November 11, 2013

Alogliptin, the Latest DPP-4 Inhibitor

I have to be disappointed in my research sources. My (what I thought was my best source of oral medications) resources have turned out to be a big disappointment to me. I had been relying on the National Diabetes Information Clearinghouse (NDIC), which is part of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), and a division of the U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS). Apparently, the secretary of HHS, Kathleen Sebelius could care less whether the NDIC is kept up to date.

I am finding more and more information in other sources and finding it necessary to maintain separate files to keep up with many of the FDA approved oral medications. A good example of this is the latest Dipeptidyl Peptidase-4 (DPP-4) inhibitor to be licensed in the United States for the treatment of type 2 diabetes, alogliptin (Nesina, Takeda Pharmaceuticals), has been launched in 2013 and is the fourth DPP-4 inhibitor now approved for use.

“Three formulations of alogliptin were approved in January; as well as Nesina, the fixed-dose combination of alogliptin and metformin hydrochloride (Kazano) and alogliptin and pioglitazone( Oseni) are also now available in for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes. The last two are mixed or combination medications, which I missed in my blog, back on October 30 and Nesina belonged in my blog on November 1.

Embarrassed? Yes, and there may be other medications that I have let slip through the cracks. I have not included medications approved in other countries, even though I have readers in other countries. I am not prepared to monitor every medication as I do not have the resources to do this, but I do apologized for missing several approved in the USA.

DPP-4 inhibitors have recently been linked to a scare about a potential association with pancreatic cancer. The latest data, however, suggest there is no confirmed link yet, but that only time will tell whether this continues to be the case.

The alogliptin/metformin combination will carry a boxed warning about the risk for lactic acidosis. Two post marketing studies will be required for this formulation. For alogliptin/pioglitazone, the FDA is requiring enhanced pharmacovigilance for severe adverse events. And, as with pioglitazone, it will carry a boxed warning for heart failure.”

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