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Randomized Controlled Trial Multicenter Study
Uric Acid Therapy Improves Clinical Outcome in Women With Acute Ischemic Stroke.
- Laura Llull, Carlos Laredo, Arturo Renú, Belén Pérez, Elisabet Vila, Víctor Obach, Xabier Urra, Anna Planas, Sergio Amaro, and Ángel Chamorro.
- From the Department of Neuroscience, Comprehensive Stroke Center, Hospital Clinic, University of Barcelona, August Pi i Sunyer Biomedical Research Institute (Institut d'Investigacions Biomèdiques Agustí Pi i Sunyer), Barcelona, Spain (L.L., C.L., A.R., V.O., X.U., S.A., Á.C.); Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain (B.P., E.V.); Department of Brain Ischemia and Neurodegeneration, Institute for Biomedical Research of Barcelona, Spanish Research Council, Barcelona, Spain (A.P.); and Institut d'Investigacions Biomèdiques Agustí Pi i Sunyer, Barcelona, Spain (A.P.).
- Stroke. 2015 Aug 1; 46 (8): 2162-7.
Background And PurposeIt is unknown whether women and men with acute ischemic stroke respond similar to an antioxidant regimen administered in combination with thrombolysis. Here, we investigated the independent effect of sex on the response to uric acid (UA) therapy in patients with acute stroke treated with alteplase.MethodsIn the Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke (URICO-ICTUS) trial, 206 women and 205 men were randomized to UA 1000 mg or placebo. In this reanalysis of the trial, the primary outcome was the rate of excellent outcome at 90 days (modified Rankin Scale, 0-1, or 2, if premorbid score of 2) in women and men using regression models adjusted for confounders associated with sex. The interaction of UA levels by treatment on infarct growth was assessed in selected patients.ResultsExcellent outcome occurred in 47 of 111 (42%) women treated with UA, and 28 of 95 (29%) treated with placebo, and in 36 of 100 (36%) men treated with UA and 38 of 105 (34%) treated with placebo. Treatment and sex interacted significantly with excellent outcome (P=0.045). Thus, UA therapy doubled the effect of placebo to attain an excellent outcome in women (odd ratio [95% confidence interval], 2.088 [1.050-4.150]; P=0.036), but not in men (odd ratio [95% confidence interval], 0.999 [0.516-1.934]; P=0.997). The interactions between treatment and serum UA levels (P<0.001) or allantoin/UA ratio (P<0.001) on infarct growth were significant only in women.ConclusionsIn women with acute ischemic stroke treated with alteplase, the administration of UA reduced infarct growth in selected patients and was better than placebo to reach excellent outcome.Clinical Trial RegistrationURL: https://clinicaltrials.gov. Unique identifier: NCT00860366.© 2015 American Heart Association, Inc.
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