Does statin increase the risk of intracerebral hemorrhage in stroke survivors? A meta-analysis and trial sequential analysis.

cardiovascular events cerebrovascular disease meta-analysis secondary stroke prevention statin trial sequential analysis

Journal

Therapeutic advances in neurological disorders
ISSN: 1756-2856
Titre abrégé: Ther Adv Neurol Disord
Pays: England
ID NLM: 101480242

Informations de publication

Date de publication:
2019
Historique:
received: 06 05 2019
accepted: 30 06 2019
entrez: 7 8 2019
pubmed: 7 8 2019
medline: 7 8 2019
Statut: epublish

Résumé

It remains debatable whether statin increases the risk of intracerebral hemorrhage (ICH) in poststroke patients. We systematically searched PubMed, EMBASE, and CENTRAL for randomized controlled trials. Trial sequential analysis (TSA) was conducted to assess the reliability and conclusiveness of the available evidence in the meta-analysis. To evaluate the overall effectiveness, the net composite endpoints were derived by totaling ischemic stroke, hemorrhagic stroke, transient ischemic attack (TIA), myocardial infarction, and cardiovascular mortality. A total of 17 trials with 11,576 subjects with previous ischemic stroke, TIA, or ICH were included, in which statin therapy increased the risk of hemorrhagic stroke (risk ratio [RR], 1.42; 95% confidence interval [CI], 1.07-1.87), but reduced the risk of ischemic stroke (RR, 0.85; 95% CI, 0.75-0.95). For the net composite endpoints, statin therapy was associated with a 17% risk reduction (95% CI, 12-21%; number needed to treat = 6). With a control event rate 2% and RR increase 40%, the TSA suggested a conclusive signal of an increased risk of hemorrhagic stroke in stroke survivors taking statin. However, with the sensitivity analysis by changing assumptions, the conclusions about hemorrhagic stroke risk were less robust. Statin therapy in poststroke patients increased the risk of hemorrhagic stroke but effectively reduced ischemic stroke risk. Weighing the benefits and potential harms, statin has an overall beneficial effect in patients with previous stroke or TIA. However, more studies are required to investigate the conclusiveness of the increased hemorrhagic stroke risk revealed in our study.

Sections du résumé

BACKGROUND BACKGROUND
It remains debatable whether statin increases the risk of intracerebral hemorrhage (ICH) in poststroke patients.
METHODS METHODS
We systematically searched PubMed, EMBASE, and CENTRAL for randomized controlled trials. Trial sequential analysis (TSA) was conducted to assess the reliability and conclusiveness of the available evidence in the meta-analysis. To evaluate the overall effectiveness, the net composite endpoints were derived by totaling ischemic stroke, hemorrhagic stroke, transient ischemic attack (TIA), myocardial infarction, and cardiovascular mortality.
RESULTS RESULTS
A total of 17 trials with 11,576 subjects with previous ischemic stroke, TIA, or ICH were included, in which statin therapy increased the risk of hemorrhagic stroke (risk ratio [RR], 1.42; 95% confidence interval [CI], 1.07-1.87), but reduced the risk of ischemic stroke (RR, 0.85; 95% CI, 0.75-0.95). For the net composite endpoints, statin therapy was associated with a 17% risk reduction (95% CI, 12-21%; number needed to treat = 6). With a control event rate 2% and RR increase 40%, the TSA suggested a conclusive signal of an increased risk of hemorrhagic stroke in stroke survivors taking statin. However, with the sensitivity analysis by changing assumptions, the conclusions about hemorrhagic stroke risk were less robust.
CONCLUSIONS CONCLUSIONS
Statin therapy in poststroke patients increased the risk of hemorrhagic stroke but effectively reduced ischemic stroke risk. Weighing the benefits and potential harms, statin has an overall beneficial effect in patients with previous stroke or TIA. However, more studies are required to investigate the conclusiveness of the increased hemorrhagic stroke risk revealed in our study.

Identifiants

pubmed: 31384308
doi: 10.1177/1756286419864830
pii: 10.1177_1756286419864830
pmc: PMC6657129
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1756286419864830

Déclaration de conflit d'intérêts

Conflict of interest statement: The authors declare no conflicts of interest in preparing this article.

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Auteurs

Ru Jian Jonathan Teoh (RJJ)

International Health Program, National Yang-Ming University, Taipei.

Chi-Jung Huang (CJ)

Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taipei.

Chi Peng Chan (CP)

Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.

Li-Yin Chien (LY)

International Health Program, National Yang-Ming University, Taipei.

Chih-Ping Chung (CP)

Department of Neurology, National Yang-Ming University, Taipei.

Shih-Hsien Sung (SH)

Department of Medicine, National Yang-Ming University, Taipei.

Chen-Huan Chen (CH)

Department of Internal Medicine, Taipei Veterans General Hospital, Taipei.

Chern-En Chiang (CE)

Department of Medicine, National Yang-Ming University, Taipei.

Hao-Min Cheng (HM)

Center for Evidence-based Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shih-Pai Road, Beitou District, Taipei 11217.

Classifications MeSH