Effect and Safety of Rosuvastatin in Acute Ischemic Stroke.
- Author:
Ji Hoe HEO
1
;
Dongbeom SONG
;
Hyo Suk NAM
;
Eung Yeop KIM
;
Young Dae KIM
;
Kyung Yul LEE
;
Ki Jeong LEE
;
Joonsang YOO
;
Youn Nam KIM
;
Byung Chul LEE
;
Byung Woo YOON
;
Jong S. KIM
Author Information
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords: Stroke; Rosuvastatin; Statin; Diffusion-weighted imaging
- MeSH: Cerebral Hemorrhage; Follow-Up Studies; Hemorrhage; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Infarction; Magnetic Resonance Imaging; Random Allocation; Recurrence; Stroke*; Rosuvastatin Calcium
- From:Journal of Stroke 2016;18(1):87-95
- CountryRepublic of Korea
- Language:English
- 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.
