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 Johnson, Sylvia Wassertheil-Smoller, Sybil Crawford, Lihong Qi, Lisa W. Martin, Judith Ockene, Jo Ann E. Manson

Research output: Contribution to journalArticle

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Abstract

Objectives: 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. Design: Observational study: secondary data analysis from the Women's Health Initiative (WHI) clinical trials. Setting: Women were recruited from 40 participating sites. Participants: Cohort of 68 132 women followed through 2005 (parent study) and for an additional 5 years in the extension study. Main outcome measures: 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 (timevarying 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. Results: 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. Conclusions: 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.

Original languageEnglish (US)
Article numbere007075
JournalBMJ Open
Volume5
Issue number2
DOIs
StatePublished - Jan 1 2015

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Women's Health
Observational Studies
Stroke
Platelet Aggregation Inhibitors
Proportional Hazards Models
Outcome Assessment (Health Care)
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Salmoirago-Blotcher, E., Hovey, K. M., Andrews, C. A., Robinson, J. G., Johnson, K., Wassertheil-Smoller, S., ... Manson, J. A. E. (2015). Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: An observational study from the Women's Health Initiative. BMJ Open, 5(2), [e007075]. https://doi.org/10.1136/bmjopen-2014-007075

Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women : An observational study from the Women's Health Initiative. / Salmoirago-Blotcher, Elena; Hovey, Kathleen M.; Andrews, Christopher A.; Robinson, Jennifer G.; Johnson, Karen; Wassertheil-Smoller, Sylvia; Crawford, Sybil; Qi, Lihong; Martin, Lisa W.; Ockene, Judith; Manson, Jo Ann E.

In: BMJ Open, Vol. 5, No. 2, e007075, 01.01.2015.

Research output: Contribution to journalArticle

Salmoirago-Blotcher, E, Hovey, KM, Andrews, CA, Robinson, JG, Johnson, K, Wassertheil-Smoller, S, Crawford, S, Qi, L, Martin, LW, Ockene, J & Manson, JAE 2015, 'Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: An observational study from the Women's Health Initiative', BMJ Open, vol. 5, no. 2, e007075. https://doi.org/10.1136/bmjopen-2014-007075
Salmoirago-Blotcher, Elena ; Hovey, Kathleen M. ; Andrews, Christopher A. ; Robinson, Jennifer G. ; Johnson, Karen ; Wassertheil-Smoller, Sylvia ; Crawford, Sybil ; Qi, Lihong ; Martin, Lisa W. ; Ockene, Judith ; Manson, Jo Ann E. / Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women : An observational study from the Women's Health Initiative. In: BMJ Open. 2015 ; Vol. 5, No. 2.
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abstract = "Objectives: 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. Design: Observational study: secondary data analysis from the Women's Health Initiative (WHI) clinical trials. Setting: Women were recruited from 40 participating sites. Participants: Cohort of 68 132 women followed through 2005 (parent study) and for an additional 5 years in the extension study. Main outcome measures: 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 (timevarying 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. Results: 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. Conclusions: 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.",
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AU - Andrews, Christopher A.

AU - Robinson, Jennifer G.

AU - Johnson, Karen

AU - Wassertheil-Smoller, Sylvia

AU - Crawford, Sybil

AU - Qi, Lihong

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