FDA Will Review Diabetes Rx for Heart Risk

Diabetes patients using saxagliptin may face greater likelihood of heart failure

/ Author:  / Reviewed by: Robert Carlson, M.D Beth Bolt, RPh

(RxWiki News) Saxagliptin is a popular diabetes medication that helps lower blood sugar levels. Because research has shown that it may worsen heart failure, the FDA plans to review data on this medication.

Approved by the U.S. Food and Drug Administration (FDA) in 2009, saxagliptin (brand name Onglyza and Kombiglyze XR) is prescribed, along with diet and exercise, for patients with type 2 diabetes.

A study published in the fall of 2013 in The New England Journal of Medicine found the medication to be related to increased hospitalization rates for heart failure. Based on these results, the FDA plans to further investigate the link between saxagliptin and heart failure.

"Ask a doctor about heart failure risks if taking saxagliptin."

Deepak Bhatt, MD, senior physician and professor from the VA Boston Healthcare System and the TIMI (Thrombolysis In Myocardial Infarction) Study Group, Cardiovascular Division, Brigham and Women’s Hospital and Harvard Medical School, and his colleagues reviewed data on 16,492 patients with type 2 diabetes who also had risk factors for heart disease.

Patients were taking either 5 mg of saxagliptin daily (or 2.5 mg daily in patients with renal, or kidney, impairment) or a matching dose of placebo.

Authors noted that patients who received saxagliptin had better control of blood sugar levels and a reduced need for insulin therapy. After meals, when blood sugar is high, the medication raises the amount of insulin produced by the body.

Saxagliptin did not appear to increase the likelihood of dying or other major cardiovascular risks, including heart attacks or strokes.

More patients in the saxagliptin group, however, were hospitalized for heart failure compared to the placebo group (3.5 percent vs. 2.8 percent). Heart failure is a condition where the heart is not pumping sufficiently to meet the body’s needs.

AstraZeneca, the manufacturer of Onglyza, supported the study and is scheduled to deliver trial data to the FDA by early March. After analyzing this research (which is considered to be “preliminary”), the FDA will report its findings to the public.

The health regulator advises patients to continue taking saxagliptin as directed, and consult with their health care professionals about questions or concerns. Health care professionals are directed to continue prescribing the medication according to label recommendations.

If you have an adverse reaction to saxagliptin, the FDA urges you to report events and side effects to MedWatch Safety Information and Adverse Event Reporting Program. To complete a report online, see the URL listed in the citations below.

The study was published in The New England Journal of Medicine and presented at the European Society Cardiology 2013 Congress in Amsterdam.

Review Date: 
February 15, 2014
Last Updated:
February 17, 2014