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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

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.

Author Affiliations: Department of Clinical Neurological Sciences, University of Western Ontario, London (Drs Hackam and Hachinski), and Institute for Clinical Evaluative Sciences and University of Toronto, Toronto (Drs Austin, Juurlink, Mamdani, Li, and Kapral, Ms Huang, and Mr Paterson), Ontario, Canada.

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