Cardiovascular outcome trial · N Engl J Med 2006
SPARCL trial
High-dose atorvastatin after stroke or transient ischemic attack.
The bottom line
In patients with a recent stroke or TIA but no known coronary disease, high-dose atorvastatin modestly reduced recurrent stroke and cardiovascular events, though it slightly increased hemorrhagic stroke risk and did not improve overall mortality.
BenefitUS status: US-approved
At a glance
- Medicine
- 80 mg of atorvastatin per day
- Compared with
- Placebo
- People
- 4,731
- Who took part
- Patients who had had a stroke or TIA within one to six months before study entry, had LDL cholesterol levels of 100 to 190 mg per deciliter (2.6 to 4.9 mmol per liter), and had no known coronary heart disease
- Design
- randomized, double-blind, placebo-controlled
- Follow-up
- median follow-up of 4.9 years
- Main question
- First nonfatal or fatal stroke
Main result
265 patients (11.2 percent) receiving atorvastatin and 311 patients (13.1 percent) receiving placebo had a fatal or nonfatal stroke (5-year absolute reduction in risk, 2.2 percent; adjusted hazard ratio, 0.84; 95 percent confidence interval, 0.71 to 0.99; P=0.03; unadjusted P=0.05)
Effect on LDL cholesterol
The mean LDL cholesterol level during the trial was 73 mg per deciliter (1.9 mmol per liter) among patients receiving atorvastatin and 129 mg per deciliter (3.3 mmol per liter) among patients receiving placebo
Other results
The five-year absolute reduction in the risk of major cardiovascular events was 3.5 percent (hazard ratio, 0.80; 95 percent confidence interval, 0.69 to 0.92; P=0.002). The overall mortality rate was similar, with 216 deaths in the atorvastatin group and 211 deaths in the placebo group (P=0.98)
Safety
The atorvastatin group had 218 ischemic strokes and 55 hemorrhagic strokes, whereas the placebo group had 274 ischemic strokes and 33 hemorrhagic strokes. Rates of serious adverse events were similar between groups. Elevated liver enzyme values were more common in patients taking atorvastatin.
In the trial's own words
“During a median follow-up of 4.9 years, 265 patients (11.2 percent) receiving atorvastatin and 311 patients (13.1 percent) receiving placebo had a fatal or nonfatal stroke (5-year absolute reduction in risk, 2.2 percent; adjusted hazard ratio, 0.84; 95 percent confidence interval, 0.71 to 0.99; P=0.03; unadjusted P=0.05).”
Quoted from the abstract of N Engl J Med 2006, checked word for word against PubMed. PubMed 16899775 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the SPARCL trial find?
In patients with a recent stroke or TIA but no known coronary disease, high-dose atorvastatin modestly reduced recurrent stroke and cardiovascular events, though it slightly increased hemorrhagic stroke risk and did not improve overall mortality.
Who was in SPARCL?
4,731 people. Patients who had had a stroke or TIA within one to six months before study entry, had LDL cholesterol levels of 100 to 190 mg per deciliter (2.6 to 4.9 mmol per liter), and had no known coronary heart disease.
What was SPARCL's main result?
265 patients (11.2 percent) receiving atorvastatin and 311 patients (13.1 percent) receiving placebo had a fatal or nonfatal stroke (5-year absolute reduction in risk, 2.2 percent; adjusted hazard ratio, 0.84; 95 percent confidence interval, 0.71 to 0.99; P=0.03; unadjusted P=0.05)
How much did LDL cholesterol change in SPARCL?
The mean LDL cholesterol level during the trial was 73 mg per deciliter (1.9 mmol per liter) among patients receiving atorvastatin and 129 mg per deciliter (3.3 mmol per liter) among patients receiving placebo
Related trials
- IDEAL (2005)High-dose atorvastatin lowered LDL-C more than usual-dose simvastatin and reduced some secondary cardiovascular endpoints and nonfatal MI, but did not significantly reduce the primary composite of major coronary events or all-cause mortality after prior MI.
- TNT (2005)In patients with stable coronary disease, treating to a much lower LDL target with high-dose atorvastatin (80 mg) further reduced major cardiovascular events compared with the standard 10 mg dose, though with more liver enzyme elevations and no difference in overall mortality.
- CORONA (2007)In older patients with ischemic systolic heart failure, rosuvastatin lowered LDL cholesterol but did not reduce cardiovascular events or death, though it was safe and reduced cardiovascular hospitalizations.
- CARDS (2004)In people with type 2 diabetes but no prior cardiovascular disease and no high LDL-cholesterol, taking atorvastatin 10 mg daily substantially lowered the risk of heart attacks, revascularization, and stroke, with no increase in adverse events.
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