Twenty-one randomised controlled trials were included in the review (22,542 patients reported in the text, range 100 to 5,993 per trial). Total Jadad Scale scores were 3 (eight trials), 4 (10 trials) or 5 (three trials).
Trough FEV1 (19 trials): Compared with placebo, all active treatment drugs were shown to be more efficacious (statistically and clinically) with point estimates above the minimal clinically important difference of 100mL (reported fully in the review). After 12 and 24 weeks, no statistically significant differences in trough FEV1 were found between aclidinium and tiotropium (5µg), tiotropium (18µg) and glycopyrronium (50µg).
The probabilities of aclidinium being a better treatment than these other drugs ranged from 41% to 59% at 12 weeks and from 48% to 72% at 24 weeks.
Health status according to SGRQ scores (14 trials): Compared with placebo, all active treatment drugs were associated with statistically significant improvements in SGRQ score (a lower score). One of the comparisons at 24 weeks (aclidinium versus placebo) demonstrated a clinically significant improvement exceeding four units (difference in CFB 4.63, 95% Crl -6.85 to -2.42). After 12 and 24 weeks, no statistically significant differences in SGRQ score were found between aclidinium and tiotropium (18µg) or glycopyrronium (50µg). At 24 weeks, aclidinium demonstrated a statistically significant reduction in SGRQ score compared with tiotropium (5µg) (difference in CFB -2.44, 95% Crl -4.82 to -0.05).
The probabilities of aclidinium being a better treatment than these other drugs ranged from 64% to 86% at 12 weeks and from 88% to 98% at 24 weeks.
Relief from dyspnoea according to TDI focal scores (10 trials): Compared with placebo, all active treatment drugs were associated with statistically significant improvements in TDI focal score (a higher score). One of the comparisons at 24 weeks (aclidinium versus placebo) demonstrated a clinically significant improvement of one unit (difference in CFB 1.00, 95% Crl 0.43 to 1.57). After 12 and 24 weeks, no statistically significant differences were shown between aclidinium and tiotropium (18µg) or glycopyrronium (50µg).
The probabilities of aclidinium being a better treatment than these other drugs ranged from 59% to 74%.
Similar results for the outcomes were shown in other scenario and covariate analyses. The proportions of patients who achieved the minimal clinically important difference of more than four units in SGEQ score and more than one unit in TDI score were statistically significantly higher for all active treatment drugs when they were each compared with placebo. All results were fully reported in the review.