Summary

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• Ohtuvayre (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• Ensifentrine significantly improved lung function (FEV₁ area under the curve at 0-12 hours) compared to placebo in both ENHANCE-1 and ENHANCE-2 trials: ENHANCE-1: 87 ml (95% CI, 55 to 119; \(P < 0.001\)); ENHANCE-2: 94 ml (95% CI, 65 to 124; \(P < 0.001\)).
• In the ENHANCE-1 trial, ensifentrine showed significant improvements in symptoms and quality of life at Week 24, while the ENHANCE-2 trial did not demonstrate significant improvements in these outcomes.
• Ensifentrine reduced the rate and time to first exacerbation in both trials: Rate reduction (ENHANCE-1: rate ratio 0.64, 95% CI, 0.40 to 1.00; \(P = 0.050\)); (ENHANCE-2: rate ratio 0.57, 95% CI, 0.38 to 0.87; \(P = 0.009\)); Time to first exacerbation (ENHANCE-1: hazard ratio 0.62, 95% CI, 0.39 to 0.97; \(P = 0.038\)); (ENHANCE-2: hazard ratio 0.58, 95% CI, 0.38 to 0.87; \(P = 0.009\)).
• The rate of adverse events was similar between ensifentrine and placebo groups in the studies.
• No specific adverse effects or safety concerns were highlighted in the provided studies.
• Patients aged 40-80 years with moderate to severe symptomatic COPD, many of whom were also receiving long-acting muscarinic antagonists (69%) or long-acting β₂-agonists (55%), were included in the studies.