The efficacy and safety of linagliptin in elderly patients with type 2 diabetes: a pooled analysis of eight placebo-controlled clinical trials
Abstract
Objective: To evaluate the efficacy and safety of dipeptidyl peptidase-4 inhibitor, linagliptin, in subjects aged 60 years or older with type 2 diabetes mellitus (T2DM). Methods: Data from eight 24-week, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies were analyzed. Patients aged 60 years or older with T2DM were received oral linagliptin (5 mg/d) or placebo in combination with metformin, or metformin plus sulfonylurea. Efficacy was assessed by the changes in glycosylated hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline to 24 weeks of treatment. Safety endpoint included the frequency and intensity of adverse events. Results: A total of 1 421 patients (placebo 429, linagliptin 992) were included in the full analysis set (FAS). Mean ages of the subjects were (67.4±5.6) years in the linagliptin group and (66.7±5.6) years in the placebo group. Baseline HbA1c was (8.0±0.8) % in the linagliptin group and (8.1±0.9) % in the placebo group. At the end of 24-week, placebo-adjusted reduction in HbA1c in subjects with linagliptin was (0.7±0.1)% (95%CI 0.6-0.8, P<0.000 1), and placebo-adjusted reduction in FPG in subjects with linagliptin was (0.88±0.12) mmol/L(95%CI 0.65-1.11, P<0.000 1). Overall safety and tolerability in the two groups were similar. Adverse events occurred in 57.1% of patients in the placebo group and 61.1% of patients in the linagliptin group, and the incidence of adverse events leading to…
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Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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