TRIP

Galvus licensed for use in renal impairment

MIMS News, 2012

Galvus (vildagliptin) is now suitable for use with caution in patients with type 2 diabetes and moderate or severe renal impairment.
Galvus 50mg tablets are taken once daily in combination with a sulfonylurea or twice daily in combination with metformin or a glitazone
This licence change is based on the results of a prospective 24-week double-blind study in 515 patients with renal impairment.
Participants were randomised to receive or placebo, in addition to their existing antidiabetic therapy.
Researchers found that the safety profile of vildagliptin was similar to that of placebo but vildagliptin provided a statistically and clinically significant reduction in HbA 1C levels compared with placebo.
The combination product (vildagliptin metformin) remains contraindicated in patients with creatinine clearance <60ml/min because of the metformin component.