The efficacy and safety of vildagliptin in patients with type 2 diabetes: a meta-analysis of randomized clinical trials.

WHAT IS KNOWN AND OBJECTIVE: Dipeptidyl peptidase-4 (DPP-4) inhibitors are a relatively new class of drugs for the management of type 2 diabetes (T2DM). Vildagliptin is an oral DPP-4 inhibitor approved in more than 70 countries. The purpose of this meta-analysis is to provide an update on the clinical efficacy and safety of vildagliptin in patients with T2DM.

METHODS: A literature search identified 30 randomized controlled trials comparing vildagliptin with comparators (placebo or other hypoglycaemic agents). Meta-analyses were conducted for HbA1c, weight, fasting plasma glucose (FPG), hypoglycaemia and other adverse events. The outcomes of HbA1c, weight and FPG were analysed as weighted mean differences (WMD), and the number of ADRs events as relative risks (RR).

RESULTS: Compared with placebo, vildagliptin lowered HbA1c {WMD, -0·77% [95% confidence interval (CI), -0·96% to -0·58%] for 100 mg/day of vildagliptin and -0·58% [95% CI, -0·72% to -0·44%] for 50 mg/day of vildagliptin}. The effect was non-inferior to thiazolidinediones, sulfonylureas and α-glycosidase inhibitors, but inferior to metformin. Compared with placebo, treatment with 50 mg/day of vildagliptin caused neutral weight changes, while 100 mg/day of vildagliptin resulted in slight weight gain [0·95 kg (95% CI, 0·73-1·17 kg)]. In addition, compared to comparators, vildagliptin was not associated with an increase in overall risk for any adverse events [RR, 0·97 (95% CI, 0·94-0·99)]. The incidence of hypoglycaemia was low with vildagliptin, and the risk with vildagliptin was not significantly different from the comparators [0·85 (95% CI, 0·49-1·47)]. The use of vildagliptin did not display any increased risks of infection [1·03 (95% CI, 0·94-1·13) for nasopharyngitis and 1·07 (95% CI, 0·90-1·27) for upper respiratory tract infection].

WHAT IS NEW AND CONCLUSION: Vildagliptin is effective in glycaemic control with a low risk of hypoglycaemia and other adverse reactions. This may have an important impact on patient adherence to this medication.