Drug updated on 12/11/2024
Dosage Form | Nebulizer (oral inhalation; 175 mcg/3 mL) |
Drug Class | Anticholinergics |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
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Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Trough forced expiratory volume in 1 second (FEV₁) improvement: Revefenacin (REV) at a dose of 175 µg/day significantly improved trough FEV₁, with a mean difference (MD) of 143.67 (95% confidence interval (CI): 129.67 to 157.68; I²=96%) compared to placebo, based on a meta-analysis of 809 participants from four studies. The improvement in trough FEV₁ was dose-dependent, with an effective threshold identified at 88 µg/day (R² = 0.7017).
- Comparison with Other Drugs: Although evidence was rated as very low to low quality, REV at 175 µg/day was found to be inferior to tiotropium regarding long-term efficacy in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
- Safety Profile: Revefenacin did not significantly increase the risk of adverse events (AEs) or serious adverse events (SAEs) compared to placebo, with an odds ratio (OR) of 0.98 (95% CI: 0.81 to 1.18; I²=34%; 2,286 participants; 7 studies) and an OR of 0.89 (95% CI: 0.55 to 1.46; I²=0%; 2,318 participants; 7 studies), respectively, indicating a comparable safety profile to tiotropium and ipratropium.
- The studies included in the systematic review focused on patients with moderate to very severe COPD, comprising a total of 3,121 participants across 9 randomized controlled trials (RCTs). The quality of evidence for most outcomes was rated as low to very low, highlighting the need for further studies to evaluate the efficacy, long-term safety, and cost-effectiveness of REV compared to other long-acting muscarinic antagonists (LAMAs) in varied populations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Yupelri (revefenacin) Prescribing Information. | 2022 | Mylan Specialty L.P., Morgantown, WV |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The Efficacy and Safety of Revefenacin for the Treatment of Chronic Obstructive Pulmonary Disease: A Systematic Review | 2021 | Frontiers in Pharmacology |