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Heart drug trial cut short.

Federal officials have halted a largescale clinical trial -- originally designed to see whether any of three drugs could increase long-term survival of people with mild arrhythmia following a heart attack -- after finding evidence that the lone drug remaining in the trial increased volunteers' risk of death during the study period. In April 1989, researchers had stopped testing the study's two other drugs for the same reason (SN: 4/29/89, p.260).

The National Heart, Lung, and Blood Institute (NHLBI) announced this week that it notified researchers on Aug. 2 to warn their patients to stop taking moricizine, made by Du Pont Pharmaceuticals in Wilmington, Del.

Researchers in the Cardiac Arrhythmia Suppression Trial (CAST II) had recruited 1,346 men and women who had survived a heart attack but developed mild rhythm irregularities due to damaged ventricles, the lower heart chambers. During the study, each volunteer took one of three daily doses of moricizine or placebo pills.

On July 30 of this year -- 18 months into the trial -- a review of the data revealed a disturbing trend:97 people in the moricizine group had died, compared with 74 in the placebo group. Although researchers have not yet established the cause of each death, study director Lawrence M. Friedman says the preliminary findings suggest that moricizine itself can trigger life-threatening episodes of arrhythmia in such patients. NHLBI ended the trial because the apparent risks of the treatment outweighed any possible benefits.

In an Aug. 9 letter sent to more than 100,000 U.S. physicians, Du Pont's medical marketing director, John N. Hurley, states that the study's results apply only to people with mild arrhythmia. He adds that physicians can continue to prescribe moricizine (Ethmozine) for people with life-threatening arrhythmias, pointing out that the FDA approved the drug specifically for such cases in 1990.
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Title Annotation:testing of moricizine halted
Publication:Science News
Date:Aug 17, 1991
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