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Low-dose pravastatin reduced atherothrombotic infarction in certain patients with stroke
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NASHVILLE, Tenn. — Low-dose pravastatin appears to reduce the incidence of atherothrombotic infarction in patients experiencing noncardioembolic stroke, but did not alter the incidence of other types of stroke, according to results of the JSTARS study.
Researchers examined whether low-dose pravastatin would prevent recurrence in patients with ischemic stroke. The effect of statin therapy on prevention of recurrent stroke had not been studied in an Asian population, whose age- and sex-adjusted stroke mortality rates are high, Masayasu Matsumoto, MD, PhD, from the department of clinical neuroscience and therapeutics at Hiroshima University, Hiroshima, Japan, said during a press conference. The SPARCL trial, which did not include many Asian participants, previously demonstrated an association between treatment with atorvastatin (Lipitor, Pfizer) 80 mg/day and a decrease in overall incidence of stroke in patients with stroke or transient ischemic attack, he said.
Masayasu Matsumoto
Matsumoto and colleagues hypothesized that the neuroprotective mechanism of statins might attenuate cerebrovascular inflammation and atherosclerosis, which could lead to prevention of recurrent stroke in patients with ischemic stroke.
The researchers enrolled 1,578 patients aged 45 to 80 years from 123 centers in Japan who had a noncardioembolic ischemic stroke between 1 month and 3 years before recruitment in the JSTARS randomized controlled trial. The primary endpoint was recurrence of stroke or other cerebrovascular event. Patients were assigned pravastatin 10 mg/day or standard care and were followed for a mean of 4.9 years.
Compared with controls, the statin group had lower total cholesterol (P < .001), lower LDL (P < .001), lower triglycerides (P = .006) and higher HDL (P = .004) by the end of the study period, Matsumoto said.
After adjustment for stroke subtype, elevated BP and diabetes status, the researchers found no difference between the groups in the cumulative incidence of stroke or other cerebrovascular events (2.56%/year vs. 2.65%/year; adjusted HR = 0.97; 95% CI, 0.73-1.29) and secondary endpoints of lacunar infarction (1.26%/year vs. 1.01%/year; adjusted HR = 1.25; 95% CI, 0.81-1.92), hemorrhagic stroke (0.31%/year vs. 0.31%/year; adjusted HR = 1; 95% CI, 0.45-2.22), vascular events (3.23%/year vs. 3.81%/year; adjusted HR = 0.85; 95% CI, 0.66-1.09) or any death (0.9%/year vs. 1.11%/year; adjusted HR = 1.23; 95% CI, 0.79-1.93). However, the statin group had a lower cumulative incidence rate of the secondary endpoint of atherothrombotic infarction compared with the control group (0.21%/year vs. 0.65%/year; adjusted HR = 0.33; 95% CI, 0.15-0.74).
“These results may help refine preventive strategies for stroke recurrence,” Matsumoto said. – by Erik Swain
Reference:
Matsumoto M. Plenary Session III: LB16. Presented at: International Stroke Conference; Feb. 11-13, 2015; Nashville, Tenn.
Disclosure: Matsumoto reports no relevant financial disclosures.
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Larry B. Goldstein, MD, FAAN, FANA, FAHA
This study used a very low dose of pravastatin. This is one potential reason that the effect was neutral, aside from the post hoc subgroup analysis of people with atherothrombotic stroke, for whom there may have been a benefit.
The SPARCL trial, which I was involved with and which was funded by Pfizer, was previously the only large, prospective, randomized trial designed to test the impact of statins on reducing stroke and other CV events in patients after recent stroke or TIA. Unlike JSTARS, SPARCL evaluated a relatively high dose of a high-potency statin. The choice of using a low dose of a low-potency statin in JSTARS was because SPARCL suggested that statins might increase the risk for brain hemorrhage after stroke, a finding that has not been seen consistently in other observational studies.
Other data suggest that if a patient is on a statin and has an ischemic stroke, in the acute setting, it is important to maintain that statin. In a prospective, randomized trial testing that hypothesis, patients did worse if their statin was withdrawn. A fair amount of observational studies support this finding. For patients who have hemorrhagic stroke, it is not entirely as clear. The data are becoming more persuasive that those patients should also be maintained on a statin. Within SPARCL, the small group of patients who were randomized to the statin and who had a baseline brain hemorrhage derived no benefit. That’s a potential caveat, but that observation was also based on a post hoc subgroup analysis and needs to be considered exploratory.
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