Trial Design and Patient Population
The SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial randomized 4,731 patients to either atorvastatin 80 mg daily (n=2,365) or placebo (n=2,366) 2
Patients were followed for a median duration of 4.9 years 1, 2
The trial enrolled patients aged 21 to 92 years (40% female; 93% White, 3% Black or African American, 1% Asian, 3% other) who had experienced a stroke or transient ischemic attack within the previous 6 months 2
Key Efficacy Results with 80 mg Dosing
Atorvastatin 80 mg reduced fatal or nonfatal stroke from 13.1% in the placebo group to 11.2% in the treatment group, representing a 16% relative risk reduction 1, 3
The 5-year absolute risk reduction for stroke was 2.2% 4
Major cardiovascular events were reduced by 20% (5-year absolute risk reduction 3.5%; HR 0.80; 95% CI 0.69-0.92; p=0.002) 3, 5
Major coronary events were reduced by 35-43% 4
LDL-C Reduction Achieved
During the treatment phase, the mean LDL-C level was 73 mg/dL (1.9 mmol/L) in the atorvastatin 80 mg group compared to 129 mg/dL (3.3 mmol/L) in the placebo group 1
Baseline LDL-C levels were 132.7 mg/dL (3.43 mmol/L) in the atorvastatin group 1
The net difference in statin use between the two treatment groups was 78.1% 1
Safety Profile at 80 mg Dose
There was a higher incidence of hemorrhagic stroke in the atorvastatin 80 mg group (2.3% vs 1.4% for placebo; HR 1.66; 95% CI 1.08-2.55) 3, 2
Persistent hepatic transaminase elevations (≥3 x ULN twice within 4 to 10 days) occurred in 0.9% of the atorvastatin group compared to 0.1% in placebo 2
Elevations of CK (>10 x ULN) were rare but higher in the atorvastatin group (0.1%) compared to placebo (0%) 2
Diabetes was reported as an adverse reaction in 6.1% of subjects in the atorvastatin group versus 3.8% in the placebo group 2