Summary of findings 2. Indacaterol versus twice‐daily long‐acting beta2‐agonists for chronic obstructive pulmonary disease.
| Indacaterol versus twice‐daily long‐acting beta2‐agonists for chronic obstructive pulmonary disease | ||||||
| Patient or population: patients with chronic obstructive pulmonary disease Settings: community Intervention: indacaterol Comparison: twice‐daily long‐acting beta2‐agonists | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Twice‐daily long‐acting beta2‐agonists | Indacaterol | |||||
| End‐of‐study trough FEV1 mL Follow‐up: 12 to 52 weeks | Mean end‐of‐study trough FEV1 in the control groups was 1310 to 1390 mL | Mean end‐of‐study trough FEV1 in the intervention groups was 73.76 mL higher (57.33 to 90.19 higher) | 2708 (4 studies) | ⊕⊕⊕⊕ High | This value is less than the minimum clinically important difference of 100 mLd (Donahue 2005) | |
| Number of participants with a clinically significant improvement in quality of life SGRQ Follow‐up: 26 to 52 weeks | 498 per 1000 | 515 per 1000 (464 to 567)a | OR 1.07 (0.87 to 1.32) | 1520 (2 studies) | ⊕⊕⊕⊝ Moderateb | |
| Number of participants with a clinically significant improvement in dyspnoea TDI Follow‐up: 12 to 52 weeks | 581 per 1000 | 606 per 1000 (566 to 647)a | OR 1.11 (0.94 to 1.32) | 2536 (3 studies) | ⊕⊕⊕⊝ Moderateb | |
| Number of participants experiencing at least 1 exacerbation Exacerbations Follow‐up: 26 to 52 weeks | 241 per 1000 | 254 per 1000 (215 to 297) | OR 1.07 (0.86 to 1.33) | 1869 (2 studies) | ⊕⊕⊕⊝ Moderateb | |
| Serious adverse events Adverse events Follow‐up: 12 to 52 weeks | 78 per 1000 | 80 per 1000 (63 to 101) | OR 1.02 (0.79 to 1.32) | 3266 (4 studies) | ⊕⊕⊕⊝ Moderateb | |
| Mortality Deaths Follow‐up: 12 to 52 weeks | 2 per 1000 | 2 per 1000 (1 to 7) | OR 1.00 (0.31 to 3.28) | 3266 (4 studies) | ⊕⊕⊕⊝ Moderatec | |
| *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 taken from raw responder numbers at the end of treatment. Absolute risk and 95% CIs calculated from www.nntonline.net/visualrx. b95% CIs around the point estimate of effect include both no difference and appreciable benefit. c95% CIs around the point estimate of effect include both significant benefit and significant harm.
dMinimum clinically important difference.