Summary of findings for the main comparison. Aclidinium bromide compared to placebo for stable chronic obstructive pulmonary disease.
| Aclidinium bromide compared to placebo for stable chronic obstructive pulmonary disease | ||||||
| Patient or population: patients with stable chronic obstructive pulmonary disease Settings: community Intervention: aclidinium bromide Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Aclidinium bromide | |||||
| Mortality (all‐cause) Follow‐up: 6‐52 weeks | 5 per 1000 | 5 per 1000 (2 to 10) | OR 0.92 (0.43 to 1.94) | 5252 (9 studies) | ⊕⊕⊝⊝ low1 | |
| Exacerbations requiring steroids, antibiotics or both Follow‐up: 4‐52 weeks | 137 per 1000 | 122 per 1000 (105 to 141) | OR 0.88 (0.74 to 1.04) | 5624 (10 studies) | ⊕⊕⊕⊝ moderate2,3,4 | |
| Quality of life Number of patients who achieved at least 4 units improvement in SGRQ total score Follow‐up: 12‐52 weeks | 396 per 1000 | 494 per 1000 (462 to 527) | OR 1.49 (1.31 to 1.7) | 4420 (7 studies) | ⊕⊕⊕⊕ high | The mean quality of life (SGRQ total score change from baseline) in the intervention groups was 2.34 lower (3.18 to 1.51 lower); (4442 participants; 7 studies) |
| Functional capacity Six‐minute walking distance | See comment | See comment | Not estimable | 0 (0) | See comment | No study assessed functional capacity |
| Hospital admissions due to exacerbations Follow‐up: 4‐52 weeks | 37 per 1000 | 24 per 1000 (17 to 33) | OR 0.64 (0.46 to 0.88) | 5624 (10 studies) | ⊕⊕⊕⊕ high2,3 | |
| Non‐fatal serious adverse events Follow‐up: 4‐52 weeks | 56 per 1000 | 50 per 1000 (40 to 64) | OR 0.89 (0.7 to 1.14) | 5651 (10 studies) | ⊕⊕⊕⊝ moderate2,3,4 | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 ‐2 for imprecision: the CI includes the possibility of both appreciable benefit and harm. 2Chanez 2010 failed to report some outcomes of lung function in the published full text but it is unlikely to affect this outcome. 3Chanez 2010 is double blinded for aclidinium and placebo arms though it is open label for tiotropium arm with no study limitation for this comparison. 4 ‐1 for imprecision: the CI includes important benefit and potential harm.