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Original Contributions |

Statins and Intracerebral Hemorrhage:  A Retrospective Cohort Study

Daniel G. Hackam, MD, PhD; Peter C. Austin, PhD; Anjie Huang, MSc; David N. Juurlink, MD, PhD; Muhammad M. Mamdani, PharmD, MA, MPH; J. Michael Paterson, MSc; Vladimir Hachinski, MD, DSc; Ping Li, PhD; Moira K. Kapral, MD, MSc
Arch Neurol. 2012;69(1):39-45. doi:10.1001/archneurol.2011.228.
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Background A recent post hoc analysis of a large randomized trial in patients with cerebrovascular disease suggested that statins may increase the risk of intracerebral hemorrhage (ICH).

Objective To examine the association between statins and ICH in patients with recent ischemic stroke in a population-based setting.

Design Retrospective propensity-matched cohort study with accrual from July 1, 1994, to March 31, 2008.

Setting Ontario, Canada.

Participants A total of 17 872 patients aged 66 years and older who initiated statin therapy following acute ischemic stroke and were followed for a median of 4.2 years (interquartile range, 2.4-5.0 years). To enhance causal inference, we conducted several tests of specificity to exclude healthy user bias in this sample.

Main Outcome Measure Hospitalization or emergency department visit for ICH defined using validated diagnosis coding.

Results Overall, 213 episodes of ICH occurred. In the primary analysis comparing statin users with nonusers, we found no association between statins and ICH (hazard ratio = 0.87; 95% confidence interval, 0.65-1.17). Subgroup and dose-response analyses yielded similar results. In tests of specificity, statin therapy was not associated with bone mineral density testing, vitamin D or B12 screening, gastrointestinal endoscopy, or elective knee arthroplasty, suggesting that results were not due to healthy user bias or differences in quality of care.

Conclusion Statin exposure following ischemic stroke was not associated with ICH.

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Figure 1. Cohort creation. Sampling of patients with acute ischemic stroke in Ontario, Canada, between July 1, 1994, and March 31, 2008.

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Figure 2. Subgroup analyses. Risk for intracerebral hemorrhage (ICH) in relation to statin exposure in predefined subgroups. Squares indicate hazard ratios (HRs); whiskers, 95% confidence intervals; and SES, socioeconomic status.

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