Medication does not reduce risk of recurrent CV events among patients with diabetes

March 30, 2014, The JAMA Network Journals

Use of the drug aleglitazar, which has shown the ability to lower glucose levels and have favorable effects on cholesterol, did not reduce the risk of cardiovascular death, heart attack or stroke among patients with type 2 diabetes and recent heart attack or unstable angina, according to a JAMA study released online to coincide with presentation at the 2014 American College of Cardiology Scientific Sessions.

Cardiovascular disease remains the dominant cause of death among with type 2 diabetes. No drug therapy specifically directed against diabetes nor strategy for tight glucose control has been shown to unequivocally reduce the rate of cardiovascular complications in this population, according to background information in the article. In phase 2 trials, aleglitazar significantly reduced glycated hemoglobin levels (measure of blood glucose over an extended period of time), triglycerides, and low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol (HDL-C).

A. Michael Lincoff, M.D., of the Cleveland Clinic, and colleagues conducted a phase 3 trial in which 7,226 patients hospitalized for heart attack or with were randomly assigned to receive aleglitazar or placebo daily. The AleCardio trial was conducted in 720 hospitals in 26 countries throughout North America, Latin America, Europe, and Asia-Pacific regions.

The trial was terminated early (July 2013) after an average follow-up of 104 weeks, due to lack of efficacy and a higher rate of adverse events in the aleglitazar group.

The researchers found that although aleglitazar reduced glycated hemoglobin and improved serum HDL-C and triglyceride levels, the drug did not decrease the time to , nonfatal , or nonfatal stroke (primary end points). These events occurred in 344 patients (9.5 percent) in the aleglitazar group and 360 patients (10.0 percent) in the placebo group.

Aleglitazar use was associated with increased risk of kidney abnormalities, bone fractures, gastrointestinal bleeding, and hypoglycemia (low blood sugars).

"These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk," the authors conclude.

Explore further: Development of new diabetes drug halted by maker

More information: DOI: 10.1001/jama.2014.3321

Related Stories

Development of new diabetes drug halted by maker

July 10, 2013
(HealthDay)—The development of what might have become a significant diabetes drug has been halted by its maker amid concerns that the medication raises the risk for fractures, kidney problems and heart failure in those ...

Heart risks of glucose-lowering drugs being overlooked in clinical trials

March 12, 2014
Why is heart failure not more rigorously assessed in clinical trials of antidiabetes drugs? In a Personal View, published in The Lancet Diabetes & Endocrinology journal, Professor John McMurray of The University of Glasgow ...

Among patients with recent ACS, use of enzyme inhibitor does not reduce risk of cardiovascular event

November 18, 2013
Stephen J. Nicholls, M.B.B.S., Ph.D., of the South Australian Health and Medical Research Institute and University of Adelaide, Adelaide, Australia, and colleagues determined the effects of varespladib, a drug that inhibits ...

Analysis supports use of risk equations to guide statin therapy

March 29, 2014
In an analysis of almost 11,000 patients, an assessment of equations that help guide whether a patient should begin taking a statin (cholesterol lowering medication) found that observed and predicted 5-year atherosclerotic ...

Blood glucose measure appears to provide little benefit in predicting risk of CVD

March 25, 2014
In a study that included nearly 300,000 adults without a known history of diabetes or cardiovascular disease (CVD), adding information about glycated hemoglobin (HbA1c), a measure of longer-term blood sugar control, to conventional ...

Non-HDL-C level associated with risk of major cardiovascular events among patients taking statins

March 27, 2012
Levels of non-high-density lipoprotein cholesterol (non-HDL-C) among statin-treated patients appears to be associated with the risk of developing a major cardiovascular event, such as a heart attack or stroke, as are levels ...

Recommended for you

A nanoparticle inhalant for treating heart disease

January 18, 2018
A team of researchers from Italy and Germany has developed a nanoparticle inhalant for treating people suffering from heart disease. In their paper published in the journal Science Translational Medicine, the group describes ...

Starting periods before age of 12 linked to heightened risk of heart disease and stroke

January 15, 2018
Starting periods early—before the age of 12—is linked to a heightened risk of heart disease and stroke in later life, suggests an analysis of data from the UK Biobank study, published online in the journal Heart.

'Decorated' stem cells could offer targeted heart repair

January 10, 2018
Although cardiac stem cell therapy is a promising treatment for heart attack patients, directing the cells to the site of an injury - and getting them to stay there - remains challenging. In a new pilot study using an animal ...

Two simple tests could help to pinpoint cause of stroke

January 10, 2018
Detecting the cause of the deadliest form of stroke could be improved by a simple blood test added alongside a routine brain scan, research suggests.

Exercise is good for the heart, high blood pressure is bad—researchers find out why

January 10, 2018
When the heart is put under stress during exercise, it is considered healthy. Yet stress due to high blood pressure is bad for the heart. Why? And is this always the case? Researchers of the German Centre for Cardiovascular ...

Heart-muscle patches made with human cells improve heart attack recovery

January 10, 2018
Large, human cardiac-muscle patches created in the lab have been tested, for the first time, on large animals in a heart attack model. This clinically relevant approach showed that the patches significantly improved recovery ...

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.