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FDA to Add Heart Failure Warnings to DPP-4 Type 2 Diabetes Medications

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Washington, DC Type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease, according to a recent safety review by the US Food and Drug Administration (FDA).

Saxagliptin (Onglyza, Kombiglyze XR) and alogliptin (Nesina, Kazano, Oseni) are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes.

The FDA announced that as a result of the findings, it will be adding new warnings to the labels on all saxagliptin- and alogliptin- containing medications.

The findings are from an FDA evaluation of two large clinical trials conducted in patients with heart disease. Each trial showed that more patients were hospitalized for heart failure who received saxagliptin- or alogliptin-containing medicines compared to patients who received placebo.

In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. This translates to 35 out of every 1,000 patients compared to 28 out of every 1,000 patients, respectively. Risk factors included a history of heart failure or kidney impairment.

In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group, which translates to 39 out of every 1,000 patients compared to 33 out of every 1,000 patients, respectively.

In addition to adding warnings to these medication labels, the FDA is recommending that health care professionals consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control.

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READER COMMENTS

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Good medications. In June of 2015, it was discovered that I had type 2 diabetes. By the end of the month, I was given a prescription for Metformin. I stated the ADA diet and followed it completely for several weeks but was unable to get my blood sugar below 140. With no results to how for my hard work, I panicked and called my doctor. His response? Deal with it. I began to feel that something wasn’t right and do my own research. Then I found Rachel’s blog http://myhealthlives.com/i-finally-reversed-my-diabetes/ . I read it from cover to cover and I started the diet and by the next morning, my blood sugar was 100. Since then, I have a fasting reading between the mid 70s and 80s. My doctor was so surprised at the results that, the next week, he took me off the Metformin. I lost 30 pounds in the first month and lost more than 6 inches off my waist and I’m able to work out twice a day while still having lots of energy. The truth is we can get off the drugs and help myself by trying natural methods

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