High-dose atorvastatin reduces recurrent stroke, not mortality (SPARCL)

General

Clinical Question:
Does high-dose atorvastatin improve outcomes after stroke or transient ischemic attack?

Bottom Line:
High-dose atorvastatin reduces the risk of recurrent stroke, but does not improve mortality rates. A reduction in the risk of transient ischemic attack (TIA) or unclassified stroke was partially offset by an increase in the risk of hemorrhagic stroke. (LOE = 1b)

Reference:
Amarenco P, Bogousslavsky J, Callahan A 3rd, et al, for the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006;355:549-559.  [PMID:16899775]

Study Design:
Randomized controlled trial (double-blinded)

Allocation:
Uncertain

Setting:
Inpatient (any location) with outpatient follow-up

Synopsis:
In this study, patients presenting within 6 months of an ischemic or hemorrhagic stroke or TIA were randomly assigned (allocation concealment uncertain) to either atorvastatin 80 mg per day or placebo. Patients had to be ambulatory, have a Rankin scale score of less than 4 of 6, and a low-density lipoprotein cholesterol level of 100 mg/dL to 190 mg/dL (2.6 to 4.9 mmol/L). Their mean age was 63 years, 60% were male, and 69% suffered a stroke as the index event. Analysis was by intention to treat and patients were followed up for a mean of 4.9 years. Groups were balanced at the start of the study and of the 4731 patients who were randomized, a similar number in each group (2272 vs 2253) were observed through the end of the study. At the end of the study, patients who took atorvastatin were less likely to have a stroke (11.2% vs 13.1%; P = .03; number needed to treat = 53 for 5 years to prevent 1 stroke). However, there was no difference in overall mortality bewteen groups (9.1% for atorvastatin vs 8.9% for placebo; P = .77) and there was a significant increase in the risk of hemorrhagic stroke in those taking atorvastatin (1.66; 95% CI, 1.08 - 2.55; number needed to treat to harm = 107 for 5 years). To be fair, the study was not powered to detect a difference in mortality rate.

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