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Cholesterol-lowering drugs may not live up to studies

Two-thirds of people taking widely prescribed cholesterol-lowering drugs do not get as much benefit as drug company statements suggest they should, a study found.

Although the reasons are not 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 drugmakers, 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 Mount Sinai Medical Center in New York City said the new research "says that those inserts have nothing to do with reality."

Sprecher 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.

Elsewhere . . .

MOM CHARGED IN 6 KIDS' DEATHS: The mother of six children who died in a house fire in Independence, Miss., was charged with manslaughter after authorities say it appeared they had been left home alone.

Tate County District Attorney John Champion said six counts of culpable negligence manslaughter were filed against Christie Rene Greenwood late Saturday after an investigation into the early morning fire.

The victims were identified as Andria Greenwood and Adrian Greenwood, both 3; Kenel Greenwood, 9; Ricky Crudupt, 7; Myron Greenwood, 5; and LaParis Greenwood, 1.

The fire is still under investigation, but its cause appeared to be a wood-burning heater made from a 55-gallon drum.

Greenwood could face 20 years in prison for each count.

DEATH SENTENCE: A black man was sentenced to death Sunday for killing three white men in a racially motivated shooting rampage. Ronald Taylor, 41, was convicted in the March 1, 2000, violence that started at his apartment in suburban Wilkinsburg, outside of Pittsburgh, and continued at two nearby restaurants.