Related Experiment Video
Updated: May 22, 2026

Minimally Invasive Endoscopic Intracerebral Hemorrhage Evacuation
Published on: October 15, 2021
Statin therapy and the risk of intracerebral hemorrhage: a meta-analysis of 31 randomized controlled trials
James S McKinney1, William J Kostis
1Cardiovascular Institute of New Jersey and the Department of Neurology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ 08901, USA. mckinnjs@umdnj.edu
Insights
Statin therapy does not increase the risk of intracerebral hemorrhage (ICH). This meta-analysis found statins significantly reduce total stroke and all-cause mortality, confirming their safety and efficacy.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Pharmacology
Background:
- Statin therapy is known to reduce ischemic stroke risk.
- Some studies suggest a potential increased risk of intracerebral hemorrhage (ICH) with statin use.
- This meta-analysis addresses the safety concerns regarding statins and ICH.
Purpose of the Study:
- To evaluate the association between statin therapy and the risk of intracerebral hemorrhage (ICH).
- To synthesize evidence from randomized controlled trials (RCTs) reporting ICH events.
- To assess the overall impact of statins on stroke and mortality outcomes.
Main Methods:
- Comprehensive literature search of major databases (Medline, Web of Science, Cochrane Library) through January 2012.
- Inclusion of 31 randomized controlled trials (RCTs) that reported ICH or hemorrhagic stroke.
- Random effects models used for analysis; heterogeneity was not observed.
Main Results:
- No significant difference in ICH incidence between statin and control groups (OR, 1.08; P=0.47).
- ICH risk was independent of low-density lipoprotein (LDL) reduction or achieved LDL levels.
- Significant reductions observed in total stroke (OR, 0.84; P<0.0001) and all-cause mortality (OR, 0.92; P=0.0007) with statin therapy.
Conclusions:
- Statin therapy is not associated with an increased risk of intracerebral hemorrhage (ICH).
- The findings support the use of statins for reducing overall stroke incidence and all-cause mortality.
- This meta-analysis provides robust evidence for the safety and efficacy of statin therapy.
Background And Purpose:
Statin therapy decreases the risk of ischemic stroke. An increased risk of intracerebral hemorrhage (ICH) has been observed in some studies. To investigate this issue, we performed a meta-analysis of randomized controlled trials using statins that reported ICH.
Methods:
We performed a literature search of Medline, Web of Science, and The Cochrane Library through January 25, 2012, and identified additional randomized controlled trials by reviewing reference lists of retrieved studies and prior meta-analyses. All randomized controlled trials of statin therapy that reported ICH or hemorrhagic stroke were included. The primary outcome variable was ICH. Thirty-one randomized controlled trials were included. All analyses used random effects models and heterogeneity was not observed in any of the analyses.
Results:
A total of 91,588 subjects were included in the active group and 91,215 in the control group. There was no significant difference in incidence of ICH observed in the active treatment group versus control (OR, 1.08; 95% CI, 0.88-1.32; P=0.47). ICH risk was not related to the degree of low-density lipoprotein reduction or achieved low-density lipoprotein cholesterol. Total stroke (OR, 0.84; 95% CI, 0.78-0.91; P<0.0001) and all-cause mortality (OR, 0.92; CI, 0.87-0.96; P=0.0007) were significantly reduced in the active therapy group. There was no evidence of publication bias.
Conclusions:
Active statin therapy was not associated with significant increase in ICH in this meta-analysis of 31 randomized controlled trials of statin therapy. A significant reduction in all stroke and all-cause mortality was observed with statin therapy.
Related Concept Videos
Hemorrhagic Stroke l: Introduction
Atherosclerosis III: Management
Lipid-Lowering Drugs: Statins and Miscellaneous Agents
Hemorrhagic Stroke ll: Pathophysiology
Venous Thrombosis III: Interprofessional Care
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...