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Statins Don't Seem to Harm Female Fertility

Hormone levels stay normal in young women taking cholesterol drugs

THURSDAY, Jan. 2, 2003 (HealthDayNews) -- Women of childbearing age who take statins needn't worry that the cholesterol-lowering drugs will harm their ability to become pregnant, a new study suggests.

Statins can cut the risk of heart attacks by 30 percent to 50 percent in both men and women by slashing the amount of cholesterol the body generates. However, the blood fat is a key precursor molecule for the production of reproductive hormones like estrogen and progestin. So scientists have feared that women who take statins may weaken their fertility.

Cholesterol is also important in fetal and early childhood development, so statin warning labels caution against their use in pregnant and nursing women. The labels also state that women capable of becoming pregnant should take the drugs only if they're highly unlikely to conceive.

Dr. C. Noel Bairey Merz, lead author of the latest study, said the results don't change that recommendation. And they don't directly prove that statins have no effect on fertility, she adds.

But the study did find that women taking statins had hormone levels that were within the normal range for reproduction, said Bairey Merz, director of the Women's Health Program at Cedars-Sinai Medical Center in Los Angeles.

With additional evidence, the findings could help doctors better advise young women with high cholesterol about how to use a statin.

"If you really needed to take it because of a very bad family history you could take it, come off and have a child, and go back on," Bairey Merz said. "There are plenty of serious health conditions that a woman can manage, with the help of her physician, and have a family."

Bairey Merz and her colleagues published their study in the December issue of the American Journal of Medicine.

Roughly a third of people over age 20 have borderline high cholesterol, defined as 200 milligrams per deciliter of blood, or worse. Under the most recent guidelines from the National Cholesterol Education Program, 36 million Americans are eligible to take statins to reduce their cholesterol -- 140 percent more than the 15 million in the previous and more conservative recommendations from 1993.

While the fraction of women who are considering pregnancy and who have high cholesterol is likely to be small, potentially millions might be candidates for statins to control their blood fat if the drugs were safe for them.

Statins have passed safety studies cleanly, yet fewer than one in five subjects in these trials have been women. What's more, the scant studies that have looked at the drugs' impact on reproductive hormone -- such as estrogen, progestin, and others -- typically didn't include women of childbearing age.

Bairey Merz's group evaluated the impact of statins on reproductive hormones in 453 women participating in an ongoing government-funded look at cardiovascular disease. All were being treated for suspected blocked blood flow, or ischemia, to the heart, a condition that can trigger heart attacks.

Of the total, 114 had yet to reach menopause, making them technically of childbearing age, and 17 of them were taking statins. Another 25 women in the early stages of menopause were on the drugs, too, along with 95 postmenopausal women.

The researchers monitored levels of four hormones: estrogen and progestin, and FSH and LH, which trigger the ovaries to release eggs. "Statins and resulting low blood [cholesterol] levels are not associated with adverse effects on reproductive hormone levels," they wrote.

Dr. Nanette Santoro, a reproductive endocrinologist at Albert Einstein College of Medicine' Montefiore Medical Center in New York City, has looked at the effects of statins on female hormones. Santoro consulted for Merck & Co., makers of Zocor, on such a study that found no significant effect of the drug on the reproductive molecules.

But, Santoro said, until the warning labels change, she won't feel comfortable prescribing statins to women in their childbearing years.

"Once it does, I would. It could probably be given with the caution that they don't get pregnant, but I think it's a reasonable thing to do," she said.

What To Do

To learn more about high cholesterol and how to keep it in check, visit the American Heart Association. You can also try the Heart Information Network.

SOURCES: C. Noel Bairey Merz, M.D., medical director, Women's Health Program, Cedars-Sinai Medical Center, Los Angeles; Nanette Santoro, M.D., professor and director, division of reproductive endocrinology, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, N.Y.; December 2002 American Journal of Medicine
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