., additional, Del Vecchio, S., additional, Mantini, G., additional, De Tommasi, F., additional, Meucci, G., additional, Cordoni, M., additional, Bechi, S., additional, Barsotti, L., additional, Baldini, P., additional, Romei, M., additional, Scopelliti, G., additional, Lauri, G., additional, Pestelli, F., additional, Furiozzi, F., additional, Cocchieri, M., additional, Severini, D., additional, Patriarchi, F., additional, Chiocchi, P., additional, Buccolieri, M., additional, Martinelli, S., additional, Wee, A., additional, Angelici, F., additional, Bernardinangeli, M., additional, Proietti, G., additional, Biscottini, B., additional, Panciarola, R., additional, Marinacci, L., additional, Perna, G.P., additional, Gabrielli, D., additional, Moraca, A., additional, Moretti, L., additional, Partemi, L., additional, Gregori, G., additional, Amici, R., additional, Patteri, G., additional, Capone, P., additional, Savini, E., additional, Morgagni, G.L., additional, Paccaloni, L., additional, Pezzuoli, F., additional, Carincola, S., additional, Papi, S., additional, De Crescentini, S., additional, Gerardi, P., additional, Midi, P., additional, Gallenzi, E., additional, Pajes, G., additional, Mancone, C., additional, Di Spirito, V., additional, Di Gennaro, M., additional, Calcagno, S., additional, Toscano, S., additional, Antonicoli, S., additional, Carta, F., additional, Giorgi, G., additional, Comito, F., additional, Daniele, E., additional, Ciarla, O., additional, Gelfo, P.G., additional, Acquaviva, A., additional, Testa, D., additional, Testa, G., additional, Pagliaro, F.A., additional, Russo, F., additional, Vetta, F., additional, Marchese, I., additional, Di Sciascio, G., additional, D'Ambrosio, A., additional, Leggio, F., additional, Del Sindaco, D., additional, Lacchè, A., additional, Avallone, A., additional, Risa, M.P., additional, Azzolini, P., additional, Baldo, E., additional, Giovannini, E., additional, Pulignano, G., additional, Tondo, C., additional, Picchio, E., additional, ani, E., additional, Tanzi, P., additional, Pozzar, F., additional, Farnetti, F., additional, Azzarito, M., additional, Santini, M., additional, Varveri, A., additional, Ferraiuolo, G., additional, Valtorta, C., additional, Gaspardone, A., additional, Barbato, G., additional, Ceci, V., additional, Aspromonte, N., additional, Bellocci, F., additional, Colizzi, C., additional, Fedele, F., additional, Perez, F.I., additional, Galati, A., additional, Rossetti, A., additional, Mainella, A., additional, etta, D., additional, Matteucci, C., additional, Busi, G., additional, De Angelis, A., additional, Farina, G., additional, Granatelli, A., additional, Leone, F., additional, Frasca, F., additional, Di Giovambattista, R., additional, Castellani, G., additional, Massaro, G., additional, Mastrogiuseppe, G., additional, Vacri, A., additional, De Sanctis, F., additional, Cioli, M., additional, Di Luzio, S., additional, Napoletano, C., additional, Piccioni, L.L., additional, De Simone, G., additional, Ottaviano, A., additional, Mazza, V., additional, Spedaliere, C., additional, Staniscia, D., additional, Calgione, E., additional, De Marco, G., additional, Chiacchio, T., additional, Di Napoli, T., additional, Romanzi, S., additional, Salvatore, G., additional, Golino, P., additional, Palermo, A., additional, Mascia, F., additional, Vetrano, A., additional, Vinciguerra, A., additional, Caliendo, L., additional, Longobardi, R., additional, De Caro, G., additional, Di Nola, R., additional, Piemonte, F., additional, Prinzi, D., additional, De Rosa, P., additional, De Rosa, V., additional, Riello, F., additional, Capuano, V., additional, Vecchio, G., additional, Landi, M., additional, Amato, S., additional, Garofalo, M., additional, D'Avino, M., additional, Sensale, P., additional, Maiolica, O., additional, Santoro, R., additional, Caso, P., additional, Miceli, D., additional, Maurea, N., additional, Bianchi, U., additional, Crispo, C., additional, Chiariello, M., additional, Perrone Filardi, P., additional, Russo, L., additional, Capuano, N., additional, Ungaro, G., additional, Vergara, G., additional, Scafuro, F., additional, D'Angelo, G., additional, Campaniello, C., additional, Bottiglieri, P., additional, Volpe, A., additional, Battista, R., additional, De Risi, L., additional, Cardillo, G., additional, Sibilio, G., additional, Marino, A.P., additional, Silvestri, F., additional, Predotti, P., additional, Iervoglini, A., additional, De Matteis, C., additional, Sarnicola, P., additional, Matarazzo, M.M., additional, Baldi, S., additional, Iuliano, V., additional, Astarita, C., additional, Cuccaro, P., additional, Liguori, A., additional, Liguori, G., additional, Gregorio, G., additional, Petraglia, L., additional, Antonelli, G., additional, Amodio, G., additional, De Luca, I., additional, Traversa, D., additional, Franchini, G., additional, Lenti, M.L., additional, Cavallari, D., additional, D'Agostino, C., additional, Scalera, G., additional, Altamura, C.M., additional, Russo, M., additional, Mascolo, A.R., additional, Pettinati, G., additional, Ciricugno, S.A., additional, Scrutinio, D., additional, Passantino, A., additional, Mastrangelo, D., additional, Di Masi, A., additional, De Carne, R., additional, Cannone, M., additional, Dibiase, F., additional, Pensato, M., additional, Loliva, F., additional, Trapani, F., additional, Panettieri, I., additional, Leone, L., additional, Di Biase, M., additional, Carrone, M., additional, Gallone, V., additional, Cocco, F., additional, Costantini, M., additional, Tritto, C., additional, Cavalieri, F., additional, Stella, L., additional, Magliari, F., additional, Callerame, M., additional, De Giorgi, A., additional, Pellegrino, L., additional, Correra, M., additional, Portulano, V., additional, Nisi, G.L., additional, Grassi, G., additional, Cristallo, E., additional, De Laura, D., additional, Salerno, C., additional, Fanelli, R., additional, Villella, M., additional, Pede, S., additional, Renna, A., additional, De Lorenzi, E., additional, Urso, L., additional, Lenti, V., additional, Peluso, A., additional, Baldi, N., additional, Polimeni, G., additional, Palma, P., additional, Lauletta, R., additional, Tagliamonte, E., additional, Cirillo, T., additional, Silvestri, B., additional, Centonze, G., additional, D'Alessandro, B., additional, Truncellito, L., additional, Mecca, D., additional, Petruzzi, M.A., additional, Coviello, R.O.M., additional, Lopizzo, A., additional, telli, M., additional, Barbuzzi, S., additional, Gubelli, S., additional, Germinario, G., additional, Cosentino, N., additional, Mingrone, A., additional, Vico, R., additional, Borrello, G., additional, Mazza, M.L., additional, Cimino, R., additional, Galasso, D., additional, Cassadonte, F., additional, Talarico, U., additional, Perticone, F., additional, Cassano, S., additional, Catapano, F., additional, Calemme, S., additional, Feraco, E., additional, Cloro, C., additional, Misuraca, G., additional, Caporale, R., additional, Vigna, L., additional, Spagnuolo, V., additional, De Rosa, F., additional, Spadafora, G., additional, Zampaglione, G., additional, Russo, R., additional, Schipani, F.A., additional, Ferragina, A.F., additional, Stranieri, D., additional, Musca, G., additional, Carpino, C., additional, Bencardino, P., additional, Raimondo, F., additional, Musacchio, D., additional, Pulitanò, G., additional, Ruggeri, A., additional, Provenzano, A., additional, Salituri, S., additional, Musolino, M., additional, Calandruccio, S., additional, Marrari, A., additional, Tripodi, E., additional, Scali, R., additional, Anastasio, L., additional, Arone, A., additional, Aragona, P., additional, Donnangelo, L., additional, Comito, M.G.A., additional, Bilotta, F., additional, Vaccaro, I., additional, Rametta, R., additional, Ventura, V., additional, Bonvegna, A., additional, Alì, A., additional, Cinnirella, C., additional, Raineri, M., additional, Pompeo, F., additional, Cascio Ingurgio, N., additional, Carini, V., additional, Coco, R., additional, Giunta, G., additional, Leonardi, G., additional, Randazzo, V., additional, Di Blasi, V., additional, Tamburino, C., additional, Russo, G., additional, Mangiameli, S., additional, Cardillo, R., additional, Castelli, D., additional, Inserra, V., additional, Arena, A., additional, Gulizia, M.M., additional, Raciti, S., additional, Rapisarda, G., additional, Romano, R., additional, Prestifilippo, P., additional, Braschi, G.B., additional, Ledda, G., additional, Terrazzino, R., additional, De Caro, M., additional, Scilabra, G., additional, agnino, B., additional, Grassi, R., additional, Di Tano, G., additional, Scimone, G.F., additional, Vasquez, L., additional, Coppolino, C., additional, Casale, A., additional, Castelli, M., additional, D'Urso, G., additional, D'Antonio, E., additional, Lo Presti, L., additional, Badalamenti, E., additional, Conti, P., additional, Sanfilippo, N., additional, Cirrincione, V., additional, Cinà, M.T., additional, Cusimano, G., additional, Taormina, A., additional, Giuliano, P., additional, Bajardi, A., additional, Mandalà, V., additional, Canonico, A., additional, Geraci, G., additional, Sabella, F.P., additional, Enia, F., additional, Floresta, A.M., additional, Lo Cascio, I., additional, Gumina, D., additional, Cavallaro, A., additional, Piccione, G., additional, Ferrante, R., additional, Blandino, M., additional, Iudicello, M.S., additional, Mossuti, E., additional, Romano, G., additional, Lombardo, L., additional, Monastra, P., additional, Di Vincenzo, D., additional, Porcu, M., additional, Orrù, P., additional, Muscas, F., additional, Giardina, G., additional, Corda, M., additional, Locci, G., additional, Podda, A., additional, Ledda, M., additional, Siddi, P., additional, Lai, C., additional, Pili, G., additional, Mercuro, G., additional, Mureddu, G., additional, Ganau, A., additional, Meloni, G., additional, Poddighe, G., additional, and Sanna, G., additional

Published
2017
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18. The Mw7.8 2016 Kaikōura earthquake

Author

Stirling, Mark W., primary, Litchfield, N. J., additional, Villamor, Pilar, additional, Van Dissen, Russ J., additional, Nicol, Andy, additional, Pettinga, Jarg, additional, Barnes, Philip, additional, Langridge, Robert M., additional, Little, Tim, additional, Barrell, David, additional, Mountjoy, Joshu, additional, Ries, W. F., additional, Rowland, Julie V., additional, Fenton, C., additional, Hamling, Ian, additional, Asher, C., additional, Barrier, Andrea, additional, Benson, Adrian, additional, Bischoff, Alan, additional, Borella, Josh, additional, Carne, R., additional, Cochran, Ursula, additional, Cockcroft, Matt, additional, Cox, Simon, additional, Duke, Grace, additional, Fenton, F., additional, Gasston, C., additional, Grimshaw, Chris, additional, Hale, D., additional, Hall, Brendan S., additional, Hao, Ken X., additional, Hatem, Alex, additional, Hemphill-Haley, Mark, additional, Heron, David, additional, Howarth, J., additional, Juniper, Z., additional, Kane, Tim, additional, Kearse, J., additional, Khajavi, Narges, additional, Lamarche, Geoffroy, additional, Lawson, S., additional, Lukovic, Biljana, additional, Madugo, C., additional, Manousakis, I., additional, McColl, Sam, additional, Noble, D., additional, Pedley, Kate, additional, Sauer, K., additional, Stahl, T., additional, Strong, Delia, additional, Townsend, Dougal, additional, Toy, Virginia, additional, Villeneuve, Marlene, additional, Wandres, A., additional, Williams, J., additional, Woelz, Susanne, additional, and Zinke, Robert, additional

Published
2017
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19. The prevalence of vitamin B12 deficiency in a random sample from the Australian population

Author

Moore,E, Pasco,J, Mander,A, Sanders,K, Carne,R, Jenkins,N, Black,M, Schneider,H, Ames,D, Watters,D, Moore,E, Pasco,J, Mander,A, Sanders,K, Carne,R, Jenkins,N, Black,M, Schneider,H, Ames,D, and Watters,D

Abstract

Objective: Vitamin B12 deficiency is common in older adults, and may increase the risk of cognitive impairment. The distribution of vitamin B12 insufficiency in younger age groups is less studied. This study aims to assess the prevalence of vitamin B12 deficiency (<156ρmol/L) and subclinical low-normal levels (156-250ρmol/L) in a large, random sample of the Australian population across the adult life span. Methods: We examined serum vitamin B12 levels in a random sample of 1,085 men and 1,125 women aged 20-97 years between 1994 and 2006; in the Barwon Statistical Division, a regional area in south eastern Australia that is representative of the socioeconomic status of the Australian population. Results: The age-standardised prevalence of vitamin B12 deficiency in this cohort of men and women was 3.6%. Subclinical low-normal vitamin B12 levels (156-250ρmol/L) were found in 26%. Serum vitamin B12 levels declined with age among men (p-value <0.001) and were lower in men than women (p-value <0.001). Vitamin B12 levels were higher among supplement users (8.0% of the cohort). Conclusions: Vitamin B12 levels decline with age, and have been associated with neurodegenerative diseases and cognitive decline. Early intervention by diet education or supplement use to address this age-associated decline in vitamin levels may be an effective strategy to prevent decline in a significant segment of the population. Such intervention may need to start in mid-life (from 50-years of age) before the onset age-related decline in vitamin B12 levels.

Published
2014

22. Depression in temporal lobe epilepsy surgery patients: An FDG-PET study

Author

Salzberg, M, Taher, T, Davie, M, Carne, R, Hicks, RJ, Cook, M, Murphy, M, Vinton, A, O'Brien, TJ, Salzberg, M, Taher, T, Davie, M, Carne, R, Hicks, RJ, Cook, M, Murphy, M, Vinton, A, and O'Brien, TJ

Abstract

PURPOSE: Depression is common in temporal lobe epilepsy (TLE) and after temporal lobectomy, and its etiology is obscure. In nonepileptic depression (including depression associated with other neurologic disorders), a consistent PET imaging finding is frontal lobe hypometabolism. Many TLE patients have hypometabolism involving frontal regions. Thus in data available from routine clinical assessments in an epilepsy surgery unit, we tested the hypothesis that the pattern of hypometabolism, particularly in the frontal lobe, may be associated with the depression seen in patients with TLE and TLE surgery. METHODS: We studied 23 medically refractory TLE patients who underwent anterior temporal lobectomy and who had preoperative FDG-PET scanning. All patients had pre- and postoperative psychiatric assessment. By using statistical parametric mapping (SPM-99), patterns of hypometabolism were compared between patients who had a preoperative history of depression (n=9) versus those who did not (n=14) and between those in whom postoperative depression developed (n=13) versus those in whom it did not (n=10). A significant region of hypometabolism was set at p<0.001 for a cluster of >or=20 contiguous voxels. RESULTS: Patients with a history of depression at any time preoperatively showed focal hypometabolism in ipsilateral orbitofrontal cortex compared with those who did not (t=4.64; p<0.001). Patients in whom depression developed postoperatively also showed hypometabolism in the ipsilateral orbitofrontal region (t=5.10; p<0.001). CONCLUSIONS: Although this study is methodologically limited, and other explanations merit consideration, orbitofrontal cortex dysfunction, already implicated in the pathophysiology of nonepileptic depression, may also be relevant to the depression of TLE and temporal lobectomy.

Published
2006

32. Induced seismicity and its implications for CO2 storage risk.

Author

Nicol, A., Carne, R., Gerstenberger, M., and Christophersen, A.

Subjects
GEOLOGICAL carbon sequestration, INDUCED seismicity, EXTRACTION (Chemistry), HYDROCARBONS, GAS reservoirs, CHEMICAL reduction, CARBON dioxide mitigation
Abstract

Abstract: Seismicity induced by fluid injection and extraction is a widely observed phenomenon. These earthquakes can exceed magnitudes of M 6 and have the potential to impact on the containment, infrastructure and public perceptions o f safety at CO2 storage sites. We examine induced seismicity globally using published data from 75 sites dominated by water injection and hydrocarbon extraction to estimate the timing (relative to injection/extraction), locations, size range and numbers of induced earthquakes. Most induced earthquakes occur during injection/extraction (∼70%) and are clustered at shallow depths in the region of the reservoir. The rates and maximum magnitudes of induced earthquakes generally increase with rising reservoir pressures, total fluid volumes and injection/extraction rates. The likelihood of an earthquake greater than or equal to a given magnitude being induced during injection is approximately proportional to the total volume of fluid injected/extracted, which appears to provide a proxy fo r changes in rock dynamics. If this observation holds for CO2 storage sites, then we can expect the rates and maximum magnitudes of induced earthquakes to be significantly higher fo r commercial-scale operations (e.g., 50 Mt) than for pilot projects (e.g., 50 kt). In accord with these results the risks associated with induced seismicity may also rise with project size. Mitigation and monitoring measures at commercial-size sequestration sites, including installation of microseismic networks, public education on the expected seismicity and pressure relief wells, will be key for risk reduction. [Copyright &y& Elsevier]

Published
2011
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33. Temporal lobe epilepsy [3]

Author

Carne, R. P., O Brien, T. J., Kilpatrick, C. J., Macgregor, L. R., Rodney Hicks, Murphy, M. A., Bowden, S. C., Kaye, A. H., and Cook, M. J.

34. The Mw7.8 2016 Kaikōura earthquake: Surface fault rupture and seismic hazard context

Author

Stirling, M. W., Litchfield, N. J., Villamor, P., Dissen, R. J., Nicol, A., Pettinga, J., Barnes, P., Langridge, R. M., Little, T., Barrell, D. J. A., Mountjoy, J., Ries, W. F., Rowland, J., Fenton, C., Hamling, I., Asher, C., Barrier, A., Benson, A., Bischoff, A., Borella, J., Carne, R., Cochran, U. A., Cockroft, M., Cox, S. C., Duke, G., Fenton, F., Gasston, C., Grimshaw, C., Hale, D., Hall, B., Hao, K. X., Hatem, A., Hemphill-Haley, M., Heron, D. W., Howarth, J., Juniper, Z., Kane, T., Jesse Kearse, Khajavi, N., Lamarche, G., Lawson, S., Lukovic, B., Madugo, C., Manousakis, I., Mccoll, S., Noble, D., Pedley, K., Sauer, K., Stah, T., Strong, D. T., Townsend, D. B., Toy, V., Villeneuve, M., Wandres, A., Williams, J., Woelz, S., and Zinke, R.

38. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial

Author

Marco Dauriz, Giovanni Targher, Pier Luigi Temporelli, Donata Lucci, Lucio Gonzini, Gian Luigi Nicolosi, Roberto Marchioli, Gianni Tognoni, Roberto Latini, Franco Cosmi, Luigi Tavazzi, Aldo Pietro Maggioni, Simona Barlera, Maria Grazia Franzosi, Aldo P. Maggioni, Maurizio Porcu, Salim Yusuf, Fulvio Camerini, Jay N. Cohn, Adriano Decarli, Bertram Pitt, Peter Sleight, Philip A. Poole‐Wilson, Enrico Geraci, Marino Scherillo, Gianna Fabbri, Barbara Bartolomei, Daniele Bertoli, Franco Cobelli, Claudio Fresco, Antonietta Ledda, Giacomo Levantesi, Cristina Opasich, Franco Rusconi, Gianfranco Sinagra, Fabio Turazza, Alberto Volpi, Martina Ceseri, Gianluca Alongi, Antonio Atzori, Filippo Bambi, Desiree Bastarolo, Francesca Bianchini, Iacopo Cangioli, Vittoriana Canu, Concetta Caporusso, Gabriele Cenni, Laura Cintelli, Michele Cocchio, Alessia Confente, Eva Fenicia, Giorgio Friso, Marco Gianfriddo, Gianluca Grilli, Beatrice Lazzaro, Giuseppe Lonardo, Alessia Luise, Rachele Nota, Mariaelena Orlando, Rosaria Petrolo, Chiara Pierattini, Valeria Pierota, Alessandro Provenzani, Velia Quartuccio, Anna Ragno, Chiara Serio, Alvise Spolaor, Arianna Tafi, Elisa Tellaroli, Stefano Ghio, Elisa Ghizzardi, Serge Masson, Lella Crociati, Maria Teresa La Rovere, Ugo Corrà, Andrea Finzi, Marco Gorini, Valentina Milani, Giampietro Orsini, Elisa Bianchini, Silvia Cabiddu, Ilaria Cangioli, Laura Cipressa, Maria Lucia Cipressa, Giuseppina Di Bitetto, Barbara Ferri, Luisa Galbiati, Andrea Lorimer, Carla Pera, Paola Priami, Antonella Vasamì, T. Moccetti, M.G. Rossi, E. Pasotti, F. Vaghi, P. Roncarolo, M.T. Zunino, F. Matta, E. Actis Perinetto, F. Gaita, G. Azzaro, M. Zanetta, A.M. Paino, U. Parravicini, D. Vegis, R. Conte, P. Ferraro, A. De Bernardi, S. Morelloni, M. Fagnani, P. Greco Lucchina, L. Montagna, E. Bellone, D. Sappè, F. Ferraro, M. Delucchi, S.G. Reynaud, M. Dore, A. La Brocca, N. Massobrio, L. Bo, R. Trinchero, M. Imazio, G. Brocchi, A. Nejrotti, L. Rissone, S. Gabasio, C. Zocchi, S. Randazzo, A. Crenna, P. Giannuzzi, E. Bonanomi, A. Mezzani, M. De Marchi, G. Begliuomini, C.A. Gianonatti, A. Gavazzi, A. Grosu, L. Dei Cas, S. Nodari, P. Garyfallidis, A. Bertoletti, C. Bonifazi, S. Arisi, F. Mascaro, M. Fraccarollo, S. Dell'Orto, M. Sfolcini, F. Bortolini, D. Raccagni, A. Turelli, M. Santarone, E. Miglierina, L. Sormani, R. Jemoli, F. Tettamanti, S. Pirelli, C. Bianchi, S. Verde, M. Mariani, V. Ziacchi, A. Ferrazza, A. Russo, M. Bortolotti, G.F. Pasini, A. Volpi, K.N. Jones, D. Cuzzucrea, G. Gullace, C. Carbone, A. Granata, S. De Servi, G. Del Rosso, C. Inserra, E. Renaldini, C. Zappa, M. Moretti, R. Zanini, M. Ferrari, E. Moroni, A. Cei, C. Lissi, E. Dovico, C. Fiorentini, P. Palermo, B. Brusoni, M. Negrini, J. Heyman, G.B. Danzi, A. Finzi, M. Frigerio, F. Turazza, L. Beretta, A. Sachero, F. Casazza, L. Squadroni, F. Lombardi, L. Marano, A. Margonato, G. Fragasso, O.C. Febo, E. Aiolfi, F. Olmetti, A. Grieco, V. Antonazzo, G. Specchia, A. Mortara, F. Robustelli, M.G. Songini, C. Schweiger, A. Frisinghelli, M. Palvarini, C. Campana, L. Scelsi, N. Ajmone Marsan, F. Cobelli, A. Gualco, C. Opasich, S. De Feo, R. Mazzucco, M.A. Iannone, T. Diaco, D. Zaniboni, G. Milanesi, D. Nassiacos, S. Meloni, P. Giani, T. Nicoli, C. Malinverni, A. Gusmini, L. Pozzoni, G. Bisiani, P. Margaroli, A. Schizzarotto, A. Daverio, G. Occhi, N. Partesana, P. Bandini, M.G. Rosella, S. Giustiniani, G. Cucchi, R. Pedretti, R. Raimondo, R. Vaninetti, A. Fedele, I. Ghezzi, E. Rezzonico, J.A. Salerno Uriarte, F. Morandi, F. Salvucci, C. Valenti, G. Graziano, M. Romanò, C. Cimminiello, I. Mangone, M. Lombardo, P. Quorso, G. Marinoni, M. Breghi, M. Erckert, A. Dienstl, G. Mirante Marini, C. Stefenelli, G. Cioffi, E. Buczkowska, A. Bonanome, F. Bazzanini, L. Parissenti, C. Serafini, G. Catania, L. Tarantini, G. Rigatelli, S. Boni, A. Pasini, E. Masini, A.A. Zampiero, M. Zanchetta, L. Franceschetto, P. Delise, C. Marcon, A. Sacchetta, L. Borgese, L. Artusi, P. Casolino, F. Corbara, A. Banzato, M. Barbiero, M.P. Aldegheri, R. Bazzucco, G. Crivellenti, A. Raviele, C. Zanella, P. Pascotto, P. Sarto, S. Milan, E. Barbieri, P. Girardi, W. Dalla Villa, J. Dalle Mule, M.L. Di Sipio, R. Cazzin, D. Milan, P. Zonzin, M. Carraro, R. Rossi, E. Carbonieri, I. Rossi, P. Stritoni, P. Meneghetti, G. Risica, P.L. Tenderini, C. Vassanelli, L. Zanolla, G. Perini, G. Brighetti, R. Chiozza, G. Giuliano, R. Gortan, R. Cesanelli, G.L. Nicolosi, R. Piazza, L. Mos, O. Vriz, D. Pavan, G. Pascottini, E. Alberti, M. Werren, L. Solinas, G. Sinagra, F. Longaro, P. Fioretti, M.C. Albanese, D. Miani, R. Gianrossi, A. Pende, P. Rubartelli, O. Magaia, S. Domenicucci, D. Caruso, A.S. Faraguti, L. Magliani, F. Miccoli, G. Guglielmino, D. Bertoli, A. Cantarelli, S. Orlandi, A. Vallebona, A. Pozzati, G. Brega, L.G. Pancaldi, R. Vandelli, S. Urbinati, M.G. Poci, M. Zoli, G.M. Costa, U. Guiducci, G. Zobbi, F. Tartagni, A. Tisselli, A. Gentili, P. Pieri, E. Cagnetta, S. Bendinelli, A. Barbieri, R. Conti, R. Ferrari, F. Merlini, A. Fucili, P. Moruzzi, E. Buia, M. Galvani, D. Ferrini, G. Baggioni, P. Yiannacopulu, G. Canè, A. Bonfiglioli, R. Zandomeneghi, L. Brugioni, A. Giannini, R. Di Ruvo, M. Giuliani, L. Rusconi, P. Del Corso, G. Piovaccari, F. Bologna, P. Venturi, F. Melandri, E. Bagni, L. Bolognese, R. Perticucci, A. Zuppiroli, M. Nannini, N. Consoli, P. Petrone, C. Pipitò, L. Colombi, D. Bernardi, P.R. Mariani, R. Testa, F. Mazzinghi, F. Cosmi, D. Cosmi, A. Zipoli, A. Cecchi, G. Castelli, M. Ciaccheri, F. Mori, F. Pieri, P. Valoti, D. Chiarantini, G.M. Santoro, C. Minneci, F. Marchi, M. Milli, G. Zambaldi, A.A. Brandinelli Geri, M. Cipriani, M. Alessandri, S. Severi, S. Stefanelli, A. Comella, R. Poddighe, A. Digiorgio, M. Carluccio, S. Berti, A. Rizza, V. Bonatti, V. Molendi, A. Brancato, N. D'Aprile, G. Giappichini, S. Del Vecchio, G. Mantini, F. De Tommasi, G. Meucci, M. Cordoni, S. Bechi, L. Barsotti, P. Baldini, M. Romei, G. Scopelliti, G. Lauri, F. Pestelli, F. Furiozzi, M. Cocchieri, D. Severini, F. Patriarchi, P. Chiocchi, M. Buccolieri, S. Martinelli, A. Wee, F. Angelici, M. Bernardinangeli, G. Proietti, B. Biscottini, R. Panciarola, L. Marinacci, G.P. Perna, D. Gabrielli, A. Moraca, L. Moretti, L. Partemi, G. Gregori, R. Amici, G. Patteri, P. Capone, E. Savini, G.L. Morgagni, L. Paccaloni, F. Pezzuoli, S. Carincola, S. Papi, S. De Crescentini, P. Gerardi, P. Midi, E. Gallenzi, G. Pajes, C. Mancone, V. Di Spirito, M. Di Gennaro, S. Calcagno, S. Toscano, S. Antonicoli, F. Carta, G. Giorgi, F. Comito, E. Daniele, O. Ciarla, P.G. Gelfo, A. Acquaviva, D. Testa, G. Testa, F.A. Pagliaro, F. Russo, F. Vetta, I. Marchese, G. Di Sciascio, A. D'Ambrosio, F. Leggio, D. Del Sindaco, A. Lacchè, A. Avallone, M.P. Risa, P. Azzolini, E. Baldo, E. Giovannini, G. Pulignano, C. Tondo, E. Picchio, E. ani, P. Tanzi, F. Pozzar, F. Farnetti, M. Azzarito, M. Santini, A. Varveri, G. Ferraiuolo, C. Valtorta, A. Gaspardone, G. Barbato, V. Ceci, N. Aspromonte, F. Bellocci, C. Colizzi, F. Fedele, F.I. Perez, A. Galati, A. Rossetti, A. Mainella, D. etta, C. Matteucci, G. Busi, A. De Angelis, G. Farina, A. Granatelli, F. Leone, F. Frasca, R. Di Giovambattista, G. Castellani, G. Massaro, G. Mastrogiuseppe, A. Vacri, F. De Sanctis, M. Cioli, S. Di Luzio, C. Napoletano, L.L. Piccioni, G. De Simone, A. Ottaviano, V. Mazza, C. Spedaliere, D. Staniscia, E. Calgione, G. De Marco, T. Chiacchio, T. Di Napoli, S. Romanzi, G. Salvatore, P. Golino, A. Palermo, F. Mascia, A. Vetrano, A. Vinciguerra, L. Caliendo, R. Longobardi, G. De Caro, R. Di Nola, F. Piemonte, D. Prinzi, P. De Rosa, V. De Rosa, F. Riello, V. Capuano, G. Vecchio, M. Landi, S. Amato, M. Garofalo, M. D'Avino, P. Sensale, O. Maiolica, R. Santoro, P. Caso, D. Miceli, N. Maurea, U. Bianchi, C. Crispo, M. Chiariello, P. Perrone Filardi, L. Russo, N. Capuano, G. Ungaro, G. Vergara, F. Scafuro, G. D'Angelo, C. Campaniello, P. Bottiglieri, A. Volpe, R. Battista, L. De Risi, G. Cardillo, G. Sibilio, A.P. Marino, F. Silvestri, P. Predotti, A. Iervoglini, C. De Matteis, P. Sarnicola, M.M. Matarazzo, S. Baldi, V. Iuliano, C. Astarita, P. Cuccaro, A. Liguori, G. Liguori, G. Gregorio, L. Petraglia, G. Antonelli, G. Amodio, I. De Luca, D. Traversa, G. Franchini, M.L. Lenti, D. Cavallari, C. D'Agostino, G. Scalera, C.M. Altamura, M. Russo, A.R. Mascolo, G. Pettinati, S.A. Ciricugno, D. Scrutinio, A. Passantino, D. Mastrangelo, A. Di Masi, R. De Carne, M. Cannone, F. Dibiase, M. Pensato, F. Loliva, F. Trapani, I. Panettieri, L. Leone, M. Di Biase, M. Carrone, V. Gallone, F. Cocco, M. Costantini, C. Tritto, F. Cavalieri, L. Stella, F. Magliari, M. Callerame, A. De Giorgi, L. Pellegrino, M. Correra, V. Portulano, G.L. Nisi, G. Grassi, E. Cristallo, D. De Laura, C. Salerno, R. Fanelli, M. Villella, S. Pede, A. Renna, E. De Lorenzi, L. Urso, V. Lenti, A. Peluso, N. Baldi, G. Polimeni, P. Palma, R. Lauletta, E. Tagliamonte, T. Cirillo, B. Silvestri, G. Centonze, B. D'Alessandro, L. Truncellito, D. Mecca, M.A. Petruzzi, R.O.M. Coviello, A. Lopizzo, M. telli, S. Barbuzzi, S. Gubelli, G. Germinario, N. Cosentino, A. Mingrone, R. Vico, G. Borrello, M.L. Mazza, R. Cimino, D. Galasso, F. Cassadonte, U. Talarico, F. Perticone, S. Cassano, F. Catapano, S. Calemme, E. Feraco, C. Cloro, G. Misuraca, R. Caporale, L. Vigna, V. Spagnuolo, F. De Rosa, G. Spadafora, G. Zampaglione, R. Russo, F.A. Schipani, A.F. Ferragina, D. Stranieri, G. Musca, C. Carpino, P. Bencardino, F. Raimondo, D. Musacchio, G. Pulitanò, A. Ruggeri, A. Provenzano, S. Salituri, M. Musolino, S. Calandruccio, A. Marrari, E. Tripodi, R. Scali, L. Anastasio, A. Arone, P. Aragona, L. Donnangelo, M.G.A. Comito, F. Bilotta, I. Vaccaro, R. Rametta, V. Ventura, A. Bonvegna, A. Alì, C. Cinnirella, M. Raineri, F. Pompeo, N. Cascio Ingurgio, V. Carini, R. Coco, G. Giunta, G. Leonardi, V. Randazzo, V. Di Blasi, C. Tamburino, G. Russo, S. Mangiameli, R. Cardillo, D. Castelli, V. Inserra, A. Arena, M.M. Gulizia, S. Raciti, G. Rapisarda, R. Romano, P. Prestifilippo, G.B. Braschi, G. Ledda, R. Terrazzino, M. De Caro, G. Scilabra, B. agnino, R. Grassi, G. Di Tano, G.F. Scimone, L. Vasquez, C. Coppolino, A. Casale, M. Castelli, G. D'Urso, E. D'Antonio, L. Lo Presti, E. Badalamenti, P. Conti, N. Sanfilippo, V. Cirrincione, M.T. Cinà, G. Cusimano, A. Taormina, P. Giuliano, A. Bajardi, V. Mandalà, A. Canonico, G. Geraci, F.P. Sabella, F. Enia, A.M. Floresta, I. Lo Cascio, D. Gumina, A. Cavallaro, G. Piccione, R. Ferrante, M. Blandino, M.S. Iudicello, E. Mossuti, G. Romano, L. Lombardo, P. Monastra, D. Di Vincenzo, M. Porcu, P. Orrù, F. Muscas, G. Giardina, M. Corda, G. Locci, A. Podda, M. Ledda, P. Siddi, C. Lai, G. Pili, G. Mercuro, G. Mureddu, A. Ganau, G. Meloni, G. Poddighe, G. Sanna, Dauriz, Marco, Targher, Giovanni, Temporelli, Pier Luigi, Lucci, Donata, Gonzini, Lucio, Nicolosi, Gian Luigi, Marchioli, Roberto, Tognoni, Gianni, Latini, Roberto, Cosmi, Franco, Tavazzi, Luigi, Maggioni, Aldo Pietro, on behalf of the GISSI-HF, Investigator, Margonato, Alberto, Moccetti, T., Rossi, M. G., Pasotti, E., Vaghi, F., Roncarolo, P., Zunino, M. T., Matta, F., Actis Perinetto, E., Gaita, F., Azzaro, G., Zanetta, M., Paino, A. M., Parravicini, U., Vegis, D., Conte, R., Ferraro, P., De Bernardi, A., Morelloni, S., Fagnani, M., Greco Lucchina, P., Montagna, L., Bellone, E., Sappè, D., Ferraro, F., Delucchi, M., Reynaud, S. G., Dore, M., La Brocca, A., Massobrio, N., Bo, L., Trinchero, R., Imazio, M., Brocchi, G., Nejrotti, A., Rissone, L., Gabasio, S., Zocchi, C., Randazzo, S., Crenna, A., Giannuzzi, P., Bonanomi, E., Mezzani, A., De Marchi, M., Begliuomini, G., Gianonatti, C. A., Gavazzi, A., Grosu, A., Dei Cas, L., Nodari, S., Garyfallidis, P., Bertoletti, A., Bonifazi, C., Arisi, S., Mascaro, F., Fraccarollo, M., Dell'Orto, S., Sfolcini, M., Bortolini, F., Raccagni, D., Turelli, A., Santarone, M., Miglierina, E., Sormani, L., Jemoli, R., Tettamanti, F., Pirelli, S., Bianchi, C., Verde, S., Mariani, M., Ziacchi, V., Ferrazza, A., Russo, A., Bortolotti, M., Pasini, G. F., Volpi, A., Jones, K. N., Cuzzucrea, D., Gullace, G., Carbone, C., Granata, A., De Servi, S., Del Rosso, G., Inserra, C., Renaldini, E., Zappa, C., Moretti, M., Zanini, R., Ferrari, M., Moroni, E., Cei, A., Lissi, C., Dovico, E., Fiorentini, C., Palermo, P., Brusoni, B., Negrini, M., Heyman, J., Danzi, G. 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L., Paccaloni, L., Pezzuoli, F., Carincola, S., Papi, S., De Crescentini, S., Gerardi, P., Midi, P., Gallenzi, E., Pajes, G., Mancone, C., Di Spirito, V., Di Gennaro, M., Calcagno, S., Toscano, S., Antonicoli, S., Carta, F., Giorgi, G., Comito, F., Daniele, E., Ciarla, O., Gelfo, P. G., Acquaviva, A., Testa, D., Testa, G., Pagliaro, F. A., Russo, F., Vetta, F., Marchese, I., Di Sciascio, G., D'Ambrosio, A., Leggio, F., Del Sindaco, D., Lacchè, A., Avallone, A., Risa, M. P., Azzolini, P., Baldo, E., Giovannini, E., Pulignano, G., Tondo, C., Picchio, E., Biffani, E., Tanzi, P., Pozzar, F., Farnetti, F., Azzarito, M., Santini, M., Varveri, A., Ferraiuolo, G., Valtorta, C., Gaspardone, A., Barbato, G., Ceci, V., Aspromonte, N., Bellocci, F., Colizzi, C., Fedele, F., Perez, F. I., Galati, A., Rossetti, A., Mainella, A., Ciuffetta, D., Matteucci, C., Busi, G., De Angelis, A., Farina, G., Granatelli, A., Leone, F., Frasca, F., Di Giovambattista, R., Castellani, G., Massaro, G., Mastrogiuseppe, G., Vacri, A., De Sanctis, F., Cioli, M., Di Luzio, S., Napoletano, C., Piccioni, L. L., De Simone, G., Ottaviano, A., Mazza, V., Spedaliere, C., Staniscia, D., Calgione, E., De Marco, G., Chiacchio, T., Di Napoli, T., Romanzi, S., Salvatore, G., Golino, P., Palermo, A., Mascia, F., Vetrano, A., Vinciguerra, A., Caliendo, L., Longobardi, R., De Caro, G., Di Nola, R., Piemonte, F., Prinzi, D., De Rosa, P., De Rosa, V., Riello, F., Capuano, V., Vecchio, G., Landi, M., Amato, S., Garofalo, M., D'Avino, M., Sensale, P., Maiolica, O., Santoro, R., Caso, P., Miceli, D., Maurea, N., Bianchi, U., Crispo, C., Chiariello, M., Perrone Filardi, P., Russo, L., Capuano, N., Ungaro, G., Vergara, G., Scafuro, F., D'Angelo, G., Campaniello, C., Bottiglieri, P., Volpe, A., Battista, R., De Risi, L., Cardillo, G., Sibilio, G., Marino, A. P., Silvestri, F., Predotti, P., Iervoglini, A., De Matteis, C., Sarnicola, P., Matarazzo, M. 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F., Stranieri, D., Musca, G., Carpino, C., Bencardino, P., Raimondo, F., Musacchio, D., Pulitanò, G., Ruggeri, A., Provenzano, A., Salituri, S., Musolino, M., Calandruccio, S., Marrari, A., Tripodi, E., Scali, R., Anastasio, L., Arone, A., Aragona, P., Donnangelo, L., Comito, M. G. A., Bilotta, F., Vaccaro, I., Rametta, R., Ventura, V., Bonvegna, A., Alì, A., Cinnirella, C., Raineri, M., Pompeo, F., Cascio Ingurgio, N., Carini, V., Coco, R., Giunta, G., Leonardi, G., Randazzo, V., Di Blasi, V., Tamburino, C., Russo, G., Mangiameli, S., Cardillo, R., Castelli, D., Inserra, V., Arena, A., Gulizia, M. M., Raciti, S., Rapisarda, G., Romano, R., Prestifilippo, P., Braschi, G. B., Ledda, G., Terrazzino, R., De Caro, M., Scilabra, G., Graffagnino, B., Grassi, R., Di Tano, G., Scimone, G. F., Vasquez, L., Coppolino, C., Casale, A., Castelli, M., D'Urso, G., D'Antonio, E., Lo Presti, L., Badalamenti, E., Conti, P., Sanfilippo, N., Cirrincione, V., Cinà, M. T., Cusimano, G., Taormina, A., Giuliano, P., Bajardi, A., Mandalà, V., Canonico, A., Geraci, G., Sabella, F. P., Enia, F., Floresta, A. M., Lo Cascio, I., Gumina, D., Cavallaro, A., Piccione, G., Ferrante, R., Blandino, M., Iudicello, M. S., Mossuti, E., Romano, G., Lombardo, L., Monastra, P., Di Vincenzo, D., Porcu, M., Orrù, P., Muscas, F., Giardina, G., Corda, M., Locci, G., Podda, A., Ledda, M., Siddi, P., Lai, C., Pili, G., Mercuro, G., Mureddu, G., Ganau, A., Meloni, G., Poddighe, G., Sanna, G., Barlera, Simona, Franzosi, Maria Grazia, Porcu, Maurizio, Yusuf, Salim, Camerini, Fulvio, Cohn, Jay N., Decarli, Adriano, Pitt, Bertram, Sleight, Peter, Poole-Wilson, Philip A., Geraci, Enrico, Scherillo, Marino, Fabbri, Gianna, Bartolomei, Barbara, Bertoli, Daniele, Cobelli, Franco, Fresco, Claudio, Ledda, Antonietta, Levantesi, Giacomo, Opasich, Cristina, Rusconi, Franco, Sinagra, Gianfranco, Turazza, Fabio, Volpi, Alberto, Ceseri, Martina, Alongi, Gianluca, Atzori, Antonio, Bambi, Filippo, Bastarolo, Desiree, Bianchini, Francesca, Cangioli, Iacopo, Canu, Vittoriana, Caporusso, Concetta, Cenni, Gabriele, Cintelli, Laura, Cocchio, Michele, Confente, Alessia, Fenicia, Eva, Friso, Giorgio, Gianfriddo, Marco, Grilli, Gianluca, Lazzaro, Beatrice, Lonardo, Giuseppe, Luise, Alessia, Nota, Rachele, Orlando, Mariaelena, Petrolo, Rosaria, Pierattini, Chiara, Pierota, Valeria, Provenzani, Alessandro, Quartuccio, Velia, Ragno, Anna, Serio, Chiara, Spolaor, Alvise, Tafi, Arianna, Tellaroli, Elisa, Ghio, Stefano, Ghizzardi, Elisa, Masson, Serge, Crociati, Lella, La Rovere, Maria Teresa, Corrà, Ugo, Di Giulio, Paola, Finzi, Andrea, Gorini, Marco, Milani, Valentina, Orsini, Giampietro, Bianchini, Elisa, Cabiddu, Silvia, Cangioli, Ilaria, Cipressa, Laura, Cipressa, Maria Lucia, Di Bitetto, Giuseppina, Ferri, Barbara, Galbiati, Luisa, Lorimer, Andrea, Pera, Carla, Priami, Paola, and Vasamì, Antonella

Subjects
Blood Glucose, Male, Glycated Hemoglobin A, heart failure, Kaplan-Meier Estimate, prediabetes, 030204 cardiovascular system & hematology, time factors, Settore MED/11, cause of death, 0302 clinical medicine, Glycemic control, prediabetic state, Cause of Death, italy, middle aged, Prevalence, 80 and over, double-blind method, blood glucose, risk factors, 030212 general & internal medicine, Prediabetes, Rosuvastatin Calcium, humans, rosuvastatin calcium, Cause of death, Original Research, Metabolic Syndrome, Aged, 80 and over, adult, Chronic heart failure, Diabetes mellitus, Heart failure, Mortality, Cardiology and Cardiovascular Medicine, Hazard ratio, chronic heart failure, diabetes mellitus, glycemic control, mortality, Treatment Outcome, Adolescent, Biomarkers, Chronic Disease, Diabetes Mellitus, Fatty Acids, Omega-3, Double-Blind Method, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hospitalization, Heart Failure, Italy, Prediabetic State, Risk Assessment, Proportional Hazards Models, Risk Factors, Time Factors, risk assessment, Middle Aged, kaplan-meier estimate, aged, female, Prediabete, young adult, Female, omega-3, Human, hospitalization, Adult, medicine.medical_specialty, Diabetes mellitu, proportional hazards models, Time Factor, hydroxymethylglutaryl-coa reductase inhibitors, prevalence, fatty acids, 03 medical and health sciences, Young Adult, male, Internal medicine, Post-hoc analysis, glycated hemoglobin a, medicine, Intensive care medicine, Aged, Glycated Hemoglobin, Proportional hazards model, business.industry, Risk Factor, biomarkers, Biomarker, medicine.disease, Clinical trial, adolescent, Proportional Hazards Model, treatment outcome, aged, 80 and over, chronic disease, fatty acids, omega-3, cardiology and cardiovascular medicine, Hydroxymethylglutaryl-CoA Reductase Inhibitor, business
Abstract

Background The independent prognostic impact of diabetes mellitus ( DM ) and prediabetes mellitus (pre‐ DM ) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐ DM on survival outcomes in the GISSI ‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial. Methods and Results We assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI ‐ HF trial, who were stratified by presence of DM (n=2852), pre‐ DM (n=2013), and non‐ DM (n=2070) at baseline. Compared with non‐ DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐ DM patients and those with pre‐ DM . Cox regression analysis showed that DM , but not pre‐ DM , was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI , 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI , 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI , 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI , 1.01–1.29, respectively). Conclusions Presence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 00336336.

Published
2017
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40. Receive + Heart = Love. Bidirectional Nourishment in the Practice of Medicine.

Author

Carne R

Abstract

Attitudinal considerations are so important in the practice of meeting the patient as whole person, and in our literature, these are underexamined. Where does love sit in the transactionality of medical practice? Is this an uncomfortable question? In times which challenge intention and resolve, could the reflection be in some way nourishing?, Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (Copyright © 2022 The Author(s).)

Published
2022
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41. Neurological Health: Not Merely the Absence of Disease: Current Wellbeing Instruments Across the Spectrum of Neurology.

Author

Ziegeler B, D' Souza W, Vinton A, Mulukutla S, Shaw C, and Carne R

Abstract

Objective: Well-being and quality of life can vary independently of disease. Instruments measuring well-being and quality of life are commonly used in neurology, but there has been little investigation into the extent in which they accurately measure wellbeing/quality of life or if they merely reflect a diseased state of an individual., Design: Systematic searches, thematic analysis and narrative synthesis were undertaken. Individual items from instruments represented in ≥ 5 publications were categorised independently, without prior training, by five neurologists and one well-being researcher, as relating to 'disease-effect' or 'Well-being' with a study-created instrument. Items were additionally categorised into well-being domains., Data Sources: MEDLINE, EMBASE, EMCARE and PsycINFO from 1990 to 2020 were performed, across the 13 most prevalent neurological diseases., Results: 301 unique instruments were identified. Multiple sclerosis had most unique instruments at 92. SF-36 was used most, in 66 studies. 22 instruments appeared in ≥ 5 publications: 19/22 'well-being' outcome instruments predominantly measured disease effect (Fleiss kappa = .60). Only 1/22 instruments was categorised unanimously as relating to well-being. Instruments predominantly measured mental, physical and activity domains, over social or spiritual., Conclusions: Most neurological well-being or quality-of-life instruments predominantly measure disease effect, rather than disease-independent well-being. Instruments differed widely in well-being domains examined., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (Copyright © 2022 The Author(s).)

Published
2022
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42. Long-term mood, quality of life, and seizure freedom in intracranial EEG epilepsy surgery.

Author

Swarup O, Waxmann A, Chu J, Vogrin S, Lai A, Laing J, Barker J, Seiderer L, Ignatiadis S, Plummer C, Carne R, Seneviratne U, Cook M, Murphy M, and D'Souza W

Subjects
Electrocorticography, Electroencephalography, Freedom, Humans, Retrospective Studies, Seizures, Treatment Outcome, Epilepsy surgery, Quality of Life
Abstract

Objectives: To determine the long-term outcomes in patients undergoing intracranial EEG (iEEG) evaluation for epilepsy surgery in terms of seizure freedom, mood, and quality of life at St. Vincent's Hospital, Melbourne., Methods: Patients who underwent iEEG between 1999 and 2016 were identified. Patients were retrospectively assessed between 2014 and 2017 by specialist clinic record review and telephone survey with standardized validated questionnaires for: 1) seizure freedom using the Engel classification; 2) Mood using the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E); 3) Quality-of-life outcomes using the QOLIE-10 questionnaire. Summary statistics and univariate analysis were performed to investigate variables for significance., Results: Seventy one patients underwent iEEG surgery: 49 Subdural, 14 Depths, 8 Combination with 62/68 (91.9%) of those still alive, available at last follow-up by telephone survey or medical record review (median of 8.2 years). The estimated epileptogenic zone was 62% temporal and 38% extra-temporal. At last follow-up, 69.4% (43/62) were Engel Class I and 30.6% (19/62) were Engel Class II-IV. Further, a depressive episode (NDDI-E > 15)was observed in 34% (16/47), while a 'better quality of life' (QOLIE-10 score < 25) was noted in 74% (31/42). Quality of life (p < 0.001) but not mood (p = 0.24) was associated with seizure freedom., Significance: Long-term seizure freedom can be observed in patients undergoing complex epilepsy surgery with iEEG evaluation and is associated with good quality of life., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Published
2021
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43. Efficacy and tolerability of adjuvant perampanel: an Australian multicenter real-world observational study in refractory focal and generalized epilepsy syndromes.

Author

Sagar P, Wawryk O, Vogrin S, Whitham E, Kiley M, Frasca J, Carne R, Seneviratne U, Cook MJ, Lawn N, Nikpour A, and D'Souza WJ

Subjects
Adult, Aged, Anticonvulsants therapeutic use, Australia, Drug Therapy, Combination, Humans, Male, Nitriles, Pyridones therapeutic use, Retrospective Studies, Treatment Outcome, Drug Resistant Epilepsy drug therapy, Epilepsy, Generalized drug therapy, Epileptic Syndromes drug therapy
Abstract

Purpose: To explore the efficacy and tolerability of adjuvant perampanel (PER) and their associated risk factors in late add-on drug-resistant epilepsy., Method: Retrospective multicenter 'real-world' observational study. Consecutively identified patients commenced on PER, with mixed epilepsy syndromes, from nine Australian epilepsy centers. Primary efficacy endpoints were at least 50% reduction in seizure frequency (responders), seizure freedom, and retention at 6 and 12 months, following a 3-month titration period. Tolerability endpoints were cessation of PER for any reason, cessation of PER due to treatment-emergent adverse events (TEAE), or cessation due to inefficacy. Outcomes were assessed for a-priori risk factors associated with efficacy and tolerability., Results: Three-hundred and eighty seven adults were identified and followed up for a median of 12.1 months (IQR 7.0-25.2). Focal epilepsy accounted for 79.6% (FE), idiopathic generalized epilepsy (IGE), 10.3% and developmental epileptic encephalopathy (DEE) 10.1%, of the cohort. All patients had drug-resistant epilepsy, 71.6% had never experienced six months of seizure freedom, and the mean number of antiepileptic medications (AEDs) prior to starting PER was six. At 12 months, with missing cases classified as treatment failure, retention was 40.0%, responder 21.7%, and seizure freedom 9.0%, whereas, using last outcome carried forward (LOCF), responder and seizure freedom rates were 41.3% and 14.7%, respectively. Older age of epilepsy onset was associated with a marginal increase in the likelihood of seizure freedom at 12-month maintenance (OR 1.04, 95% CI 1.02, 1.06). Male sex (adjusted OR [aOR] 2.06 95% CI 1.33, 3.19), lower number of prior AEDs (aOR 0.84, 95% CI 0.74, 0.96) and no previous seizure-free period of at least 6-month duration (aOR 2.04 95% CI 1.21, 3.47) were associated with retention. Perampanel combined with a GABA receptor AED was associated with a lower responder rate at 12 months but reduced cessation of PER. The most common TEAEs were neuropsychiatric (18.86%), followed by dizziness (13.70%), and sleepiness (5.68%)., Conclusions: Adjuvant PER treatment, even in late-add on drug-resistant epilepsy is an effective and well-tolerated treatment for drug-resistant epilepsy., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Published
2021
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44. Improved irritability, mood, and quality of life following introduction of perampanel as late adjunctive treatment for epilepsy.

Author

Moraes JS, Hepworth G, Ignatiadis S, Dharan A, Carne R, Seneviratne U, Cook MJ, and D'Souza WJ

Subjects
Adult, Affect drug effects, Affect physiology, Cohort Studies, Drug Therapy, Combination, Female, Humans, Irritable Mood physiology, Male, Middle Aged, Nitriles, Prospective Studies, Retrospective Studies, Seizures drug therapy, Seizures psychology, Surveys and Questionnaires, Treatment Outcome, Young Adult, Anticonvulsants administration & dosage, Drug Resistant Epilepsy drug therapy, Drug Resistant Epilepsy psychology, Irritable Mood drug effects, Pyridones administration & dosage, Quality of Life psychology
Abstract

Objective: The objective of this study was to evaluate the efficacy and tolerability of perampanel (PER) in late adjunctive treatment of focal epilepsy. We assessed outcomes 1) according to patients' clinical profiles and the broad mechanism of action (MoA) of concomitant antiepileptic drugs (AEDs) and 2) the effects of PER on adverse events, irritability, mood, and quality of life (QOL)., Methods: Consecutive patients commenced on PER at two epilepsy centers in Melbourne, Australia were identified. A nested cohort underwent detailed prospective assessment, while the remainder were retrospectively analyzed. Six- and 12-month efficacy endpoints were at least a 50% reduction in seizure frequency (responders) and complete seizure freedom. The prospective cohort underwent standardized validated questionnaires at 0, 1, 3, 6, and 12 months using the modified semi-structured seizure interview (SSI), Liverpool Adverse Events Profile (LAEP), Quality of Life in Epilepsy-Patient-Weighted (QOLIE-10-P), Neurological Disorders Depression Inventory Epilepsy (NDDI-E), and an Irritability Questionnaire., Results: One hundred sixty patients were followed for a median of 6 months: the mean number of prior AEDs was 6, 99% had drug-resistant epilepsy, and 72% had never experienced a prior seizure-free period of at least 6 months (=continuously refractory epilepsy). Perampanel was associated with responder and seizure freedom rates of 30.6% and 9.4% at 6 months and 19.4% and 4.4% (5.6% adjusted for the titration period) at 12 months. Having "continuously refractory epilepsy" was associated with a reduced likelihood of seizure freedom at 6 months (5% vs. 30%; p = 0.001) and 12 months (3% vs. 13%; p = 0.058). Quality of Life in Epilepsy-Patient-Weighted, irritability, and NDDI-E showed mean improvement at 6 months from baseline., Significance: Even when used as late add-on adjunctive therapy in patients with highly refractory focal epilepsy, PER can result in 12-month seizure freedom of 5.6%. The likelihood of seizure freedom was associated with prior "continuous medication refractoriness". Six months after introduction of PER patients reported improved mood, QOL, and decreased irritability., Competing Interests: Declaration of competing interest This study was supported by an investigator-initiated grant from EISAI Australia Pty Limited. Eisai was not involved in the study design, the collection, analysis, and interpretation of the data gathered, the writing of the report, or the decision to submit the article for publication., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Published
2020
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45. Characteristics of motor vehicle crashes associated with seizure: Car crash semiology.

Author

Neal A, Carne R, Odell M, Ballek D, D'Souza WJ, and Cook MJ

Subjects
Adult, Age Factors, Case-Control Studies, Databases, Factual, Female, Humans, Male, Seizures diagnosis, Time Factors, Victoria epidemiology, Young Adult, Accidents, Traffic statistics & numerical data, Seizures epidemiology
Abstract

Objective: To examine the characteristics of seizure-related vehicle crashes (SRC)., Method: Using a nested case-control design, we identified and compared cases of SRC involving confirmed epilepsy patients with 137,126 non-seizure-related crash controls (NSRC) in the Australian state of Victoria. SRC were identified from approximately 20,000 epileptologist medical records by cross-referencing this source with the Victorian Police Traffic Incident database and the Road Crash Information System Database (RCISD)., Results: Seventy-one SRC involving 62 patients with epilepsy were identified. Thirty-seven SRC resulted in injury and could be identified in the RCISD and compared to NSRC. Seizure-related crashes typically involved a single vehicle (57% vs 29%, p < 0.001) carrying a sole occupant (95% vs 48%, p = 0.001). Most SRC began with an "out of control movement" (51% vs 10%, p < 0.001) and the subsequent collision type differed significantly between the groups ( p < 0.001). The majority of SRC were a "collision with a fixed object" (54% vs 17%, p < 0.001) involving an "off path on straight" mechanism (48% vs 10%, p < 0.001). Regarding all 71 SRC, generalized as compared with focal epilepsy crashes involved younger drivers ( p < 0.001), seizure-provoking factors ( p = 0.033), and occurred earlier in the day ( p = 0.004)., Conclusions: Given the distinct SRC features, we propose that clinicians, crash investigators, and driver licensing authorities incorporate collision characteristics into the overall assessment of suspected SRC. Further research should examine restricting driving immediately after risk periods as a harm-minimization strategy., (© 2018 American Academy of Neurology.)

Published
2018
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46. Cognitive impairment and vitamin B12: a review.

Author

Moore E, Mander A, Ames D, Carne R, Sanders K, and Watters D

Subjects
Alzheimer Disease drug therapy, Alzheimer Disease etiology, Cognition Disorders drug therapy, Dementia drug therapy, Dementia etiology, Humans, Vitamin B 12 therapeutic use, Vitamin B 12 Deficiency drug therapy, Vitamins therapeutic use, Cognition Disorders etiology, Vitamin B 12 Deficiency complications
Abstract

Background: This review examines the associations between low vitamin B12 levels, neurodegenerative disease, and cognitive impairment. The potential impact of comorbidities and medications associated with vitamin B12 derangements were also investigated. In addition, we reviewed the evidence as to whether vitamin B12 therapy is efficacious for cognitive impairment and dementia., Methods: A systematic literature search identified 43 studies investigating the association of vitamin B12 and cognitive impairment or dementia. Seventeen studies reported on the efficacy of vitamin B12 therapy for these conditions., Results: Vitamin B12 levels in the subclinical low-normal range (<250 ρmol/L) are associated with Alzheimer's disease, vascular dementia, and Parkinson's disease. Vegetarianism and metformin use contribute to depressed vitamin B12 levels and may independently increase the risk for cognitive impairment. Vitamin B12 deficiency (<150 ρmol/L) is associated with cognitive impairment. Vitamin B12 supplements administered orally or parenterally at high dose (1 mg daily) were effective in correcting biochemical deficiency, but improved cognition only in patients with pre-existing vitamin B12 deficiency (serum vitamin B12 levels <150 ρmol/L or serum homocysteine levels >19.9 μmol/L)., Conclusion: Low serum vitamin B12 levels are associated with neurodegenerative disease and cognitive impairment. There is a small subset of dementias that are reversible with vitamin B12 therapy and this treatment is inexpensive and safe. Vitamin B12 therapy does not improve cognition in patients without pre-existing deficiency. There is a need for large, well-resourced clinical trials to close the gaps in our current understanding of the nature of the associations of vitamin B12 insufficiency and neurodegenerative disease.

Published
2012
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47. The multiple mini-interview: how long is long enough?

Author

Dodson M, Crotty B, Prideaux D, Carne R, Ward A, and de Leeuw E

Subjects
Humans, Psychometrics, Time Factors, Interviews as Topic methods, School Admission Criteria, Students, Medical psychology
Abstract

Objectives: The multiple mini-interview (MMI) overcomes the limitations of the traditional panel interview by multiple sampling to provide improved objectivity and reliability. Reliability of the MMI is affected by number of stations; however, there are few data reporting the influence of interview duration on MMI outcome and reliability. We aimed to determine whether MMI stations can be shortened without affecting applicant rankings or compromising test reliability., Methods: A total of 175 applicants were interviewed and assessed at 10 8-minute stations. Applicants were scored once after 8 minutes at five control stations and twice after 5 minutes and 8 minutes at five experimental stations. Scores at 5 and 8 minutes were compared using t-tests and correlation coefficients. Rankings of applicants based on 5- and 8-minute scores were compared using Spearman's rank order coefficient. The reliability of the MMI was examined for 5- and 8-minute scores using generalisability theory., Results: Mean scores at 5 minutes were lower than mean scores at 8 minutes. Cumulative scores at 5 minutes were also lower. There were highly significant correlations between 5- and 8-minute scores at all experimental stations (0.82-0.91; P < 0.01) and between the cumulative scores at 5 and 8 minutes (0.92; P < 0.01). There was a strong correlation between applicant rankings based on cumulative 5- and 8-minute scores (Spearman's rank order coefficient 0.92). Reliability was not affected., Conclusions: Reducing the duration of MMI stations from 8 to 5 minutes conserves resources with minimal effect on applicant ranking and test reliability.

Published
2009
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48. Depression in temporal lobe epilepsy surgery patients: an FDG-PET study.

Author

Salzberg M, Taher T, Davie M, Carne R, Hicks RJ, Cook M, Murphy M, Vinton A, and O'Brien TJ

Subjects
Adult, Anterior Temporal Lobectomy, Brain Mapping methods, Cerebral Cortex diagnostic imaging, Cerebral Cortex metabolism, Cerebral Cortex physiopathology, Depressive Disorder diagnosis, Depressive Disorder metabolism, Epilepsy, Temporal Lobe diagnostic imaging, Epilepsy, Temporal Lobe psychology, Female, Fluorodeoxyglucose F18 metabolism, Frontal Lobe metabolism, Frontal Lobe physiopathology, Functional Laterality physiology, Humans, Image Processing, Computer-Assisted, Male, Postoperative Complications diagnosis, Postoperative Complications diagnostic imaging, Postoperative Complications metabolism, Preoperative Care, Depressive Disorder diagnostic imaging, Epilepsy, Temporal Lobe surgery, Frontal Lobe diagnostic imaging, Positron-Emission Tomography statistics & numerical data
Abstract

Purpose: Depression is common in temporal lobe epilepsy (TLE) and after temporal lobectomy, and its etiology is obscure. In nonepileptic depression (including depression associated with other neurologic disorders), a consistent PET imaging finding is frontal lobe hypometabolism. Many TLE patients have hypometabolism involving frontal regions. Thus in data available from routine clinical assessments in an epilepsy surgery unit, we tested the hypothesis that the pattern of hypometabolism, particularly in the frontal lobe, may be associated with the depression seen in patients with TLE and TLE surgery., Methods: We studied 23 medically refractory TLE patients who underwent anterior temporal lobectomy and who had preoperative FDG-PET scanning. All patients had pre- and postoperative psychiatric assessment. By using statistical parametric mapping (SPM-99), patterns of hypometabolism were compared between patients who had a preoperative history of depression (n=9) versus those who did not (n=14) and between those in whom postoperative depression developed (n=13) versus those in whom it did not (n=10). A significant region of hypometabolism was set at p<0.001 for a cluster of >or=20 contiguous voxels., Results: Patients with a history of depression at any time preoperatively showed focal hypometabolism in ipsilateral orbitofrontal cortex compared with those who did not (t=4.64; p<0.001). Patients in whom depression developed postoperatively also showed hypometabolism in the ipsilateral orbitofrontal region (t=5.10; p<0.001)., Conclusions: Although this study is methodologically limited, and other explanations merit consideration, orbitofrontal cortex dysfunction, already implicated in the pathophysiology of nonepileptic depression, may also be relevant to the depression of TLE and temporal lobectomy.

Published
2006
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49. Infant development following the use of intravenous nutrition to women with persistently low urinary oestriol excretion.

Author

Carne RJ and Drew JH

Subjects
Amino Acids therapeutic use, Female, Follow-Up Studies, Glucose therapeutic use, Humans, Infant Mortality, Infant, Newborn, Pregnancy, Time Factors, Developmental Disabilities prevention & control, Estriol urine, Fetal Death prevention & control, Parenteral Nutrition, Pregnancy Complications therapy
Abstract

During the 6-year period 1971 to 1976, 10,545 patients had urinary oestriol determinations during pregnancy and 333 (3.2%) had persistently low values. Of the 335 resultant infants 206 were from patients treated with intravenous dextrose and/or amino-acids (treated group) and 129 from nontreated patients (nontreated group). The stillbirth rate was 2.4% in the treated group and 11.6% in the untreated group (p greater than 0.001), and the neonatal death rates were 2.9% and 4.7% respectively (p = NS). Assessment of the surviving infants to 7 years of age revealed no significant differences in growth between treated and nontreated groups. There was no increase in the incidence of major neurological abnormalities in the treated infants (2.9%) when compared to those from nontreated pregnancies (1.3%) (p = NS), nor was there a significant difference in the incidence of minor neurological abnormality or findings on psychological assessments. We conclude that dextrose and/or amino-acid infusions given to pregnant women with low oestriol excretion reduced the perinatal mortality rate without significant compromise to subsequent development of surviving infants.

Published
1987
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