Although the reasons for this are not entirely clear, researchers suspect a simple answer: Patients do not take their pills as diligently as they should.

``It's extremely difficult to get people to do anything on a routine basis,'' said lead investigator Dr. Dennis L. Sprecher, whether it's taking pills, eating healthier food or getting more exercise.

All of these things can help people bring down dangerously high cholesterol levels. However, over the past decade, cholesterol-lowering drugs have become an increasingly important part of this combination as research demonstrates how they ward off heart attacks and death.

These benefits of the pills, known collectively as statins, have been proven in carefully conducted large studies. Sprecher and colleagues at the Cleveland Clinic set out to learn whether they work as well in ordinary practice as they do in those formal experiments.

He presented his results Sunday at the opening of the American Heart Association's annual scientific meeting in Anaheim. They were based on a follow up of 375 patients who began statin treatment at the Cleveland Clinic.

The doctors checked whether the prescriptions had lowered the patients' levels of LDL, the bad kind of cholesterol that increases the risk of heart trouble.

After at least one follow-up visit, they found that 66 percent of them benefitted less than would be predicted by the so-called ``package insert,'' the instructions for doctors that are written by drug makers and approved and edited by the Food and Drug Administration. Parts of these instructions are included in drug advertising.

Eighteen percent of patients showed no change in their LDL levels or had even worse readings than when they started.

Dr. Valentin Fuster of Mt. Sinai Medical Center in New York City said the new research ``says that those inserts have nothing to do with reality.''

Predictions in the package inserts are based on the findings of studies in which patients are carefully chosen and frequently reminded to take their pills as instructed. In ordinary life, however, people are typically told once by doctors why they need the medicines and then sent home with their prescriptions.

Sprecher said his research shows that occasional prompting can be helpful. Compliance improved 25 percent when high school students were hired to call patients once a month and remind them to take their statins.

He said there is no biological reason to suspect that the drugs fail to lower cholesterol as well in ordinary life as they do in formal studies if they are taken properly.

In May, the federal government's National Cholesterol Education Program issued new guidelines for who should take statins. At the meeting Sunday, Dr. Gilbert J. L'Italine of the University of Maryland said this increases the number of Americans who would benefit from the drugs from about 15 million to 36 million. Sixty percent are men and 40 percent are women.

Dr. Robert Corti of Mt. Sinai also presented new evidence of how statins protect the heart. His group used magnetic imaging scans to look at the same buildups in patients' hearts over two years while on the drugs.

He found that these lumps, called plaque, began to shrink after one year and were about one-quarter smaller after two years. Perhaps even more important, however, was evidence that they had grown harder and less likely to break.

Experts believe that plaque rupture is the main underlying cause of heart attacks, since this triggers the formation of blood clots that choke of the heart's internal blood supply. Firm lumps are considered much less dangerous than soft, squishy ones.

Medical Editor Daniel Q. Haney is a special correspondent for The Associated Press.

On the Net:

AHA site: http://www.americanheart.org/

Reference Source 102

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