Treatment with the anti-diabetic drug alogliptin does not increase CV risk in patients with ACS

September 2, 2013

Patients with type 2 diabetes and high cardiovascular risk due to recent acute coronary syndromes had similar rates of cardiovascular events when treated with the anti-diabetic agent alogliptin compared to placebo according to results of the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial presented at the European Society of Cardiology Congress.

"Compared with placebo, treatment with alogliptin resulted in similar rates of the primary endpoint, which was a composite of cardiovascular death, , and stroke ," said the chair of the study's steering committee William B. White, MD, from the University of Connecticut School of Medicine in Farmington, Connecticut, USA.

"The findings could guide clinicians to choose among the many anti-diabetic agents available when treating patients with type 2 diabetes and very high cardiovascular risk," he suggested.

EXAMINE, designed as a non-inferiority trial, was undertaken to satisfy U.S. Food and Drug Administration requirements that new be subjected to studies to rule out cardiovascular risk.

"It represents the first cardiovascular safety trial of an anti-diabetic drug in patients with . 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 or mortality," noted Dr. White.

"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," he added.

The trial recruited 5,380 patients from 898 centers in 49 countries and randomized them to receive alogliptin or placebo, administered in a double-blind fashion along with standard-of-care treatment for and .

Due to its renal clearance, alogliptin dosing was modified according to kidney function, with 71.4% of patients receiving 25 mg, 25.7% receiving 12.5 mg, and 2.9% receiving 6.25 mg daily.

After a median follow-up of 18 months, and up to 40 months, the primary endpoint, which was a composite of , myocardial infarction, and stroke had occurred at a similar rate in alogliptin and placebo-treated patients (11.3% vs 11.8% respectively; P <0.001 for non-inferiority).

As would be expected with an antihyperglycemic agent, end-of-study glycated hemoglobin levels were significantly lower in patients on alogliptin than placebo with a mean change from baseline of -0.33% and +0.03% respectively.

Incidences of hypoglycemia, malignancy, pancreatitis, and dialysis were similar for both groups.

To date, research has yet to identify a diabetes drug that is not only safe but actually beneficial to the heart – an important issue for diabetic patients who are at high risk for cardiovascular problems.

The EXAMINE trial satisfied FDA requirements to show cardiovascular safety but built into the trial design, as a secondary objective, was an exploration for cardiac benefits which were not found.

"There is a need for safe glucose lowering therapies in patients with diabetes who are at an elevated risk for cardiovascular disease," he added. "Given the EXAMINE study design and high risk patient population evaluated, these results provide key insights to clinicians treating diabetes patients with cardiovascular disease."

Explore further: Median follow-up results from the ALTITUDE study

Related Stories

Median follow-up results from the ALTITUDE study

August 27, 2012

Preliminary results from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE) do not support administration of aliskiren on top of standard therapy with renin-angiotensin-aldosterone system (RAAS) ...

Metformin cuts cardio events in high-risk type 2 diabetes

January 8, 2013

(HealthDay)—Metformin therapy significantly reduces cardiovascular events in high-risk patients with type 2 diabetes compared to treatment with glipizide, according to a study published online Dec. 10 in Diabetes Care.

Drug may improve outcomes after heart attack

March 12, 2013

The prescription drug eplerenone appears to reduce the risk of cardiovascular mortality and heart failure after a heart attack by more than one-third, according to research presented today at the American College of Cardiology's ...

n-3 fatty acids no benefit for high-risk cardio patients

May 9, 2013

(HealthDay)—For patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who have not had a myocardial infarction, daily treatment with n-3 fatty acids does not reduce cardiovascular mortality ...

Statins reduce CV events in CAD patients with very low LDL-C

September 1, 2013

Aggressive treatment with statins reduces the risk of subsequent cardiovascular events in patients with coronary artery disease even if they have very low LDL cholesterol levels, reveals research presented at ESC Congress ...

Recommended for you

Heart attack treatment hypothesis 'busted'

July 6, 2015

Researchers have long had reason to hope that blocking the flow of calcium into the mitochondria of heart and brain cells could be one way to prevent damage caused by heart attacks and strokes. But in a study of mice engineered ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.