Abstract
Limited data are available on gender differences in patients with post-stroke spasticity (PSS) treated with onabotulinumtoxinA (onabotA). This subgroup analysis of data from the BOTOX(®) Economic Spasticity Trial (BEST) focused on onabotA-treated patients stratified by gender. BEST was a double-blind, placebo-controlled, randomized study with an open-label extension that allowed for up to five treatments. It evaluated the effectiveness of onabotA + Standard of Care (SC) vs. placebo + SC for the treatment of PSS. At baseline, out of 139 patients treated with onabotA, females (n = 54) had a slightly higher body mass index (BMI) compared to males (n = 85) (28.3 vs. 26.9 kg/m(2)), and a greater percentage of females (40.7%) took analgesic medications compared to males (31.8%). Scores from baseline assessments for pain, spasticity severity, and stroke recovery were comparable between groups. Despite these similarities at baseline, females received an average lower dose (range, 337-365 U) of onabotA compared to males (range, 343-421 U) across treatment sessions. Females also had lower changes from baseline compared to males on pain, spasticity severity, stroke recovery, and functional goal achievement assessments across most onabotA treatment sessions. There is a need for further investigation into treatment approaches to optimize outcomes for both males and females with PSS.