Type 2 diabetes is so common around the world that pharmaceutical companies are very keen to develop the optimal orally-administered drug, that would earn them major profits. A variety of medications for the condition are now in the pipeline, but they have to be carefully studied before being put on the market.

One of the latest – examined by an Israeli-led international outcome study – is saxagliptin (known commercially as Onglyza). The US Food and Drug Administration (FDA) requested the outcome trials to approve the cardiovascular safety of the drug.

One of the largest studies on saxagliptin, a new drug from the incretin family, was led by researchers from Hadassah University Medical Center in Jerusalem and the TIMI study group. The researchers just released results finding no excess risk for heart attack from the pill, but also noted that there was also no reduction in the risk for heart attack and an unexpected increase in hospitalization for heart failure.

“Few diabetes drugs have been studied as thoroughly as saxagliptin,” said study co-principal investigator Prof. Itamar Raz, head of the diabetes unit at the Ein Kerem hospital. “This type of trial sets new standards for FDA-required drug safety studies.”

“Patients under saxagliptin had better blood glucose control, a reduced need for insulin and a beneficial effect on the kidney, while hypoglycemia was more frequent. Other side effects suspected of being related to this class [of drugs] – such as pancreatitis – were not found,” said Raz.

“We hope these findings will help to guide physicians and improve their ability to prescribe different diabetes drugs in a more evidence-based and datadriven way,” said study co-principal investigator Dr. Deepak Bhatt from the VA Boston Healthcare System and the TIMI study group of the cardiovascular division and Brigham and Women’s Hospital and Harvard Medical School.

The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR-TIMI 53) trial was designed to determine the effect of the diabetes drug saxagliptin, a selective dipeptidyl peptidase 4 (DPP-4) inhibitor, on cardiovascular outcome. This large, double-blind, placebo-controlled international study was conducted at 788 sites in 26 countries and included 16,492 patients with type 2 diabetes who were randomized to receive either saxagliptin or matching placebo over a median of 2.1 years of follow-up.

Treatment with all other diabetes and cardiovascular medications was left to the discretion of the treating physician.

The primary endpoint, which was a composite of cardiovascular death, nonfatal heart attack or non-fatal ischemic stroke, was similar in intervention and control groups. Researchers also report that the secondary endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina, coronary revascularization or heart failure occurred in 12.8 percent of patients who received saxagliptin group compared to 12.4% in the placebo group.

These results were presented at the European Society Cardiology 2013 Congress in Amsterdam and published simultaneously in the New England Journal of Medicine.


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