Gefapixant Reduces Cough-Induced Stress Urinary Incontinence in Women with Chronic Cough
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A phase 3b randomized controlled trial has demonstrated that gefapixant significantly reduces episodes of cough-induced stress urinary incontinence (CSUI) in women with refractory or unexplained chronic cough, marking a breakthrough in treating this challenging condition.
The study included 375 women aged 18 and older with chronic cough lasting at least one year and CSUI persisting for over three months.
Participants were randomized to receive gefapixant 45 mg twice daily or placebo for 12 weeks. The primary outcome was the percentage change in daily CSUI episodes over seven days at week 12.
Results showed a -52.8% reduction in CSUI episodes with gefapixant compared to -41.1% with placebo, yielding an estimated treatment difference of -11.7% (P = 0.004).
Gefapixant also demonstrated consistent safety, with the most common adverse events being taste-related disturbances. Adverse events occurred in 70% of the gefapixant group compared to 37% in the placebo group, aligning with prior studies of the drug.
This trial establishes gefapixant as the first treatment to demonstrate efficacy in reducing CSUI episodes among women with chronic cough, addressing a significant unmet medical need. The findings highlight gefapixant’s potential as a dual-action therapy, improving both chronic cough and its impact on urinary health, with a manageable safety profile.