TY - JOUR
T1 - Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant
T2 - A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups
AU - Smith, Jaclyn A
AU - Birring, Surinder S
AU - Dicpinigaitis, Peter V
AU - McGarvey, Lorcan P
AU - Morice, Alyn H
AU - Pavord, Ian D
AU - Satia, Imran
AU - Green, Stuart
AU - Iskold, Beata
AU - La Rosa, Carmen
AU - Li, Qing
AU - Martin Nguyen, Allison
AU - Schelfhout, Jonathan
AU - Muccino, David
N1 - Funding Information:
JAS has received personal fees from Bayer, Bellus Healthcare, Boehringer Ingelheim, GlaxoSmithKline, Menlo, NeRRe Pharmaceuticals, and Shionogi; nonfinancial support from Vitalograph; grant support and personal fees related to the submitted work from Afferent Pharmaceuticals/Merck & Co., Inc.; and grant support from Bayer, Bellus, GlaxoSmithKline, Menlo, and NeRRe Pharmaceuticals. The VitaloJAK algorithm is owned by Manchester University NHS Foundation Trust (MFT) and licensed to Vitalograph Ltd; MFT receives royalties from Vitalograph that may be shared with the department in which JAS works. JAS is also funded by the NIHR Manchester Biomedical Research Centre and a Wellcome Investigator Award and is an NIHR Senior Investigator. SSB has received advisory board/consultancy fees from Bayer, Menlo, Merck & Co., Inc., Patara, Pfizer, and Sanofi; speaker fees from Roche; and grant support from Boehringer Ingelheim and Merck & Co., Inc. PVD has received advisory board/consultancy fees from Bayer HealthCare Pharmaceuticals, Bellus Health Inc, Chiesi, Merck & Co., Inc., and Shionogi. PVD is editor-in-chief of Lung. LPM has received advisory board/consultancy fees from Applied Clinical Intelligence, Bayer, Bellus Health, Bionorica, Chiesi, Merck & Co., Inc., Nocion Therapeutics, and Shionogi. AHM has received consulting fees from Bayer, Bellus, Boehringer Ingelheim, Merck & Co., Inc., Pfizer, Proctor & Gamble, and Shionogi; lecture fees from AstraZeneca and Boehringer Ingelheim; and grant support from Afferent, Infirst, Merck & Co., Inc., and Proctor & Gamble. IDP has received personal fees from Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Genentech, GlaxoSmithKline, Knopp, Novartis, Regeneron, Sanofi, and Teva; and grant support from NIHR. IS has received personal fees from educational talks for general practitioners from AstraZeneca and GlaxoSmithKline; grants and personal fees from Merck Canada; consulting fees from Genentech; a European Respiratory Society Respire 3 Marie Curie Fellowship; and an E.J. Moran Campbell Early Career Award from the Department of Medicine, McMaster University (outside the submitted work). SG, BI, CLR, QL, AMN, JS, and DM are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ USA, who may own stock and/or hold stock options in the Company.
Funding Information:
Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Medical writing and editorial assistance were provided under the direction of the authors by Alexandra Kennedy, PhD, and Jenna Lewis, MA, ELS, of MedThink SciCom. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/8/1
Y1 - 2022/8/1
N2 - INTRODUCTION: In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC).METHODS: Here, the efficacy of gefapixant 45 mg vs placebo was evaluated across COUGH-1/COUGH-2 in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis (RCC, UCC). Awake cough frequency reductions at Week 12 and LCQ response rates (i.e., ≥ 1.3-point improvement) at Week 24 were assessed.RESULTS: Among 1360 participants analyzed, gefapixant 45 mg resulted in consistent awake cough frequency reductions overall and across predefined subgroups at Week 12. Gefapixant also resulted in improved LCQ scores across subgroups at Week 24; ≥ 70% of participants in each subgroup treated with gefapixant 45 mg had an LCQ response.CONCLUSION: These data suggest gefapixant 45 mg provides consistent objective and subjective efficacy across subgroups of individuals with RCC or UCC.
AB - INTRODUCTION: In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC).METHODS: Here, the efficacy of gefapixant 45 mg vs placebo was evaluated across COUGH-1/COUGH-2 in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis (RCC, UCC). Awake cough frequency reductions at Week 12 and LCQ response rates (i.e., ≥ 1.3-point improvement) at Week 24 were assessed.RESULTS: Among 1360 participants analyzed, gefapixant 45 mg resulted in consistent awake cough frequency reductions overall and across predefined subgroups at Week 12. Gefapixant also resulted in improved LCQ scores across subgroups at Week 24; ≥ 70% of participants in each subgroup treated with gefapixant 45 mg had an LCQ response.CONCLUSION: These data suggest gefapixant 45 mg provides consistent objective and subjective efficacy across subgroups of individuals with RCC or UCC.
KW - Antitussives
KW - Cough frequency
KW - P2X3-receptor antagonist
KW - Patient-reported outcomes
KW - Refractory chronic cough
KW - Unexplained chronic cough
UR - http://www.scopus.com/inward/record.url?scp=85135547934&partnerID=8YFLogxK
U2 - 10.1007/s00408-022-00553-y
DO - 10.1007/s00408-022-00553-y
M3 - Article
C2 - 35895098
SN - 0341-2040
VL - 200
SP - 423
EP - 429
JO - Lung
JF - Lung
IS - 4
ER -