Statins associated with decreased strokes and death but not increased intracerebral hemorrhage in meta-analysis of randomized trials

Statin therapy was associated with significant reductions in all strokes and death but not with a significant increase in intracerebral hemorrhages (ICHs) in a meta-analysis of 31 randomized, controlled trials.

Because of a possible increased risk of hemorrhagic stroke observed in several studies of statin use for stroke prevention, study authors searched peer-reviewed literature through January 2012 for all randomized, controlled trials of statin therapy that reported ICH or hemorrhagic stroke. The primary outcome was ICH. Results were published online May 15 in Stroke.

There were 91,588 subjects in the active (statin-taking) group and 91,215 in the control group, with a median length of follow-up of 46.8 months. ICH occurred in 358 subjects (0.39%) in the active group versus 318 (0.35%) in the control group. In the primary analysis, assessing ICH risk in 30 studies of statin treatment, active therapy was not associated with an increase in ICH (odds ratio [OR], 1.08; 95% CI, 0.88 to 1.32; P=0.47).

There were 6,262 strokes in this meta-analysis. The overall stroke rate was 3.13% in the active group versus 3.72% in the control group. Statin therapy was associated with a significant reduction in total stroke (OR, 0.84; 95% CI, 0.78 to 0.91; P<0.0001).

Overall mortality was 20,195 deaths. There was a significantly lower rate of all-cause mortality in the active group (10.67%) than in the control group (11.43%; OR, 0.92; 95% CI, 0.87 to 0.96; P=0.0007). The number needed to treat with active statin therapy to prevent 1 death was 167 (absolute risk reduction=0.6%, P<0.0001).

The authors concluded, “Statin therapy was not associated with a significant increased risk of ICH. There was no effect on ICH risk related to the degree of decline in [low-density lipoprotein] or to the achieved level. The significant reduction in total stroke and all-cause mortality more than offset any slight increase in ICH risk. These findings support the current recommendations to prescribe statins in otherwise appropriate patients.”