Statins work as well for women as men: study

Statins work as well for women as men: study

SUMMARY: Women benefit from cholesterol-lowering drugs known as statins, but researchers warn that a woman's overall risk of heart complications should be assessed before beginning statin therapy. Women already at low risk may not see enough improvement to justify potential side effects of statin therapy.

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NEW YORK (Reuters Health) - Despite doubts raised by some studies, a new research review suggests that cholesterol-lowering statins offer as much protection for women as for men.
In an analysis of 18 clinical trials, researchers found that overall, statins cut the risk of heart attack, stroke and death to a similar degree in both men and women.
Those odds were lowered by 19 percent in women, and 23 percent in men, according to findings published in the Journal of the American College of Cardiology.
Researchers say the findings mean that a patient's sex should not drive statin treatment decisions.
"From what we know now, gender shouldn't be a factor when someone is otherwise an appropriate candidate for statin therapy," said lead researcher Dr. William J. Kostis, of Massachusetts General Hospital and Harvard Medical School in Boston.
Dr. Lori Mosca, who wrote an editorial published with the study, agreed that "we shouldn't draw conclusions based on whether someone is a man or woman, or black or white."
But that doesn't mean that every woman with high cholesterol needs to go on statin therapy either, according to Mosca, who directs preventive cardiology at New York-Presbyterian Hospital/Columbia University Medical Center.
Statins include well-known cholesterol fighters like atorvastatin (Lipitor), simvastatin (Zocor), pravastatin (Pravachol) and rosuvastatin (Crestor).
The drugs can cut the risk of heart attack and premature death in people with cardiovascular disease -- like those who've already had a heart attack or been treated for clogged arteries.
But some statin studies have found that women do not benefit as much as men do when it comes to "primary prevention" of cardiovascular disease. That means preventing first-time heart problems or stroke, or sudden death.
"There's little dispute that in men and women who already have cardiovascular disease, the benefit (of statins) is similar," Mosca said.
But primary prevention is more complex, since people's risk of future heart problems will vary widely depending on age, other health problems like diabetes and high blood pressure, and lifestyle habits like smoking.
And generally speaking, women start off at a lower risk of developing heart disease compared with men. So the "net benefit" of using statins to prevent heart trouble could still be less for women, explained Mosca.
"It's important to remember that (the new study) is talking about relative risk reduction," Mosca said.
So for example, if a drug halved your risk of a heart attack over the next five years, that's a big drop in the relative risk. But if you're already at low risk of having a heart attack, the absolute benefit could be small.
The current study combined the results from 18 clinical trials involving more than 141,000 patients in all; that included some 40,000 women. In each, patients were randomly assigned to either take a statin or be in a "control" group; in most cases, the control patients were given placebo pills.
Overall, women and men showed a similar benefit when it came to cutting the risk of heart attack, stroke and death. That included the eight trials focused on primary prevention.
But in some studies, that meant lowering an already fairly low risk.
In one trial called JUPITER, for instance, women not on statins suffered heart attacks, strokes and other complications at a rate of 2.1 percent over two years. The rate was 1.1 percent among statin users.
Both Mosca and Kostis said that for any one woman, the "bigger picture" is key in deciding on statin treatment.
A woman who has high cholesterol but is otherwise free of heart risks is different from a woman who smokes or has diabetes or high blood pressure.
"I think it's very important for women to weigh in the fact that heart disease is your biggest killer," Mosca said. "But also understand that there are risks to statins, and there are costs."
Statins are generally considered safe, Kostis said.
But potential side effects include muscle and joint aches, nausea and constipation. More-serious problems are uncommon, but can include a breakdown of muscle called rhabdomyolysis.
And Mosca pointed out that little is known about whether women are more vulnerable to side effects than men are. Of the studies in this review, only two broke down side effects by sex.
She also pointed to a study published earlier this month finding that women on statins had a higher risk of developing diabetes than those not on drugs -- with known diabetes risk factors taken into account.
That study, which included more than 150,000 U.S. women, does not prove that statins are to blame.
But it raises concerns about the possible effects of years of statin use. "Women should be aware that we really don't understand all of the long-term risks yet," Mosca said.
She also said that one "very clear" message for women is the importance of a healthy lifestyle -- regular exercise, not smoking and maintaining a normal weight.
"Make healthy lifestyle choices all along the way," Mosca said. "Then you may not even be in the position of having to worry about going on (drug) therapy."
About one-quarter of adults age 45 and older in the United States now take statins, which run anywhere from $11 to over $200 per month.
The cost-effectiveness of putting people at low risk on stains is not clear. In the JUPITER study of low-risk patients, researchers estimated that the cost of preventing one cardiovascular "event" would be $287,000 -- though treatment with generic statins would bring that down.
The current study was funded by the Robert Wood Johnson Foundation, and the researchers report no financial conflicts of interest.
Mosca has consulted for drug companies Gilead Sciences Inc. and Sanofi.