Source: DGNews  |  Posted 2 years ago

By Ed Susman

ORLANDO, Fla -- November 20, 2009 -- Women derive substantial benefit with rosuvastatin treatment if they have high levels of C-reactive protein and relatively modest levels of low density lipoprotein cholesterol, according to a study presented here November 17 at the American Heart Association (AHA) Scientific Sessions 2009.

A new analysis of the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) shows that apparently healthy women may reduce their relative risk of major cardiovascular events by 46%.

In comparing the results with the findings in men, Samie Mora, MD, Brigham and Women’s Hospital, and Harvard Medical School, Boston, Massachusetts, reported that women had a 46% risk reduction versus placebo for women (P = .002) and 42% reduction versus placebo for men (P = .001).

Women had a greater benefit than men in preventing revascularisation, where doctors observed a 76% reduction in the need for arterial revascularisation compared with placebo (P < .001). However, statins reduced stroke more in men than women.

Dr. Mora and colleagues analysed outcomes from the 6,801 women enrolled in the 17,802-patient trial. The mean age of the participants was 66 years. None of the participants had a history of atherosclerosis. All had an elevated biomarker for inflammation -- highly sensitive C-reactive protein. They were randomised to receive rosuvastatin 20 mg or to placebo. The results in women were compared with the results among the 11,002 men in the study.

Participants who took rosuvastatin for 1.9 years reduced median low-density lipoprotein cholesterol to 55 mg/dL, down from a median of 108 mg/dL. The corresponding reduction in the rate of myocardial infarction (MI), stroke, arterial revascularisation, or cardiovascular death was 44% (P < .00001).

In terms of safety, rosuvastatin was not associated with a significant increase in myopathy or cancer in men or women, but, compared with placebo, there was a higher incidence of physician-reported diabetes in women taking rosuvastatin (1.59% vs 1.05%, respectively; P = .008) but not in men (1.48% vs 1.32%; P = .29).

The serious adverse event rate in women taking rosuvastatin was 7.7%, compared with a 7.4% rate among women on placebo. The serious adverse event rate in men on rosuvastatin was 7.6% compared with 7.9% on placebo.

Based on this analysis, treating 36 women with rosuvastatin 20 mg for less than 2 years would prevent 1 MI, cardiovascular death, stroke, or revascularisation, which was slightly higher than the number to treat of 25 reported for the total JUPITER population.

Funding for this study was provided by AstraZeneca.

[Presentation title: Rosuvastatin for the Primary Prevention of Cardiovascular Events in Women With Elevated hsCRP and Low LDLC: Sex-Specific Outcomes From the JUPITER Trial. Abstract 1426]