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Adverse Effects of Statins-Reply.

Adverse Effects of Statins To the Editor In his Viewpoint, Dr Thompson wrote, “Although statins reduce total stroke, they increase the risk of hemorrhagic stroke consistent with the observation that low cholesterol levels are associated with an increase in hemorrhagic stroke.”1 The statement could be misleading and requires clarification. First, there are no data suggesting a statin-associated increased risk of hemorrhagic stroke among patients with no history of cerebrovascular disease. A meta-analysis of 10 trials involving a total of 83 205 patients without a history of stroke found a nonsignificant reduction in brain hemorrhage with statin treatment (relative risk [RR], 0.81; 95% CI, 0.60-1.08).2 Whether statin treatment increases the risk of brain hemorrhage among those with a history of stroke or transient ischemic attack is more controversial. The observations of increased brain bleeding risk in the Heart Protection Study and the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial2 were based on post hoc exploratory analyses of small numbers of patients. Nevertheless, meta-analysis of data from these 2 trials suggests an increased risk (RR, 1.73; 95% CI, 1.19-2.50). In contrast, a meta-analysis3 including cohort and case-control studies and randomized trials found no increased risk of intracerebral hemorrhage associated with statins in patients with a prior stroke or transient ischemic attack (RR, 1.03; 95% CI, 0.82-1.30). Second, the relationship between lipid levels and intracerebral bleeding risk may differ between general populations and individuals treated with statins. Although lower cholesterol levels have been associated with an increased risk of brain hemorrhage in some epidemiological studies, such a relationship has not been found in trials of statin lipid-lowering therapy. For example, there is no increase in brain hemorrhage with highvs low-intensity statin therapy.4 In the SPARCL trial,5 there was no independent relationship between quartile of achieved low-density lipoprotein cholesterol (LDL-C) and brain hemorrhage among patients treated with statins. If real, the mechanism underlying a higher risk of brain hemorrhage with statins in patients with a history of cerebrovascular disease remains uncertain. There is no evidence that statin treatment increases the risk of brain hemorrhage in patients without a history of stroke, and additional data are needed to better determine whether there is a higher risk of intracerebral bleeding despite an overall benefit in secondary stroke prevention populations.