Japan Statin Treatment Against Recurrent Stroke | Clinical Trial - J-STARS

Feb 18, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
02/18/2015
Original Posted Date:
02/18/2015
References

Description:

The goal of the trial was to evaluate treatment with low-dose pravastatin compared with placebo among Japanese patients with prior ischemic stroke.

Contribution to the Literature: The J-STARS trial failed to show a reduction in recurrent cerebrovascular events with low-dose pravastatin.

Study Design

Patients with prior ischemic stroke were randomized to pravastatin 10 mg (n = 793) versus control (n = 785). Study design: parallel.

Inclusion criteria:

  • Japanese patients with prior ischemic stroke 1 month to 3 years ago
  • Total cholesterol 180-240 mg/dl
  • Age >45 years, <80 years
  • Total number of enrollees: 1,578
  • Duration of follow-up: mean 4.9 years
  • Mean patient age: 66 years
  • Percentage female: 31%
  • Percentage diabetics: 23%
  • Other salient features/characteristics: Mean systolic blood pressure = 137 mm Hg

Exclusion criteria:

  • Cardioembolic stroke

Principal Findings:

The primary outcome, any cerebrovascular event, occurred in 2.56%/year in the low-dose pravastatin group versus 2.65%/year in the control group (p = NS).

Secondary outcomes:

  • Atherothrombotic infarction: 0.21%/year vs. 0.65%/year (p < 0.05), respectively
  • Any death: 0.90%/year vs. 1.11%/year, respectively
  • Hemorrhagic stroke: 0.31%/year vs. 0.31%/year, respectively

Interpretation:

Among Japanese patients with prior ischemic stroke, low-dose pravastatin did not prevent recurrent cerebrovascular events, although it did prevent atherothrombotic infarction. The follow-up period was long; however, the dose of pravastatin that was tested may have been too low to prevent recurrent cerebrovascular events.

References:

Presented by Dr. Masayasu Matsumoto at the International Stroke Conference (ISC), February 13, 2015, Nashville, TN.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Statins

Keywords: Stroke, Pravastatin, Cholesterol, Dyslipidemias, Infarction, Primary Prevention, Diabetes Mellitus, Hydroxymethylglutaryl-CoA Reductase Inhibitors


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