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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The effect of vildagliptin relative to sulphonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: The VIRTUE study
International Journal of Clinical Practice, Volume 67, No. 10, Year 2013
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Description
Aims To assess, in a real-world setting, the effect of vildagliptin compared with sulphonylurea (SU) treatment on hypoglycaemia in Muslim patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. Methods This multinational, non-interventional study, conducted in Asia and the Middle East, included Muslim adult patients with T2DM who received treatment with vildagliptin or SU as add-on to metformin or monotherapy. During a ~16-week observation period, data were collected up to 6 weeks before and 6 weeks after Ramadan fasting. The primary study objective was to compare the proportion of patients with ≥ 1 hypoglycaemic event (HE) during fasting. Results Of > 1300 patients enrolled in the study, 684 were treated with vildagliptin and 631 with SUs. Significantly fewer patients experienced ≥ 1 HE with vildagliptin compared with those receiving SUs (5.4% vs. 19.8%, respectively; p < 0.001); no vildagliptin-treated patients reported a grade 2 HE, vs. 4 SU-treated patients (p = 0.053). Mean HbA1c changes from baseline were vildagliptin: -0.24%, SUs: +0.02% (p < 0.001). Mean body weight reductions from baseline were vildagliptin: -0.76 kg, SUs: -0.13 kg (p < 0.001). A higher proportion of SU-treated patients experienced adverse events (AEs) compared with vildagliptin (22.8% vs. 10.2%). This difference was driven by hypoglycaemia as the most common AE. Conclusions In this real-world study of fasting Muslim patients with T2DM, vildagliptin was associated with significantly fewer hypoglycaemic episodes compared with SU therapy. This outcome is particularly meaningful when viewed in the context of good glycaemic and weight control observed in vildagliptin-treated patients. Vildagliptin was well tolerated in this patient population. Linked Comment: Ahmed. Int J Clin Pract 2013; 67: 933-4. © 2013 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.
Authors & Co-Authors
Al-Arouj, Monira M.
Kuwait, Dasman
Dasman Diabetes Institute
Hassoun, Ahmed A.K.
United Arab Emirates, Dubai
Dubai Diabetes Center
Medlej, Rita C.
Lebanon, Beirut
Université Saint-joseph de Beyrouth
Pathan, Md Faruque
Bangladesh, Dhaka
Birdem Hospital
Shaltout, Inass Fahiem
Egypt, Giza
Cairo University
Chawla, Manoj S.
India, Mumbai
Lina Diabetes Care
Hristoskova, Sashka
Switzerland, Basel
Novartis International ag
diTommaso, Shelley
Switzerland, Basel
Novartis International ag
Kadwa, M. Y.
Switzerland, Basel
Novartis International ag
Statistics
Citations: 80
Authors: 9
Affiliations: 7
Identifiers
Doi:
10.1111/ijcp.12243
ISSN:
13685031
e-ISSN:
17421241
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cross Sectional Study