Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies.
Author(s): Pratley RE(1), McCall T, Fleck PR, Wilson CA, Mekki Q.
Affiliation(s): Author information:
(1)Diabetes and Metabolism Translational Medicine Unit, Department of Medicine,
College of Medicine, University of Vermont. Burlington, Vermont 05403, USA.
richard.pratley@uvm.edu
Publication date & source: 2009, J Am Geriatr Soc. , 57(11):2011-9
OBJECTIVES: To compare the efficacy and safety of alogliptin, a dipeptidyl
peptidase-4 (DPP-4) enzyme inhibitor, in elderly (> or =65) and younger (<65)
patients with type 2 diabetes mellitus.
DESIGN: Pooled analysis of six randomized, double-blind, placebo-controlled
studies of alogliptin.
PARTICIPANTS: Patients aged 18 to 80 with type 2 diabetes mellitus and inadequate
glycemic control.
INTERVENTIONS: Elderly (mean age 70.0; n=455) and younger (mean age 51.8;
n=1,911) patients received alogliptin 12.5 mg (n=922), alogliptin 25 mg (n=910),
or placebo (n=534) for 26 weeks (12 weeks in a Phase 2 study). The studies
evaluated alogliptin as monotherapy and coadministered with pioglitazone,
glyburide, metformin, or insulin.
MEASUREMENTS: Efficacy endpoints included change from baseline in glycosylated
hemoglobin (HbA1c), fasting plasma glucose (FPG), weight, and lipid values.
Safety variables included hypoglycemic events, adverse events, and blood
pressure.
RESULTS: Least-squares mean HbA1c decreased from baseline by 0.7% and 0.8% in
elderly patients receiving alogliptin 12.5 and 25 mg, respectively, and 0.5% and
0.6%, respectively, in younger patients (P<.001 for both alogliptin doses vs
placebo for both age groups P=.70 for 12.5 mg and .68 for 25 mg for differences
between age groups). Results were similar for FPG. Incidence of hypoglycemia was
8.3% or less in all alogliptin groups (< or =10.5% for placebo), with no apparent
difference between elderly and younger patients. Changes in weight were
negligible in all treatment groups in both age categories. The safety profiles of
alogliptin were similar in the age and dose groups.
CONCLUSION: Alogliptin was effective and well tolerated in the elderly patients
enrolled in these studies. Improvements in HbA1c were similar to those seen in
younger patients, and no increase in the risk of hypoglycemia, weight gain, or
other adverse events was apparent in elderly patients.
|