title: Comparison of hypoglycaemia episodes in people with type-2 diabetes fasting in Ramazan, treated with vildaglipton or sulphonylurea: results of the Pakistani cohort of the VIRTUE study.
abstract: OBJECTIVE
  To assess the effect of vildagliptin in comparison to sulphonylurea (SU) on hypoglycaemia in Muslim patients with type 2 diabetes mellitus fasting during Ramadan.
  
  
  METHODS
  VIRTUE was a multicenter, prospective, observational study, which enrolled 244 patients from Pakistan who were re-analysed. All included patients were treated with vildagliptin (n=121) or SU (n=121) as add-on to metformin or as monotherapy for 16 weeks. The primary outcome of interest was to compare the proportion of patients with ≥1 hypoglycaemic event (HE) during fasting between vildagliptin and SU cohort. Changes in HbA1c and body weight and treatment adherence were also measured.
  
  
  RESULTS
  Of the 244 patients enrolled, 120 patients in the vildagliptin cohort (99.2%) and 119 patients in the SU cohort (98.3%) completed the study. Patients experiencing at least one HE were fewer with vildagliptin when compared with SUs (5.8% vs. 14.2%; p<0.033). The reduction in HbA1c was 0.3% with vildagliptin from a baseline of 7.6% and 0.1% with SU from a baseline of 7.4% (between-treatment difference: -0.1% p<0.054). A reduction of 0.3 kg was seen with vildagliptin treatment vs. 0.2 kg weight gain in the SU group. Adverse events were experienced by 15.7% in the vildagliptin cohort and 17.4% in the SU group.
  
  
  CONCLUSIONS
  The treatment with vildagliptin was associated with fewer hypoglycaemic events compared with SUs and was well tolerated with good glycaemic and weight control in patients with T2DM fasting during Ramadan.
authors.forename: Saeed Ahmed
authors.initials: SA
authors.lastname: Mahar
authors.forename: Mohammad Imtiaz
authors.initials: MI
authors.lastname: Hasan
authors.forename: Mohammad Imran Hasan
authors.initials: MI
authors.lastname: Khan
authors.forename: Asher
authors.initials: A
authors.lastname: Fawwad
authors.forename: Shakir
authors.initials: S
authors.lastname: Hussain
authors.forename: Neeta
authors.initials: N
authors.lastname: Maheshwary
authors.forename: Kishore
authors.initials: K
authors.lastname: Kumar
authors.forename: Ahson
authors.initials: A
authors.lastname: Siddiqi
authors.forename: Muhammad Athar
authors.initials: MA
authors.lastname: Khan
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000208:ethnology; D005215:Fasting; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007514:Islam; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D010154:Pakistan; D011759:Pyrrolidines / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D000077597:Vildagliptin
chemical_list: D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D013453:Sulfonylurea Compounds; D000077597:Vildagliptin; D000218:Adamantane