Galvus/Metformin Combo Approved in EU for Type 2’s

European health authorities have approved Eucreas, an oral tablet combining Galvus (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes. Eucreas is the first single-tablet combination of a member of the new DPP-4 inhibitor class with metformin to be approved in the European Union. The approval comes after Novartis, the maker of Eucreas, proposed changes to the EU label recommending that liver monitoring be conducted at the start of treatment, every 3 months for the first year, and periodically thereafter. The Eucreas approval closely follows European approval of the updated label for Galvus, which was announced earlier this month.

The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and both medicines will be available in the first European countries within the next few weeks.

Studies show that more than half of patients currently taking medication to manage their type 2 diabetes are still not reaching blood glucose goals. Combination therapy usually becomes necessary due to progressive worsening of blood glucose control during the natural course of the disease.

In clinical studies, patients inadequately controlled on metformin, a commonly prescribed oral therapy for type 2 diabetes, were 4 times more likely to achieve blood glucose control by adding Galvus to their treatment compared with those who treated with metformin alone. Furthermore, Galvus when administered with metformin resulted in an additional 1.1% glucose reduction as measured by HbA1C.

In clinical trials, the addition of Galvus to metformin provided blood glucose control without weight gain and with fewer cases of hypoglycemia, side effects associated with other therapies for type 2 diabetes such as sulfonylureas or thiazolidinediones.

Eucreas has been approved for use in patients with type 2 diabetes who are inadequately controlled with metformin alone or who are being treated with Galvus and metformin as separate tablets. Eucreas is recommended for use twice-daily at a dose of either 50 mg vildagliptin/850 mg metformin or 50 mg vildagliptin/1000 mg metformin.

Saydah S et al. Poor Control of Risk Factors for Vascular Disease Among Adults With Previously Diagnosed Diabetes. JAMA. 2004;291:335-342.

Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999;281:2005-2012.

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DID YOU KNOW: Probiotics Increase Mortality Risk for Patients with Severe Acute Pancreatitis: Probiotic prophylaxis In patients with predicted severe acute pancreatitis did not reduce the risk for infectious complications and was associated with an increased risk for mortality, the New York Times reports. Of 298 patients with predicted severe acute pancreatitis, 153 were randomly assigned within 72 hours of symptom onset to receive an enterally delivered multispecies probiotic preparation, and 145 received placebo. Infectious complications developed in 30% of the patients in the probiotics group, compared with 28% of the patients in the placebo group. In all, 16% of patients on probiotics died, compared with 6% of those on placebo (2.5-fold relative risk for probiotics). The authors write that "probiotics can no longer be considered to be harmless adjuncts to enteral nutrition, especially in critically ill patients . Lancet, published online February 14, 2008

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