Significantly less (P <.05) supplemental albuterol was observed in the group of responders defined by a one-unit improvement in TDI.
The improvement in PSP after 8 weeks of treatment was significantly correlated with the reduction in PANSS: after 8 weeks of treatment, the responders (defined as those with a reduction in PANSS total score ≥ 50%) experienced a greater improvement in PSP than the non-responders.
The primary effectiveness end point will be evaluated for non-inferiority, with a nested test of superiority, based on the proportion of responders (defined as alive, free from HF-related events, with improvements in New York Heart Association class or improvement in Kansas City Cardiomyopathy Questionnaire quality of life score) at 12 months.
Fifty-five per-cent (43/78) of the cCH patients were frequency responders, defined as experiencing at least a 50% reduction in attack frequency.
The proportion of responders, defined as patient with ≥ 50% reduction in mean pain score from baseline to endpoint, was used to assess the efficacy.
The percentage of responders defined as subjects for whom the attack frequency decreased by ≥50% compared to run-in per visits in the double-blind period.
The primary outcome measure for this review was proportion of responders, defined as patients with at least 50% reduction in frequency and/or intensity of pain.
The proportion of responders, defined as patient with ≥ 50% reduction in mean pain score from baseline to endpoint, was also used to assess the efficacy of the treatment.
Two found no significant support for an adequate therapeutic effect (responders defined as 50% reduction in headache days per month), and the other found only a moderate benefit (responders defined as 30% improvement in pain) in 39% of the treated subjects.
During the follow-up, the proportion of responders, defined as patients no longer overusing symptomatic medications or with a greater than 50% reduction in headache days, tended to be higher in the prophylaxis group.
The proportion of responders, defined as patients with at least 50% reduction in frequency and/or intensity of pain, was all above 60% and the mean proportion was 80% (Figure 2).
