Statins and Intracerebral Hemorrhage

Author:

Hackam Daniel G.1,Woodward Mark1,Newby L. Kristin1,Bhatt Deepak L.1,Shao Mingyuan1,Smith Eric E.1,Donner Allan1,Mamdani Muhammad1,Douketis James D.1,Arima Hisatomi1,Chalmers John1,MacMahon Stephen1,Tirschwell David L.1,Psaty Bruce M.1,Bushnell Cheryl D.1,Aguilar Maria I.1,Capampangan Dan J.1,Werring David J.1,De Rango Paola1,Viswanathan Anand1,Danchin Nicolas1,Cheng Ching-Lan1,Yang Yea-Huei Kao1,Verdel B. Marianne1,Lai Mei-Shu1,Kennedy James1,Uchiyama Shinichiro1,Yamaguchi Takenori1,Ikeda Yasuo1,Mrkobrada Marko1

Affiliation:

1. From the University of Western Ontario, London, ON, Canada (D.G.H., A.D., M. Mrkobrada); George Institute for Global Health, University of Sydney, Sydney, Australia (M.W., H.A., J.C., S.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (L.K.N.); VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical, School, Boston, MA (D.L.B.); Cleveland Clinic, Cleveland, OH (M.S.); Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada (E.E.S....

Abstract

Background— A recent large, randomized trial suggested that statins may increase the risk of intracerebral hemorrhage. Accordingly, we systematically reviewed the association of statins with intracerebral hemorrhage in randomized and observational data. Methods and Results— We screened 17 electronic bibliographic databases to identify eligible studies and consulted with experts in the field. We used DerSimonian-Laird random-effects models to compute summary risk ratios with 95% confidence intervals. Randomized trials, cohort studies, and case-control studies were analyzed separately. Only adjusted risk estimates were used for pooling observational data. We included published and unpublished data from 23 randomized trials and 19 observational studies. The complete data set comprised 248 391 patients and 14 784 intracerebral hemorrhages. Statins were not associated with an increased risk of intracerebral hemorrhage in randomized trials (risk ratio, 1.10; 95% confidence interval, 0.86–1.41), cohort studies (risk ratio, 0.94; 95% confidence interval, 0.81–1.10), or case-control studies (risk ratio, 0.60; 95% confidence interval, 0.41–0.88). Substantial statistical heterogeneity was evident for the case-control studies (I 2 =66%, P =0.01), but not for the cohort studies (I 2 =0%, P =0.48) or randomized trials (I 2 =30%, P =0.09). Sensitivity analyses by study design features, patient characteristics, or magnitude of cholesterol lowering did not materially alter the results. Conclusions— We found no evidence that statins were associated with intracerebral hemorrhage; if such a risk is present, its absolute magnitude is likely to be small and outweighed by the other cardiovascular benefits of these drugs.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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