New Diabetes Drugs Still Present Risks

The search has been on for a new and improved drug treatment for type 2 diabetes that would leave the complications of Avandia in the past. That hasn’t happened.

New Class of Diabetes Drugs, DPP-4

The latest findings concern a newer class of diabetes drugs called DPP-4 that lower blood sugar. They’ve been touted as the latest and greatest improvement over Avandia which was heralded as a diabetes treatment until it was linked to a rise in heart attacks. Since 2008 it has largely been off the U.S. market and was entirely removed from the market in Europe.

Two large studies presented at an international cardiology meeting this week at least started off hopeful about the newer class of drugs, gliptins, also known as DPP-4 inhibitors because they block the protein DPP-4, which breaks down incretin, a hormone that stimulates the production of insulin. When incretin is not broken down it allows the pancreas to produce insulin which naturally keeps blood sugars in check.

The studies were conducted independent of each other, one involving more than 16,000 patients for two years, the other averaging 18 months with 5,400 patients participating.

The drugs are marketed as Onglyza (Bristol-Myers Squibb and AstraZeneca) and Nesina (Takeda Pharmaceutical) did not lower the risk of heart attack and Onglyza led to a statistically significant rate in heart-failure hospitalization, 3.5% versus 2.8% for the control group. Neither drug increased the risk of heart attack though.

DPP-4 drugs have been sold in the U.S. since 2006 and they are FDA approved. Drugs in this class include Januvia (Merck), Galvus (Novartis), Onglyza, Tradjenta (Eli Lilly and Boehringer Ingelheim). Also in developed are the generic names of dutogliptin, gemigliptin, alogliptin and Anagliptin.

Other side effects of this class of drugs include headache, skin reactions and nasopharyngitis, pancreatitis (an inflammation of the pancreas), as well as thyroid and pancreatic cancer.

Last June, a Duke University study suggested Avandia might not be as bad as first thought. Researchers, working on behalf of GSK, suggested it should be allowed back into the U.S. market even though the FDA issued guidance for industry in 2008 stating that studies for new diabetic drugs rule out the risk of heart attack.

None of this bad news has hurt sales of Ongylza at $709 million in 2012, reports Drugwatch. That pales in comparison to the blockbuster Januvia, another DPP-4 drug, with sales of $5.8 billion.

Expect to see these “darlings of diabetes treatment” soon sold as weight loss drugs since they seem to inhibit appetite.