Safety and efficacy of gefapixant, a novel drug for the treatment of chronic cough: A systematic review and meta-analysis of randomized controlled trials.

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From: Annals of Thoracic Medicine(Vol. 16, Issue 2)
Publisher: Medknow Publications and Media Pvt. Ltd.
Document Type: Article
Length: 4,811 words
Lexile Measure: 1950L

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Byline: Ahmed. Abu-Zaid, Aseel. Aljaili, Amnah. Althaqib, Fatima. Adem, Doaa. Alhalal, Amena. Almubarak, Saud. Aldughaither, Sarah. Alghabban, Ghaidaa. Alfaraj, Ahmed. Masoud, Nujud. Alsuhaibani

AIM: We conducted this systematic review and meta-analysis to investigate the efficacy and safety of gefapixant, a novel P2X3 receptor antagonist, in patients with chronic cough. METHODS: We searched four databases for randomized controlled trials (RCTs). We assessed the cough frequency, severity, total Leicester cough questionnaire (LCQ) score, and adverse events. We analyzed the data using Open Meta-Analyst and Review Manager Software. RESULTS: We included four unique studies (comprising five stand-alone RCTs) with 439 patients. Compared to placebo, gefapixant had positive anti-tussive effects by improving awake cough frequency (mean difference [MD] = -5.27, 95% confidence interval [CI] [-6.12, -4.42], P < 0.00001), night cough frequency (MD = -3.71, 95% CI [-6.57, -0.85], P = 0. 01), 24 h cough frequency (MD = -4.18, 95% CI [-5.01, -3.36], P < 0.00001), cough severity using the Visual Analog Scale (MD = -13.36, 95% CI [-17.80, -8.92], P < 0.00001), cough severity diary (MD = -0.88, 95% CI [-1.25, -0.51], P < 0.00001), and total LCQ score (MD = 2.00, 95% CI [1.15, 2.86], P = 0. 00001). Meta-regression analyses showed a positive correlation between the gefapixant dose and the incidence of any adverse event (relative risk [RR] = 0.239, 95% CI [0.093, 1.839], P = 0.001) and incidence of adverse event related to treatment (RR = 0.520, 95% CI [0.117, 0.922], P = 0.011). CONCLUSIONS: In patient with chronic cough, gefapixant exhibits favorable anti-tussive outcomes by improving the cough frequency, severity, and quality of life. While gefapixant is largely tolerable, its side effects (notably taste alteration) are dose dependent.

Cough is considered the most frequent symptom which seeks clinical advice in the United States.[1] According to epidemiological studies, it is estimated that 4%-10% of adults worldwide suffer from cough.[2] Despite extensive research endeavors, an available, effective, and approved therapy for cough has not been discovered yet.[2],[3] It is approximated that 12% of adult patients with cough progress to the stage of chronic cough that lasts 8 weeks or longer.[4]

Gastroesophageal reflux disease, asthma, and nasal/sinus illnesses constitute the most common sources of chronic cough in patients with normal chest radiological results. Furthermore, patients with chronic cough are characteristically liable to many disorders, such as gastroesophageal reflux disease, pulmonary fibrosis, chronic obstructive pulmonary disease, and bronchiectasis.[5] Several environmental factors may induce chronic cough, such as temperature changes, fragrances, and smokes.[6] Other factors, such as citric acid,[7] mannitol,[8] capsaicin,[9] and other inhaled tussive agents, may also lead to an increased occurrence of cough.

Chronic refractory cough is described as a persistent cough continuing for more than 8 weeks in spite of evaluation and treatment according to the most contemporary guidelines.[10] The rough incidence of chronic refractory cough can reach up to 50% in patients with chronic cough, despite extensive investigation and treatment trials.[11],[12] Cough hypersensitivity syndrome, a cough instigated by stimuli that do not often trigger cough, can be related to...

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Gale Document Number: GALE|A660154798