title: Effects of vildagliptin relative to sulfonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: influence of age and treatment with/without metformin in the VIRTUE study.
abstract: BACKGROUND
  VIRTUE was a prospective, observational study assessing the effectiveness and safety of vildagliptin vs sulfonylureas (SUs) (both as monotherapy and in combination with metformin) in patients with type 2 diabetes mellitus who fasted during Ramadan. A post hoc analysis was carried out to assess the effect of treatment with/without metformin and age (<65 years or ≥65 years).
  
  
  METHODS
  Patients were recruited from the Middle East and Asia. The primary end point was proportion of patients with one or more hypoglycemic event (HE) during Ramadan. Secondary end points included change from baseline in glycated hemoglobin (HbA1c), body weight, and safety.
  
  
  RESULTS
  Overall, 684 patients received vildagliptin and 631 received SUs. Most patients received dual therapy with metformin (n=1,148) and were aged <65 years (n=1,189). A few patients experienced one or more HE with vildagliptin vs SU monotherapy (6.5% vs 14.5%) and with vildagliptin + metformin vs SUs + metformin (5.3% vs 20.6%); the latter achieved statistical significance (P<0.001) in both age subgroups (<65 years: 5.5% vs 18.4%, P<0.001; ≥65 years: 2.8% vs 30.9%, P<0.001). Vildagliptin was associated with numerically greater HbA1c and body weight reductions vs SUs, regardless of the therapy type or age. A higher proportion of SU- vs vildagliptin-treated patients experienced adverse events across all subgroups.
  
  
  CONCLUSIONS
  A few patients experienced HEs with vildagliptin vs SUs regardless of age, and in patients on dual therapy. Vildagliptin ± metformin was also associated with good glycemic and weight control and was well tolerated. Vildagliptin might be a useful treatment option for patients with type 2 diabetes mellitus, particularly high-risk populations such as the elderly fasting during Ramadan.
authors.affiliation: Dubai Diabetes Centre, Dubai, UAE.
authors.forename: Ahmed Ak
authors.initials: AA
authors.lastname: Hassoun
authors.affiliation: Department of Endocrinology, BIRDEM Hospital, Dhaka, Bangladesh.
authors.forename: Md Faruque
authors.initials: MF
authors.lastname: Pathan
authors.affiliation: Department of Endocrinology, Hotel Dieu de France Hospital; Chronic Care Centre, Saint Joseph University, Beirut, Lebanon.
authors.forename: Rita C
authors.initials: RC
authors.lastname: Medlej
authors.affiliation: Dasman Diabetes Institute, Dasman, Kuwait.
authors.forename: Monira
authors.initials: M
authors.lastname: Alarouj
authors.affiliation: Faculty of Medicine, Cairo University, Cairo, Egypt.
authors.forename: Inass
authors.initials: I
authors.lastname: Shaltout
authors.affiliation: Lina Diabetes Care Centre, Mumbai, India.
authors.forename: Manoj S
authors.initials: MS
authors.lastname: Chawla
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Ditte
authors.initials: D
authors.lastname: Knap
authors.affiliation: Novartis Healthcare Private Limited, Hyderabad, India.
authors.forename: Julius A
authors.initials: JA
authors.lastname: Vaz
keywords: Ramadan; age; metformin; sulfonylurea; type 2 diabetes; vildagliptin