Time to Response with Sodium Oxybate for the Treatment of @entity25 ( @entity25 ) and Cataplexy in @entity1 with XXXX .

@entity1 @entity2725 @entity9091 @entity2724 @entity7510 @entity25
Study Objectives: This post hoc analysis evaluated the time to response that can be expected with sodium oxybate (SXB) for treatment of @entity25 and @entity2725 in @entity1 with @entity2724 . Methods: Data were from a 4-week, double-blind, randomized, placebo-controlled trial ( @entity9091 ; N = 136) of oral SXB 3 g, 6 g, and 9 g nightly, and its 12-month open-label extension ( @entity7510 ). Two response definitions were utilized: >= 20% improvement in ESS score ( @entity25 responders), and >= 50% reduction in weekly @entity2725 attacks ( @entity2725 responders). These thresholds were previously determined to be clinically relevant based on analysis of the relationship of Clinical Global Impression of Change with ESS and number of @entity2725 attacks. Kaplan-Meier curves and median times to first response, based on above criteria, and to maximum response were estimated. Results: Among 86 @entity1 randomized to SXB in @entity9091 and continued into @entity7510 , 77.6% and 90.7% were @entity25 and @entity2725 responders, respectively. The median (95% CI) times to first response were 37 (31-50) days for @entity25 and 25 (17-29) days for @entity2725 , and median times to maximum response were 106 (85-164) days for @entity25 and 213 (94-279) days for @entity2725 . @entity7510 results among 31 @entity1 initially randomized to placebo were consistent with those treated with SXB throughout, but with longer times to maximum response. Conclusions: Response onset, assessed as clinically meaningful improvements in @entity25 and @entity2725 , was observed in most @entity1 within 2 months; a longer period is needed to achieve maximum response. Clinicians should recognize that time to initial and maximum response may take weeks to months.
