- The Washington Times - Monday, November 12, 2001

ANAHEIM, Calif. (AP) Two-thirds of people taking widely prescribed cholesterol-lowering medicines do not get as much benefit as drug company statements suggest they should, a study found.
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 is 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.
The benefits of the pills, known collectively as statins, have been proven in carefully conducted large studies. Dr. 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 yesterday 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 the patients benefited 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. Eighteen percent of patients showed no change in their LDL levels or had even worse readings than when they started.
Dr. Valentin Fuster of Mount 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.
Dr. 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 yesterday, 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 Mount Sinai also presented new evidence of how statins protect the heart. His group used magnetic imaging scans to look at plaque buildups in patients' hearts over two years while on the drugs.


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