http://stroke.ahajournals.org/content/46/8/2162.abstract?etoc
- Laura Llull, MD;
- Carlos Laredo, MSc;
- Arturo Renú, MD;
- Belén Pérez, PhD;
- Elisabet Vila, PhD;
- Víctor Obach, MD;
- Xabier Urra, MD, PhD;
- Anna Planas, PhD;
- Sergio Amaro, MD, PhD;
- Ángel Chamorro, MD, PhD
+ Author Affiliations
- Correspondence to Ángel Chamorro, MD, PhD, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain. E-mail achamorro@clinic.ub.es
Abstract
Background and Purpose—It
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.
Methods—In 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.
Results—Excellent
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.
Conclusions—In women with acute ischemic stroke treated with alteplase, the administration of UA reduced infarct growth(You didn't objectively measure infarct growth DID YOU?) in selected patients
and was better than placebo to reach excellent outcome.
Clinical Trial Registration—URL: https://clinicaltrials.gov. Unique identifier: NCT00860366.
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