PMID- 24001317 OWN - NLM STAT- MEDLINE DCOM- 20140430 LR - 20221207 IS - 1742-1241 (Electronic) IS - 1368-5031 (Print) IS - 1368-5031 (Linking) VI - 67 IP - 10 DP - 2013 Oct TI - The effect of vildagliptin relative to sulphonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: the VIRTUE study. PG - 957-63 LID - 10.1111/ijcp.12243 [doi] AB - 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. CI - (c) 2013 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd. FAU - Al-Arouj, M AU - Al-Arouj M AD - Dasman Diabetes Institute, Kuwait, Kuwait. FAU - Hassoun, A A K AU - Hassoun AA FAU - Medlej, R AU - Medlej R FAU - Pathan, M F AU - Pathan MF FAU - Shaltout, I AU - Shaltout I FAU - Chawla, M S AU - Chawla MS FAU - Hristoskova, S AU - Hristoskova S FAU - Ditommaso, S AU - Ditommaso S FAU - Kadwa, M Y AU - Kadwa MY LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20130903 PL - India TA - Int J Clin Pract JT - International journal of clinical practice JID - 9712381 RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Nitriles) RN - 0 (Pyrrolidines) RN - 0 (Sulfonylurea Compounds) RN - I6B4B2U96P (Vildagliptin) RN - PJY633525U (Adamantane) SB - IM CIN - Int J Clin Pract. 2013 Oct;67(10):933-4. PMID: 24073969 MH - Adamantane/*analogs & derivatives/therapeutic use MH - Aged MH - Diabetes Mellitus, Type 2/*drug therapy/ethnology MH - Fasting/*physiology MH - Female MH - Glycated Hemoglobin/metabolism MH - Humans MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/*therapeutic use MH - *Islam MH - Male MH - Medication Adherence/ethnology MH - Middle Aged MH - Nitriles/*therapeutic use MH - Prospective Studies MH - Pyrrolidines/*therapeutic use MH - Sulfonylurea Compounds/*therapeutic use MH - Vildagliptin MH - Weight Loss/drug effects PMC - PMC4230330 EDAT- 2013/09/05 06:00 MHDA- 2014/05/03 06:00 PMCR- 2014/11/13 CRDT- 2013/09/05 06:00 PHST- 2013/06/07 00:00 [received] PHST- 2013/07/09 00:00 [accepted] PHST- 2013/09/05 06:00 [entrez] PHST- 2013/09/05 06:00 [pubmed] PHST- 2014/05/03 06:00 [medline] PHST- 2014/11/13 00:00 [pmc-release] AID - 10.1111/ijcp.12243 [doi] PST - ppublish SO - Int J Clin Pract. 2013 Oct;67(10):957-63. doi: 10.1111/ijcp.12243. Epub 2013 Sep 3.