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No evidence for adverse effects of vildagliptin
5 March 2010
MedWire News: Results from two meta-analyses investigating the safety profile of the dipeptidyl peptidase (DPP)-4 inhibitor vildagliptin found no evidence for increased cardiovascular, cerebrovascular, or liver-related adverse effects associated with the drug versus all comparators.
Vildagliptin, an oral antidiabetic agent that stabilizes concentrations of glucagon-like peptide and increases the secretion of insulin, has recently been approved for use in the European Union.
“The safety of any new therapeutic entity is of great importance, particularly if it is indicated for a chronic and progressive disease such as Type 2 diabetes, that requires lifelong treatment,” say researchers.
Anja Schweizer and colleagues from Novartis Pharma AG in Basel, Switzerland, assessed the cardiovascular and cerebrovascular safety of vildagliptin, while Monica Ligueros–Saylan and co-workers from Novartis Pharmaceuticals Corporation in East Hanover, New Jersey, USA, investigated possible liver-related complications associated with the drug.
Schweizer and team pooled data from 25 Phase III studies of vildagliptin used either as monotherapy or in combination with other medication. Included studies ranged in duration from 12 weeks to 2 or more years and included 1393 and 6116 patients who took vildagliptin 50 mg once or twice a day, respectively, as well as 6061 controls (placebo or active comparators).
The researchers found that patients who took vildagliptin had no increased risk for the composite endpoint of acute coronary syndrome, transient ischemic attack, stroke, and cerebrovascular death, compared with controls with, risk ratios of less than 1 for both doses.
Ligueros–Saylan and co-workers carried out a similar analysis of 38 studies in which vildagliptin was compared with placebo or other medications, with 2049 and 6116 patients treated with vildagliptin 50 mg once or twice a day, respectively, versus 6210 who received any comparator (controls).
The risks for mild hepatic enzyme elevations, mild enzyme elevations accompanied by elevated bilirubin levels, hepatic adverse events, pancreatitis-related adverse events, infections and infestations, and selected skin-related adverse events were no different in vildagliptin-treated individuals compared with controls.
The team note that patients with mild renal impairment had a higher overall incidence of any adverse event compared with controls, but no significant differences were observed between patients who took vildagliptin 50 mg twice a day and controls for these patients.
“The present data including studies of up to more than 2 years’ duration should reduce concern about several specific risks, but continued surveillance is required to ultimately determine the risk/benefit balance for vildagliptin and other incretin-based therapeutics,” conclude Ligueros-Saylan et al.
The results of both studies are published in the journal Diabetes, Obesity, and Metabolism.
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