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. DESIGN: A post hoc pooled analysis of 25 randomized, double-blind, parallel group clinical studies with results available as of 1 December 2011. SETTING: Multicenter, international clinical trials. SUBJECTS:Patients with type 2 diabetes aged 65 years or older. INTERVENTIONS: Patients were randomized to sitagliptin 100 mg/day (n = 1,261) or a comparator (n = 1,185) for 12 weeks to 2 years. MAIN OUTCOME MEASURES: 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.
RCT Entities:
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. DESIGN: A post hoc pooled analysis of 25 randomized, double-blind, parallel group clinical studies with results available as of 1 December 2011. SETTING: Multicenter, international clinical trials. SUBJECTS:Patients with type 2 diabetes aged 65 years or older. INTERVENTIONS:Patients were randomized to sitagliptin 100 mg/day (n = 1,261) or a comparator (n = 1,185) for 12 weeks to 2 years. MAIN OUTCOME MEASURES: 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: J Wainstein; L Katz; S S Engel; L Xu; G T Golm; S Hussain; E A O'Neill; K D Kaufman; B J Goldstein Journal: Diabetes Obes Metab Date: 2011-12-22 Impact factor: 6.577
Authors: L Olansky; C Reasner; T L Seck; D E Williams-Herman; M Chen; L Terranella; A Mehta; K D Kaufman; B J Goldstein Journal: Diabetes Obes Metab Date: 2011-09 Impact factor: 6.577
Authors: Debora Williams-Herman; Jeremy Johnson; Rujun Teng; Edmund Luo; Michael J Davies; Keith D Kaufman; Barry J Goldstein; John M Amatruda Journal: Curr Med Res Opin Date: 2009-03 Impact factor: 2.580
Authors: Samuel S Engel; Elizabeth Round; Gregory T Golm; Keith D Kaufman; Barry J Goldstein Journal: Diabetes Ther Date: 2013-05-23 Impact factor: 2.945
Authors: Catherine C Cowie; Keith F Rust; Earl S Ford; Mark S Eberhardt; Danita D Byrd-Holt; Chaoyang Li; Desmond E Williams; Edward W Gregg; Kathleen E Bainbridge; Sharon H Saydah; Linda S Geiss Journal: Diabetes Care Date: 2008-11-18 Impact factor: 17.152