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Merck has announced the approval of sitagliptin plus generic metformin (Janumet), the first tablet to combine a dipeptidyl pepti-dase-4 (DPP-4) inhibitor for the treatment of type-2 diabetes. Sitagliptin (Janu-via, Merck) was approved for patients with type-2 diabetes in the U.S. in 2006 either as monotherapy or as combination therapy when added to either met-formin (Glucophage, Bristol-Myers Squibb), a glucose-lowering agent, or a thiazolidinedione such as drug rosiglitazone maleate (Avandia tablet, GlaxoSmithKline) or pioglitazone medication (Actos drug, Takeda/Eli Lilly).

Janumet is approved as an adjunct to diet and exercise to improve glycemic control in adult patients with type-2 diabetes whose glucose levels are not adequately controlled with metformin drug or sitagliptin alone or for those who are using sitagliptin and metformin. It is not indicated for type-1 diabetes or diabetic ketoacidosis.

The combination tablet targets diminished insulin release, uncontrolled production of glucose, and insulin resistance. The drug’s labeling contains a boxed warning about the risk of lactic acidosis.

More information on Janumet is presented in this month’s Pharmaceutical Approval Update column on page 290.

Metformin (Glucophage drugs , Bristol-Myers Squibb) may help protect against cancer. Researchers from the University of Dundee in the United Kingdom found a 37% reduced risk with metformin and say that their findings warrant a randomized trial. During 10 years of follow-up, cancer occurred in 297 of 4,085 patients (7.3%) new to using metformin, compared with 474 (11.6%) of 4,085 non-users.

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