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From the Department of Neurology (M.B., M.R.-Y., R.L., J.C.), Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Department of Neurology (F.N., J.V.), Hospital Universitario de La Princesa, Madrid, Spain; Department of Neurology (M.C., J.S.) and Biostatistics Unit (M.G.-G.), Hospital Universitari Doctor Josep Trueta, Girona, Spain; Department of Pharmacology (I.L., M.A.M.), School of Medicine, Universidad Complutense, Madrid, Spain; Department of Neurosciences (A.D.), Hospital Universitari Germans Trias i Pujol, Universitat Autónoma de Barcelona, Badalona, Spain.
Address correspondence and reprint requests to Dr. José Castillo, Department of Neurology, Hospital Clínico Universitario, Travesa da Choupana s/n, 15706 Santiago de Compostela, Spain mecasti{at}usc.es
Background: Pretreatment with statins has been shown to reduce brain injury in cerebral ischemia. In this controlled randomized study, we investigated the influence of statin pretreatment and its withdrawal on the outcome of acute ischemic stroke patients.
Methods: From 215 patients admitted within 24 hours of a hemispheric ischemic stroke, 89 patients on chronic statin treatment were randomly assigned either to statin withdrawal for the first 3 days after admission (n = 46) or to immediately receive atorvastatin 20 mg/day (n = 43). The primary outcome event was death or dependency (modified Rankin Scale [mRS] score > 2) at 3 months. Early neurologic deterioration (END) and infarct volume at days 4 to 7 were secondary outcome variables. In a secondary analysis, outcome variables were compared with the nonrandomized patients without previous statin therapy (n = 126).
Results: Patients with statin withdrawal showed a higher frequency of mRS score > 2 at the end of follow-up (60.0% vs 39.0%; p = 0.043), END (65.2% vs 20.9%; p < 0.0001), and greater infarct volume (74 [45, 126] vs 26 [12, 70] mL; p = 0.002) compared with the non–statin-withdrawal group. Statin withdrawal was associated with a 4.66 (1.46 to 14.91)–fold increase in the risk of death or dependency, a 8.67 (3.05 to 24.63)–fold increase in the risk of END, and an increase in mean infarct volume of 37.63 mL (SE 10.01; p < 0.001) after adjusting for age and baseline stroke severity. Compared with patients without previous treatment with statins, statin withdrawal was associated with a 19.01 (1.96 to 184.09)–fold increase in the risk of END and an increase in mean infarct volume of 43.51 mL (SE 21.91; p = 0.048).
Conclusion: Statin withdrawal is associated with increased risk of death or dependency at 90 days. Hence, this treatment should be continued in the acute phase of ischemic stroke.
This project was partially supported by grants from the Spanish Ministry of Health (Instituto de Salud Carlos III) RETICS-RD06/0026.
Disclosure: Dr. José Castillo, Dr. José Vivancos, and Dr. Antonio Dávalos are scientific advisors to Pfizer. Dr. Antonio Dávalos is a member of the SPARCL Writing Committee. The rest of the authors report no conflicts of interest.
Partial results of this investigation were presented at the 31st International Stroke Conference in Kissimmee, FL (February 2006).
Received December 27, 2006. Accepted in final form March 29, 2007.
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