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1. Treatment of Open-Angle Glaucoma and Ocular Hypertension with the Fixed-Dose Combination of Preservative-Free Tafluprost/Timolol: Clinical Outcomes from Ophthalmology Clinics in Italy

Author

Oddone F, Scorcia V, Iester M, Sisto D, De Cilla S, Bettin P, Cagini C, Figus M, Marchini G, Rossetti L, Rossi G, Salgarello T, Scuderi GL, and Staurenghi G

Subjects
fixed-dose combination therapy, intraocular pressure, ocular hypertension, pf tafluprost/timolol fc, preservative-free topical medication, primary open-angle glaucoma, Ophthalmology, RE1-994
Abstract

Francesco Oddone,1 Vincenzo Scorcia,2 Michele Iester,3 Dario Sisto,4 Stefano De Cilla,5 Paolo Bettin,6 Carlo Cagini,7 Michele Figus,8 Giorgio Marchini,9 Luca Rossetti,10 Gemma Rossi,11 Tommaso Salgarello,12,13 Gian Luca Scuderi,14 Giovanni Staurenghi15 On behalf of the VISIONARY Study Group (Italy)1Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy; 2Department of Ophthalmology, University Magna Græcia of Catanzaro, Catanzaro, Italy; 3Eye Clinic of Genoa, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genova, Genova, Italy; 4Ophthalmology Department, University of Bari, Bari, Italy; 5Department of Health Sciences, Eye Clinic, University of Piemonte Orientale, Novara, Italy; 6Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, Italy; 7Department of Medicine and Surgery, Ophthalmology Section, University of Perugia, Perugia, Italy; 8Ophthalmology, Department of Surgery, Medicine, Molecular and Emergency, University of Pisa, Pisa, Italy; 9Ophthalmology Unit, Department of Neurosciences, Biomedicine and Movement, University of Verona, Verona, Italy; 10Eye Clinic, San Paolo Hospital, University of Milan, Milano, Italy; 11University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; 12Ophthalmology Unit, Department of Ageing, Neurosciences, Head-Neck and Orthopaedics Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; 13Institute of Ophthalmology, Università Cattolica del Sacro Cuore, Roma, Italy; 14NESMOS Department, Ophthalmology Unit, St. Andrea Hospital, Università di Roma La Sapienza, Roma, Italy; 15Eye Clinic, Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milano, ItalyCorrespondence: Francesco Oddone, Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy, Tel + 39 06 85356727, Email oddonef@gmail.comIntroduction: The VISIONARY study examined the intraocular pressure (IOP)-lowering efficacy and tolerability of the preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in a real-world setting. The country-level data reported herein comprise the largest and first observational study of PF tafluprost/timolol FC therapy in Italy.Methods: An observational, multicenter, prospective study included adult Italian patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) demonstrating insufficient response or poor tolerability with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Treatment was switched to PF tafluprost/timolol FC therapy at baseline. Primary endpoint was the absolute mean IOP change from baseline at Month 6. Exploratory and safety endpoints included change in IOP at Weeks 4 and 12, ocular signs, symptom severity and reporting of adverse events (AEs).Results: Overall, 160 OAG/OHT patients were included. Mean ± standard deviation IOP was reduced from 19.6 ± 3.6 mmHg at baseline to 14.5 ± 2.6 mmHg at Month 6 (reduction of 5.1 ± 3.7 mmHg; 24.1%; p < 0.0001). IOP reduction was also statistically significant at Week 4 (23.1%; p < 0.0001) and Week 12 (24.7%; p < 0.0001). Based on data cutoff values for mean IOP change of ≥ 20%, ≥ 25%, ≥ 30% and ≥ 35%, respective Month 6 responder rates were 68.1%, 48.7%, 36.2% and 26.9%. Most ocular signs and symptoms were significantly reduced in severity from baseline at Month 6. Two non-serious and mild AEs were reported during the study period, among which, one AE was treatment-related (eyelash growth). &#x2003Conclusion: Italian OAG and OHT patients demonstrated a significant IOP reduction from baseline at Week 4 that was maintained over a 6-month period following a switch from topical PGA or beta-blocker monotherapy to PF tafluprost/timolol FC therapy. Severity of most ocular signs and symptoms was significantly reduced during the study period, and PF tafluprost/timolol FC was generally well tolerated.Keywords: fixed-dose combination therapy, intraocular pressure, ocular hypertension, PF tafluprost/timolol FC, preservative-free topical medication, primary open-angle glaucoma

Published
2022

6. Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)

Author

Bacharach, J., Tatham, A., Ferguson, G., Belalcazar, S., Thieme, H., Goodkin, M. L., Chen, M. Y., Guo, Q., Liu, J., Robinson, M. R., Bejanian, M., Wirta, D. L., Alezzandrini, A., Bercovich, G., Deromedis, P., Furno Sola, F., Gentile, C., Lerner, S., Lupinacci, A., Zeolite, C., Birt, C., Crichton, A., Gagne, S., Giunta, M., Harasymowycz, P., Jinapriya, D., Nicolela, M., Nixon, D., Saurel, P., Yan, D., Yuen, D., Arango, S., Martinez, A., Parra Restrepo, J. C., Korda, V., Kadlecova, J., Svacinova, J., Khairy, H., El Ibiary, H., El Sanabary, Z., Bell, K., Greslechner, R., Koch, J., Lorenz, K., Oberacher-Velten, I., Schmickler, S., Schuart, C., Bandello, F., Cagini, C., Figus, M., Mastropasqua, L., Rossetti, L., Uva, M. G., Thayanithi, S., Wells, A., Husain, R., Koh, V., Lim, D., Tin, A., Gous, P., Venter, L., Kee, C., Kook, M., Park, K. -H., Eraslan, M., Kayikcioglu, O., Yildirim, N., Bourne, R., Choudhary, A., Cordeiro, F., Dubois, V., Kirwan, J., Lim, S., Martin, K., Nithy, A., Prabhu, A., Amir, A., Barnebey, H., Beck, A., Bergstrom, L., Borisuth, N., Branch, J. D., Briggs, J., Bylsma, S., Chang, P., Christie, W., Cotter, F., Depenbusch, M., Goldberg, D. F., Greiner, J., Gupta, S., Gutmark, R., Han, Y., Heersink, S., Kahook, M., Khouri, A., Kim, J., Kushnick, H., Lin, C., Luchs, J., Maharaj, A., Mansberger, S. L., Mares, F., Miller-Ellis, E., Modi, S., Paul, M., Pitha, I., Saltzmann, R., Sato, M., Savestsky, M., Segal, B., Segal, Z., Serle, J., Sherwood, M., Singh, I., Smith, S. E., Song, J., Sorenson, R., Tenkman, L., Tekwani, N., Tubbs, C., Tyson, F., Vizzeri, G., Vold, S., Vu, Q., Warren, K. S., and Wirta, D.

Subjects
Adult, Male, medicine.medical_specialty, Intraocular pressure, genetic structures, Corneal Touch, Ocular hypertension, Glaucoma, Timolol, Young Adult, Double-Blind Method, Ophthalmology, Clinical endpoint, Humans, Medicine, Pharmacology (medical), Original Research Article, Antihypertensive Agents, Intraocular Pressure, Aged, Aged, 80 and over, Drug Implants, Dose-Response Relationship, Drug, Bimatoprost, business.industry, Middle Aged, medicine.disease, eye diseases, Female, Ocular Hypertension, sense organs, Implant, Ophthalmic Solutions, business, Glaucoma, Open-Angle, medicine.drug
Abstract

Objective To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). Results Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. Conclusions The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma. Clinicaltrials.gov Identifier NCT02250651. Supplementary Information The online version contains supplementary material available at 10.1007/s40265-021-01624-9.

Published
2021

8. Effect of COVID-19-related lockdown on ophthalmic practice in Italy: A report from 39 institutional centers

Author

Dell'Omo, Roberto, Filippelli, M., Virgili, Gianni, Bandello, F., Querques, G., Lanzetta, P., Avitabile, T., Viola, F., Reibaldi, M., Semeraro, F., Quaranta, L., Rizzo, Stanislao, Midena, E., Campagna, G., Costagliola, C., Marolo, P., Traverso, C. E., Iester, M., Cutolo, C. A., Azzolini, C., Donati, S., Premi, E., Nucci, P., Vujosevic, S., Staurenghi, G., Bottoni, F., Romano, Federica, Grosso, D., Borrelli, E., Sacconi, R., Milella, P., Ganci, S., Romano, M. R., Ricciardelli, G., Allegrini, D., Casaluci, M., Romano, D., Marchini, G., Chemello, F., Amantea, Carlotta, Frisina, R., Pilotto, E., Parrozzani, R., Veritti, D., Sarao, V., Daniele, T., Busin, M., Parmeggiani, F., De Nadai, K., Furiosi, L., Mastropasqua, R., Battaglia, B., Gironi, Marco, Gandolfi, S., Luciani, E., Mora, P., Schiavi, C., Bertaccini, Paolo Antonio, Finzi, A., Roda, M., Cagini, C., Lupidi, M., Giansanti, F., Bacherini, Daniela, Tosi, G., De Benedetto, E., Nardi, M., Figus, M., Posarelli, C., Mariotti, Cesare, Pirani, V., Nicolai, Massimo, Bonini, S., Coassin, M., Di Zazzo, A., Savastano, Maria Cristina, Savastano, Alfonso, Gambini, Gloria, Vico, U. D., Spadea, L., Iannaccone, A., Nucci, C., Ricci, F., Aiello, F., Afflitto, G. G., Mastropasqua, L., D'Onofio, G., Evangelista, F., Brescia, L., Napolitano, P., Polisena, P., Gianfrancesco, N., Trivisonno, D., Petti, F., Simonelli, F., Rossi, S., Tartaglione, A., Rosa, N., Bernardo, M. D., Iaculli, C., Valeria Bux, A., Maggiore, Giuseppe, Boscia, F., Sborgia, G., Grassi, M. O., Scorcia, V., Giannaccare, G., Parisi, Giuseppe, Cillino, S., Alaimo, F., Aragona, P., Meduri, A., Pinna, A., Sollazzo, A., Peiretti, E., Siotto, E., dell'Omo R., Virgili G., Rizzo S. (ORCID:0000-0001-6302-063X), Romano F., Amantea C., Gironi M., Bertaccini P., Bacherini D., Mariotti C., Nicolai M., Savastano M. (ORCID:0000-0003-1397-4333), Savastano A., Gambini G., Maggiore G., Parisi G., Dell'Omo, Roberto, Filippelli, M., Virgili, Gianni, Bandello, F., Querques, G., Lanzetta, P., Avitabile, T., Viola, F., Reibaldi, M., Semeraro, F., Quaranta, L., Rizzo, Stanislao, Midena, E., Campagna, G., Costagliola, C., Marolo, P., Traverso, C. E., Iester, M., Cutolo, C. A., Azzolini, C., Donati, S., Premi, E., Nucci, P., Vujosevic, S., Staurenghi, G., Bottoni, F., Romano, Federica, Grosso, D., Borrelli, E., Sacconi, R., Milella, P., Ganci, S., Romano, M. R., Ricciardelli, G., Allegrini, D., Casaluci, M., Romano, D., Marchini, G., Chemello, F., Amantea, Carlotta, Frisina, R., Pilotto, E., Parrozzani, R., Veritti, D., Sarao, V., Daniele, T., Busin, M., Parmeggiani, F., De Nadai, K., Furiosi, L., Mastropasqua, R., Battaglia, B., Gironi, Marco, Gandolfi, S., Luciani, E., Mora, P., Schiavi, C., Bertaccini, Paolo Antonio, Finzi, A., Roda, M., Cagini, C., Lupidi, M., Giansanti, F., Bacherini, Daniela, Tosi, G., De Benedetto, E., Nardi, M., Figus, M., Posarelli, C., Mariotti, Cesare, Pirani, V., Nicolai, Massimo, Bonini, S., Coassin, M., Di Zazzo, A., Savastano, Maria Cristina, Savastano, Alfonso, Gambini, Gloria, Vico, U. D., Spadea, L., Iannaccone, A., Nucci, C., Ricci, F., Aiello, F., Afflitto, G. G., Mastropasqua, L., D'Onofio, G., Evangelista, F., Brescia, L., Napolitano, P., Polisena, P., Gianfrancesco, N., Trivisonno, D., Petti, F., Simonelli, F., Rossi, S., Tartaglione, A., Rosa, N., Bernardo, M. D., Iaculli, C., Valeria Bux, A., Maggiore, Giuseppe, Boscia, F., Sborgia, G., Grassi, M. O., Scorcia, V., Giannaccare, G., Parisi, Giuseppe, Cillino, S., Alaimo, F., Aragona, P., Meduri, A., Pinna, A., Sollazzo, A., Peiretti, E., Siotto, E., dell'Omo R., Virgili G., Rizzo S. (ORCID:0000-0001-6302-063X), Romano F., Amantea C., Gironi M., Bertaccini P., Bacherini D., Mariotti C., Nicolai M., Savastano M. (ORCID:0000-0003-1397-4333), Savastano A., Gambini G., Maggiore G., and Parisi G.

Abstract

Background/objectives: To compare the number of eye surgical procedures performed in Italy in the 2 months following the beginning of lockdown (study period) because of COVID-19 epidemic with those performed in the two earlier months of the same year (intra-year control) and in the period of 2019 corresponding to the lockdown (inter-year control). Methods: Retrospective analysis of surgical procedures carried out at 39 Academic hospitals. A distinction was made between elective and urgent procedures. Intravitreal injections were also considered. Percentages for all surgical procedures and incidence rate ratios (IRR) for rhegmatogenous retinal detachment (RRD) events were calculated. A p value <0.05 was considered significant. Results: A total of 20,886 versus 55,259 and 56,640 patients underwent surgery during the lockdown versus intra-and inter-year control periods, respectively. During the lockdown, only 70% of patients for whom an operation/intravitreal injection was recommended, finally underwent surgery; the remaining patients did not attend because afraid of getting infected at the hospital (23%), taking public transportation (6.5%), or unavailable swabs (0.5%). Elective surgeries were reduced by 96.2% and 96.4%, urgent surgeries by 49.7% and 50.2%, and intravitreal injections by 48.5% and 48.6% in the lockdown period in comparison to intra-year and inter-year control periods, respectively. IRRs for RRDs during lockdown dropped significantly in comparison with intra- and inter-year control periods (CI: 0.65–0.80 and 0.61–0.75, respectively, p < 0.001 for both). Conclusion: This study provides a quantitative analysis of the reduction of eye surgical procedures performed in Italy because of the COVID-19 epidemic.

Published
2022

9. Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

Author

Oddone, F., Tanga, L., Kothy, P., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Zimina, M., Erichev, V., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Aguirrec, I. R., Lopez-Lopez, F., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Medina, J. G., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Kirwan, J., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Male, 030213 general clinical medicine, Intraocular pressure, genetic structures, Ocular hypertension, Timolol, Glaucoma, 0302 clinical medicine, Prostaglandins, Synthetic, Medicine, Pharmacology (medical), Prospective Studies, Open-angle glaucoma, media_common, Original Research, Aged, 80 and over, Fixed-dose combination, General Medicine, Middle Aged, Drug Combinations, Tolerability, 030220 oncology & carcinogenesis, Female, Glaucoma, Open-Angle, medicine.drug, medicine.medical_specialty, medicine.drug_class, Tonometry, Ocular, 03 medical and health sciences, Preservative-free topical medication, Ophthalmology, Humans, media_common.cataloged_instance, European union, Antihypertensive Agents, Intraocular Pressure, Aged, business.industry, Preservatives, Pharmaceutical, Prostaglandins F, Tafluprost, Correction, medicine.disease, eye diseases, sense organs, Prostaglandin analogue, business
Abstract

Introduction: A non-interventional, multicenter, European, prospective evaluation of the effectiveness, tolerability, and safety of a topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) demonstrating insufficient response to topical beta-receptor blockers or prostaglandin analogue (PGA) monotherapy. Methods: Mean intraocular pressure (IOP) change from baseline was measured at study visits following a switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change at month 6. Change from baseline concerning ocular signs and symptoms was also explored. Results: Analyses included 577 patients (59.6% female). Mean age (SD) was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p < 0.0001 for all visits). At month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% cutoff values for mean IOP, respectively. Significant reductions were observed concerning corneal fluorescein staining (p < 0.0001), dry eye symptoms, irritation, itching, and foreign body sensation (p < 0.001 for each parameter). Conjunctival hyperemia was significantly reduced at all study visits (p < 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) were reported, one of which was serious (status asthmaticus). Most AEs were mild to moderate in severity, and the majority had resolved or were resolving at the end of the study period. Conclusion: In clinical practice, PF tafluprost/timolol FC provided statistically and clinically significant IOP reductions in patients with OAG and OHT insufficiently controlled on or intolerant to PGA or beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and was maintained over the 6-month study period. Key symptoms of ocular surface health improved. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.

Published
2020

10. Correction to: Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment (Advances in Therapy, (2022), 39, 8, (3501-3521), 10.1007/s12325-022-02166-6)

Author

Oddone, F., Kirwan, J., Lopez-Lopez, F., Zimina, M., Fassari, C., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Erichev, V., Adbulaeva, E., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Rodriguez-Agirretxe, I., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Pharmacology (medical), General Medicine
Abstract

The authors would like to acknowledge missing data for all prior latanoprost users as a whole. The following sentence has been added to the manuscript (page 8, first paragraph): Mean (SD) reduction from baseline at Month 6 for users of all latanoprost formulations (preserved and PF) was 6.1 (4.25) mmHg (25.9%; p\0.0001). The authors have also prepared a table to summarise the change in intraocular pressure following a switch to the preservative-free tafluprost/timolol fixed-dose combination from all latanoprost formulations (preserved and preservative-free formulations). See Table 1 below.(Table Preseneted.) .The original article has been corrected.

Published
2022

11. Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment

Author

Oddone, F., Kirwan, J., Lopez-Lopez, F., Zimina, M., Fassari, C., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Erichev, V., Adbulaeva, E., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Rodriguez-Agirretxe, I., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Adult, Hyperemia, Tafluprost/timolol fixed-dose combination, Ocular hypertension, VISIONARY study, Travoprost, Preservative-free topical medication, Prostaglandin analogue monotherapy, Humans, Pharmacology (medical), Prospective Studies, Chronic, Open-angle glaucoma, Antihypertensive Agents, Intraocular Pressure, Real-world evidence, Prostaglandins A, Fatigue Syndrome, Chronic, Prostaglandins F, Glaucoma, General Medicine, Beta-blocker monotherapy, Fatigue Syndrome, Drug Combinations, Bimatoprost, Open-Angle, Timolol, Latanoprost, Glaucoma, Open-Angle
Abstract

Introduction: The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy. Methods: A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6. Results: The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p

Published
2022

13. Correction: One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy (Eye, (2020), 10.1038/s41433-020-0869-1)

Author

Bandello, F., Coassin, M., Di Zazzo, A., Rizzo, S., Biagini, I., Pozdeyeva, N., Sinitsyn, M., Verzin, A., De Rosa, P., Calabro, F., Avitabile, T., Bonfiglio, V., Fasce, F., Barraquer, R., Mateu, J. L., Kohnen, T., Carnovali, M., Malyugin, B., Aragona, P., Arvedi, P., Cagini, C., Caretti, L., Cavallini, G. M., Cillino, S., Figini, I., Franco, L. M., La Mantia, A., Laborante, A., Lanzetta, P., Marcigaglia, M., Mariotti, C., Martini, E., Mastropasqua, L., Morselli, S., Passani, F., Pece, A., Pertile, G., Pioppo, A., Pirondini, C., Prantera, M., Rapisarda, A., Romano, M. R., Scarpa, G., Schiano-Lomoriello, D., Scorcia, V., Scuderi, G., Semeraro, F., Spedale, F., Staurenghi, G., Tognetto, D., Tosi, M., Trabucchi, G., Trivella, F., Villani, E., Vento, A., Vinciguerra, P., Alio, J. L., Alfonso Sanchez, J. F., Montiel, F. A., Lorenz, K., Panova, I., Eremina, A., Ciprandi, G., Bandello, F., Coassin, M., Di Zazzo, A., Rizzo, S., Biagini, I., Pozdeyeva, N., Sinitsyn, M., Verzin, A., De Rosa, P., Calabro, F., Avitabile, T., Bonfiglio, V., Fasce, F., Barraquer, R., Mateu, J. L., Kohnen, T., Carnovali, M., Malyugin, B., Aragona, P., Arvedi, P., Cagini, C., Caretti, L., Cavallini, G. M., Cillino, S., Figini, I., Franco, L. M., La Mantia, A., Laborante, A., Lanzetta, P., Marcigaglia, M., Mariotti, C., Martini, E., Mastropasqua, L., Morselli, S., Passani, F., Pece, A., Pertile, G., Pioppo, A., Pirondini, C., Prantera, M., Rapisarda, A., Romano, M. R., Scarpa, G., Schiano-Lomoriello, D., Scorcia, V., Scuderi, G., Semeraro, F., Spedale, F., Staurenghi, G., Tognetto, D., Tosi, M., Trabucchi, G., Trivella, F., Villani, E., Vento, A., Vinciguerra, P., Alio, J. L., Alfonso Sanchez, J. F., Montiel, F. A., Lorenz, K., Panova, I., Eremina, A., and Ciprandi, G.

Subjects
not available, Drug Therapy
Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

14. Subclinical subretinal fluid detectable only by optical coherence tomography in choroidal naevi—the SON study

Author

Fung, A. T., Guan, R., Forlani, V., Y. -C., Li, Chhablani, J., Maltsev, D. S., Zur, D., Iglicki, M., Couturier, A., Shinojima, A., Almeida, A. C., Busch, C., Lupidi, M., Cagini, C., Rishi, P., Gabrielle, P. -H., Fraser-Bell, S., Amphornphruet, A., Chotcomwongse, P., Chen, Y. H., Pellegrini, M., Rodriguez-Valdez, P. J., Cebeci, Z., Giancipoli, E., Chaikitmongkol, V., Okada, M., Lains, I., Sala-Puigdollers, A., Ozimek, M., Rehak, M., and Loewenstein, A.

Subjects
medicine.medical_specialty, Skin Neoplasms, genetic structures, Physical examination, Article, chemistry.chemical_compound, Optical coherence tomography, Ophthalmology, medicine, Humans, Fluorescein Angiography, skin and connective tissue diseases, Aged, Retrospective Studies, Subclinical infection, optical coherence tomography, medicine.diagnostic_test, business.industry, Melanoma, subretinal fluid, Retrospective cohort study, Retinal, Fluorescein angiography, medicine.disease, eye diseases, Cross-Sectional Studies, chemistry, choroidal naevi—the SON study, sense organs, Subretinal fluid, business, Tomography, Optical Coherence
Abstract

BACKGROUND: Subretinal fluid is a risk factor for growth and malignant transformation of choroidal naevi, however it is unclear if this applies to subclinical fluid that is only detectable by optical coherence tomography (OCT). The objective of this study was to determine the prevalence and associations of subclinical but OCT-detectable subretinal fluid over choroidal naevi. METHODS: Cross-sectional study of 309 consecutive cases of choroidal naevi imaged by OCT between July 2017 to January 2019. Multicentre international study involving ten retinal specialist centres. All patients presenting to retinal specialists had routine clinical examination and OCT imaging. The prevalence of subclinical OCT-detectable subretinal fluid over choroidal naevi and its associations with other features known to predict growth and malignant transformation were noted and analysed. RESULTS: Of 309 identified consecutive cases, the mean patient age was 65 years, 89.3% of patients were Caucasian and 3.9% were Asian. The prevalence of subclinical but OCT-detectable subretinal fluid associated with choroidal naevi was 11.7% (36/309). Naevi with fluid were associated with larger basal diameters, greater thickness, presence of a halo, orange pigmentation, hyperautofluorescence, and hypodensity on B-scan ultrasonography. CONCLUSION AND RELEVANCE: Of choroidal naevi where subretinal fluid is not visible on clinical examination, 11.7% demonstrate subretinal fluid on OCT scans. These naevi more commonly exhibit features known to be associated with growth and transformation to melanoma. The presence of subclinical OCT-detectable fluid over choroidal naevi may assist in their risk stratification.

Published
2021

15. Correction to: Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study (Advances in Therapy, (2020), 37, 4, (1436-1451), 10.1007/s12325-020-01239-8)

Author

Oddone, F., Tanga, L., Kothy, P., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Zimina, M., Erichev, V., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Aguirrec, I. R., Lopez-Lopez, F., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Kirwan, J., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Published
2020

16. Correction: One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy (Eye, (2020), 34, 11, (2112-2122), 10.1038/s41433-020-0869-1)

Author

Bandello, F., Coassin, M., Di Zazzo, A., Rizzo, S., Biagini, I., Pozdeyeva, N., Sinitsyn, M., Verzin, A., De Rosa, P., Calabro, F., Avitabile, T., Bonfiglio, V., Fasce, F., Barraquer, R., Mateu, J. L., Kohnen, T., Carnovali, M., Malyugin, B., Aragona, P., Arvedi, P., Cagini, C., Caretti, L., Cavallini, G. M., Cillino, S., Figini, I., Franco, L. M., La Mantia, A., Laborante, A., Lanzetta, P., Marcigaglia, M., Mariotti, C., Martini, E., Mastropasqua, L., Morselli, S., Passani, F., Pece, A., Pertile, G., Pioppo, A., Pirondini, C., Prantera, M., Rapisarda, A., Romano, M. R., Scarpa, G., Schiano-Lomoriello, D., Scorcia, V., Scuderi, G., Semeraro, F., Spedale, F., Staurenghi, G., Tognetto, D., Tosi, M., Trabucchi, G., Trivella, F., Villani, E., Vento, A., Vinciguerra, P., Alio, J. L., Alfonso Sanchez, J. F., Montiel, F. A., Lorenz, K., Panova, I., Eremina, A., and Ciprandi, G.

Published
2020

20. The Effectiveness of 0.6% Povidone Iodine Eye Drops in Reducing the Conjunctival Bacterial Load and Needle Contamination in Patients Undergoing Anti-VEGF Intravitreal Injection: A Prospective, Randomized Study

Author

Reibaldi, M, Avitabile, T, Bandello, F, Longo, A, Bonfiglio, V, Russo, A, Castellino, N, Rejdak, R, Nowomiejska, K, Toro, M, Furino, C, Cillino, S, Fiore, T, Cagini, C, Grassi, P, Musumeci, R, Cocuzza, C, Martinelli, M, Fallico, M, Cocuzza, CE, Reibaldi, M, Avitabile, T, Bandello, F, Longo, A, Bonfiglio, V, Russo, A, Castellino, N, Rejdak, R, Nowomiejska, K, Toro, M, Furino, C, Cillino, S, Fiore, T, Cagini, C, Grassi, P, Musumeci, R, Cocuzza, C, Martinelli, M, Fallico, M, and Cocuzza, CE

Abstract

The study purpose was to assess the efficacy of a preservative-free 0.6% povidone iodine eye drops as perioperative prophylactic treatment for reducing conjunctival bacterial load and the rate of needle contamination in patients undergoing intravitreal anti-vascular endothelial growth factor injection. Enrolled patients were randomized to either the study group (0.6% povidone iodine, three day-prophylactic treatment before the injection) or to the control group (placebo, three day-prophylactic treatment). Conjunctival swabs were obtained before and after the prophylactic treatment in both groups. Intravitreal injections were performed in a sterile fashion. The injection needle and a control needle were collected for microbiological culture. Data from 254 and 253 eyes in the study group and control group, respectively, were analyzed. Bacterial growth from conjunctival swab cultures was significantly lower after 0.6% povidone iodine prophylaxis compared to baseline and to placebo prophylaxis (p < 0.001), showing an 82% eradication rate in the study group. No injection needle showed bacterial contamination in the study group, whereas six needles were culture-positive in the control group (p = 0.015). No serious ocular and non-ocular adverse events were recorded. The 0.6% povidone iodine solution proved an effective treatment in reducing conjunctival bacterial load and risk of needle contamination.

Published
2019

22. Intraocular lens dislocation: A novel in-situ scleral refixation technique using a 25 Gauge trocar in the anterior chamber

Author

Giansanti, F., Tartaro, R., Caporossi, Tomaso, Murro, V., Savastano, Alfonso, Barca, Francesco, Bacherini, Daniela, Fiore, T., Cagini, C., Rizzo, Stanislao, Caporossi T., Savastano A., Barca F., Bacherini D., Rizzo S. (ORCID:0000-0001-6302-063X), Giansanti, F., Tartaro, R., Caporossi, Tomaso, Murro, V., Savastano, Alfonso, Barca, Francesco, Bacherini, Daniela, Fiore, T., Cagini, C., Rizzo, Stanislao, Caporossi T., Savastano A., Barca F., Bacherini D., and Rizzo S. (ORCID:0000-0001-6302-063X)

Abstract

Objective Intraocular lens (IOL) repositioning using a closed-eye approach could be carried out in some selected cases. Our study focuses on the efficacy and safety of a IOL closed-eye repositioning technique using scleral suture, which is performed using a trocar as an intrastromal limbal guide. Methods and analysis Thirty-one eyes of 31 patients with late IOL dislocation operated on between January 2015 and May 2017 were included in this retrospective non-comparative consecutive case series study. The patients had a single-piece in-the-bag dislocation or a 3-pieces in-the-bag or out-of-the-bag dislocation. The patients underwent an anterior vitrectomy and a scleral refixation in a closed chamber using a 10/0 polypropylene suture passed through a 25 Gauge trocar inserted in the anterior chamber. Results The mean follow-up time was 19.54 months. Average preoperative best-corrected visual acuity (BCVA) was 0.73 LogMar (±0.21 SD); while average postoperative BCVA was 0.27 LogMar (±0.23 SD). Fifteen patients underwent anterior pars plana vitrectomy (PPV) while 16 patients did not; moreover, two patients underwent PPV. Six patients had an increase of postoperative intraocular pressure, two patients had postoperative decentration, two patients had postoperative cystoid macular oedema, none of the patients had major complications such as retinal detachment, choroidal detachment, malignant glaucoma, irreversible corneal decompensation and endophthalmitis. Conclusion We can affirm that our technique may be safe and useful in the case of 3-piece in-the bag or out-of the bag dislocated IOLs and also in the case of in-the-bag single-piece dislocated IOLs.

Published
2018

23. Bimanual microincision cataract surgery with implantation of the new incise® MJ14 intraocular lens through a 1.4 mm incision

Author

Cavallini, Gm, Verdina, T, De Maria, M, Fornasari, E, Torlai, G, Volante, V, Donati, S, Cagini, C., and DE MARIA, Michele

Subjects
medicine.medical_specialty, genetic structures, medicine.medical_treatment, Clear corneal incision, Intraocular lens, Astigmatism, Cataract surgery, 03 medical and health sciences, 0302 clinical medicine, lcsh:Ophthalmology, Anterior segment-optical coherence tomography, Bimanual microincision cataract surgery, Posterior capsule opacification, Ophthalmology, medicine, business.industry, Significant difference, cataract surgery, bimanual microincision cataract surgery, posterior capsule opacification, anterior segment-optical coherence tomography, intraocular lens, clear corneal incision, Microincision cataract surgery, medicine.disease, eye diseases, lcsh:RE1-994, 030221 ophthalmology & optometry, Implant, sense organs, business, 030217 neurology & neurosurgery
Abstract

AIM: To analyze the visual outcomes and the posterior capsule opacification (PCO) with the new Incise® MJ14 intraocular lens (IOL) implanted through a 1.4 mm clear corneal incision (CCI) in patients who underwent bimanual microincision cataract surgery (B-MICS). METHODS: Eighty eyes which underwent cataract surgery using B-MICS technique performed by the same experienced surgeon were included in the study: 40 eyes were implanted with an Incise® MJ14 IOL through a 1.4 mm CCI (group A) without enlargement of the main CCI, while 40 eyes were implanted with an Akreos® MI60 IOL with enlargement of the main CCI to 1.8 mm (group B). Best corrected visual acuity (BCVA), astigmatism and endothelial cell loss were evaluated before and after surgery at 7, 30d and 6mo. Anterior segment-optical coherence tomography (AS-OCT) of CCI was performed at 1, 3, 7, 30d, 6 and 18mo. PCO incidence was evaluated at 18mo using EPCO 2000 Software. RESULTS: Mean BCVA improvement and endothelial cell loss were statistically significant at 18mo in both groups with no difference between the two groups; no statistically significant difference in surgically induced astigmatism (SIA) was noticed in the two groups. At AS-OCT the only significant alterations in the CCI were endothelial gaping and local detachment of Descemet’s membrane at 1 and 7d after surgery; no statistically significant alterations were found at 1, 6 and 18mo. PCO score at 18mo was 0.03±0.07 for group A and 0.08±0.18 for group B (P=0.11) with no sign of central optic plate invasion in both groups. CONCLUSION: The implant of the new Incise® MJ14 IOL through a 1.4 mm CCI and B-MICS technique appeared to be a safe and effective procedure with rapid visual recovery. PCO rate resulted very low and the CCI presented few morphological alterations which were only detectable in the first days postoperatively and achieved fast corneal healing during the long-term follow-up.

Published
2017

27. Visual pathway involvement in multiple sclerosis: Look straight in the eyes

Author

Gaetani, L., Iaccheri, B., Cerquaglia, A., Gentili, L., Fiore, T., Di Gregorio, M., Mancini, A., Calabresi, P., Cagini, C., Sarchielli, P., Di Filippo, M., Calabresi P. (ORCID:0000-0003-0326-5509), Gaetani, L., Iaccheri, B., Cerquaglia, A., Gentili, L., Fiore, T., Di Gregorio, M., Mancini, A., Calabresi, P., Cagini, C., Sarchielli, P., Di Filippo, M., and Calabresi P. (ORCID:0000-0003-0326-5509)

Abstract

Visual symptoms are a common clinical manifestation of multiple sclerosis (MS) and are frequently due to acute optic neuritis (ON). However, the entire visual pathway can be involved throughout the disease course. We describe the case of a young MS patient who experienced visual symptoms that were eventually found to be caused by retinal periphlebitis, an inflammatory process of the anterior visual pathway, which is common during MS, but rarely symptomatic. This case reinforces the concept that in all MS patients complaining visual symptoms, a complete work-up should be performed in order to rule out possible ON mimicries.

Published
2017

31. Protein intake and urinary albumin excretion rates in the EURODIAB IDDM Complications Study

Author

Toeller, M, Buyken, A, Heitkamp, G, Brämswig, S, Mann, J, Milne, R, Gries, F. A, Keen, H, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Klischan, A, Forst, T, Schumacher, W, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, Mitchell, DAVID ROSS, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Djs, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, Manuel, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, Sivieri, P., R, Carta, Q, Petraroli, G, Papazoglu, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Henio, Ev, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Vrhovac, V., Toeller, M, Buyken, A, Heitkamp, G, Bramswig, S, Mann, J, Milne, R, Gries, Fa, Keen, H, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Klischan, A, Forst, T, Schumacher, W, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglu, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, and Vrhovac, V

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Urinary system, Physiology, Albuminuria, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetic Nephropathies, Dietary Proteins, Europe, Female, Humans, Middle Aged, Nephropathy, Protein intake, urinary albumin, Diabetic nephropathy, Excretion, Diabetes mellitus, Internal medicine, Diabetes Mellitus, Internal Medicine, Medicine, Proteinuria, business.industry, medicine.disease, Endocrinology, Blood pressure, medicine.symptom, business, Type 1, Kidney disease
Abstract

For people with insulin-dependent diabetes mellitus (IDDM) renal disease represents a life-threatening and costly complication. The EURODIAB IDDM Complications Study, a cross-sectional, clinic-based study, was designed to determine the prevalence of renal complications and putative risk factors in stratified samples of European individuals with IDDM. The present study examined the relationship between dietary protein intake and urinary albumin excretion rate (AER). Food intake was assessed centrally by a standardized 3-day dietary record. Urinary AER was determined in a central laboratory from a timed 24-h urine collection. Complete data were available from 2696 persons with IDDM from 30 centres in 16 European countries. In individuals who reported protein consumption less than 20 % of total food energy intake, mean AER was below 20 μg/min. In those in whom protein intake constituted more than 20 %, mean AER increased, a trend particularly pronounced in individuals with hypertension and/or poor metabolic control. Trends reached statistical significance for intakes of total protein (% of energy, p = 0.01) and animal protein (% of energy, p = 0.02), while no association was seen for vegetable protein (p = 0.83). These findings support the current recommendation for people with diabetes not to exceed a protein intake of 20 % of total energy. Monitoring and adjustment of dietary protein appears particularly desirable for individuals with AER exceeding 20 μg/min (approximately 30 mg/24 h), especially when arterial pressure is raised and/or diabetic control is poor. [Diabetologia (1997) 40: 1219–1226]

Published
1997

32. Repeatability of three-day dietary records in the EURODIAB IDDM Complications Study

Author

Toeller M, Buyken A, Heitkamp G, Milne R, Klischan A, Gries FA, Fuller JH, Keen H, Krans HMJ, Navalesi R, Sjolie AK, Stephenson JM, Viberti GC, Karamanos B, Tountas C, Kofinis A, Petrou K, Katsilambros N, RoussiPenessi D, Cignarelli M, Giorgino R, DeGeco ML, Ramunni I, IonescuTirgoviste C, Strachinariu R, Nicolau A, Tamas G, Kerenyi Z, Ahmed AM, Toth J, Kempler P, Muntoni S, Songini M, Stabilini M, Fossarello M, Pintus S, Ferriss B, Cronin CC, Humphreys M, Forst T, Schumacher W, Wagener W, Venhaus A, Rottiers R, Priem H, Deschoolmeester MJ, Ebeling P, Sinisalo M, Koivisto VA, IdziorWalus B, Solnica B, SzopinskaCiba L, Solnica K, Lemkes HHPJ, Jansen JJ, EltedeWever BM, NunesCorrea J, Boavida J, Carvalho R, Afonso MJ, Monteiro M, David R, Jepson E, McHardyYoung S, Betteridge DJ, Milne M, Thompson T, Michel G, Wirion R, Paquet S, Hornick H, Boulton AJM, Ashe H, Fernando DJS, Curwell J, Pozza G, Slaviero G, Comi G, Fattor B, Marchi M, Mehnert H, Nuber A, Janka H, Nichting M, Standl E, Crepaldi G, Nosadini R, Cathelineau G, Cathelineau BV, Jellal M, Grodner N, Feiss PG, Baclet N, Santeusanio F, Rosi G, Ventura MRM, Cagini C, Marino C, Penno G, Miccoli R, Nannipieri M, Manfredi S, Bertolotto A, Ghirlanda G, Manto A, Cotroneo P, Ward JD, Tesfaye S, Mody C, Rudd C, Papazoglou N, Goutzourela M, Manes C, Molinatti GM, Vitelli F, Porta M, Pagano GF, Estivi P, Sivieri R, Carta Q, Petraroli G, BenSoussan D, Fallas MC, Fallas P, Dhanaeus C, Bourgeois MD, Muggeo M, Cacciatori V, Bellavere F, Galante P, Gemma ML, Branzi P, Irsigler K, Abrahamian H, Gurdet C, Hornlein B, Willinger C, Strohner H, Just M, Walford S, Wardle EV, Henio S, Cooke H, Roglic G, Resman Z, Metelko Z, Skrabalo Z., BANDELLO , FRANCESCO, Toeller, M, Buyken, A, Heitkamp, G, Milne, R, Klischan, A, Gries, Fa, Fuller, Jh, Keen, H, Krans, Hmj, Navalesi, R, Sjolie, Ak, Stephenson, Jm, Viberti, Gc, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Forst, T, Schumacher, W, Wagener, W, Venhaus, A, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Francesco, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Manto, A, Cotroneo, P, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Papazoglou, N, Goutzourela, M, Manes, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Bourgeois, Md, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, and Skrabalo, Z.

Subjects
Dietary Fiber, medicine.medical_specialty, Alcohol Drinking, European community, Saturated fat, Population, Medicine (miscellaneous), the EURODIAB IDDM Study, Diabetes mellitus, Dietary Carbohydrates, medicine, Humans, education, education.field_of_study, Nutrition and Dietetics, business.industry, Reproducibility of Results, Repeatability, medicine.disease, Dietary Fats, Diet Records, Confidence interval, Surgery, Europe, three-day dietary records, Diabetes Mellitus, Type 1, Nutrition Assessment, Quartile, Cohort, Dietary Proteins, Energy Intake, business, Demography
Abstract

Objectives: Repeatability of a dietary method is important in determining the quality of nutritional data. It should be assessed in the population of interest. This study evaluated the repeatability of nutritional data from standardized three-day dietary records, from the clinic-based, cross-sectional multi-centre EURODIAB IDDM Complications Study. Design and Subjects: 15% of the total EURODIAB cohort was randomly selected to test the repeatability of nutritional intake data. Two three-day records, completed three weeks apart, were available for 216 diabetic patients (7.5%) representative of the total cohort. All records were analysed centrally, for intakes of protein (animal and vegetable), fat (saturated fat and cholesterol), carbohydrate, fibre, alcohol and energy. Repeatability was measured comparing mean intakes, determining the proportion of patients classified into the same/opposite quartile by the two three-day records and assessing mean differences with standard deviations (s.d.d). Results: There were no significant differences in mean energy and nutrient intakes between the first and second records. Classification of individuals into the opposite quartile occurred only in 0–4% of patients and overall about 50% (range 44–74%) of the subjects were classified into the same quartiles of intakes. Only small mean differences were found for energy intake (−156 (1633) kJ; 95% confidence limits −375, 63 kJ) and nutrients with s.d.ds comparable to intra-individual variations in the general population. The differences in energy intake were randomly distributed over the range of intakes. Conclusions: The present study demonstrates that standardized three day dietary records show a high degree of repeatability within a short period of time in a sample of European IDDM patients. The good repeatability strengthens the conclusions drawn from the nutritional data in the EURODIAB IDDM Complications Study. Sponsorship: Nutrition Co-ordinating Centre research funds, Diabetes Research Institute at Heinrich-Heine University, Dusseldorf. The EURODIAB IDDM Complications Study was supported by the European Community.

Published
1997

33. Microalbuminuria in type 1 diabetes: Rates, risk factors and glycemic threshold

Author

Chaturvedi, Nish, Bandinelli, Simona, Mangili, Ruggero, Penno, Guiseppe, Rottiers, Raoul E., Fuller, John H., Karamanos, B., Kofinis, A., Petrou, K., Giorgino, R., Giorgino, F., Picca, G., Angarano, A., De Pergola, G., Ionescu-Tirgoviste, C., Coszma, A., Songini, M., Casu, A., Pedron, M., Fossarello, M., Ferriss, J. B., Grealy, G., Keefe, D. O., White, A., Cleary, P. E., Toeller, M., Arden, C., Rottiers, R., Tuyttens, C., Priem, H., Ebeling, P., Kylliainen, M., Kyostio-Renvall, T., Idzior-Walus, B., Sieradzki, J., Cyganek, K., Lemkes, H. H. P. J., Roest, C., Nunes-Correa, J., Rogado, M. C., Gardete-Correia, L., Cardoso, M. C., Michel, G., Wirion, R., Cardillo, S., Pozza, G., Mangili, R., Asnaghi, V., Lattanzio, Rosangela, Galardi, G., Standl, E., Schaffler, B., Brand, H., Harms, A., Ben Soussan, D., Verier-Mine, O., Fuller, J. H., Holloway, J., Asbury, L., Betteridge, D. J., Cathelineau, G., Bouallouche, A., Villatte Cathelineau, B., Santeusanio, F., Rosi, G., D’ Alessandro, V., Cagini, C., Navalesi, R., Penno, G., Bandinelli, S., Miccoli, R., Ghirlanda, G., Saponara, C., Cotroneo, P., Manto, A., Minnella, A., Ward, J. D., Tesfaye, S., Eaton, S., Mody, C., Porta, M., Perin, P. Cavallo, Borra, M., Giunti, S., Papazoglou, N., Manes, Gianfranco, Muggeo, M., Iagulli, M., Irsigler, K., Abrahamian, H., Walford, S., Wardle, E. V., Sinclair, J., Hughes, S., Roglic, G., Metelko, Z., Resman, Z., Sjolie, A. -. K., Chaturvedi, N., Ferriss, B., Webb, D., Viberti, G. -. C., Swaminathan, R., Lumb, P., Collins, A., Sankaralingham, S., Aldington, S., Mortemore, T., and Lipinski, H.

Subjects
Albuminuria, Blood sugar control, Cardiovascular disease, Insulin resistance, Renal disease, Adolescent, Adult, Blood Glucose, Body Constitution, Cohort Studies, Diabetes Mellitus, Type 1, Differential Threshold, Disease Progression, Europe, Female, Follow-Up Studies, Humans, Incidence, Insulin Resistance, Male, Middle Aged, Prospective Studies, Reference Values, Risk Factors, Triglycerides, Nephrology, endocrine system diseases, urologic and male genital diseases, Gastroenterology, Waist–hip ratio, Proteinuria, Settore MED/30 - MALATTIE APPARATO VISIVO, female genital diseases and pregnancy complications, medicine.symptom, Type 1, medicine.medical_specialty, Internal medicine, Diabetes mellitus, Diabetes Mellitus, medicine, Risk factor, Glycemic, Type 1 diabetes, business.industry, nutritional and metabolic diseases, medicine.disease, Endocrinology, Microalbuminuria, business
Abstract

Microalbuminuria in type 1 diabetes: Rates, risk factors and glycemic threshold.BackgroundThe occurrence of microalbuminuria in type 1 diabetes is strongly predictive of renal and cardiovascular disease and is still likely to occur despite improvements in glycemic control. A better understanding of microalbuminuria is required to inform new interventions. We determined the incidence and risk factors for microalbuminuria [albumin excretion rate (AER) 20 to 200 μg/min] in the EURODIAB Prospective Complications Study.MethodsThis is a seven-year follow-up (between 1988 and 1991) of 1134 normoalbuminuric men and women (aged 15 to 60) with type 1 diabetes from 31 European centers. Risk factors and AER were measured centrally.ResultsThe incidence of microalbuminuria was 12.6% over 7.3 years. Independent baseline risk factors were HbA1c (7.1 vs. 6.2%, P = 0.0001) and AER (9.6 vs. 7.8 μg/min, P = 0.0001) and, independent of these, fasting triglyceride (0.99 vs. 0.88 mmol/L, P = 0.01), low-density lipoprotein cholesterol (3.5 vs. 3.2 mmol/L, P = 0.02), body mass index (24.0 vs. 23.4 kg/m2, P = 0.01), and waist to hip ratio (WHR; 0.85 vs. 0.83, P = 0.009). Triglyceride and WHR risk factors were nearly as strong as AER in predicting microalbuminuria (standardized regression effects of 1.3 for triglyceride and WHR and 1.5 for AER). Blood pressure at follow-up, but not at baseline, was also raised in those who progressed. There was no evidence of a threshold of HbA1c on microalbuminuria risk.ConclusionsThe incidence of microalbuminuria in patients with type 1 diabetes remains high, and there is no apparent glycemic threshold for it. Markers of insulin resistance, such as triglyceride and WHR, are strong risk factors. Systemic blood pressure is not raised prior to the onset of microalbuminuria.

Published
2001

35. Fibrinogen and von Willebrand factor in IDDM: relationships to lipid vascular risk factors, blood pressure, glycaemic control and urinary albumin excretion rate: the EURODIAB IDDM Complications Study

Author

Greaves, M, Malia, Rg, Goodfellow, K, Mattock, M, Stevens, Lk, Stephenson, Jm, Fuller, Jh, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Giorgino, R, Cignarelli, M, Decicco, Ml, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, D, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, Jb, Cronin, Cc, Whyte, Ae, Cleary, Pe, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Rottiers, R, Priem, H, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Brachter, J, Nunescorrea, J, Boavida, J, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Djs, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Janka, Hu, Nuber, A, Mehnert, H, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Crepaldi, G, Nosadini, R, Segato, T, Midena, E, Cipollina, Mr, Fedele, D, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, Roberto, Nannipieri, Monica, Manfredi, S, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Perin, Pc, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Skazagar, G, Kontogiannis, I, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Hughes, S, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Keen, H, Navelesi, R, Sjolie, Ak, Viberti, Gc, Ward, J, Partridge, T, John, Wg, Collins, A, Dredge, A, Sharp, R, Kohner, E, Aldington, S, Cockley, S., Greaves, M, Malia, Rg, Goodfellow, K, Mattock, M, Stevens, Lk, Stephenson, Jm, Fuller, Jh, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Giorgino, R, Cignarelli, M, Decicco, Ml, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, D, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, Jb, Cronin, Cc, Whyte, Ae, Cleary, Pe, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Rottiers, R, Priem, H, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Brachter, J, Nunescorrea, J, Boavida, J, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Dj, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Francesco, Janka, Hu, Nuber, A, Mehnert, H, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Crepaldi, G, Nosadini, R, Segato, T, Midena, E, Cipollina, Mr, Fedele, D, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Perin, Pc, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Skazagar, G, Kontogiannis, I, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Hughes, S, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Keen, H, Navelesi, R, Sjolie, Ak, Viberti, Gc, Ward, J, Partridge, T, John, Wg, Collins, A, Dredge, A, Sharp, R, Kohner, E, Aldington, S, and Cockley, S.

Subjects
Blood Glucose, Male, Glycated Hemoglobin A, Endocrinology, Diabetes and Metabolism, Blood lipids, Blood Pressure, Fibrinogen, Body Mass Index, Risk Factors, biology, Smoking, von Willebrand factor, fibrinogen, The EURODIAB IDDM Study, Europe, Cholesterol, Cardiovascular Diseases, Female, medicine.symptom, medicine.drug, Type 1, Adult, medicine.medical_specialty, HDL, LDL, Von Willebrand factor, Internal medicine, Diabetes mellitus, von Willebrand Factor, Internal Medicine, medicine, Diabetes Mellitus, Humans, Albuminuria, Cholesterol, HDL, Cholesterol, LDL, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetic Angiopathies, Triglycerides, Glycated Hemoglobin, business.industry, Vascular disease, medicine.disease, Blood pressure, Endocrinology, biology.protein, Microalbuminuria, business
Abstract

The interrelationships between fibrinogen, von Willebrand factor, a marker of vascular endothelial cell damage, and serum lipids were explored in well-characterised subjects with insulin-dependent diabetes mellitus. The 2091 subjects were enrolled into a cross-sectional, clinic-based study of complications, from 16 European countries: the EURODIAB IDDM Complications study. The anticipated significant relationships between both plasma fibrinogen and plasma von Willebrand factor concentrations and age and glycaemic control, and between fibrinogen and body mass index, were noted. Fibrinogen, adjusted for age and glycated haemoglobin concentration, was also related to smoking habits and was higher in the quartiles with highest systolic and diastolic blood pressures. There was a clustering of vascular risk factors, with a positive relationship between plasma fibrinogen and serum triglyceride concentrations in both genders and between fibrinogen and total cholesterol in males. An inverse relationship between fibrinogen and high density lipoprotein cholesterol was also apparent in males. A prominent feature was a positive relationship between both fibrinogen and von Willebrand factor and albumin excretion rate (p < 0.001 and p < 0.003 respectively) in those with retinopathy but not in these without this complication. In view of previous observations on blood pressure and albuminuria in these subjects the findings are consistent with the hypothesis that microalbuminuria and increased plasma von Willebrand factor are due to endothelial cell perturbation in response to mildly raised blood pressure in subjects with retinopathy. Fibrinogen may also contribute to microvascular disease and its relationships to lipid vascular risk factors suggest a possible pathogenic role in arterial disease in diabetes.

Published
1997

36. Nutritional intake of 2868 IDDM patients from 30 centres in Europe

Author

Toeller, M, Klischan, A, Heitkamp, G, Schumacher, W, Milne, R, Buyken, A, Karamanos, B, Gries, Fa, Fuller, Jh, Keen, H, Krans, Hmj, Navalesi, R, Sjolie, Ak, Stephenson, Jm, Viberti, Gc, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Forst, T, Wagener, W, Venhaus, A, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Lemkes, Hhpj, Janse, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Alfonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Djs, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, Roberto, Nannipieri, Monica, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Bourgeois, Md, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z., Toeller, M, Klischan, A, Heitkamp, G, Schumacher, W, Milne, R, Buyken, A, Karamanos, B, Gries, Fa, Fuller, Jh, Keen, H, Krans, Hmj, Navalesi, R, Sjolie, Ak, Stephenson, Jm, Viberti, Gc, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Forst, T, Wagener, W, Venhaus, A, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Lemkes, Hhpj, Janse, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Alfonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Francesco, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Bourgeois, Md, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, and Skrabalo, Z.

Subjects
medicine.medical_specialty, education.field_of_study, Cross-sectional study, business.industry, Endocrinology, Diabetes and Metabolism, Saturated fat, Population, Nutritional intake, IDDM patients, medicine.disease, Diet Records, Endocrinology, Internal medicine, Diabetes mellitus, Cohort, Internal Medicine, medicine, Population study, education, business, Cohort study
Abstract

The EURODIAB IDDM Complications Study, a cross-sectional, clinic-based study, was designed to measure the prevalence of diabetic complications in stratified samples of European insulin-dependent diabetic (IDDM) patients. As diet may be related to diabetic complications, nutritional intake was analysed in the study population. The aims of this first nutritional paper are to describe the nutrient intake in 2868 IDDM patients from 30 centres in 16 countries throughout Europe, to investigate the degree of regional differences in nutrient intake and to compare current intakes with recommended levels. Nutritional intake from 1458 male and 1410 female IDDM patients was assessed by a validated 3-day record (two weekdays, Sunday) and centrally analysed. Mean energy intake for all patients was 2390 +/- 707 kcal/day. Mean protein intake was 1.5 +/- 0.5 g/kg body weight. Carbohydrate intake was 43% and fibre intake 18 g/day. Alcohol intake for the total cohort was 2% of energy. Total fat contributed 38% of energy, with 14% from saturated fat. The Italian centres reported lower total and saturated fat intakes compared with other centres. Recommendations from the Diabetes and Nutrition Study Group of the EASD for total fat, saturated fatty acids and carbohydrate were only achieved by 14%, 14% and 15% of patients, respectively. The data of the present study clearly indicate current problems in the nutritional intake of European IDDM patients. These findings contribute to the definition of future targets in the nutritional management of IDDM patients, to be achieved as part of the initiatives taken by the St. Vincent Declaration action programme.

Published
1996

37. Cardiovascular disease and its risk factors in IDDM in Europe

Author

Koivisto VA, Stevens LK, Mattock M, Ebeling P, Muggeo M, Stephenson J, IdziorWalus B, Karamanos B, Tountas C, Kofinis A, Petrou K, Katsilambros N, Cignarelli M, Giorgino R, DeGeco ML, Ramunni I, IonescuTirgoviste C, Iosif CM, Pitei C, Buligescu S, Tamas G, Kerenyi Z, Ahmed AM, Toth J, Kempler P, Muntoni S, Songini M, Stabilini M, Fossarello M, Pintus S, Ferris B, Cronin CC, Toeller M, Klischan A, Forst T, Gries FA, Wagener W, Rottiers R, Priem H, Sinisalo M, Solnica B, SzopinskaCiba L, Solnica K, Krans M, Lemkes HHPJ, Jansen JJ, NunesCorrea J, Rogado C, Boavida JM, Correia LG, Michel G, Wirion R, Boulton AJM, Ashe H, Fernando DJS, Pozza G, Slaviero G, Comi B, Fattor F, Janka HU, Nuber A, Mehnert H, BenSoussan D, Fallas MC, Fallas P, Jepson E, McHardyYoung S, Fuller JH, Betteridge DJ, Milne M, Crepaldi C, Nosadini R, Cathelineau G, Cathelineau BV, Jellal M, Grodner N, Feiss PG, Santeusanio F, Rosi G, Cagini C, Marino C, Navalesi R, Penno G, Miccoli R, Nannipieri M, Stefano M, Ghirlanda G, Controneo P, Manto A, Teodonio C, Minnella A, Ward JD, Tesfaye S, Mody C, Rudd C, Molinatti GM, Vitelli F, Porta M, Pagano GF, Estivi P, Sivieri R, Carta Q, Petraroli G, Papazoglou N, Manes G, Triantaphyllou G, Ioannides A, Cacciatori V, Bellavere F, Galante P, Gemma ML, Irsigler K, Abrahamian H, Gurdet C, Hornlein B, Willinger C, Walford S, Wardle EV, Roglic G, Resman Z, Metelko Z, Skrabalo Z, Keen H, Sjolie AK, Viberti GC, Ward J, John G, Collins A, Sharp R., BANDELLO , FRANCESCO, Koivisto, Va, Stevens, Lk, Mattock, M, Ebeling, P, Muggeo, M, Stephenson, J, Idziorwalus, B, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, C, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferris, B, Cronin, Cc, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Wagener, W, Rottiers, R, Priem, H, Sinisalo, M, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, M, Lemkes, Hhpj, Jansen, Jj, Nunescorrea, J, Rogado, C, Boavida, Jm, Correia, Lg, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Dj, Pozza, G, Slaviero, G, Comi, B, Fattor, F, Bandello, Francesco, Janka, Hu, Nuber, A, Mehnert, H, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Crepaldi, C, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Stefano, M, Ghirlanda, G, Controneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Keen, H, Sjolie, Ak, Viberti, Gc, Ward, J, John, G, Collins, A, and Sharp, R.

Subjects
medicine.medical_specialty, Cross-sectional study, Endocrinology, Diabetes and Metabolism, Population, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Cardiovascular disease, EURODIAB IDDM study, 03 medical and health sciences, 0302 clinical medicine, Insulin resistance, Internal medicine, Diabetes mellitus, Internal Medicine, Medicine, Risk factor, education, Advanced and Specialized Nursing, education.field_of_study, business.industry, medicine.disease, 3. Good health, Endocrinology, Blood pressure, Albuminuria, Metabolic syndrome, medicine.symptom, business
Abstract

OBJECTIVE To study the prevalence of cardiovascular disease (CVD), its risk factors, and their associations in IDDM patients in different European countries. RESEARCH DESIGN AND METHODS The prevalence of CVD (a past history or electrocardiogram abnormalities) and its risk factors were examined in a cross-sectional study in 3,250 IDDM patients from 16 European countries (EURODIAB IDDM Complications Study). The patients were examined in 31 centers and were stratified between centers for age, sex, and duration of diabetes. The mean ± SD duration of diabetes was 14.7 ± 9.3 years. RESULTS The prevalence of CVD was 9% in men and 10% in women. The prevalence increased with age (from 6% in patients 15–29 years old to 25% in patients 45–59 years old) and with duration of diabetes. The between-center variation for the whole population was from 3 to 19%. In both sexes, fasting triglyceride concentration was higher and HDL cholesterol lower in those patients with CVD than in those without. In men, duration of diabetes was longer, waist-to-hip ratio greater, and hypertension more common in patients with CVD. In women, a greater BMI was associated with increased prevalence of CVD. There was no association between insulin dose, HbA1c level, age-adjusted rate of albumin excretion, or smoking status and CVD. Waist-to-hip ratio, particularly in men, was positively associated with age, age-adjusted HbA1c, prevalence of smoking, daily insulin dose, albumin excretion rate, and fasting triglyceride concentrations. CONCLUSIONS The overall prevalence of CVD in these IDDM patients was ∼ 10%, increasing with age and duration of diabetes and with a sixfold variation between different European centers. CVD prevalence was most strongly associated with elevated triglyceride and decreased HDL cholesterol concentrations. CVD was also associated with albuminuria, but when adjusted by age, this association vanished. Increasing waist-to-hip ratio was associated with a number of adverse characteristics, particularly in IDDM men, reflecting the metabolic syndrome previously described in other populations.

Published
1996

38. Survey on retinopathy of prematurity (ROP) in Italy

Author

Borroni, C, Carlevaro, C, Morzenti, S, De Ponti, E, Bozzetti, V, Console, V, Capobianco, S, Tagliabue, Pe, Italian ROP study Group, Dolcino, D, Gazzolo, D, Fabiani, F, Pedretti, S, Mangili, G, Iacono, G, Rossi Brunori, P, Nascimbeni, G, Spallino, L, Merazzi, D, Magaldi, R, Rinaldi, M, Priolo, E, Capris, P, Gambaro, S, Daniele, I, Osnaghi, S, Araimo, G, Piozzi, E, Mazza, M, Ilardi, L, Chiesi, C, Roversi, Mf, Cavallotti, B, Malguzzi, S, Salvia, G, Sarnelli, Mg, Ganguzza, O, Guagliano, R, Barillà, D, Bollani, L, Cagini, C, Germini, C, Gatta, A, Laborante, A, Fogli, L, Caroni, G, Anselmetti, G, Soldi, A, Ferrero, L, Maestri, Ma, Gregorutti, V, Boiti, C, Miani, F, Sonetti, P, Pignatto, S, Gusson, E, and Mansoldo, C.

Subjects
Male, congenital, hereditary, and neonatal diseases and abnormalities, Pediatrics, medicine.medical_specialty, genetic structures, Birth weight, Posterior ROP, Gestational Age, Intensive Care Units, Neonatal, Sepsis, Intensive care, retinopathy, medicine, Birth Weight, Humans, Retinopathy of Prematurity, Prospective Studies, Erythropoietin, Extremely preterm infants, business.industry, Research, Incidence (epidemiology), Retinopathy of prematurity (ROP), Infant, Newborn, Plus-disease, Gestational age, Retinopathy of prematurity, Laserterapy, medicine.disease, eye diseases, Intraventricular hemorrhage, Italy, Relative risk, Multivariate Analysis, Female, Laser Therapy, sense organs, business, Intracranial Hemorrhages, Retinopathy
Abstract

Background This study aims to investigate the incidence and the relative risk factors of retinopathy of prematurity (ROP) and posterior-ROP (P-ROP): ROP in Zone I and posterior Zone II, as well as to analyze the occurrence of surgical treatment of ROP and to evaluate the short term outcome of the disease in Italy. Methods It is a prospective multicenter observational study; all infants with a birth weight (BW) ≤ 750 g and/or a gestational age (GA) ≤27 weeks born between January 1st 2008 and December 31st 2009 in 25 III level Italian neonatal intensive care units were eligible for the study. Results 421 infants were examined: 265 (62.9%) developed ROP and 102 (24.2%) P-ROP. Following the multivariate analysis erythropoietin-therapy (p

Published
2013

39. BLOOD-PRESSURE, RETINOPATHY AND URINARY ALBUMIN EXCRETION IN IDDM - THE EURODIAB IDDM COMPLICATIONS STUDY

Author

Stephenson, Jm, Fuller, Jh, Viberti, Gc, Sjolie, Ak, Navalesi, R, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Giorgino, R, Cignarelli, M, Decicco, M, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, D, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, Jb, Cronin, Cc, Whyte, Ae, Cleary, Pe, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Wagener, W, Rottiers, R, Priem, H, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Brachter, J, Nunescorrea, J, Boavida, J, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Djs, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Mehnert, H, Nuber, A, Janka, H, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, Roberto, Nannipieri, Monica, Manfredi, S, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Perin, Pc, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Skazagar, G, Kontogiannis, I, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Hughes, S, Roglic, G, Resman, Z, Metelko, Z, and Skrabalo, Z.

Subjects
Adult, Male, medicine.medical_specialty, THE EURODIAB IDDM COMPLICATIONS STUDY, Endocrinology, Diabetes and Metabolism, Urology, Blood Pressure, Nephropathy, Diabetic nephropathy, Diastole, Reference Values, Risk Factors, Diabetes mellitus, Internal medicine, Internal Medicine, medicine, Confidence Intervals, Prevalence, Albuminuria, Humans, Age of Onset, Proteinuria, Diabetic Retinopathy, business.industry, Diabetic retinopathy, medicine.disease, Europe, Endocrinology, Blood pressure, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Female, medicine.symptom, business, Retinopathy
Abstract

Several studies have shown an association between blood pressure and nephropathy, but few have been large enough to examine whether, or how, this relation is influenced by retinopathy. We have therefore examined the independent relations of blood pressure to urinary albumin excretion and retinopathy in a cross-sectional observational study of over 3000 insulin-dependent diabetic patients (the EURODIAB IDDM Complications Study). The relation of blood pressure to urinary albumin excretion differed strikingly between patients with (46%) and without (54%) retinopathy. In those with retinopathy, mean urinary albumin excretion rate was normal (20 micrograms/min) below median diastolic pressure (75 mmHg) and increased steeply (p0.001) with blood pressure above this level. However, in patients without retinopathy, mean albumin excretion rate was normal across the range of diastolic pressure. This finding could not be explained by differences in glycaemic control or duration of diabetes between patients with and without retinopathy. These data identify a subgroup of patients whose high risk of nephropathy may reflect abnormal renal vulnerability to mildly raised blood pressure. Retinopathy is a close correlate of this vulnerability. Detection of even mild retinopathy, together with raised blood pressure, may be important in assessing nephropathy risk.

Published
1995

40. The relationship between smoking and microvascular complications in the EURODIAB IDDM Complications Study

Author

Chaturvedi, N, Stephenson, Jm, Fuller, Jh, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Giorgino, R, Cignarelli, M, Decicco, Ml, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, D, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, Jb, Cronin, Cc, Whyte, Ae, Cleary, Pe, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Wagener, W, Rottiers, Rr, Priem, H, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Brachter, J, Nunescorrea, J, Boavida, J, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Djs, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Fb, Janka, Hu, Nuber, A, Mehnert, Hm, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, Roberto, Nannipieri, Monica, Manfredi, S, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Perin, Pc, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Skazagar, G, Kontogiannis, I, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Hughes, S, Roglic, G, Resman, Z, Metelko, Z, and Skrabalo, Z.

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Adolescent, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Sex Factors, Risk Factors, Internal medicine, Diabetes mellitus, Surveys and Questionnaires, Internal Medicine, medicine, Odds Ratio, Prevalence, Albuminuria, Humans, Risk factor, Glycemic, Demography, Advanced and Specialized Nursing, Glycated Hemoglobin, Sex Characteristics, Diabetic Retinopathy, business.industry, Incidence (epidemiology), Smoking, Odds ratio, Diabetic retinopathy, Middle Aged, medicine.disease, EURODIAB IDDM COMPLICATIONS STUDY, Hypoglycemia, Surgery, SMOKING AND MICROVASCULAR COMPLICATIONS, Diabetes Mellitus, Type 1, Smoking cessation, Microalbuminuria, Female, Smoking Cessation, business, Diabetic Angiopathies
Abstract

OBJECTIVE To examine the relationship between smoking and both glycemic control and microvascular complications in patients with insulin-dependent diabetes mellitus (IDDM). RESEARCH DESIGN AND METHODS This was a prevalence survey of 3,250 men and women aged 15–60 years with IDDM from 31 diabetes centers in 16 European countries. Participants completed a questionnaire, had retinal photographs taken, and performed a 24-h urine collection. HbA1c, frequency of hypoglycemic and ketoacidotic episodes, urinary albumin excretion rates, and retinopathy were compared by smoking category. RESULTS The prevalence of smoking was 35% in men and 29% in women. Current smokers had poorer glycemic control and, among men, were more likely to have had a ketoacidotic episode than were those who never smoked. Ex-smokers had equivalent glycemic control and marginally more hypoglycemic episodes did than those who never smoked. Current smokers had a higher prevalence of microalbuminuria and total retinopathy than did those who never smoked. Ex-smokers had a higher prevalence of macroalbuminuria and proliferative retinopathy than did those who never smoked, but both had a similar prevalence of microalbuminuria. Adjustment for either current or long-term glycemic control could not fully account for these differences. CONCLUSIONS Smoking is associated with poorer glycemic control and an increased prevalence of microvascular complications compared with not smoking. Ex-smokers can achieve glycemic control equivalent to and have a prevalence of early complications similar to that of those who never smoked. We suggest that poorer glycemic control can account for some of the increased risk of complications in smokers, and that quitting smoking would be effective in reducing the incidence of complications. Urgent action is required to reduce the high smoking rates in people with IDDM.

Published
1995

43. Retinopathy and Vision Loss in Insulin-dependent Diabetes in Europe

Author

Sjølie, Anne Katrin, primary, Stephenson, Judith, additional, Aldington, Steve, additional, Kohner, Eva, additional, Janka, Hans, additional, Stevens, Lynda, additional, Fuller, John, additional, Karamanos, B., additional, Tountas, C., additional, Kofinis, A., additional, Petrou, K., additional, Katsilambros, N., additional, Cignarelli, M., additional, Giorgino, R., additional, De Geco, M.L., additional, Ramunni, I., additional, Ionescu-Tirgoviste, C., additional, Iosif, C.M., additional, Pitei, C., additional, Buligescu, S., additional, Tamas, G., additional, Kerenyi, Z., additional, Ahmed, A.M., additional, Toth, J., additional, Kempler, P., additional, Muntoni, S., additional, Songini, M., additional, Stabilini, M., additional, Fossarello, M., additional, Pintus, S., additional, Ferriss, B., additional, Cronin, C.C., additional, Toeller, M., additional, Klischan, A., additional, Forst, T., additional, Gries, F.A., additional, Rottiers, R., additional, Priem, H., additional, Ebeling, P., additional, Sinisalo, M., additional, Koivisto, V.A., additional, Idzior-Walus, B., additional, Solnica, B., additional, Szopinska-Ciba, L., additional, Solnica, K., additional, Krans, H.M.J., additional, Lemkes, H.H.P.J., additional, Jansen, J.J., additional, Nunes-Cornea, J., additional, Boavida, J., additional, Michel, G., additional, Wirion, R., additional, Boulton, A.J.M., additional, Ashe, H., additional, Fernando, D.J.S., additional, Pozza, G., additional, Slaviero, G., additional, Comi, G., additional, Fattor, B., additional, Bandello, F., additional, Mehnert, H., additional, Nuber, A., additional, Janka, H., additional, Ben Soussan, D., additional, Fallas, M.C., additional, Fallas, P., additional, Jepson, E., additional, McHardy-Young, S., additional, Fuller, J.H., additional, Betteridge, D.J., additional, Milne, M., additional, Crepaldi, G., additional, Nosadini, R., additional, Cathelineau, G., additional, Villatte Cathelineau, B., additional, Jellal, M., additional, Grodner, N., additional, Gervais Feiss, P., additional, Santeusanio, F., additional, Rosi, G., additional, Ventura, M.R.M., additional, Cagini, C., additional, Marino, C., additional, Navalesi, R., additional, Penno, G., additional, Miccoli, R., additional, Nannipieri, M., additional, Manfredi, S., additional, Ghirlanda, G., additional, Cotroneo, P., additional, Manto, A., additional, Teodonio, C., additional, Minnella, A., additional, Ward, J.D., additional, Tesfaye, S., additional, Mody, C., additional, Rudd, C., additional, Molinatti, G.M., additional, Vitelli, F., additional, Porta, M., additional, Pagano, G.F., additional, Cavallo Perin, P., additional, Estivi, P., additional, Sivieri, R., additional, Carta, Q., additional, Petraroli, G., additional, Papazoglou, N., additional, Manes, G., additional, Triantaphyllou, G., additional, Ioannides, A., additional, Muggeo, M., additional, Cacciatori, V., additional, Bellavere, F., additional, Galante, P., additional, Gemma, M.L., additional, Irsigler, K., additional, Abrahamian, H., additional, Gurdet, C., additional, Hornlein, B., additional, Willinger, C., additional, Walford, S., additional, Wardle, E.V., additional, Roglic, G., additional, Resman, Z., additional, Metelko, Z., additional, and Skrabalo, Z., additional

Published
1997
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49. Plasma levels of matrix metalloproteinase-2, -3, -10, and tissue inhibitor of metalloproteinase-1 are associated with vascular complications in patients with type 1 diabetes: the EURODIAB Prospective Complications Study

Author

Peeters, Stijn A., Engelen, Lian, Buijs, Jacqueline, Chaturvedi, Nish, Fuller, John H., Schalkwijk, Casper G., Stehouwer, Coen D, Karamanos, B., Kofinis, A., Petrou, K., Giorgino, F., Picca, G., Angarano, A., Null, de P. e. r. g. o. l. a. G., Laviola, L., Giorgino, R., Ionescu Tirgoviste, C., Coszma, A., Guja, C., Songini, M., Casu, A., Pedron, M., Pintus, S., Fossarello, M., Ferriss, J. B., Grealy, G., O'Keefe, D., Toeller, M., Arden, C., Rottiers, R., Tuyttens, C., Priem, H., Ebeling, P., Kylliainen, M., Koivisto, V. A., Idzior Walus, B., Sieradzki, J., Cyganek, K., Solnica, B., Lemkes, H. H. P. J., Lemkes Stuffken, J. C., Nunes Correa, J., Rogado, M. C., Gardete Correia, L., Cardoso, M. C., Silva, A., Boavida, J., Machado Sa Marques, M., Michel, G., Wirion, R., Cardillo, S., Pozza, G., Mangili, R., Asnaghi, V., Standl, E., Schaffler, B., Brand, H., Harms, A., Ben Soussan, M., Verier Mine, O., Fallas, P., Fallas, M. C., Fuller, J. H., Holloway, J., Asbury, L., Betteridge, D. J., Cathelineau, G., Bouallouche, A., Villatte Cathelineau, B., Santeusanio, F., Rosi, G., D'Alessandro, V., Cagini, C., Bottini, P., Reboldi, G. P., Navalesi, R., Penno, Giuseppe, Bandinelli, S., Miccoli, Roberto, Nannipieri, Monica, Ghirlanda, G., Saponara, C., Cotroneo, P., Manto, A., Minnella, A., Ward, J. D., Tesfaye, S., Eaton, S., Mody, C., Borra, M., Cavallo Perin, P., Giunti, S., Grassi, G., Pagano, G. F., Porta, M., Sivieri, R., Vitelli, F., Veglio, M., Papazoglou, N., Manes, G., Muggeo, M., Iagulli, M., Cacciatori, V., Cattedra di Malattie del Metabolismo, V., Irsigler, K., Abrahamian, H., Walford, S., Sinclair, J., Hughes, S., Mclelland, V., Ward, J., Roglic, G., Metelko, Z., Pepeonik, Z. R., Clinicum, Department of Medicine, Interne Geneeskunde, MUMC+: MA Interne Geneeskunde (3), and RS: CARIM - R3 - Vascular biology

Subjects
Male, Endocrinology, Diabetes and Metabolism, Matrix metalloproteinase, Gastroenterology, Cohort Studies, Endocrinology, Prospective Studies, Endothelial dysfunction, Original Investigation, Settore MED/30 - MALATTIE APPARATO VISIVO, Middle Aged, Cardiovascular disease, 3. Good health, Europe, Diabetes and Metabolism, Albuminuria, Retinopathy, Tissue inhibitor of metalloproteinase, Type 1 diabetes, Adult, Biomarkers, Cross-Sectional Studies, Diabetes Complications, Diabetes Mellitus, Type 1, Female, Humans, Matrix Metalloproteinase 10, Matrix Metalloproteinase 2, Matrix Metalloproteinase 3, Tissue Inhibitor of Metalloproteinase-1, Vascular Diseases, Cardiology and Cardiovascular Medicine, medicine.symptom, Type 1, medicine.medical_specialty, education, Inflammation, Diabetes mellitus, Internal medicine, medicine, Diabetes Mellitus, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, 3121 General medicine, internal medicine and other clinical medicine, business
Abstract

Background Impaired regulation of extracellular matrix remodeling by matrix metalloproteinases (MMPs) and tissue inhibitor of metalloproteinase (TIMP) may contribute to vascular complications in patients with type 1 diabetes. We investigated associations between plasma MMP-1, −2, −3, −9, −10 and TIMP-1, and cardiovascular disease (CVD) or microvascular complications in type 1 diabetic patients. We also evaluated to which extent these associations could be explained by low-grade inflammation (LGI) or endothelial dysfunction (ED). Methods 493 type 1 diabetes patients (39.5 ± 9.9 years old, 51% men) from the EURODIAB Prospective Complications Study were included. Linear regression analysis was applied to investigate differences in plasma levels of MMP-1, −2, −3, −9, −10, and TIMP-1 between patients with and without CVD, albuminuria or retinopathy. All analyses were adjusted for age, sex, duration of diabetes, Hba1c and additionally for other cardiovascular risk factors including LGI and ED. Results Patients with CVD (n = 118) showed significantly higher levels of TIMP-1 [β = 0.32 SD (95%CI: 0.12; 0.52)], but not of MMPs, than patients without CVD (n = 375). Higher plasma levels of MMP-2, MMP-3, MMP-10 and TIMP-1 were associated with higher levels of albuminuria (p-trends were 0.028, 0.004, 0.005 and 0.001, respectively). Severity of retinopathy was significantly associated with higher levels of MMP-2 (p-trend = 0.017). These associations remained significant after further adjustment for markers of LGI and ED. Conclusions These data support the hypothesis that impaired regulation of matrix remodeling by actions of MMP-2, -3 and-10 and TIMP-1 contributes to the pathogenesis of vascular complications in type 1 diabetes. Electronic supplementary material The online version of this article (doi:10.1186/s12933-015-0195-2) contains supplementary material, which is available to authorized users.

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50. Retinopathy and Vision Loss in Insulin-dependent Diabetes in Europe: The EURODIAB IDDM Complications Study

Author

Karamanos, B., Tountas, C., Kofinis, A., Petrou, K., Katsilambros, N., Cignarelli, M., Giorgino, R., De Geco, M.L., Ramunni, I., Ionescu-Tirgoviste, C., Iosif, C.M., Pitei, C., Buligescu, S., Tamas, G., Kerenyi, Z., Ahmed, A.M., Toth, J., Kempler, P., Muntoni, S., Songini, M., Stabilini, M., Fossarello, M., Pintus, S., Ferriss, B., Cronin, C.C., Toeller, M., Klischan, A., Forst, T., Gries, F.A., Rottiers, R., Priem, H., Ebeling, P., Sinisalo, M., Koivisto, V.A., Idzior-Walus, B., Solnica, B., Szopinska-Ciba, L., Solnica, K., Krans, H.M.J., Lemkes, H.H.P.J., Jansen, J.J., Nunes-Cornea, J., Boavida, J., Michel, G., Wirion, R., Boulton, A.J.M., Ashe, H., Fernando, D.J.S., Pozza, G., Slaviero, G., Comi, G., Fattor, B., Bandello, F., Mehnert, H., Nuber, A., Janka, H., Ben Soussan, D., Fallas, M.C., Fallas, P., Jepson, E., McHardy-Young, S., Fuller, J.H., Betteridge, D.J., Milne, M., Crepaldi, G., Nosadini, R., Cathelineau, G., Villatte Cathelineau, B., Jellal, M., Grodner, N., Gervais Feiss, P., Santeusanio, F., Rosi, G., Ventura, M.R.M., Cagini, C., Marino, C., Navalesi, R., Penno, G., Miccoli, R., Nannipieri, M., Manfredi, S., Ghirlanda, G., Cotroneo, P., Manto, A., Teodonio, C., Minnella, A., Ward, J.D., Tesfaye, S., Mody, C., Rudd, C., Molinatti, G.M., Vitelli, F., Porta, M., Pagano, G.F., Cavallo Perin, P., Estivi, P., Sivieri, R., Carta, Q., Petraroli, G., Papazoglou, N., Manes, G., Triantaphyllou, G., Ioannides, A., Muggeo, M., Cacciatori, V., Bellavere, F., Galante, P., Gemma, M.L., Irsigler, K., Abrahamian, H., Gurdet, C., Hornlein, B., Willinger, C., Walford, S., Wardle, E.V., Roglic, G., Resman, Z., Metelko, Z., Skrabalo, Z., Sjølie, Anne Katrin, Stephenson, Judith, Aldington, Steve, Kohner, Eva, Janka, Hans, Stevens, Lynda, and Fuller, John

Published
1997
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