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.
Diabetes Obes Metab
; 16(11): 1078-86, 2014 Nov.
Article
in En
| MEDLINE
| ID: mdl-24865132
ABSTRACT
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Purines
/
Quinazolines
/
Blood Glucose
/
Glycated Hemoglobin
/
Diabetes Mellitus, Type 2
/
Dipeptidyl-Peptidase IV Inhibitors
/
Hypoglycemia
Type of study:
Clinical_trials
/
Incidence_studies
/
Prognostic_studies
Limits:
Aged
/
Aged80
/
Female
/
Humans
/
Male
Language:
En
Journal:
Diabetes Obes Metab
Journal subject:
ENDOCRINOLOGIA
/
METABOLISMO
Year:
2014
Document type:
Article
Affiliation country:
Austria