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| |  Alogliptin Efficacy and Tolerability for Elderly Type 2 Diabetic Patients Is Similar to That for Younger Patients: Presented at EASD By Bruce Sylvester VIENNA, Austria -- October 6, 2009 -- A pooled analysis of data from 5 randomised, placebo-controlled, phase 3 studies and 1 randomised, placebo-controlled, phase 2 study shows that the efficacy and tolerability of treatment with alogliptin is similar between elderly and non-elderly patients. “No increased risk of hypoglycaemia or other adverse events was apparent in the elderly patients,” said lead investigator Richard Pratley, MD, Diabetes and Metabolism Translational Medicine Unit, University of Vermont College of Medicine, Burlington, Vermont, at a poster presentation on October 2 here at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD). The purpose of the analysis was to compare the efficacy, safety, and tolerability of investigative alogliptin between elderly (>=65 years) and non-elderly patients. Researchers evaluated the 6 studies for efficacy and safety of alogliptin 12.5 or 25 mg once daily for up to 26 weeks in elderly patients (n = 455) and patients aged younger than 65 years (n = 1,911) The investigators compared placebo-corrected data between both alogliptin dose groups and cohorts, using standard statistical tools. In both age groups, haemoglobin A1C decreases for both doses of alogliptin were statistically larger versus placebo (P < .001). Both doses of alogliptin statistically significantly reduced fasting plasma glucose versus placebo in both elderly and non-elderly patients (P < .05). Changes in weight from baseline to week 26 were negligible in all treatment groups in both age categories. There were no clinically meaningful changes in blood pressure, creatinine clearance, or lipid results in either dose of alogliptin in either age group after 26 weeks of treatment. Notably, no significant differences appeared in the incidence of hypoglycaemia between the 2 alogliptin doses in either age group (<8.3% in all dosing and age groups). Funding for this study was provided by Takeda Pharmaceuticals. [Presentation title: Alogliptin Use in the Elderly: A Pooled Analysis From Phase 2-3 Studies. Abstract 765]
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