- For moderate-severe COPD, revefenacin once a day for 12 weeks yields significant trough FEV1 improvements.
- Higher dose of 175 µg gave greater improvements in patients on concomitant long-acting beta-2 agonists.
Why this matters
- The authors say that revefenacin has good potential to be the first once-a-day long-acting bronchodilator for patients who would do better with nebulized antimuscarinic therapy.
- Day 85, with 88 or 175 µg, trough FEV1, respectively, improved vs placebo by:
- First study: 79.2 (P=.0003) and 146.3 mL (P<.0001>
- Second study: 160 and 147 mL (P<.0001>
- Pooled results showed increases in trough FEV1 of:
- 119.8 mL with 88 µg, and
- 148.1 mL with 175 µg.
- Difference between the 2 doses was not significant.
- Adverse event rates were similar among placebo and 2 drug doses.
- 2 double-blind trials, 3256 patients ≥40 years randomly allocated to 1 of 2 drug doses or placebo.
- Endpoint: 24-hour trough FEV1 on day 85.
- Funding: Theravance Biopharma R&D, Inc. (Dublin, Ireland).
- Relatively short 3-month treatment period.
- Small subgroups.