P115 Association between baseline cough burden and gefapixant discontinuations due to taste-related adverse events

Introduction and Objectives The phase 3 COUGH-1/-2 trials ( NCT03449134, NCT03449147) demonstrated that gefapixant 45 mg twice daily (BID) is effective for treatment of refractory or unexplained chronic cough but may be associated with taste-related adverse events (taste AEs), potentially affecting treatment continuation. Here, we evaluate whether there is an association between baseline cough burden and gefapixant discontinuations due to taste AEs.Methods COUGH-1/-2 methods have previously been reported (McGarvey et al. Lancet. 2022;399:909–923). This post hoc analysis evaluated odds of discontinuing treatment with gefapixant 45 mg BID due to taste AEs based on baseline cough burden variables (24-hour cough frequency, cough severity visual analog scale, Cough Severity Diary, and Leicester Cough Questionnaire).Results Of 683 participants receiving gefapixant 45 mg BID, 95 (13.9%) discontinued treatment due to taste AEs. Subgroups with categorically lower baseline cough burden had higher odds of discontinuation rates due to taste AEs ( figure 1).Abstract P115 Figure 1Probability of discontinuing gefapixant 45 mg BID due to taste-related AEs in baseline cough burden groups based on 24-hour cough frequency, cough severity VAS, CSD total score, and LCQ total score. AE, adverse event; BID, twice daily; CSD, Cough Severity Diary; LCQ, Leicester Cough Questionnaire; OR, odds ratio; VAS, visual analog scale. a Estimated ORs based on logistic regression with the following covariates: age, sex, region, study, baseline cough duration. bFor the LCQ, a lower total score indicates a higher cough burdenConclusions These findings suggest that patients with higher baseline cough burden may be more willing to continue treatment regardless of taste AEs. Because results of this post hoc analysis are observational, they require further confirmation.