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SPARCL: Statin treatment did not affect outcomes in patients with type 2 diabetes, metabolic syndrome

Callahan A. Arch Neurol. 2011;doi:10.1001/archneurol.2011.146.

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A cohort of patients with type 2 diabetes mellitus or metabolic syndrome did not benefit from statin treatment, according to recent results.

The secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial aimed to determine whether treatment with atorvastatin (Lipitor, Pfizer) could reduce stroke in patients with type 2 diabetes or metabolic syndrome who had recently had a stroke or transient ischemic attack.

There were 794 patients with type 2 diabetes at enrollment; 642 patients retrospectively included in a metabolic syndrome cohort; and 3,295 patients in a reference group who belonged to neither category.

Compared with the reference group, those with type 2 diabetes were at an increased risk for stroke (HR=1.62; 95% CI, 1.33-1.98), major CV events (HR=1.66; 95% CI, 1.39-1.97) and revascularization procedures (HR=2.39; 95% CI, 1.78-3.19).

There was no increased risk for stroke (P=.78) or major CV events (P=.38) among patients with metabolic syndrome compared with those in the reference group. However, patients with metabolic syndrome were more likely to undergo revascularization procedures (HR=1.78; 95% CI, 1.26-2.5).

No significant treatment interactions were observed for the SPARCL primary endpoint (P=.47), according to the results.

The primary endpoint was combined risk for nonfatal and fatal stroke, and secondary endpoints included major coronary events, major CV events, any coronary disease event and any revascularization procedure. Regression analysis was conducted to determine whether the effect of treatment varied based on the presence of type 2 diabetes or metabolic syndrome.

“The SPARCL trial was unique in that it was specifically designed to evaluate the effects of statin treatment in subjects with a recent noncardioembolic stroke or TIA and no known CHD,” the researchers wrote. “Although the possibility of variation in the benefit of statin treatment in subjects with or without type 2 diabetes or [metabolic syndrome] cannot be excluded by this analysis, there was no evidence of a difference in treatment effect.”

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