September 3, 2013
Clinical Trials Offer Positive Results For Specific Class Of Diabetes Drug
redOrbit Staff & Wire Reports - Your Universe Online
While a new class of diabetes pill known as DPP-4 inhibitors does not appear to increase a person’s risk of heart attack, there is some indication that there could be other negative cardiovascular effects associated with the drugs.
“The findings also raise questions about whether drugs that only lower blood sugar, without addressing cholesterol, blood pressure or lifestyle factors, are enough to improve heart health,” Shirley S. Wang of the Wall Street Journal reported. “Previous small trials had suggested a possible benefit from lowering blood sugar.”
The SAVOR-TIMI 53 and Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trials were presented Monday at the European Society of Cardiology Congress 2013 in Amsterdam and simultaneously published in two papers in the New England Journal of Medicine (NEJM).
In the SAVOR-TIMI 53 trial, 16,492 individuals who had type 2 diabetes and were considered to be high risk of a cardiovascular event were randomized to receive either the DPP-4 inhibitor saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) or placebo, reported Larry Husten of Forbes. The study showed that the medication was able to improve the patient’s glycemic control, but did not appear to reduce their cardiovascular risk.
The EXAMINE study focused on 5,380 patients from 898 centers in 49 countries, and randomized them to receive either the anti-diabetic agent alogliptin (Nesina, Takeda Pharmaceuticals) or a placebo. The trial found that treatment with alogliptin produced a similar primary endpoint (a composite of cardiovascular death, myocardial infarction and nonfatal stroke) as placebo -- 11.3 percent for the former versus 11.8 percent for the latter.
"[EXAMINE] represents the first cardiovascular safety trial of an anti-diabetic drug in patients with acute coronary syndromes,” Dr. William B. White, a professor at the University of Connecticut School of Medicine, chairman of the study's steering committee, said in a statement.
“Hence, for those who are likely candidates for the drug in clinical practice with elevated CV risk, including those with a recent acute coronary syndrome, it is reassuring that alogliptin does not increase cardiovascular morbidity or mortality,” he added. “However, EXAMINE does not rule out longer-term benefits or risks of alogliptin with respect to cardiovascular end points as the median duration of the trial was approximately 18 months.”
Despite the mostly positive results of both studies, the slight increase in heart failure-hospitalization risk reported in saxagliptin is “a little bit concerning,” Dr. Christopher Grainger of Duke University Medical Center, who was not involved in the research, told Reuters. He added that the US Food and Drug Administration (FDA) would likely want to learn more about the drug and the potential effect it could have on a patient’s heart.
“I think what we have provided in this trial is a great deal of clarity with respect to heart-attack risk,” Deepak Bhatt, a senior physician at the Brigham & Women's Hospital in Boston who presented the SAVOR-TIMI 53 findings, told the Wall Street Journal. “But this heart-failure finding was unexpected. For that reason, it's important to be a little bit cautious in interpreting it.”