Statin Treatment Doesn't Help Heart Valve Problem

Anti-cholesterol drug ineffective against aortic stenosis in small trial

WEDNESDAY, June 8, 2005 (HealthDay News) -- Hopes that cholesterol-lowering statin drugs could slow the progression of a heart valve problem called aortic stenosis have been dampened -- but not killed -- by negative results in a Scottish study.

Aortic stenosis is the narrowing of a valve through which oxygen-rich blood flows from the heart to the body. A narrowed valve means the body gets less blood, and therefore less oxygen for physical activity.

The Scottish study included 155 patients with a form of the condition called calcific aortic stenosis, in which the three leaflets of the valve become hardened by calcium deposits. The condition progressed just as much in 77 patients who took a large daily dose -- 80 milligrams -- of the statin atorvastatin (Lipitor) as in the 78 patients who took an inactive substance over the 25 months of the trial.

The results of the study, conducted by researchers at the Royal Infirmary, Edinburgh, and the University of Edinburgh, appears in the June 9 issue of the New England Journal of Medicine.

There had been ample reason to believe that statin treatment might be effective against aortic stenosis. The condition "has many characteristics in common with atherosclerosis," the hardening of the arteries that leads to cardiovascular crises such as heart attack and stroke, the Scottish researchers noted. In particular, people with calcific aortic stenosis tend to have high cholesterol levels, the scientists said.

And in November 2002, a group led by Dr. Maurice Sarano, a cardiologist at the Mayo Clinic, found what appeared to be a real-life link. A study that followed all the adults with aortic stenosis in Olmsted County, Minn., found that those taking statins had about half the rate of aortic stenosis progression over 3.7 years than those not taking the drugs.

Sarano said at the time he was "quite excited" by the findings, but added, "I don't think we should immediately begin prescribing statins for these patients yet. We ought to formally test these medications in clinical trials."

The Scottish study was that kind of trial, but the results don't necessarily shut the door on statin treatment for aortic stenosis, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic Foundation.

"It is not encouraging, it shows no effect at all, but it is a relatively small trial for a relatively short term," Nissen said. "To answer the question on a good, scientific basis we would have to do a trial in a considerably larger population for a considerably longer duration."

But the negative results of the Scottish study mean "there may be less incentive for industry to fund such a trial," Nissen said, and "cardiologists should not be prescribing statins for aortic stenosis because evidence for a beneficial effect is not there."

"I'd like to see a study that involved a large group of patients followed for at least five years that gave a more robust indication of benefit," he said.

More information

You can learn about aortic stenosis, its causes, symptoms and treatment, from the American Heart Association.

SOURCES: Steven Nissen, M.D., cardiologist, Cleveland Clinic Foundation; June 9, 2005, New England Journal of Medicine
Consumer News