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1. Real-world use of Safinamide in motor fluctuating Parkinson's disease patients in Italy.

Author

Bovenzi, Roberta, Liguori, Claudio, Canesi, Margherita, D'Amelio, Marco, De Pandis, Maria Francesca, Marini, Carmine, Monge, Alessandra, Padovani, Alessandro, Tessitore, Alessandro, Stefani, Alessandro, Zappia, Mario, for the SYNAPSES Study Investigators Italian Group, Abbruzzese, G., Aguggia, M., Avarello, T., Barone, P., Bentivoglio, A. R., Bosco, D., Calabresi, P., and Callegarini, C.

Subjects
PARKINSON'S disease, PEOPLE with mental illness, MOVEMENT disorders
Abstract

Introduction: Safinamide is a recent antiparkinsonian drug that modulates both dopaminergic and glutamatergic systems with positive effects on motor and nonmotor symptoms of Parkinson's disease (PD). Here, we aimed to describe the efficacy and safety of safinamide in the Italian PD patients in real-life conditions. Methods: We performed a sub-analysis of the Italian cohort of the SYNAPSES study, a multi-country, multi-center, retrospective-prospective cohort observational study, designed to investigate the use of safinamide in routine clinical practice. Patients received for the first time a treatment with safinamide and were followed up for 12 months. The analysis was conducted on the overall population and in subgroups of interest: i) patients > 75 years, ii) patients with relevant comorbidities and iii) patients affected by psychiatric symptoms. Results: Italy enrolled 616/1610 patients in 52 centers, accounting for 38% of the entire SYNAPSES cohort. Of the patients enrolled, 86.0% were evaluable at 12 months, with 23.3% being > 75 years, 42.4% with psychiatric conditions and 67.7% with relevant comorbidities. Safinamide was effective on motor symptoms and fluctuations as measured through the Unified PD rating scale III and IV scores, and on the total score, without safety issues in none of the subgroups considered. Conclusion: The SYNAPSES data related to Italian patients confirms the good safety profile of safinamide even in special groups of patients. Motor fluctuations and motor impairment improved at the follow-up suggesting the significant role of safinamide in managing motor symptoms in PD patients. [ABSTRACT FROM AUTHOR]

Published
2024
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2. A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial

Author

Abbruzzese, G., Kulisevsky, J., Bergmans, B., Gomez-Esteban, J. C., Kagi, G., Raw, J., Stefani, A., Warnecke, T., Jost, W. H., Bourgeois, P., Cras, P., de Klippel, N., Dethy, S., Franco, G., Garraux, G., Geens, K., Jacquerye, P., Jeanjean, A., Santens, P., Supiot, F., van der Linden, C., Blersch, W. K., Delf, M., Hellwig, B., Herbst, H. P., Kupsch, A., Lang, M., Muhlack, S., Nastos, I., Oehlwein, C., Schlegel, E., Schwarz, J., Woitalla, D., Aguggia, M., Avarello, T., Barone, P., Baruffaldi, R., Belgrado, E., Bentivoglio, A. R., Bosco, D., Calabresi, P., Callegarini, C., Cannas, A., Centonze, D., Ceravolo, R., Colosimo, C., Comi, C., Contardi, S., Cortelli, P., Cossu, G., D'Amelio, M., de Pandis, M. F., Denaro, A., Di Lazzaro, V., Fabbrini, G., Gasparoli, E., Guidi, M., Iliceto, G., Lopiano, L., Manganotti, P., Marconi, R., Marini, C., Marsala, S. Z., Mauri, M., Moleri, M., Monge, A., Morgante, F., Negrotti, A., Nordera, G., Onofrj, M., Pacchetti, C., Padovani, A., Pontieri, F. E., Priori, A., Quatrale, R., Sensi, M., Tamma, F., Tessitore, A., Tinazzi, M., Vitale, C., Volonte, M. A., Zappia, M., Zecchinelli, A. L., Arbelo Gonzalez, J. M., Bayes, A., Blazquez, M., Calopa Garriga, M., Callen, A., Campos Arillo, V., Cubo, E., de Fabregues, O., Escalante Arroyo, S., Espinosa Rosso, R., Esquivel Lopez, A., Freire, E., Garcia Cobos, E., Garcia Moreno, J. M., Gonzalez-Ardura, J., Grandas Perez, F., Kurtis, M., Juni, J., Legarda, I., Leiva, C., Lopez Aristegui, N., Lopez Manzanares, L., Lozano, J. J., Luquin, M. R., Martinez Castrillo, J. C., Marti Domenech, M. J., Martinez, I., Mata, M., Mir Rivera, P., Pascual Sedano, B., Rodriguez Oroz, M. C., Rodriguez Uranga, J. J., Sanchez, S., Santos Garcia, D., Solano, B., Vaamonde Gamo, J., Accolla, E., Bohlhalter, S., Kalin, A., Michelis, J., Carrol, C., Henderson, E., Raha, S., Silva, N., Silverdale, M., Universidad de Sevilla. Departamento de Medicina, Abbruzzese G., Kulisevsky J., Bergmans B., Gomez-Esteban J.C., Kagi G., Raw J., Stefani A., Warnecke T., Jost W.H., Bourgeois P., Cras P., de Klippel N., Dethy S., Franco G., Garraux G., Geens K., Jacquerye P., Jeanjean A., Santens P., Supiot F., van der Linden C., Blersch W.K., Delf M., Hellwig B., Herbst H.P., Kupsch A., Lang M., Muhlack S., Nastos I., Oehlwein C., Schlegel E., Schwarz J., Woitalla D., Aguggia M., Avarello T., Barone P., Baruffaldi R., Belgrado E., Bentivoglio A.R., Bosco D., Calabresi P., Callegarini C., Cannas A., Centonze D., Ceravolo R., Colosimo C., Comi C., Contardi S., Cortelli P., Cossu G., D'Amelio M., de Pandis M.F., Denaro A., Di Lazzaro V., Fabbrini G., Gasparoli E., Guidi M., Iliceto G., Lopiano L., Manganotti P., Marconi R., Marini C., Marsala S.Z., Mauri M., Moleri M., Monge A., Morgante F., Negrotti A., Nordera G., Onofrj M., Pacchetti C., Padovani A., Pontieri F.E., Priori A., Quatrale R., Sensi M., Tamma F., Tessitore A., Tinazzi M., Vitale C., Volonte M.A., Zappia M., Zecchinelli A.L., Arbelo Gonzalez J.M., Bayes A., Blazquez M., Calopa Garriga M., Callen A., Campos Arillo V., Cubo E., de Fabregues O., Escalante Arroyo S., Espinosa Rosso R., Esquivel Lopez A., Freire E., Garcia Cobos E., Garcia Moreno J.M., Gonzalez-Ardura J., Grandas Perez F., Kurtis M., Juni J., Legarda I., Leiva C., Lopez Aristegui N., Lopez Manzanares L., Lozano J.J., Luquin M.R., Martinez Castrillo J.C., Marti Domenech M.J., Martinez I., Mata M., Mir Rivera P., Pascual Sedano B., Rodriguez Oroz M.C., Rodriguez Uranga J.J., Sanchez S., Santos Garcia D., Solano B., Vaamonde Gamo J., Accolla E., Bohlhalter S., Kalin A., Michelis J., Carrol C., Henderson E., Raha S., Silva N., and Silverdale M.

Subjects
Research Report, Male, 0301 basic medicine, Benzylamines, Parkinson's disease, Outcome Assessment, Comorbidity, Disease, Real-life evaluation, chemistry.chemical_compound, 0302 clinical medicine, Outcome Assessment, Health Care, 80 and over, MAO-B inhibitor, Aged, 80 and over, Safinamide, education.field_of_study, Alanine, Mental Disorders, Parkinson Disease, Middle Aged, Aged, Drug-Related Side Effects and Adverse Reactions, Europe, Female, Follow-Up Studies, Humans, Monoamine Oxidase Inhibitors, Retrospective Studies, Settore MED/26 - NEUROLOGIA, Erratum, Cohort study, medicine.medical_specialty, Population, MEDLINE, 03 medical and health sciences, Cellular and Molecular Neuroscience, Internal medicine, medicine, Adverse effect, education, business.industry, medicine.disease, Health Care, 030104 developmental biology, chemistry, Parkinson’s disease, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in >= 40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.

Published
2022

3. Randomized trial of safinamide add‐on to levodopa in Parkinson's disease with motor fluctuations

Author

Borgohain, R, Szasz, J, Stanzione, P, Meshram, C, Bhatt, M, Chirilineau, D, Stocchi, F, Lucini, V, Giuliani, R, Forrest, E, Rice, P, Anand, R, Sahadulla, M, Kardan, U, Keshava, B, Kishore, A, Kothari, S, Krishna Murthy, J, Kumar, S, Pal, P, Mehta, N, Prabhakar, S, Pradhan, S, Roy, A, Sankhla, C, Sethi, P, Shah, A, Shankar, N, Shukla, R, Sowani, A, Srinivasa, R, Varma, M, Vasudevan, D, Sreenivas, P, Velmurugendran, C, Vijayan, K, Bajenaru, O, Bulboaca, A, Campeanu, A, Chirileanu, D, Muresanu, D, Panea, C, Popescu, C, Simu, M, Ticmeanu, M, Avarello, T, Bonuccelli, U, Eleopra, R, Onofrj, M, and Quatrale, R

Subjects
Male, Benzylamines, Levodopa, Parkinson's disease, Motor Activity, Placebo, Severity of Illness Index, law.invention, Dose-Response Relationship, Antiparkinson Agents, chemistry.chemical_compound, Double-Blind Method, Randomized controlled trial, law, Activities of Daily Living, Clinical endpoint, Humans, Medicine, MAO-B inhibitor, Research Articles, Aged, Dyskinesia, Safinamide, Alanine, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Middle Aged, Parkinson Disease, Neurology (clinical), Neurology, safinamide, dyskinesia, business.industry, Parkinsonism, medicine.disease, chemistry, Anesthesia, Settore MED/26 - Neurologia, Drug, medicine.symptom, business, medicine.drug
Abstract

Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to l-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total on time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included off time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total on time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in off time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to l-dopa in patients with PD and motor fluctuations significantly increased total on time with no or nontroublesome dyskinesia, decreased off time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.

Published
2013

4. Clinical variables associated with treatment changes in Parkinson’s disease: results from the longitudinal phase of the REASON study

Author

Abbruzzese, Giovanni, Barone, Paolo, Ceravolo, Roberto, Fabbrini, Giovanni, Lessi, Patrizia, Ori, Alessandra, Simoni, Lucia, Tinazzi, Michele, Antonini, Angelo, Melone, MAB, Schettino, C, Capaldo, G, Iemolo, F, Sanzaro, E, Ceravolo, MG, Capecci, M, Andrenelli, E, Pontieri, FE, Pellicano, C, Benincasa, D, Fabbrini, G, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, MA, Spagnolo, F, Scaglioni, A, Abrignani, G, Abbruzzese, G, Avanzino, L, Tamburini, T, Antonini, A, Facchini, S, Biundo, R, Altavista, MC, Roberti, C, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Stampanoni Bassi, M, Tinazzi, M, Ottaviani, S, Ajena, D, Trianni, G, Caggiula, M, Valenti, G, My, F, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Asteggiano, G, L’Episcopo, MR, Saracco, E, Barone, P, Picillo, M, Moccia, M, Onofrj, M, Thomas, A, Denaro, A, Marini, C, De Santis, F, Spagnoli, V, L’Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A., Abbruzzese, Giovanni, Barone, Paolo, Ceravolo, Roberto, Fabbrini, Giovanni, Lessi, Patrizia, Ori, Alessandra, Simoni, Lucia, Tinazzi, Michele, Antonini, Angelo, Melone, Mab, Schettino, C, Capaldo, G, Iemolo, F, Sanzaro, E, Ceravolo, Mg, Capecci, M, Andrenelli, E, Pontieri, Fe, Pellicano, C, Benincasa, D, Fabbrini, G, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, Ma, Spagnolo, F, Scaglioni, A, Abrignani, G, Abbruzzese, G, Avanzino, L, Tamburini, T, Antonini, A, Facchini, S, Biundo, R, Altavista, Mc, Roberti, C, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Stampanoni Bassi, M, Tinazzi, M, Ottaviani, S, Ajena, D, Trianni, G, Caggiula, M, Valenti, G, My, F, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Asteggiano, G, L’Episcopo, Mr, Saracco, E, Barone, P, Picillo, M, Moccia, M, Onofrj, M, Thomas, A, Denaro, A, Marini, C, De Santis, F, Spagnoli, V, L’Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, and Marchet, A.

Subjects
Male, medicine.medical_specialty, Clinical variables, Neurology, Parkinson's disease, Motor symptoms, Non-motor symptoms, Parkinson’s disease, Treatment persistence, Aged, Female, Humans, Longitudinal Studies, Middle Aged, Parkinson Disease, Physician's Role, Severity of Illness Index, Treatment Outcome, Neurology (clinical), Psychiatry and Mental Health, 2708, Longitudinal Studie, Dermatology, Disease, Internal medicine, motor symptoms,non-motor symptoms, Parkinson’s disease,treatment persistence, Severity of illness, Medicine, Neuroradiology, business.industry, musculoskeletal, neural, and ocular physiology, General Medicine, medicine.disease, nervous system diseases, cardiovascular system, Physical therapy, Neurosurgery, business, Human
Abstract

To assess over a period of 9 months in a sample of Italian Parkinson’s disease (PD) patients reasons leading the neurologist to modify dopaminergic treatment and patients’ causes of dissatisfaction with ongoing therapy. To evaluate the influence of disease severity on therapy persistence. A disease severity balanced sample of PD patients with stable anti-parkinsonian drugs (APD) treatment was enrolled and evaluated every 3 months. Patients requiring APD treatment modifications were discontinued from the study. The probability to modify APD treatment is greater for higher motor (UPDRS scores) and non-motor symptoms (NMSS score) severity. Both from neurologist’s and patient’s perspective, motor symptoms were the main determinants underlying APD treatment modifications. Non-motor symptoms were cause of dissatisfaction with ongoing APD treatment for 52 % of the patients, while only 36 % of the neurologists considered these as valid reasons for therapy change. REASON is the first study in PD patients that prospectively examined reasons driving APD treatment changes. Results show that the disease severity significantly increases the probability of APD treatment change. Patients attribute greater relevance than neurologists to non-motor symptoms as reason requiring treatment changes. This confirms that patient and neurologist perceptions only partially overlap.

Published
2015

5. Adherence to anti-Parkinson drug therapy in the 'REASON' sample of Italian patients with Parkinson's disease: the linguistic validation of the Italian version of the 'Morisky Medical Adherence Scale-8 items'

Author

Fabbrini, G, Abbruzzese, G, Barone, P, Antonini, A, Tinazzi, M, Castegnaro, G, Rizzoli, S, Morisky, De, Lessi, P, Abbruzzese G, Cr, Ceravolo, R, Melone, M, Schettino, C, Califano, F, Ceravolo, M, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, F, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, M, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, M, Roberti, C, Asteggiano, G, L'Episcopo, M, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Stampanoni Bassi, M, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, De Santis, F, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A, Ori, A, Pirondi, S, Roncari, B, Sala, S, Sgarbi, S, Simoni, L, Trevisan, F, Zanoli, L, Fabbrini, G, Abbruzzese, G, Antonini, A, Barone, P, Ceravolo, R, Tinazzi, M, Melone, Mariarosa Anna Beatrice, Schettino, C, Califano, F, Ceravolo, Mg, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, Fe, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, Gioacchino, Tessitore, Alessandro, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, Ma, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, Mc, Roberti, C, Asteggiano, G, L'Episcopo, Mr, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Nullm, nullDel Sette, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Nullm, nullStampanoni Bassi, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, Nulli, nullLa Farina, Nulls, nullZambito Marsala, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, Nullf, nullDe Santi, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A, Lessi, P, Castegnaro, G, Ori, A, Pirondi, S, Rizzoli, S, Roncari, B, Sala, S, Sgarbi, S, Simoni, L, Trevisan, F, Zanoli, L., Fabbrini, G., Abbruzzese, G., Barone, P., Antonini, A., Tinazzi, M., Castegnaro, G., Rizzoli, S., Morisky, D. E., Lessi, P., Ceravolo, R., Melone, M. A., Schettino, C., Califano, F., Ceravolo, M. G., Capecci, M., Andrenelli, E., Iemolo, F., Spadaro, D., Carnemolla, A., Pontieri, F. E., Pellicano, C., Benincasa, D., Pietracupa, S., Latorre, A., Tedeschi, G., Tessitore, A., Giordano, A., Bonuccelli, U., Frosini, D., Vanelli, F., Comi, G., Volonte, M. A., Spagnolo, F., Scaglioni, A., Abrignani, G., Avanzino, L., Tamburini, T., Facchini, S., Biundo, R., Altavista, M. C., Roberti, C., Asteggiano, G., L'Episcopo, M. R., Saracco, E., Avarello, T., Bono, G., Riboldazzi, G., Leva, S., Del Sette, M., Carabelli, E., Traverso, E., Michelucci, R., Nassetti, S., Pasini, E., Padovani, A., Cottini, E., Bigni, B., Ruggieri, S., Modugno, N., Fischetti, M., Stefani, A., Pierantozzi, M., Stampanoni Bassi, M., Ottaviani, S., Ajena, D., Trianni, G., My, F., Caggiula, M., Valenti, G., Grioli, S., La Farina, I., Zambito Marsala, S., Marchini, C., Gioulis, M., Picillo, M., Moccia, M., Denaro, A., Sebastianelli, L., Onofrj, M., Thomas, A., Marini, C., De Santis, F., Spagnoli, V., L'Erario, R., Passadore, P., Belgrado, E., Mucchiut, M., Priori, A., Cogiamanian, F., Marchet, A., Ori, A., Pirondi, S., Roncari, B., Sala, S., Sgarbi, S., Simoni, L., Trevisan, F., Morisky, De, Comi, Giancarlo, and REASON study, Group

Subjects
Predictive validity, Male, Translation, Parkinson's disease, Adherence, Comprehension, Validation, Aged, Antiparkinson Agents, Female, Humans, Parkinson Disease, Translations, Medication Adherence, Surveys and Questionnaires, Neurology (clinical), Psychiatry and Mental Health, 2708, MEDLINE, Dermatology, Disease, Linguistic validation, Pharmacotherapy, Quality of life, Medicine, business.industry, General Medicine, Parkinson’s disease, medicine.disease, Psychiatry and Mental health, Antiparkinson Agent, Settore MED/26 - Neurologia, business, Human, Clinical psychology
Abstract

Information about patients' adherence to therapy represents a primary issue in Parkinson's disease (PD) management. To perform the linguistic validation of the Italian version of the self-rated 8-Item Morisky Medical Adherence Scale (MMAS-8) and to describe in a sample of Italian patients affected by PD the adherence to anti-Parkinson drug therapy and the association between adherence and some socio-demographic and clinical features. MMAS-8 was translated into Italian language by two independent Italian mother-tongue translators. The consensus version was then back-translated by an English mother-tongue translator. This translation process was followed by a consensus meeting between the authors of translation and investigators and then by two comprehension tests. The translated version of the MMAS-8 scale was then administered at the baseline visit of the "REASON" study (Italian Study on the Therapy Management in Parkinson's disease: Motor, Non-Motor, Adherence and Quality Of Life Factors) in a large sample of PD patients. The final version of the MMAS-8 was easily understood. Mean ± SD MMAS-8 score was 6.1 ± 1.2. There were no differences in adherence to therapy in relationship to disease severity, gender, educational level or decision to change therapy. The Italian version of MMAS-8, the key tool of the REASON study to assess the adherence to therapy, has shown to be understandable to patients with PD. Patients enrolled in the REASON study showed medium therapy adherence.

Published
2013

6. Reasons driving treatment modification in Parkinson's disease: Results from the cross-sectional phase of the REASON study

Author

Tinazzi, M, Abbruzzese, G, Antonini, A, Ceravolo, R, Fabbrini, G, Lessi, P, Barone, P, REASON Study Group:Abruzzese, G, Lido, V, Melone, M, Schettino, C, Califano, F, Ceravolo, M, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, F, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, M, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, M, Roberti, C, Asteggiano, G, L'Episcopo, M, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del, S, Carabelli, M, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Bassi, M, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, De Santis, F, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A, Tinazzi, M, Abbruzzese, G, Antonini, A, Ceravolo, R, Fabbrini, G, Lessi, P, Barone, P, Lido, V, Melone, M, Schettino, C, Califano, F, Ceravolo, Mg, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, F, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, M, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, M, Roberti, C, Asteggiano, G, L'Episcopo, M, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del, Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Bassi, M, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, La, Farina, I, Zambito, Marsala, S, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, De, Santi, F, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A., Tinazzi, M., Abbruzzese, G., Antonini, A., Ceravolo, R., Fabbrini, G., Lessi, P., Barone, P., Melone, M. A. B., Schettino, C., Califano, F., Ceravolo, M. G., Capecci, M., Andrenelli, E., Iemolo, F., Spadaro, D., Carnemolla, A., Pontieri, F. E., Pellicano, C., Benincasa, D., Pietracupa, S., Latorre, A., Tedeschi, G., Tessitore, A., Giordano, A., Bonuccelli, U., Frosini, D., Vanelli, F., Comi, G., Volonte, M. A., Spagnolo, F., Scaglioni, A., Abrignani, G., Avanzino, L., Tamburini, T., Facchini, S., Biundo, R., Altavista, M. C., Roberti, C., Asteggiano, G., L'Episcopo, M. R., Saracco, E., Avarello, T., Bono, G., Riboldazzi, G., Leva, S., Del Sette, M., Carabelli, E., Traverso, E., Michelucci, R., Nassetti, S., Pasini, E., Padovani, A., Cottini, E., Bigni, B., Ruggieri, S., Modugno, N., Fischetti, M., Stefani, A., Pierantozzi, M., Stampanoni Bassi, M., Ottaviani, S., Ajena, D., Trianni, G., My, F., Caggiula, M., Valenti, G., Grioli, S., La Farina, I., Zambito Marsala, S., Marchini, C., Gioulis, M., Picillo, M., Moccia, M., Denaro, A., Sebastianelli, L., Onofrj, M., Thomas, A., Marini, C., De Santis, F., Spagnoli, V., L'Erario, R., Passadore, P., Belgrado, E., Mucchiut, M., Priori, A., Cogiamanian, F., Lessi, and Comi, Giancarlo

Subjects
Male, Pediatrics, Parkinson's disease, anti-Parkinson drugs, motor symptoms, non-motor symptoms, Practice Patterns, Socioeconomic Factor, Motor symptoms, Severity of Illness Index, Antiparkinson Agents, Cohort Studies, Motor symptom, Practice Patterns, Physicians', Stage (cooking), Anti-Parkinson drug, Anti-Parkinson drugs, Non-motor symptoms, Aged, Female, Humans, Middle Aged, Parkinson Disease, Patient Satisfaction, Socioeconomic Factors, Geriatrics and Gerontology, Neurology (clinical), Neurology, musculoskeletal, neural, and ocular physiology, Antiparkinson Agent, cardiovascular system, Settore MED/26 - Neurologia, Treatment modification, Human, medicine.medical_specialty, Non-motor symptom, Disease severity, medicine, In patient, Physicians', business.industry, Advanced stage, medicine.disease, nervous system diseases, Physical therapy, Treatment decision making, Cohort Studie, business
Abstract

OBJECTIVES: To assess the association between clinical and socio-demographic features and anti-Parkinson drug (APD) treatment modifications in patients with PD and to describe neurologist and patient opinions regarding the need for changes in APD therapy. METHODS: Subjects with PD with stable APD treatment over ≥3 months prior to baseline were enrolled and evaluated for socio-demographic data, disability, disease severity and neurologist and patient views on the need to modify APD treatment. RESULTS: 775 Patients were included, 51% with Hoehn and Yahr (HY) stage 1-2 (early PD) and 49% with HY stage 2.5-4 (advanced PD). Neurologists modified APD treatment in 255 patients, 97 (25%) early PD and 158 (41%; p < 0.0001) advanced PD. APD modification was strongly associated with a low educational level and UPDRS part IV score. The most common reasons behind the APD therapy changes among neurologists were presence/worsening of motor or non-motor symptoms (88% and 37% of subjects respectively). Out of 216 patients, 92% and 51% were willing to undergo APD changes to therapy because of the presence/worsening of motor or non-motor symptoms. CONCLUSIONS: Neurologist decision to change APD therapy and patients reasons for dissatisfaction with it can be prevalently attributed to the presence/worsening of motor symptoms and motor fluctuations in the advanced stages. Non-motor symptoms were considered more often by patients. The patient educational level played a key role in treatment decision.

Published
2013

7. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease

Author

Borgohain, Rupam, Szasz, Jozsef, Stanzione, Paolo, Meshram, Chandrashekhar, Bhatt, Mohit H., Chirilineau, Dana, Stocchi, Fabrizio, Lucini, Valentina, Giuliani, Rodolfo, Forrest, Emma, Rice, Patricia, Anand, Ravi, Illiyas Sahadulla, M., Kardan, U., Keshava, B. S., Kishore, A., Kothari, S. S., Krishna Murthy, J. M., Kumar, S., Kumar Pal, P., Mehta, N., Prabhakar, S., Prabhakar, S. K. r., Pradhan, S., Roy, A. K., Sankhla, C., Sethi, P. K., Shah, A. B., Shankar, N., Shukla, R., Sowani, A., Srinivasa, R., Varma, M., Vasudevan, D., Vavilikolanu Sreenivas, P., Velmurugendran, C. U., Vijayan, K., Bajenaru, O., Bulboaca, A., Campeanu, A., Chirileanu, D., Muresanu, D., Panea, C., Popescu, C., Simu, M., Szasz, J., Ticmeanu, M., Avarello, T., Bonuccelli, Ubaldo, Eleopra, R., Onofrj, M., Quatrale, R., Stanzione, P., and Stocchi, F.

Subjects
Male, Benzylamines, Dyskinesia, Drug-Induced, Parkinson's disease, International Cooperation, law.invention, Antiparkinson Agents, Levodopa, chemistry.chemical_compound, Randomized controlled trial, law, Clinical endpoint, Medicine, add-on, Longitudinal Studies, Safinamide, Alanine, Medicine (all), safinamide, motor function, Parkinson Disease, Middle Aged, Treatment Outcome, Neurology, Settore MED/26 - Neurologia, Female, medicine.symptom, Drug, dopamine, medicine.drug, medicine.medical_specialty, Addon, Placebo, Dose-Response Relationship, Double-Blind Method, Internal medicine, Humans, safinamide, Parkinson's disease, levodopa, Aged, Dyskinesia, Dose-Response Relationship, Drug, business.industry, medicine.disease, Discontinuation, chemistry, Drug-Induced, Physical therapy, Dopamine, Motor function, Neurology (clinical), business
Abstract

In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P = 0.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.

Published
2014

8. Reasons driving treatment modification in Parkinson's disease: results from the cross-sectional phase of the REASON study

Author

Michele, Tinazzi, Giovanni, Abbruzzese, Antonini, Angelo, Roberto, Ceravolo, Giovanni, Fabbrini, Patrizia, Lessi, Barone, Paolo, Giovanni, Abruzzese, Venezia, Lido, M A, B Melone, Schettino, C, Califano, F, G Ceravolo, M, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, E Pontieri, F, Pellicano, C, Benincasa, D, Fabbrini, G, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, A Volonté, M, Spagnolo, F, Scaglioni, A, Abrignani, G, Abbruzzese, G, Avanzino, L, Tamburini, T, Antonini, A, Facchini, S, Biundo, R, C Altavista, M, Roberti, C, Asteggiano, G, R L'Episcopo, M, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, M Del Sette, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, M Stampanoni Bassi, Tinazzi, M, Ottaviani, S, Ajena, D, Trianni, G, F, My, Caggiula, M, Valenti, G, Grioli, S, I La Farina, S Zambito Marsala, Marchini, C, Gioulis, M, Barone, P, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, F De Santis, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, and Marchet, A

Published
2013

9. Frontal assessment battery scores and non-motor symptoms in parkinsonian disorders

Author

Marconi, R., Grasso, L., Antonini, A., De Gaspari, D., Barone, P., Santangelo, G., Colosimo, C., Meco, G., Avarello, T. P., Bottacchi, E., Cannas, A., Ceravolo, M. G., Ceravolo, R., Cicarelli, G., Gaglio, R. M., Giglia, L., Iemolo, F., Manfredi, M., Nicoletti, A., Pederzoli, M., Petrone, A., Pisani, A., Pontieri, F. E., Quatrale, R., Ramat, S., Scala, R., Volpe, G., Zappulla, S., Bentivoglio, R., Stocchi, F., Trianni, G., Del Dotto, P., Morgante, F., Morgante, L., Fabbrini, G., Benincasa, D., Sensi, M., Braga, M., Capecci, M., Caravona, N., D'Asta, G., De Falco, F. A., Pezzoli, G., Di Giovanni, M., Floris, G., Gallerini, S., Gurgone, G., Frosini, D., Meoni, S., Savica, R., Moschella, V., Pepe, F., Petretta, V., Randisi, M. G., Romeno, M., Picillo, M., Sorbello, V., Tiple, D., Guidubaldi, A., Muoio, R., Toni, V., Logi, C., Bartalini, S., Ulivelli, M., Perini, M., Lanfranchi, S., Griffini, S., Troianiello, B., Baratti, M., Amidei, S., Consoli, D., Iellamo, M., Cuomo, T., Scaglioni, A., Medici, D., Abbruzzese, G., Di Brigida, G., Cocco, G. A., Agnetti, V., Cossu, G., Deriu, M., Abrignani, M., Modica, C., Albani, G., Pradotto, L., Martinelli, P., Scaglione, C., Mucchiut, M., Zanini, S., Pennisi, F., Soliveri, P., Albanese, A., Bartolomei, L., L'Erario, R., Capus, L., Ferigo, L., Marano, R., Nastasi, V., Luciano, R., Maiello, L., Simone, P., Fogli, D., Lopiano, L., Pesare, M., Nordera, G., Pilleri, E., Scaravilli, T., Giaccaglini, E., Alesi, C., Corbetta, T., Sgarbi, S., Rapisarda, A., Rizzoli, S., Zanoli, L., Manfredi, A., Marconi, R, Antonini, A, Barone, P, Colosimo, C, Avarello, Tp, Bottacchi, E, Cannas, A, Ceravolo, Mg, Ceravolo, R, Cicarelli, G, Gaglio, Rm, Giglia, L, Iemolo, F, Manfredi, M, Meco, G, Nicoletti, A, Pederzoli, M, Petrone, A, Pisani, A, Pontieri, Fe, Quatrale, R, Ramat, S, Scala, R, Volpe, G, Zappulla, S, Bentivoglio, Ar, Stocchi, F, Trianni, G, Del Dotto, P, De Gaspari, D, Grasso, L, Morgante, F, Santangelo, Gabriella, Fabbrini, G, Morgante, L, and PRIAMO study, Group

Subjects
Questionnaires, Lung Diseases, Male, Aged, Aged, 80 and over, Attention Deficit Disorder with Hyperactivity, Cardiovascular Diseases, Cognition Disorders, Fatigue, Female, Frontal Lobe, Gastrointestinal Diseases, Humans, Kidney Diseases, Logistic Models, Longitudinal Studies, Middle Aged, Parkinsonian Disorders, Predictive Value of Tests, Skin Diseases, Sleep Wake Disorders, Surveys and Questionnaires, Neuropsychological Tests, 2708, Neurology (clinical), Psychiatry and Mental Health, Neurology, Disease, Logistic regression, Parkinson and cognitive impairment, 80 and over, Verbal fluency test, Neuroradiology, Sleep Disorders, General Medicine, non-motor symptoms, Psychiatry and Mental health, Settore MED/26 - NEUROLOGIA, Frontal lobe, Predictive value of tests, Psychology, medicine.medical_specialty, Dermatology, behavioral disciplines and activities, Internal medicine, medicine, Psychiatry, Surrogate endpoint, Frontal functions, Non-motor symptoms, frontal functions, parkinson and cognitive impairment
Abstract

Using data from the PRIAMO study, we investigated non-motor symptoms (NMS) versus frontal lobe dysfunction in patients with idiopathic Parkinson disease (PD); 808 patients with PD and 118 with atypical parkinsonisms (AP) were consecutively enrolled at 55 Centers in Italy. Twelve categories of NMS were investigated. Cognitive impairment was defined as a Mini-Mental Status Evaluation score ≤ 23.8 and frontal lobe dysfunction as a Frontal Assessment Battery (FAB) score ≤ 3.48. Multivariable logistic regression was used to identify predictor of frontal lobe dysfunction in 524 PD patients, and a generalized linear model was used for each of the six FAB items. Not only the total FAB scores but also the single FAB items were lower in AP versus PD (p ≤ 0.005). Age (OR = 1.05), cognitive impairment (OR = 9.54), lack of cardiovascular symptoms (OR = 3.25), attention or memory problems (OR = 0.59) and treatment with L: -DOPA (OR = 5.58) were predictors of frontal lobe dysfunction. MMSE was negatively associated with all FAB items (β ≤ -0.16) and age with all FAB items but prehension behavior (β ≤ -0.01). Previous use of L: -DOPA was negatively associated with verbal fluency (β = -0.32) possibly acting as surrogate marker of disease duration. Cognitive impairment is a predictor of frontal lobe dysfunction. Among NMS, lack of attention or memory problems were negatively associated with frontal impairment. Further studies are nonetheless needed to better identify the predictors of frontal impairment in PD patients.

Published
2012

10. The PRIAMO study: A multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson's disease

Author

Barone P., Antonini A., Colosimo C., Marconi R., Morgante L., Avarello T. P., Bottacchi E., Cannas A., Ceravolo G., Ceravolo R., Cicarelli G., Gaglio R. M., Giglia R. M., Iemolo F., Manfredi M., Meco G., Nicoletti A., Pederzoli M., Petrone A., Pisani A., Pontieri F. E., Quatrale R., Ramat S., Scala R., Volpe G., Zappulla S., Bentivoglio A. R., Stocchi F., Trianni G., Dotto P. D., PRIAMO study group, Martinelli P., Barone, Paolo, Antonini, A, Colosimo, C, Marconi, R, Morgante, L, Avarello, Tp, Bottacchi, E, Cannas, A, Ceravolo, G, Ceravolo, R, Cicarelli, G, Gaglio, Rm, Giglia, Rm, Iemolo, F, Manfredi, M, Meco, G, Nicoletti, A, Pederzoli, M, Petrone, A, Pisani, A, Pontieri, Fe, Quatrale, R, Ramat, S, Scala, R, Volpe, G, Zappulla, S, Bentivoglio, Ar, Stocchi, F, Trianni, G, Dotto, Pd, PRIAMO study, g. r. o. u. p., Barone P., Antonini A., Colosimo C., Marconi R., Morgante L., Avarello T.P., Bottacchi E., Cannas A., Ceravolo G., Ceravolo R., Cicarelli G., Gaglio R.M., Giglia R.M., Iemolo F., Manfredi M., Meco G., Nicoletti A., Pederzoli M., Petrone A., Pisani A., Pontieri F.E., Quatrale R., Ramat S., Scala R., Volpe G., Zappulla S., Bentivoglio A.R., Stocchi F., Trianni G., Dotto P.D., PRIAMO study group [.., Martinelli P., and ]

Subjects
Male, Pediatrics, Parkinson's disease, Nonmotor symptoms, Gastrointestinal Diseases, Anxiety, Antiparkinson Agents, Olfaction Disorders, Cognition, Quality of life, Apathy, complications/drug therapy/psychology, Depression (differential diagnoses), Fatigue, Depression, Parkinson Disease, Middle Aged, Psychiatric symptoms, Aged, Cognition Disorders, Female, Humans, Italy, Pain, Sleep Disorders, Intrinsic, Urination Disorders, Quality of Life, Neurology (clinical), Neurology, Settore MED/26 - NEUROLOGIA, epidemiology, medicine.symptom, Psychology, epidemiology/etiology/psychology, medicine.medical_specialty, Drooling, Aged, Antiparkinson Agents, therapeutic use, Anxiety, epidemiology/etiology/psychology, Cognition Disorders, epidemiology/etiology/psychology, Depression, epidemiology/etiology/psychology, Fatigue, epidemiology/etiology/psychology, Female, Gastrointestinal Diseases, epidemiology/etiology/psychology, Humans, Italy, epidemiology, Male, Middle Aged, Olfaction Disorders, epidemiology/etiology/psychology, Pain, epidemiology/etiology/psychology, Parkinson Disease, complications/drug therapy/psychology, Quality of Life, Sleep Disorders, Intrinsic, epidemiology/etiology/psychology, Urination Disorders, medicine, Nocturia, Urination disorder, medicine.disease, therapeutic use, Physical therapy, MULTICENTER STUDY, PARKINSON, Sleep Disorders
Abstract

We performed a multicenter survey using a semistructured interview in 1,072 consecutive patients with Parkinson's disease (PD) enrolled during 12 months in 55 Italian centers to assess the prevalence of nonmotor symptoms (NMSs), their association with cognitive impairment, and the impact on patients' quality of life (QoL). We found that 98.6% of patients with PD reported the presence of NMSs. The most common were as follows: fatigue (58%), anxiety (56%), leg pain (38%), insomnia (37%), urgency and nocturia (35%), drooling of saliva and difficulties in maintaining concentration (31%). The mean number of NMS per patient was 7.8 (range, 0-32). NMS in the psychiatric domain were the most frequent (67%). Frequency of NMS increased along with the disease duration and severity. Patients with cognitive impairment reported more frequently apathy, attention/memory deficit, and psychiatric symptoms. Apathy was the symptom associated with worse PDQ-39 score but also presence of fatigue, attention/memory, and psychiatric symptoms had a negative impact on QoL. These findings further support a key role for NMS in the clinical frame of PD and the need to address them specifically in clinical trials using dedicated scales.

Published
2009

11. The PRIAMO study: background, methods and recruitment

Author

Antonini, A, Colosimo, C, Marconi, R, Morgante, L, Barone, P, Priamo, Sg, Abbruzzese, Giovanni, Abrignani, M, Agnetti, V, Antonini Pezzoli, A, Avarello, T, Baratti, M, Bartolomei, L, Bentivoglio, A, Bottacchi, E, Bracco, F, Cannas, A, Capus, L, Ceravolo, M, Ceravolo, R, Ciacci, G, Cicarelli, G, Consoli, D, Cossu, G, Cuomo, T, De Pandis, M, Del Dotto, P, Gaglio, R, Giaccaglini, E, Giglia, L, Guidi, M, Iemolo, F, Lopiano, L, Luciano, R, Manfredi, M, Marini, P, Martinelli, P, Mauro, A, Meco, G, Mucchiut, M, Nastasi, G, Nordera, G, Pacchetti, C, Pederzoli, M, Pennisi, F, Perini, M, Petrone, A, Pontieri, F, Pramstaller, P, Quatrale, R, Scaglioni, A, Scala, R, Simone, P, Soliveri, P, Stanzione, P, Stocchi, F, Trianni, G, Troianiello, B, Volpe, G, Zàppia, M, Zappulla, S., Antonini, A, Colosimo, C, Marconi, R, Morgante, L, Barone, Paolo, PRIAMO study, g. r. o. u. p., Antonino A., Colosimo C., Marconi R., Morgante L., Barone P., on behalf of the PRIAMO study group [.., Martinelli P., and ]

Subjects
Male, Sleep Wake Disorders, medicine.medical_specialty, Pediatrics, Cross-sectional study, prevalence, Neurocognitive Disorders, Comorbidity, Dermatology, epidemiology, incidence, parkinsonism, Cohort Studies, Parkinsonian Disorders, Quality of life, Epidemiology, medicine, Humans, Dementia, Longitudinal Studies, Aged, business.industry, MULTICENTRIC STUDY, Patient Selection, Incidence (epidemiology), Parkinsonism, General Medicine, medicine.disease, Epidemiologic Studies, Psychiatry and Mental health, Cross-Sectional Studies, Autonomic Nervous System Diseases, Italy, Epidemiologic Research Design, MOTOR SYMPTOMS, Quality of Life, Physical therapy, Female, Neurology (clinical), PARKINSON, business, Cohort study
Abstract

PRIAMO (PaRkinson And non Motor symptOms) is an epidemiology study aimed to assess the prevalence and incidence of non-motor symptoms (NMS) in patients with parkinsonism. PRIAMO consists of two phases: (1) a transversal assessment of the prevalence of NMS and (2) a longitudinal observation with two follow-up visits at 12 and 24 months to establish the incidence of NMS. A secondary aim of PRIAMO is to study the relationship between NMS and quality of life. Patients with parkinsonism have been evaluated in 59 Neurology Centres widely distributed throughout Italy. PRIAMO has analysed a total of 1307 patients (out of 1325 initially enrolled). We expect that PRIAMO will substantially help to quantify the burden of NMS in patients with parkinsonism.

Published
2008

12. The PRIAMO study: age- and sex-related relationship between prodromal constipation and disease phenotype in early Parkinson’s disease

Author

L Grasso, Silvia Ramat, Simone Gallerini, Paolo Barone, G. Di Brigida, D. Fogli, Tommaso Scaravilli, M. Braga, Alessandra Nicoletti, M. Romeno, Paolo Martinelli, G. Gurgone, Cesare Colosimo, E. Pilleri, V. Sorbello, S. Amidei, F. Pennisi, Francesco Iemolo, Giorgio Trianni, Vincenzo Toni, E. Milan, Raffaele Palladino, D. Benincasa, Giovanni Pezzoli, M. G. Randisi, Alfredo Petrone, Arianna Guidubaldi, R. Alfano, Tania P. Avarello, A. Scaglioni, Anna Rita Bentivoglio, C. Modica, L. Ferigo, M. Manfredi, Domenico Consoli, Giuseppe Meco, Giampiero Volpe, S. Griffini, Francesca Morgante, R. Scala, G. Nordera, Angelo Antonini, G. Floris, Roberto Erro, R. Muoio, Salvatore Zappulla, Luigi Bartolomei, Edo Bottacchi, Antonio Pisani, V. Petretta, Giovanni Fabbrini, G. Ciacci, L. Maiello, G. Ceravolo, M. Di Giovanni, V. Nastasi, Rocco Quatrale, D. Tiple, Marcello Deriu, S. Lanfranchi, Marianna Capecci, Alberto Albanese, T. Cuomo, Francesco E. Pontieri, Vincenzo Moschella, G. Sciortino, F. A. De Falco, S. Biguzzi, Leonardo Lopiano, Marina Picillo, C. Alesi, D. De Gaspari, Michele Abrignani, Gabriella Santangelo, Fabrizio Stocchi, R. Luciano, M. Baratti, R. M. Giglia, Cesa Scaglione, B. Troianiello, Giovanni Abbruzzese, M. Mucchiut, F. Pepe, S. Zanini, L. Capus, N. Caravona, Giovanni Cossu, V. Agnetti, G. Albani, L. Kiferle, E. Giaccaglini, Roberto Marconi, M. Iellamo, R. Marano, D. Medici, Monica Ulivelli, G. A. Cocco, M. Perini, P. Del Dotto, Rosa M. Gaglio, Rodolfo Savica, C. Logi, G. Ciccarelli, P. Massimo, M. Pesare, Antonino Cannas, Roberto Ceravolo, P. Simone, Letterio Morgante, P. Soliveri, S. Meoni, Picillo, M., Palladino, R., Erro, R., Alfano, R., Colosimo, C., Marconi, R., Antonini, A., Barone, P., Morgante, L., Benincasa, D., Quatrale, R., Biguzzi, S., Braga, M., Ceravolo, G., Capecci, M., Meco, G., Caravona, N., Scala, R., De Falco, F. A., Pezzoli, G., De Gaspari, D., Bottacchi, E., Di Giovanni, M., Cannas, A., Floris, G., Gallerini, S., Grasso, L., Gaglio, R. M., Gurgone, G., Volpe, G., Zappulla, S., Ceravolo, R., Kiferle, L., Ramat, S., Meoni, S., Pisani, A., Moschella, V., Morgante, F., Savica, R., Pepe, F., Ciccarelli, G., Petretta, V., Giglia, R. M., Randisi, M. G., Iemolo, F., Avarello, T. P., Romeno, M., Santangelo, G., Stocchi, F., Sciortino, G., Sorbello, V., Nicoletti, A., Tiple, D., Fabbrini, G., Bentivoglio, A., Pontieri, F. E., Guidubaldi, A., Muoio, R., Toni, V., Del Dotto, P., Logi, C., Ciacci, G., Ulivelli, M., Perini, M., Lanfranchi, S., Griffini, S., Troianiello, B., Baratti, M., Amidei, S., Consoli, D., Iellamo, M., Cuomo, T., Scaglioni, A., Medici, D., Manfredi, M., Abbruzzese, G., Di Brigida, G., Cocco, G. A., Agnetti, V., Cossu, G., Deriu, M., Abrignani, M., Modica, C., Albani, G., Milan, E., Martinelli, P., Scaglione, C., Mucchiut, M., Zanini, S., Pennisi, F., Soliveri, P., Albanese, A., Massimo, P., Bartolomei, L., Capus, L., Ferigo, L., Marano, R., Nastasi, V., Luciano, R., Maiello, L., Simone, P., Fogli, D., Lopiano, L., Pesare, M., Nordera, G., Pilleri, E., Scaravilli, T., Giaccaglini, E., Alesi, C., Petrone, A., and Trianni, G.

Subjects
Male, Neurology, Parkinson's disease, Constipation, Heterogeneity, Parkinson, Phenotype, Prodromal, Sex, PROGRESSION, Disease, 0302 clinical medicine, Apathy, Neuroradiology, Original Communication, Cognition, Parkinson Disease, 030211 gastroenterology & hepatology, Female, medicine.symptom, NONMOTOR SYMPTOMS, Life Sciences & Biomedicine, PRIAMO study group, Human, medicine.medical_specialty, Clinical Neurology, Prodromal Symptoms, Prodromal Symptom, 03 medical and health sciences, Internal medicine, medicine, Humans, Clinical phenotype, Aged, Science & Technology, Neurology & Neurosurgery, business.industry, 1103 Clinical Sciences, Biomarker, medicine.disease, DYSFUNCTION, Biomarkers, Neurology (clinical), Neurosciences & Neurology, business, 1109 Neurosciences, 030217 neurology & neurosurgery
Abstract

Objectives To explore the impact of sex and age on relationship between prodromal constipation and disease phenotype in Parkinson’s disease at early stages. Methods A total of 385 Parkinson’s disease patients from the PRIAMO study were classified according to the presence of prodromal constipation and followed for 24 months. Multivariable mixed-effect models were applied. All analyses were performed separately for sex (64.1% men) and median age (different by sex: 67 years-old in men and 68 years-old in women). Results As for sex, prodromal constipation was associated with greater odds of attention/memory complaints and apathy symptoms in women only. As for age, prodromal constipation was associated with lower cognitive and higher apathy scores in older patients only. Conclusions Prodromal constipation anticipates lower cognitive performances and more severe apathy since the earliest stages in women and older patients. Sex- and age-related heterogeneity of prodromal markers of Parkinson’s disease may impact disease phenotype.

Published
2021

13. The progression of non-motor symptoms in Parkinson's disease and their contribution to motor disability and quality of life.

Author

Antonini A, Barone P, Marconi R, Morgante L, Zappulla S, Pontieri FE, Ramat S, Ceravolo MG, Meco G, Cicarelli G, Pederzoli M, Manfredi M, Ceravolo R, Mucchiut M, Volpe G, Abbruzzese G, Bottacchi E, Bartolomei L, Ciacci G, Cannas A, Randisi MG, Petrone A, Baratti M, Toni V, Cossu G, Del Dotto P, Bentivoglio AR, Abrignani M, Scala R, Pennisi F, Quatrale R, Gaglio RM, Nicoletti A, Perini M, Avarello T, Pisani A, Scaglioni A, Martinelli PE, Iemolo F, Ferigo L, Simone P, Soliveri P, Troianiello B, Consoli D, Mauro A, Lopiano L, Nastasi G, and Colosimo C

Subjects
Aged, Aged, 80 and over, Cohort Studies, Cross-Sectional Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Motor Skills Disorders epidemiology, Motor Skills Disorders psychology, Parkinson Disease epidemiology, Parkinson Disease psychology, Prospective Studies, Disability Evaluation, Disease Progression, Motor Skills Disorders diagnosis, Parkinson Disease diagnosis, Quality of Life psychology
Abstract

Non-motor symptoms are gaining relevance in Parkinson's disease (PD) management but little is known about their progression and contribution to deterioration of quality of life. We followed prospectively 707 PD patients (62 % males) for 2 years. We assessed non-motor symptoms referred to 12 different domains, each including 1-10 specific symptoms, as well as motor state (UPDRS), general cognition, and life quality. Hoehn & Yahr (H&Y) stage was used to categorize patient status (I-II mild; III moderate; IV-V severe). We found that individual non-motor symptoms had variable evolution over the 2-year follow-up with sleep, gastrointestinal, attention/memory and skin disturbances (hyperhidrosis and seborrhea) becoming more prevalent and psychiatric, cardiovascular, and respiratory disorders becoming less prevalent. Development of symptoms in the cardiovascular, apathy, urinary, psychiatric, and fatigue domains was associated with significant life-quality worsening (p < 0.0045, alpha with Bonferroni correction). During the observation period, 123 patients (17 %) worsened clinically while 584 were rated as stable. There was a fivefold greater increase in UPDRS motor score in worse compared with stable patients over 24 months (p < 0.0001 vs. baseline both in stable and worse group). The total number of reported non-motor symptoms increased over 24 months in patients with motor worsening compared to stable ones (p < 0.001). Thirty-nine patients died (3.4 % of patients evaluable at baseline) with mean age at death of 74 years. Deceased patients were older, had significantly higher H&Y stage and motor score, and reported a greater number of non-motor symptoms at baseline. In conclusion, overall non-motor symptom progression does not follow motor deterioration, is symptom-specific, and only development of specific domains negatively impacts quality of life. These results have consequences for drug studies targeting non-motor features.

Published
2012
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14. Serotonin syndrome: a reported case.

Author

Avarello TP and Cottone S

Subjects
Aged, Drug Incompatibility, Fatal Outcome, Humans, Levodopa adverse effects, Male, Monoamine Oxidase Inhibitors administration & dosage, Serotonin Agents administration & dosage, Serotonin Syndrome physiopathology, Selective Serotonin Reuptake Inhibitors adverse effects, Monoamine Oxidase Inhibitors adverse effects, Serotonin Agents adverse effects, Serotonin Syndrome chemically induced
Abstract

We describe a patient treated with SSRI and Ldopa, who developed agitation, rigidity, hyperreflexia, restlessness, autonomic instability, fever and finally death. CSF examination, MRI of the brain, laboratory investigations, except for serum CK, glycemia and WBC, were normal. His condition was thought to result from an central serotonin activity. The serotonin syndrome occurs following the use of serotomimetic agents (serotonin reuptake inhibitors, tricyclic and tetracyclic antidepressants, tryptophan alone or in combination with monoamine oxidase inhibitors).

Published
2002
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