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Safety and efficacy of the dipeptidyl peptidase‐4 inhibitor linagliptin in elderly patients with type 2 diabetes: a comprehensive analysis of data from 1331 individuals aged ≥ 65 years
Author(s) -
Schernthaner G.,
Barnett A. H.,
Patel S.,
Hehnke U.,
von Eynatten M.,
Woerle H.J.
Publication year - 2014
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12321
Subject(s) - linagliptin , medicine , placebo , dipeptidyl peptidase 4 inhibitor , incidence (geometry) , population , type 2 diabetes , adverse effect , clinical endpoint , diabetes mellitus , clinical trial , endocrinology , physics , alternative medicine , environmental health , pathology , optics
Aims To investigate individual patient data from a comprehensive trials programme to evaluate the safety and efficacy of the dipeptidyl peptidase‐4 ( DPP ‐4) inhibitor linagliptin across a range of glucose‐lowering regimens in a large elderly population with type 2 diabetes mellitus ( T2DM ). Methods Data were pooled from individuals aged ≥65 years, who participated in seven phase III , placebo‐controlled clinical trials of linagliptin (24–52 weeks). Safety was assessed by incidence and severity of adverse events ( AEs ) with a focus on hypoglycaemia. The primary efficacy endpoint was change in glycated haemoglobin ( HbA1c ). Results In total, 841 subjects received linagliptin 5 mg once a day and 490 received placebo. At baseline, the population had a mean ± s.d. age of 71.0 ± 4.6 years and a mean HbA1c concentration of 8.0 ± 0.8%; 63.5% of subjects received ≥2 antidiabetes drugs. Overall AEs and drug‐related AEs were experienced by similar proportions of patients (linagliptin 71.3, placebo 73.3; linagliptin 18.1, placebo 19.8%, respectively). The incidence of investigator‐reported hypoglycaemia was 21.4% with linagliptin and 25.7% with placebo. Severe hypoglycaemic events were rare and there were fewer in the linagliptin group (1.0 vs. 1.8%). At week 24, the placebo‐corrected adjusted mean ± s.e. reduction in HbA1c with linagliptin was −0.62 ± 0.06% (95% CI : −0.73, −0.51). Conclusions Data from this large cohort show that linagliptin is a well‐tolerated and efficacious therapy for elderly patients with T2DM . Treatment with linagliptin may support individualized treatment goals, while effectively managing the risk of hypoglycaemia or drug‐related side effects.