title: The effect of vildagliptin relative to sulphonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: the VIRTUE study.
abstract: OBJECTIVE
  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.
authors.affiliation: Dasman Diabetes Institute, Kuwait, Kuwait.
authors.forename: M
authors.initials: M
authors.lastname: Al-Arouj
authors.forename: A A K
authors.initials: AA
authors.lastname: Hassoun
authors.forename: R
authors.initials: R
authors.lastname: Medlej
authors.forename: M F
authors.initials: MF
authors.lastname: Pathan
authors.forename: I
authors.initials: I
authors.lastname: Shaltout
authors.forename: M S
authors.initials: MS
authors.lastname: Chawla
authors.forename: S
authors.initials: S
authors.lastname: Hristoskova
authors.forename: S
authors.initials: S
authors.lastname: Ditommaso
authors.forename: M Y
authors.initials: MY
authors.lastname: Kadwa
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000208:ethnology; D005215:Fasting / Q000502:physiology*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007514:Islam; D008297:Male; D055118:Medication Adherence / Q000208:ethnology; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D011446:Prospective Studies; D011759:Pyrrolidines / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D000077597:Vildagliptin; D015431:Weight Loss / Q000187:drug effects
chemical_list: D000218:Adamantane; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D013453:Sulfonylurea Compounds; D000077597:Vildagliptin