Efficacy and tolerability of adjunct @entity23570 based on number of XXXX at baseline and baseline predictors of efficacy: A phase III post-hoc analysis.

@entity1 @entity410 @entity5322 @entity140 @entity734 @entity23570
UNASSIGNED: @entity23570 is a selective, noncompetitive @entity140 receptor antagonist with demonstrated efficacy and tolerability in partial @entity410 in @entity1 aged >= 12 years in Phase III studies. Post-hoc analysis of these studies was conducted to determine the efficacy and tolerability of @entity23570 based on the number of concomitant @entity734 ( @entity734 ) at baseline, as well as to examine which baseline characteristics, if any, were predictors of efficacy. Efficacy parameters were based on the number of baseline @entity734 , and logistic regression analyses were used to evaluate the association of demographic and baseline clinical factors with probability of >= 50% reduction in @entity410 frequency. @entity1 on 1 AED at baseline were significantly more likely to have reduced @entity410 frequency (P<0.02) and improved 50% responder rate (P<0.02) than @entity1 on 3 @entity734 at baseline. Secondarily generalized @entity410 at baseline, unknown etiology, and use of concomitant non-inducer @entity734 were also established as positive predictors of efficacy (50% responder rate; P<0.01). @entity1 with more @entity734 at baseline were associated with greater use of inducers (P<0.01), which may result in decreased exposure of @entity23570 in these @entity1 and lower efficacy. @entity1 with 1 AED at baseline had a significantly shorter time since diagnosis compared with @entity1 in the 3 (P<0.01) @entity734 group, as well as a lower median @entity410 frequency at baseline compared to @entity1 on 3 @entity734 (P<0.05), suggesting that the reduced efficacy of @entity23570 with 3 @entity734 may also be associated with the greater severity of @entity410 in the @entity1 groups. The incidence of adverse events in @entity23570 -treated @entity1 was similar regardless of the number of @entity734 at baseline. Greater efficacy is predicted for @entity1 receiving fewer concomitant @entity734 when starting @entity23570 , as well as for those receiving concomitant treatment with @entity734 that are not @entity5322 enzyme-inducers, compared to @entity1 treated with multiple concomitant @entity734 . The results of this study provide additional information for clinicians considering adding @entity23570 to their @entity1 ' treatment regimen earlier rather than later, and offer evidence regarding the potential for increased efficacy with a decreased medication burden.
