Benefits of Using Lipid-Lowering Agents Persist After Trials End



NEW ORLEANS – In major clinical trials of lipid-lowering agents, the mortality benefit derived from medical therapy persists long after the studies end, according to a meta-analysis presented at the annual meeting of the American College of Cardiology.

Furthermore, placebo recipients who cross over to lipid-lowering therapy in the open-label phases of the studies demonstrate survival benefits as well, but never attain the protection achieved by being randomized to active treatment earlier on, according to Dr. William J. Kostis of Massachusetts General Hospital, Boston. "Persons with risk factors for coronary artery disease should be treated early," Dr. Kostis said in an interview. "The sooner you treat, the better."

He and his colleagues searched several major databases to identify randomized trials of lipid-lowering therapies that also contained an analysis of patient outcomes after the randomized portion of the trials had ended and an open-label phase had begun. Active treatment in the trials involved statins, niacin, cholestyramine, or gemfibrozil.

The analysis included eight clinical trials involving 44,255 patients, of whom 8,144 died during follow-up.

The average patient remained on the assigned treatment for approximately 5 years and was on the lipid-lowering agent in the open-label phase for approximately 6 years.

During the randomized phase of the trials, the mean all-cause mortality was significantly lower for the active treatment group (odds ratio, 0.84; P = .0006), as was cardiovascular mortality (0.72; P less than .001). The lower mortality among those initially receiving active therapy persisted during the open-label follow-up phase (OR, 0.90; P = .0035), as did the reduction in cardiovascular mortality (OR, 0.82; P = .0014).

"Being treated with a beneficial medication for a longer period of time is better, possibly because we are arresting pathophysiology at an earlier stage," Dr. Kostis proposed. He added that statins may be reducing the size of infarcts in patients who have myocardial infarctions.

Dr. Patrick Moriarty, a lipid specialist and a professor of medicine at the University of Kansas in Kansas City, agreed. "We need to start lipid-lowering therapy early to get the most benefit," and this includes interventions in children when necessary, he added.

"We treat pediatric patients all the time," he said, "not only those with familial hyperlipidemias but also those with metabolic syndrome. ... The future emphasis will be, ‘the sooner the better.’ "

Dr. Kostis and Dr. Moriarty reported having no relevant conflicts of interest.

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