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Good News for Some Who Used Diet Drugs

Study: Short-time fen-phen and Redux users probably don't have a greater risk of heart valve problems, say researchers armed with new findings.


People who took the diet drugs fen-phen or Redux for short periods of time most likely do not have any increased risk of heart valve problems, according to a new study presented last week at a meeting of the American College of Cardiology in Atlanta.

The drugs were withdrawn from the market in February after the Food and Drug Administration found evidence that heart valve defects appeared in as many as 30% of patients who used the drugs for long periods of time.

An estimated three-quarters of people who have used the drugs have done so for only short periods, and the new findings should provide comfort for them.

Dr. Neil Weissman of the Georgetown University Medical Center and his colleagues studied 1,072 overweight men and women who were randomly assigned to take either the original Redux, a new sustained-release form of Redux, or a placebo. The study was ended after three months when the drugs were withdrawn from the market.

Cardiologists examined echocardiograms of the subjects' hearts and found mild leaking or worse in 5% of patients on Redux, 5.8% of the patients on the sustained-release form and 3.6% of those who received placebos. The differences were not statistically significant.

Several other intriguing studies were also presented at the meeting:

* Dr. Thierry LeJemtel of the Albert Einstein College of Medicine reported on the first new treatment in 10 years for congestive heart failure, which affects an estimated 4.9 million Americans.

Congestive heart failure, which usually is caused by hypertension, is a condition in which the heart can no longer pump enough blood to meet the needs of the body's other organs. Its symptoms include shortness of breath, tiredness, difficulty sleeping and swelling of the extremities.

Acute cases are usually treated with diuretics, which stimulate urination to reduce blood volume and reduce the load on the heart; vasodilating agents, which expand blood vessels to increase their carrying capacity; and inotropic agents, which stimulate the heart directly to increase its pumping ability.

Thierry reported on the use of a genetically engineered version of a naturally occurring hormone called natriuretic peptide. They tested it in 127 hospitalized patients, half of whom were given the drug and half a placebo.

Within six hours of an infusion of the hormone, LeJemtel said, 69% of the patients had a significant reduction in their symptoms, compared to only 5% of those who received a placebo.

One of the drugs commonly used in treating congestive heart failure is the angiotensin converting enzyme or ACE inhibitor. These drugs reduce hypertension by relaxing blood vessels, allowing freer flow of blood. Researchers reported at the meeting that physicians could prevent 250,000 hospital admissions each year by prescribing higher doses of the drugs.

Several earlier studies showed that high doses of the drugs slow the progression of the disease, but they also indicated a possibility of kidney problems and dangerously low blood pressure. Physicians have therefore prescribed lower doses on the theory that they would be equally effective and much safer.

But a team headed by Dr. Milton Packer at Columbia University studied use of the ACE inhibitor lisinopril in 3,164 patients in 19 countries. Half took the conventional dose, while the other half took a much higher dose.

They found 717 deaths among those taking the low dose and 666 deaths among those taking the higher doses over the five years of the study, but the difference was not statistically significant. But they also found a 12% reduction in hospitalizations among those taking the higher doses. If all patients were given the higher dosage, they estimated, it would result in an average savings of $350 per patient per year.

* Small doses of estrogen given to elderly men can lower levels of "bad" cholesterol or LDL and raise levels of "good" cholesterol, HDL, but the side effects may limit potential use of the drug, researchers said. Estrogen in the blood of premenopausal women is believed to provide protection against heart disease, and several studies have shown that hormone replacement therapy in post-menopausal women is almost as helpful.

Dr. Satyendra Giri and Dr. Paul Thompson of Hartford Hospital in Connecticut administered low doses of estrogen to 22 healthy elderly men--the first time, they said, that such a test had been conducted. They found that the drug improved cholesterol balance and reduced blood pressure.

Although none of the men suffered a decrease in libido, nine of them complained of such symptoms as breast tenderness and heartburn after meals.

The study provides hope, Thompson said, that new "designer" estrogens that target the heart while minimizing hormonal effects may be useful in men as well as women.

* An aspirin a day is known to reduce the risk of heart disease, but it may work better if it is downed with a glass of purple grape juice or a mug of dark ale, according to Dr. John Folts of the University of Wisconsin Medical School.

Aspirin helps prevent formation of clots by making blood platelets less sticky, but its effect can be canceled by adrenaline produced during exercise or under stress, he said.

Folts said that chemicals called flavonoids, found in grape juice, dark ales and red wines, prevent adrenaline from inhibiting aspirin action. But, he emphasized, the alcoholic drinks should be used only in moderation.

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