Drugs Xagena
The aim of this study was to evaluate the safety and tolerability of Sitagliptin ( Januvia ) 100 mg/day in elderly patients with type 2 diabetes mellitus.
A post hoc pooled analysis of 25 randomized, double-blind, parallel group clinical studies with results available as of 1 December 2011.
Patients with type 2 diabetes ( aged 65 years or older ) were randomized to Sitagliptin 100 mg/day ( n = 1,261 ) or a comparator ( n = 1,185 ) for 12 weeks to 2 years.
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.
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.
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. ( Xagena )
Round EM, et al, Drugs Aging 2014; 31: 203-214
XagenaMedicine_2014
