Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: an observational study from the Women's Health Initiative

Elena Salmoirago-Blotcher; Kathleen M Hovey; Christopher A Andrews; Jennifer G Robinson; Karen C Johnson; Sylvia Wassertheil-Smoller; Sybil Crawford; Lihong Qi; Lisa W Martin; Judith Ockene; JoAnn E Manson

doi:10.1136/bmjopen-2014-007075

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Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: an observational study from the Women's Health Initiative

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Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: an observational study from the Women's Health Initiative

Elena Salmoirago-Blotcher, Kathleen M Hovey, Christopher A Andrews, Jennifer G Robinson, Karen C Johnson, Sylvia Wassertheil-Smoller, Sybil Crawford, Lihong Qi, Lisa W Martin, Judith Ockene, …

BMJ open, Vol.5(2), pp.e007075-e007075

02/25/2015

DOI: 10.1136/bmjopen-2014-007075

PMCID: PMC4342587

PMID: 25716175

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Abstract

To determine whether statin treatment is associated with increased risk of haemorrhagic stroke (HS) in older women. A secondary objective was to evaluate HS risk in users of combined statin and antiplatelet treatment. Observational study: secondary data analysis from the Women's Health Initiative (WHI) clinical trials. Women were recruited from 40 participating sites. Cohort of 68,132 women followed through 2005 (parent study) and for an additional 5 years in the extension study. Statin use was assessed at baseline and at follow-up visits (1, 3, 6 and 9 years). Women brought medications in original containers for inventory. Strokes were ascertained semiannually and centrally adjudicated. Risk of HS by statin use (time-varying covariate, with the 'no use' category as the referent) was estimated from Cox proportional hazard regression models adjusted for age (model 1); risk factors for HS (model 2); and possible confounders by indication (model 3). Prespecified subgroup analyses were conducted by use of antiplatelet medications. Final models included 67,882 women (mean age, 63±7 years). Over a mean follow-up of 12 years, incidence rates of HS were 6.4/10,000 person-years among statin users and 5.0/10,000 person-years among non-users (p=0.11). The unadjusted risk of HS in statin users was 1.21 (CI 0.96 to 1.53); after adjusting for age and HS risk factors the HR was 0.98 (CI 0.76 to 1.26). Risk of HS was higher among women on statins and antiplatelet agents versus women on antiplatelet medications alone (HR=1.59; CI 1.03 to 2.47); p for interaction=0.011. This retrospective analysis did not show an association between statin use and HS risk among older women. HS risk was higher among women taking statins with antiplatelet agents. These findings warrant further investigation, given potential implications for clinical decision-making.

Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage

Stroke - prevention & control

Women's Health

Follow-Up Studies

Humans

Middle Aged

Risk Factors

Proportional Hazards Models

Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects

Stroke - chemically induced

Postmenopause

Female

Retrospective Studies

Details

Title: Subtitle: Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: an observational study from the Women's Health Initiative
Creators: Elena Salmoirago-Blotcher - Centers for Behavioral and Preventive Medicine, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA
Kathleen M Hovey - Department of Epidemiology and Environmental Health, University at Buffalo, Buffalo, New York, USA
Christopher A Andrews - Department of Epidemiology and Environmental Health, University at Buffalo, Buffalo, New York, USA
Jennifer G Robinson - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA
Karen C Johnson - Department of Preventive Medicine, University of Tennessee Health Sciences Center, Memphis, Tennessee, USA
Sylvia Wassertheil-Smoller - Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, USA
Sybil Crawford - Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA
Lihong Qi - Department of Public Health Sciences, One Shields Avenue, Med Sci 1-C, University of California, Davis, California, USA
Lisa W Martin - Division of Cardiology, George Washington University School of Medicine and Health Sciences, Washington DC, USA
Judith Ockene - Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA
JoAnn E Manson - Division of Preventive Medicine, Brigham and Women's Hospital & Harvard Medical School, Boston, Massachusetts, USA
Resource Type: Journal article
Publication Details: BMJ open, Vol.5(2), pp.e007075-e007075
DOI: 10.1136/bmjopen-2014-007075
PMID: 25716175
PMCID: PMC4342587
NLM abbreviation: BMJ Open
ISSN: 2044-6055
eISSN: 2044-6055
Publisher: England
Grant note: N01WH42123 / WHI NIH HHS N01WH32111 / WHI NIH HHS N01WH42132 / WHI NIH HHS N01WH42118 / WHI NIH HHS N01WH42114 / WHI NIH HHS N01WH42110 / WHI NIH HHS N01WH32106 / WHI NIH HHS N01WH32119 / WHI NIH HHS N01WH32115 / WHI NIH HHS N01WH32102 / WHI NIH HHS N01WH24152 / WHI NIH HHS N01WH32101 / WHI NIH HHS N01WH42131 / WHI NIH HHS N01WH42108 / WHI NIH HHS N01WH42126 / WHI NIH HHS N01WH42113 / WHI NIH HHS N01WH42117 / WHI NIH HHS N01WH44221 / WHI NIH HHS N01WH32109 / WHI NIH HHS N01WH32105 / WHI NIH HHS N01WH32118 / WHI NIH HHS N01WH42122 / WHI NIH HHS N01WH42107 / WHI NIH HHS N01WH42130 / WHI NIH HHS N01WH42125 / WHI NIH HHS N01WH42112 / WHI NIH HHS N01WH42129 / WHI NIH HHS N01WH32122 / WHI NIH HHS N01WH42116 / WHI NIH HHS N01WH32108 / WHI NIH HHS N01WH32113 / WHI NIH HHS N01WH32100 / WHI NIH HHS N01WH42121 / WHI NIH HHS N01WH42115 / WHI NIH HHS N01WH42124 / WHI NIH HHS N01WH32112 / WHI NIH HHS N01WH42119 / WHI NIH HHS N01WH22110 / WHI NIH HHS N01WH42111 / WHI NIH HHS N01WH42120 / WHI NIH HHS N01WH42109 / WHI NIH HHS
Language: English
Date published: 02/25/2015
Academic Unit: Epidemiology; Internal Medicine
Record Identifier: 9983996193502771

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