Statins May Benefit Women as Much as Men

By Roxanne Nelson

(Reuters Health) - A large international analysis finds that statin drugs reduce heart risk factors like high cholesterol as effectively in women as they do in men.

The results, based on pooled data from 22 clinical trials, include a finding that reductions in deaths from any cause were similar for men and women taking statins. There has been debate over whether statins benefit women as much as they do men.

"This can give reassurance to clinicians that when treating a female patient they can apply the same risk-based considerations when prescribing statin therapy as for men," said Dr. Jordan Fulcher, a cardiologist and research fellow at the National Health and Medical Research Council Clinical Trials Center at the University of Sydney in Australia.

"In particular we demonstrated a significant all-cause mortality reduction for women taking statins, a finding which was not reported in any of the individual trials," said Fulcher, one of the report's lead authors, in an email to Reuters Health.

One expert cautioned, however, that doctors should take into consideration women's overall - generally lower - risk for heart disease compared to men, as well as some risks posed by the statins themselves when assessing a woman's need for the drugs.

Statins, which include atorvastatin (Lipitor), simvastatin (Zocor), rosuvastatin (Crestor), and others, block the body's production of cholesterol. High or abnormal cholesterol levels are considered a major risk factor for developing atherosclerosis, which can fuel heart attacks and stroke.

Previous studies of statin therapy for women have reached mixed conclusions. Some found that statins may not benefit women who were at a low risk of cardiovascular disease, as compared to men, while others have found the drugs to be helpful for both.

The current analysis is the largest to date and was conducted by the Cholesterol Treatment Trialists' Collaboration, a joint initiative coordinated by the NHMRC Clinical Trials Center in Sydney and the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) at the University of Oxford in the UK.

The analysis includes data on more than 174,000 patients. According to the results, online January 8 in The Lancet, the main measurement was the amount of low-density lipoprotein (LDL) cholesterol reduction during one year on statins - and that number was the same for women and men.

The reduction in major cardiovascular events like heart attacks relative to the LDL reduction and overall were also very similar in women and men. That included people at less than 10% risk of a major event, the authors note.

"Overall this study tells us that statins have a similar effectiveness in men and women at all levels of vascular risk," Fulcher told Reuters Health. "This ranges from men and women in the primary prevention setting at a 'lower' level of vascular risk to men and women with previous vascular disease, such as a heart attack or stroke, or who have already had bypass surgery, and are at a high risk of future events."

"Now we can say that statins appear to work just as effectively in both sexes," Fulcher said. "What questions remain are questions that apply to both sexes."

Despite the results, questions remain about women and the use of statins, wrote Dr. Lori Mosca, a professor at Columbia University Medical Center and director of Preventive Cardiology at New York-Presbyterian Hospital, in an editorial that accompanied the study.

"I agree with the authors that the proportionate risk reduction with statins was similar for men and women, when other factors considered were equal," she writes. But the "challenge is that the factors not considered by the investigators - such as absolute risk reduction - might not be equal," she notes.

The study provides more information about statin use in women, Mosca told Reuters Health. "We know more but still not enough."

For women without any history of heart problems, the number of women that would need to take statins to prevent a major cardiovascular event is generally higher than for men, she notes, due to the fact that women have a lower short-term risk.

As with any drug, statins do carry a risk of side effects, including growing evidence that their use is associated with an increased risk of diabetes, Mosca said. She pointed out that the study did not address sex-based differences in side effects.

"We need more long-term safety data for men and women," she said in an email. "Also, it is important for healthcare providers to give equal opportunity for therapy if baseline risk is similar."

Thus far, there are no indications of long-term risks in either men or women, according to Fulcher, who said Collaboration will be publishing another analysis in the future that will present that data.

SOURCE: https://bit.ly/18vgDfw and https://bit.ly/1By5lR8

Lancet 2015.

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