Galvus (vildagliptin) is a DPP-4 inhibitor approved for combination treatment of type-2 diabetes combined with metformin, sulfonylurea, or glitazones. The dose is 50 mg vildagliptin 1 – 2 times a day.
The interrelationships between the combination regimes have not been compared and Galvus has not been compared with the other DPP-4 inhibitor sitagliptine (Januvia).
Galvus has only been compared with monotherapy. Three randomized, double blinded, placebo controlled studies have compared the combination of vildagliptin with metformine, glimepiride or pioglitazones with the compounds alone. The studies compared the ability of the combination treatments in lowering HbA1c, compared to monotherapy with one of the drugs separately, as primary endpoint. The included patients were all being treated for diabetes mellitus, but had a poor glycaemic control. The studies lasted for 24 weeks and the difference in decline in HbA1c between the combination treatments and the monotherapy was for the metformin combination -1,10± 0,14 % with 95 % safety margins on [-1,37;-0,84].The glimepiride combination gave a difference on -0,64 ± 0,13 % [-0,90;-0,39], while the pioglitazone combination gave a difference on -0,67 ± 0,14 % [-0,94:-0,40].
Galvus costs 517 kr. for one month of treatment while Januvia costs 515 kr.
There is no evidence of the effect of vildagliptin effect on mortality and morbidity, and the combination treatment containing vildagliptin has not been compared with metformine + SU.
IRF states, that vildagliptin should be used in type-2 diabetics, which do not tolerate either metformine or SU.
Galvus was marketed the 5th of May 2008 and is under the rules of general reimbursement.