title: Safety of sitagliptin in elderly patients with type 2 diabetes: a pooled analysis of 25 clinical studies.
abstract: OBJECTIVE
  The aim of this study was to evaluate the safety and tolerability of sitagliptin 100 mg/day in elderly patients with type 2 diabetes.
  
  
  METHODS
  A post hoc pooled analysis of 25 randomized, double-blind, parallel group clinical studies with results available as of 1 December 2011.
  
  
  METHODS
  Multicenter, international clinical trials.
  
  
  METHODS
  Patients with type 2 diabetes aged 65 years or older.
  
  
  METHODS
  Patients were randomized to sitagliptin 100 mg/day (n = 1,261) or a comparator (n = 1,185) for 12 weeks to 2 years.
  
  
  METHODS
  In each study, investigators reported serious and non-serious adverse events that occurred during the study, and serious adverse events occurring within 14 days following the last dose of study drug. This analysis used patient-level data from each study to assess the exposure-adjusted incidence rates of specific adverse events that occurred following initiation of study drug.
  
  
  RESULTS
  Summary measures of adverse events overall were similar between the sitagliptin and non-exposed (active comparator or placebo) groups, except for higher incidences of deaths and drug-related adverse events in the non-exposed group. Incidence rates of specific adverse events were generally similar between the two groups, with the exception of hypoglycemia. A lower incidence rate of hypoglycemia was observed in the sitagliptin group compared with the non-exposed group [7.0 vs. 14.3 per 100 patient-years; difference -7.6 (95 % CI -11.2 to -4.3]), primarily due to greater use of sulfonylureas in the non-exposed group.
  
  
  CONCLUSIONS
  In this pooled safety analysis of elderly patients with type 2 diabetes, treatment with sitagliptin 100 mg/day was generally well tolerated for up to 2 years.
authors: Merck & Co., Inc., Whitehouse Station, NJ, USA, elizabeth.round@merck.com.
authors: Elizabeth M
authors: EM
authors: Round
authors: Samuel S
authors: SS
authors: Engel
authors: Gregory T
authors: GT
authors: Golm
authors: Michael J
authors: MJ
authors: Davies
authors: Keith D
authors: KD
authors: Kaufman
authors: Barry J
authors: BJ
authors: Goldstein
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D011719:Pyrazines / Q000009:adverse effects* / Q000627:therapeutic use; D000068900:Sitagliptin Phosphate; D014230:Triazoles / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D007004:Hypoglycemic Agents; D011719:Pyrazines; D014230:Triazoles; D000068900:Sitagliptin Phosphate