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Statin primary prevention efficacy ‘equivalent in women and men’

By Jeremy Cockerill | March 1, 2010

Source: MedWire News

Statins are effective for the primary prevention of cardiovascular disease (CVD) events in women, shows a gender-specific analysis of the JUPITER trial and an updated meta-analysis of relevant trials.

The study represents the first clear evidence of the equivalent efficacy of statins for primary prevention in both men and women, and is likely to expand the eligibility criteria for statin therapy in women.

“Clinicians will undoubtedly use the data… to prescribe statin therapy much earlier for women who meet the entry criteria of the JUPITER study, and this change will improve CV outcomes in women,” said the authors of an editorial accompanying the report.

The research, which appears in the journal Circulation, was a prespecified analysis of gender-specific outcomes in the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial.

This multicenter randomized trial included 6801 women aged 60 years or over and 11,001 men aged 50 years or over; all had normal lipid levels but raised levels of high-sensitivity C-reactive protein (hsCRP).

As reported previously by MedWire News, JUPITER showed that treatment with rosuvastatin 20 mg/day, as compared with placebo, nearly halved the risk for major CVD events, a composite of nonfatal myocardial infarction (MI), nonfatal stroke, unstable angina, revascularization, or CV death.

Rosuvastatin also significantly reduced other endpoints, including MI, stroke, revascularization/unstable angina, nonfatal MI, nonfatal stroke, or CV death, and all-cause mortality.

The new JUPITER analysis, by Samia Mora (Brigham and Women’s Hospital, Boston, Massachusetts, USA) and team, found that absolute CVD rates per 100 person–years were lower for women assigned to rosuvastatin and placebo (0.57 and 1.04, respectively) than for men (0.88 and 1.54, respectively).

Nevertheless, the relative risk reduction associated with rosuvastatin treatment was similar in women and men, at hazard ratios of 0.54 and 0.58, respectively.

Analysis of individual endpoints revealed that rosuvastatin therapy in women offered a significant reduction in revascularization/unstable angina and nonsignificant reductions in other endpoints.

Mora’s team then pooled these new JUPITER data with those from four other randomized placebo-controlled trials of statin therapy predominantly or exclusively for primary prevention. This meta-analysis, with data on 20,147 women and more than 276 CVD events, is nearly double the size of the previous meta-analysis on this issue.

It shows that statins reduced the risk for CVD events by 21% and total mortality by 15%; when only the three exclusively primary prevention trials were included, the relative risk reductions were 33% for CVD events and 22% for total mortality.

Mora et al conclude: “Statin treatment of apparently healthy women with elevated hsCRP and nonelevated low-density lipoprotein (LDL) cholesterol resulted in similar and significant proportional reductions in CVD compared with men.

“When these results are taken together with the results of the updated meta-analysis in women, statin therapy resulted in about a one-third relative reduction in primary CVD in women, a benefit similar to that seen in previous meta-analyses of men.”

Editorialists Claire Duvernoy (University of Michigan, Ann Arbor) and Roger Blumenthal (Johns Hopkins University, Baltimore, Maryland), called the study “compelling” and say it strengthens the evidence-base for statin therapy in asymptomatic middle-aged and older women with CV risk factors.

They added: “We await publication of the formal cost-effectiveness analyses from the landmark JUPITER data set, as well as data on the long-term safety of high-potency statin therapy.”