title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Rudolfstiftung Hospital, Vienna, Austria.
authors.forename: G
authors.initials: G
authors.lastname: Schernthaner
authors.forename: A H
authors.initials: AH
authors.lastname: Barnett
authors.forename: S
authors.initials: S
authors.lastname: Patel
authors.forename: U
authors.initials: U
authors.lastname: Hehnke
authors.forename: M
authors.initials: M
authors.lastname: von Eynatten
authors.forename: H-J
authors.initials: HJ
authors.lastname: Woerle
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects*; D015897:Comorbidity; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects*; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000453:epidemiology; D015994:Incidence; D000069476:Linagliptin; D008297:Male; D011687:Purines / Q000008:administration & dosage* / Q000009:adverse effects; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D000069476:Linagliptin; D011687:Purines; D011799:Quinazolines; C517652:hemoglobin A1c protein, human
keywords: DPP-IV inhibitor; diabetes mellitus