SAN DIEGO — Patients with normal lipid levels but elevated C-reactive protein showed a 48% reduction in the risk of stroke when taking rosuvastatin, according to a study presented, at the International Stroke Conference.
These results came from a planned additional analysis of JUPITER (Justification for Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin). Investigators presented the main results of this trial, demonstrating a reduction in overall cardiovascular mortality, at the American Heart Association meeting in November 2008. The AHA also sponsored the stroke conference.
Investigators randomized 17,802 patients to receive either 20 mg/day rosuvastatin or placebo, and they followed the patients for up to 4.5 years. During that time 33 patients in the rosuvastatin group and 64 patients in the placebo group experienced a stroke, corresponding to a statistically significant reduction of 48% in relative risk.
The Kaplan-Meier survival analysis reported here revealed that the placebo and rosuvastatin groups began diverging within the first year of the trial. By 4.5 years, about 2% of the placebo group and about 1% of the rosuvastatin patients had a stroke, for a 1% absolute difference in those patients who were followed for that long.
This difference in absolute risk implies that about 100 patients would have to be treated with rosuvastatin in order to prevent one stroke.
“This wouldn't be very large if the focus was only on preventing stroke,” Robert J. Glynn, Ph.D., Sc.D., said at a news conference. “But look at the composite primary outcome. The really striking result here is that the benefit for stroke is almost spot on the benefit for myocardial infarction. And the number needed to treat overall in the population is 25 to prevent a primary vascular event. So you can't view stroke in isolation when making a treatment decision.” Dr. Glynn is a biostatistician at the Harvard School of Public Health, Boston, and one of the co-authors of the study.
Subgroup analyses showed significant reductions in relative risk for men but not women, for patients with a BMI of 29.9 kg/m
The investigators also found significant risk reductions among patients whose C-reactive protein levels were 5 mg/L or above, for patients with LDL cholesterol above 100 mg/dL, for those with low HDL cholesterol, and for those with triglyceride levels below 150 mg/dL.
Dr. Cheryl Bushnell of Wake Forest University, Winston-Salem, N.C., commented that “C-reactive protein is elevated generally in people who are obese and do not exercise. Are we going to tell these people to do anything differently based on elevated C-reactive protein? If so, we'll be treating a lot of extra people who may not have otherwise been treated. There's a really important discussion that has to happen in terms of the risks and benefits of treatment, as well as the cost of giving C-reactive protein tests.”
Dr. Glynn received grant support for this study from AstraZeneca, which manufactures rosuvastatin (Crestor).