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Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared with component monotherapy in patients with type 2 diabetes
Author(s) -
Rosenstock J.,
Kim S. W,
Baron M. A.,
Camisasca R.P.,
Cressier F.,
Couturier A.,
Dejager S.
Publication year - 2007
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/j.1463-1326.2006.00698.x
Subject(s) - pioglitazone , vildagliptin , tolerability , medicine , type 2 diabetes , combination therapy , diabetes mellitus , gastroenterology , pharmacology , linagliptin , adverse effect , urology , endocrinology
Aim: The aim of this study was to compare efficacy and tolerability of initial combination therapy with vildagliptin/pioglitazone to component monotherapy. Methods: This 24‐week, multicentre, randomized, double‐blind, active‐controlled study assessed the effects of the dipeptidyl peptidase‐4 inhibitor vildagliptin (100 mg q.d.), pioglitazone (30 mg q.d.) and vildagliptin combined with pioglitazone (100/30 mg q.d. or 50/15 mg q.d.) in 607 drug‐naive patients with type 2 diabetes (T2DM). The primary outcome measure was change from baseline in HbA 1c in patients receiving initial combination therapy compared with pioglitazone monotherapy. Results: After 24‐week treatment, adjusted mean changes in HbA 1c from baseline (approximately 8.7%) in patients receiving pioglitazone monotherapy, 50/15 mg combination, 100/30 mg combination and vildagliptin monotherapy were −1.4 ± 0.1%, −1.7 ± 0.1%, −1.9 ± 0.1% and −1.1 ± 0.1% respectively. Both low‐dose and high‐dose combinations were significantly more efficacious than pioglitazone alone (p = 0.039 and p < 0.001 respectively). Adjusted mean changes in fasting plasma glucose were −1.9 ± 0.2, −2.4 ± 0.2, −2.8 ± 0.2 and −1.3 ± 0.2 mmol/l respectively, and both combination groups were significantly more effective than pioglitazone monotherapy (p = 0.022 and p < 0.001 respectively). The overall incidence of adverse events ranged from 45.8% in the low‐dose combination to 51.6% in the pioglitazone monotherapy group. The incidence of peripheral oedema was highest in patients receiving pioglitazone monotherapy (9.3%) and lowest in those receiving low‐dose combination (3.5%). One mild hypoglycaemic event was reported by one patient receiving high‐dose combination and one patient receiving vildagliptin monotherapy. Conclusions: First‐line treatment with vildagliptin/pioglitazone combination in patients with T2DM provides better glycaemic control than either monotherapy component yet has minimal risk of hypoglycaemia and a tolerability profile comparable with component monotherapy.