Summary of findings for the main comparison. Indacaterol versus placebo.
| Indacaterol versus placebo | ||||||
|
Patient or population: people with COPD
Settings: community
Intervention: indacaterol Comparator: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Indacaterol | |||||
| End‐of‐study trough FEV1 mL Follow‐up: 12 to 52 weeks | Mean end‐of‐study trough FEV1 in control groups was 1170 to 1360 mL | Mean end‐of‐study trough FEV1 in the intervention groups was 149.11 mL higher (137.09 to 161.12 higher) | 5001 (10 studies) | ⊕⊕⊕⊕ High | This value is greater than the minimum clinically important difference of 100 mL (Donahue 2005) | |
| Number of participants with a clinically significant improvement in QOL SGRQ Follow‐up: 12 to 52 weeks | 425 per 1000 | 548 per 1000 (519 to 578)a | OR 1.64 (1.46 to 1.845 | 4906 (9 studies) | ⊕⊕⊕⊕ High | |
| Number of participants with clinically significant improvement in dyspnoea TDI Follow‐up: 12 to 52 weeks | 440 per 1000 | 607 per 1000 (576 to 636)a | OR 1.96 (1.73 to 2.22) | 4577 (8 studies) | ⊕⊕⊕⊕ High | |
| Number of participants experiencing 1 or more exacerbations Follow‐up: 12 to 52 weeks | 222 per 1000 | 188 per 1000 (167 to 212) | OR 0.81 (0.7 to 0.94) | 4807 (7 studies) | ⊕⊕⊕⊕ High | |
| Serious adverse events Follow‐up: 12 to 52 weeks | 72 per 1000 | 72 per 1000 (60 to 87) | OR 1.00 (0.82 to 1.23) | 6065 (9 studies) | ⊕⊕⊕⊝ Moderateb | |
| Mortality Follow‐up: 12 to 52 weeks | 4 per 1000 | 2 per 1000 (1 to 4) | OR 0.42 (0.16 to 1.08) | 5694 (9 studies) | ⊕⊕⊕⊝ Moderateb | |
| *The basis for the assumed risk (e.g. 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; 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. | ||||||
aBaseline risk calculated from raw responder numbers in placebo arm at end of treatment. Absolute benefit and 95% CIs calculated from www.nntonline.net/visualrx/. b95% CIs around the point estimate of effect include both appreciable benefit and no difference.