Two Heart Drug Trials Discontinued by Sponsors

July 12, 2011

Two significant cardiovascular drug trials have been stopped by their sponsors after disappointing early results concerning safety and efficacy.

Two significant cardiovascular drug trials have been stopped by their sponsors after disappointing early results concerning safety and efficacy.

The trials which were discontinued were the PALLAS trial and the AIM-HIGH trial.

The PALLAS trial was ended by sponsor and drug manufacturer, Sanofi. PALLAS was testing the use of dronedarone, sold under the brand name Multaq, for lasting atrial fibrillation. Multaq is currently approved in the United States in order to avoid hospitalization for patients who suffer from occurrences of atrial fibrilation or atrial flutter.

It was known prior to the PALLAS trial that dronedarone has the potential to cause liver problems, but during the trial, it was discovered that the drug exhibited a small increase in cardiovascular problems in patient.

After this discovery was made, Sanofi decided to end the trial for the sake of the safety of the patients involved.

AIM-HIGH was also ended by its sponsor, the U.S. National Heart, Lung and Blood Institute (NHLBI). AIM-HIGH was dedicated to finding out whether addition of niacin to a statin drug in patients with high triglycerides and low HDL would aid in reducing cardiovascular issues.

Early data was collected and analyzed by researchers of the study found that, while patients showed improvement in their cholesterol levels, there was no significant difference between those taking niacin with a satin and those taking the statin by itself in regard to the number of strokes, heart attacks, and hospitalizations of the patients. They also discovered a slight increase in strokes in the patients taking niacin.

The NHLBI will be reviewing the data and publishing their findings later in the year. It is suggested that any patients recieving Multaq for atrial fibrillation or niacin for cholesterol should discuss questions or concerns with their physician or pharmacist.