How We Can Help

• Car Accidents
• Nursing Home Injury
• Medical Malpractice
• Child Injuries

Experimental Drug Linked to Death Risk for Irregular Heart Rhythm Patients

A new study shows that a drug used to successfully treat patients with intermittent atrial fibrillation - or irregular heart rhythm - could be deadly for patients with a permanent form of the condition.

Researchers stopped enrollment in the clinical trial of the drug dromedarone for these patients after detecting an excessive number of serious vascular events and at least 34 deaths in drug-treated patients.

Atrial fibrillation (AF) occurs when the two upper heart chambers beat erratically. It affects about 2.7 million Americans. The heart may return to normal rhythm on its own in some people with intermittent or non-permanent AF. For those with permanent AF, it does not. Permanent AF is usually managed with heart rate-controlling medications.

Dronedarone is an anti-arrhythmic drug used for patients with non-permanent AF to reduce AF recurrence and to lower the chances of being hospitalized for heart problems. It is not approved for permanent AF.

Dr. Stuart J. Connolly, lead author of the study and professor of cardiology at McMaster University in Hamilton, Ontario, Canada, said this clinical trial was investigating interventions to reduce illness and death in patients with permanent AF, a high risk population. No previous trails had been done this area, he said.

The study included only 3,236 of the planned 10,800 patients before researchers stopped recruiting and treatment in July.

“The message is that the drug dronedarone should not be used for permanent atrial fibrillation,” Connolly said in a news release.

The study’s patients, all 65 years or older with permanent AF and other risk factors for vascular events, were randomized to either dronedarone or placebo.

Among the findings reported:

• Overall risk of serious vascular events like heart attack, stroke or death from cardiovascular causes was 2.2 times greater on the drug dronedarone than on placebo: 43 dronedarone patients and 19 on placebo suffered a stroke, heart attack, systemic blood clot or cardiovascular death.
• Twenty-one cardiovascular deaths occurred among patients given dronedarone and 10 in the placebo arm.
• Thirteen arrhythmia deaths occurred in the drug group, four in the control group.
• Twenty-two treated patients had strokes, which is 2.5 times more than the nine strokes in patients on placebo.
• Dronedarone raised the risk of heart failure hospitalization for patients.
• Dronedarone patients taking the heart rhythm drug digitalis before accrual — about one-third of those treated — had a 36 percent increase in their digitalis blood levels.

While there is evidence that the increase in digitalis played a role in the increased risk of cardiovascular death, Connolly said it did not explain the increase in heart failure or stroke.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.

Your Questions Answered