Galvus licensed for use in renal impairment

on the 26 January 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
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

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

The most up-to-date drug information at your fingertips.

  • Get the prescribing support you need.
  • Register today for full access to the MIMS database, plus tables and guideline summaries, new and deleted products and consultation tools.
Register Now
Already Registered?

Forgotten password?

MIMS Clinics

Prescribing news and resources for key therapeutic areas, collated by the MIMS editors.

Twitter  

MIMS app

Access the full drug database and quick-reference tables on the go

Find out more