SPARCL Trial Treatment Duration
Yes, patients in the SPARCL trial took atorvastatin 80mg daily for a median duration of 4.9 years. 1, 2, 3
Trial Design Confirmation
The SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial randomized 4,731 patients who had experienced a stroke or TIA within 1-6 months to either atorvastatin 80mg daily or placebo, with a median follow-up of 4.9 years 3
The FDA drug label for atorvastatin specifically documents that in SPARCL, patients without clinically evident coronary heart disease but with recent stroke or TIA were treated with atorvastatin 80mg (n=2,365) or placebo (n=2,366) for a median follow-up of 4.9 years 2
Multiple guideline sources confirm this 4.9-year treatment duration as the basis for current stroke prevention recommendations with high-dose atorvastatin 1, 4, 5
Key Trial Outcomes Over This Duration
During the 4.9-year follow-up period, atorvastatin 80mg reduced fatal or nonfatal stroke from 13.1% in placebo to 11.2% in the treatment group, representing a 16% relative risk reduction 1, 3
The mean LDL-C level achieved during the treatment phase was 73 mg/dL in the atorvastatin group compared to 129 mg/dL in placebo 1, 3
The 5-year absolute risk reduction for major cardiovascular events was 3.5% (HR 0.80,95% CI 0.69-0.92, p=0.002) 4