Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke "SPARCL"

Completed

Phase 4 Results

Results

80 mg of atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events, despite a small increase in the incidence of hemorrhagic stroke. During followup, 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; P = 0.03), with the atorvastatin group having 218 ischemic strokes and 55 hemorrhagic strokes, compared to the placebo group with 274 ischemic strokes and 33 hemorrhagic strokes. The atorvastatin group had 216 deaths, compared to the placebo rate of 211 (P = 0.98). Elevated liver enzyme values were a concern with persistent elevation of alanine or aspartate aminotransferase (>3 times the upper limit of the normal group on two consecutive occasions) more frequent in the atorvastatin group (51 patients, or 2.2 percent) than in the placebo group (11 patients, or 0.5 percent; P<0.001), but there were no cases of liver failure. Sub study of 781 patients with metabolic syndrome showed a slightly reduced risk of stroke of 12% and major coronary events by 26% (both insignificant) while reducing the risk of coronary heart disease events by 43%. Sub study with results reported in "Stroke" in October 2007, using a post hoc analysis of 55,045 LDL-C measurements among the 4731 patients enrolled in SPARCL to determine the benefit and risks associated with achieving a >/=50% low-density lipoprotein cholesterol (LDL-C) reduction from baseline during a mean follow-up period of 4.9 years showed that patients with >/=50% LDL-C reduction had a 31% reduction in stroke risk (P=0.0016), a 33% reduction in ischemic stroke (P=0.0018), no statistically significant increase in hemorrhagic stroke (P=0.8864), and a 37% reduction in major coronary events (P=0.0323). A post-hoc analysis of changes in kidney function performed after the close of the study, revealed that those post-stroke or mini-stroke patients treated with 80 mg Lipitor had significantly improved kidney function compared to placebo group.