title: Effect and Safety of Rosuvastatin in Acute Ischemic Stroke.
abstract: OBJECTIVE
  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-naïve 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 mm(3) vs. placebo: 0.3±1.3 mm(3); 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.
authors: Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.
authors: Ji Hoe
authors: JH
authors: Heo
authors: Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.
authors: Dongbeom
authors: D
authors: Song
authors: Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.
authors: Hyo Suk
authors: HS
authors: Nam
authors: Department of Radiology, Gachon University, Gil Medical Center, Incheon, Korea.
authors: Eung Yeop
authors: EY
authors: Kim
authors: Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.
authors: Young Dae
authors: YD
authors: Kim
authors: Department of Neurology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Kyung-Yul
authors: KY
authors: Lee
authors: Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.
authors: Ki-Jeong
authors: KJ
authors: Lee
authors: Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.
authors: Joonsang
authors: J
authors: Yoo
authors: Clinical Trials Center, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors: Youn Nam
authors: YN
authors: Kim
authors: Department of Neurology, Hallym University Sacred Heart Hospital, Pyeongchon, Korea.
authors: Byung Chul
authors: BC
authors: Lee
authors: Department of Neurology, Seoul National University College of Medicine, Seoul, Korea.
authors: Byung-Woo
authors: BW
authors: Yoon
authors: Department of Neurology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors: Jong S
authors: JS
authors: Kim
keywords: Diffusion-weighted imaging; Rosuvastatin; Statin; Stroke