J Stroke.
2016 Jan;18(1):87-95. 10.5853/jos.2015.01578.
Effect and Safety of Rosuvastatin in Acute Ischemic Stroke
- Affiliations
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- 1Department of Neurology, Yonsei University College of Medicine, Seoul, Korea. jhheo@yuhs.ac
- 2Department of Radiology, Gachon University, Gil Medical Center, Incheon, Korea.
- 3Department of Neurology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- 4Clinical Trials Center, Severance Hospital, Yonsei University Health System, Seoul, Korea.
- 5Department of Neurology, Hallym University Sacred Heart Hospital, Pyeongchon, Korea.
- 6Department of Neurology, Seoul National University College of Medicine, Seoul, Korea.
- 7Department of Neurology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
- KMID: 2223640
- DOI: http://doi.org/10.5853/jos.2015.01578
Abstract
- BACKGROUND AND PURPOSE
The benefit of statins in acute stroke remains uncertain. Statins may prevent stroke recurrence during the acute stage of stroke via pleiotropic effects. However, statins may increase the risk of intracerebral hemorrhage. We investigated the effect and safety of rosuvastatin in acute stroke patients.
METHODS
This randomized, double-blind, multi-center trial compared rosuvastatin 20 mg and placebo in statin-naive stroke patients who underwent diffusion-weighted imaging (DWI) within 48 hours after symptom onset. The primary outcome was occurrence of new ischemic lesions on DWI at 5 or 14 days.
RESULTS
This trial was stopped early after randomization of 316 patients due to slow enrollment. Among 289 patients with at least one follow-up imaging, the frequency of new ischemic lesions on DWI was not different between groups (rosuvastatin: 27/137, 19.7% vs. placebo: 36/152, 23.6%) (relative risk 0.83, 95% confidence interval 0.53-1.30). Infarct volume growth at 5 days (log-transformed volume change, rosuvastatin: 0.2+/-1.0 mm3 vs. placebo: 0.3+/-1.3 mm3; P=0.784) was not different, either. However, hemorrhagic infarction or parenchymal/subarachnoid hemorrhage on gradient-recalled echo magnetic resonance imaging occurred less frequently in the rosuvastatin group (6/137, 4.4%) than the placebo group (22/152, 14.5%, P=0.007). Among 314 patients with at least one dose of study medication, progression or clinical recurrence of stroke tended to occur less frequently in the rosuvastatin group (1/155, 0.6% vs. 7/159, 4.4%, P=0.067). Adverse events did not differ between groups.
CONCLUSIONS
The efficacy of rosuvastatin in reducing recurrence in acute stroke was inconclusive. However, statin use was safe and reduced hemorrhagic transformation.
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