TABLE 4.
GRADE summary of findings for intervention versus controls in patients with chronic obstructive pulmonary disease (COPD).
| Patient or population | Settings | Intervention | Comparison | Outcomes (timeframe) | Relative effect (95%CI) | No. of participants | Absolute effect estimate (95%CI) | Quality of evidence | Comments |
|---|---|---|---|---|---|---|---|---|---|
| Individuals with COPD | Outpatient | Revefenacin 175 μg/day | Placebo | Change from baseline in trough FEV1 (ml) (From 10 week to 12 weeks) | NA | 809 patients in 4 RCTs | 143.67 higher (129.67 higher to 157.68 higher) | Lowa, b, c | Revefenacin 175 μg/day might improve lung function compared to placebo. |
| Individuals with COPD | Outpatient | Revefenacin 175 μg/day | Tiotropium 18 μg/day | Change from baseline in trough FEV1 (ml) (At 4 weeks) | NA | 791 patients in 2 RCTs | 13.51 higher (8.32 higher to 18.69 higher) | Very lowa, d | Revefenacin 175 μg/day might improve lung function compared to tiotropium in the short term. |
| Individuals with COPD | Outpatient | Revefenacin 175 μg/day | Tiotropium 18 μg/day | Change from baseline in trough FEV1 (ml) (At 52 weeks) | NA | 433 patients in one RCT | 39.2 lower (41.82 lower to 36.58 lower) | Lowa,d | Revefenacin 175 μg/day might not improve lung function compared to tiotropium in the long term. |
| Individuals with COPD | Outpatient | Revefenacin 22–700 μg/day | Placebo | Any adverse events (From 1 day to 12 weeks) | Odds ratio: 0.98 (0.81–1.18) | 2,286 patients in 7 RCTs | 5 fewer (51 fewer to 41 more) | Lowa | Revefenacin might not increase the risk of any adverse events compared to placebo. |
| Individuals with COPD | Outpatient | Revefenacin 88–175 μg/day | Tiotropium 18 μg/day | Any adverse events (From 4 to 52 weeks) | Odds ratio: 0.44 (0.12–1.60) | 1,262 patients in 2 RCTs | 197 fewer (477 fewer to 92 more) | Very lowa,e,f | Revefenacin might not increase the risk of any adverse events compared to tiotropium. |
| Individuals with COPD | Outpatient | Revefenacin 350–700 μg/day | Ipratropium 500 μg/day | Any adverse events (At 1 day) | Odds ratio: 0.66 (0.23–1.94) | 96 patients in one RCT | 63 fewer (158 fewer to 133 more) | Very Lowa,f,g | Revefenacin might not increase the risk of any adverse events compared to ipratropium. |
| Individuals with COPD | Outpatient | Revefenacin 22–700 μg/day | Placebo | Serious adverse events (From 1 day to 12 weeks) | Odds ratio: 0.89 (0.55–1.46) | 2,318 patients in 7 RCTs | 4 fewer (14 fewer to 14 more) | Very lowa,f | Revefenacin might not increase the risk of serious adverse events compared to placebo. |
| Individuals with COPD | Outpatient | Revefenacin 88–175 μg/day | Tiotropium 18 μg/day | Serious adverse events (From 4 to 52 weeks) | Odds ratio: 0.86 (0.61–1.21) | 1,262 patients in 2 RCTs | 16 fewer (46 fewer to 23 more) | Lowa | Revefenacin might not increase the risk of serious adverse events compared to tiotropium. |
| Individuals with COPD | Outpatient | Revefenacin 350–700 μg/day | Ipratropium 500 μg/day | Serious adverse events (At 1 day) | Odds ratio: 1.00 (0.13–7.43) | 96 patients in one RCT | 0 | Lowg,h | Revefenacin might not increase the risk of serious adverse events compared to ipratropium. |
CI: confidence interval; FEV1: Forced Expiratory Volume in 1 s; RCT: randomized controlled trial; PLA: placebo; a: very serious risk of bias (unclear selection bias, high risk of attribution, reporting, and other bias); b: very considerable inconsistence (I2 = 96%, high heterogeneity caused by different timeframe and disparate results across studies); c: upgraded because all plausible confounding would reduce demonstrated effect and the dose-response gradient was strong; d: considerable heterogeneity (I2 = 66%); e: very considerable inconsistence (I2 = 91%, high heterogeneity caused by different timeframe and non-overlapping 95% CIs); f: wide 95% CI with a lower limit <0.75 and an upper limit >1.25; g: serious risk of bias (unclear selection and other bias); h: small sample size.