Galvus licensed for use in renal impairment

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
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 vildagliptin 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 HbA1C levels compared with placebo.

The combination product Eucreas (vildagliptin + metformin) remains contraindicated in patients with creatinine clearance <60ml/min because of the metformin component.

View Galvus drug record

View Eucreas drug record

Further information: Novartis

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