William Blake LeMaster, Corey J Witenko, Melinda K Lacy, Ann W Olmsted, Edmund J Moran, Donald A Mahler
{"title":"中度至极重度慢性阻塞性肺疾病患者的瑞芬那新曲线下面积肺活量测定。","authors":"William Blake LeMaster, Corey J Witenko, Melinda K Lacy, Ann W Olmsted, Edmund J Moran, Donald A Mahler","doi":"10.2147/COPD.S483176","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Several lung function endpoints are utilized in clinical trials of inhaled bronchodilators for chronic obstructive pulmonary disease (COPD). Trough forced expiratory volume in 1 second (FEV<sub>1</sub>) is a commonly reported endpoint in COPD trials and can be complemented by area under the FEV<sub>1</sub> vs time curve (FEV<sub>1</sub> AUC), which provides information on duration and consistency of bronchodilation over a dosing interval. Revefenacin, a once-daily bronchodilator, significantly improved lung function in patients with COPD when measured by trough FEV<sub>1</sub> in two replicate Phase 3 trials. Here, we report an FEV<sub>1</sub> AUC substudy using data from these trials.</p><p><strong>Patients and methods: </strong>This post hoc analysis examined substudy data from 12-week replicate Phase 3 trials (NCT02459080/NCT02512510); patients with moderate to very severe COPD were randomized 1:1 to revefenacin 175 μg or placebo once daily. The substudy patients had FEV<sub>1</sub> AUC<sub>0-2h</sub> assessed on Day 1, and those who continued to Day 84 also underwent 24-hour serial spirometry postdose where FEV<sub>1</sub> AUC<sub>0-2h,</sub> AUC<sub>0-12h</sub>, AUC<sub>12-24h</sub>, and AUC<sub>0-24h</sub> were evaluated.</p><p><strong>Results: </strong>Fifty and 47 patients who received revefenacin and placebo underwent 24-hour serial spirometry; most baseline characteristics were aligned between groups. At Day 84 postdose, revefenacin demonstrated sustained improvements in bronchodilation over 24 hours; differences in least squares mean vs placebo were 282, 220, 205, and 212 mL for FEV<sub>1</sub> AUC<sub>0-2h</sub>, AUC<sub>0-12h</sub>, AUC<sub>12-24h</sub>, and AUC<sub>0-24h</sub> (all <i>P</i> <0.001), respectively.</p><p><strong>Conclusion: </strong>This substudy analysis supplements previous findings that revefenacin provides sustained bronchodilation over 24 hours. Assessing additional complementary COPD clinical trial endpoints can help clinicians make treatment decisions.</p>","PeriodicalId":48818,"journal":{"name":"International Journal of Chronic Obstructive Pulmonary Disease","volume":null,"pages":null},"PeriodicalIF":2.7000,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491098/pdf/","citationCount":"0","resultStr":"{\"title\":\"Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.\",\"authors\":\"William Blake LeMaster, Corey J Witenko, Melinda K Lacy, Ann W Olmsted, Edmund J Moran, Donald A Mahler\",\"doi\":\"10.2147/COPD.S483176\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Several lung function endpoints are utilized in clinical trials of inhaled bronchodilators for chronic obstructive pulmonary disease (COPD). Trough forced expiratory volume in 1 second (FEV<sub>1</sub>) is a commonly reported endpoint in COPD trials and can be complemented by area under the FEV<sub>1</sub> vs time curve (FEV<sub>1</sub> AUC), which provides information on duration and consistency of bronchodilation over a dosing interval. Revefenacin, a once-daily bronchodilator, significantly improved lung function in patients with COPD when measured by trough FEV<sub>1</sub> in two replicate Phase 3 trials. Here, we report an FEV<sub>1</sub> AUC substudy using data from these trials.</p><p><strong>Patients and methods: </strong>This post hoc analysis examined substudy data from 12-week replicate Phase 3 trials (NCT02459080/NCT02512510); patients with moderate to very severe COPD were randomized 1:1 to revefenacin 175 μg or placebo once daily. The substudy patients had FEV<sub>1</sub> AUC<sub>0-2h</sub> assessed on Day 1, and those who continued to Day 84 also underwent 24-hour serial spirometry postdose where FEV<sub>1</sub> AUC<sub>0-2h,</sub> AUC<sub>0-12h</sub>, AUC<sub>12-24h</sub>, and AUC<sub>0-24h</sub> were evaluated.</p><p><strong>Results: </strong>Fifty and 47 patients who received revefenacin and placebo underwent 24-hour serial spirometry; most baseline characteristics were aligned between groups. At Day 84 postdose, revefenacin demonstrated sustained improvements in bronchodilation over 24 hours; differences in least squares mean vs placebo were 282, 220, 205, and 212 mL for FEV<sub>1</sub> AUC<sub>0-2h</sub>, AUC<sub>0-12h</sub>, AUC<sub>12-24h</sub>, and AUC<sub>0-24h</sub> (all <i>P</i> <0.001), respectively.</p><p><strong>Conclusion: </strong>This substudy analysis supplements previous findings that revefenacin provides sustained bronchodilation over 24 hours. 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Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.
Purpose: Several lung function endpoints are utilized in clinical trials of inhaled bronchodilators for chronic obstructive pulmonary disease (COPD). Trough forced expiratory volume in 1 second (FEV1) is a commonly reported endpoint in COPD trials and can be complemented by area under the FEV1 vs time curve (FEV1 AUC), which provides information on duration and consistency of bronchodilation over a dosing interval. Revefenacin, a once-daily bronchodilator, significantly improved lung function in patients with COPD when measured by trough FEV1 in two replicate Phase 3 trials. Here, we report an FEV1 AUC substudy using data from these trials.
Patients and methods: This post hoc analysis examined substudy data from 12-week replicate Phase 3 trials (NCT02459080/NCT02512510); patients with moderate to very severe COPD were randomized 1:1 to revefenacin 175 μg or placebo once daily. The substudy patients had FEV1 AUC0-2h assessed on Day 1, and those who continued to Day 84 also underwent 24-hour serial spirometry postdose where FEV1 AUC0-2h, AUC0-12h, AUC12-24h, and AUC0-24h were evaluated.
Results: Fifty and 47 patients who received revefenacin and placebo underwent 24-hour serial spirometry; most baseline characteristics were aligned between groups. At Day 84 postdose, revefenacin demonstrated sustained improvements in bronchodilation over 24 hours; differences in least squares mean vs placebo were 282, 220, 205, and 212 mL for FEV1 AUC0-2h, AUC0-12h, AUC12-24h, and AUC0-24h (all P <0.001), respectively.
Conclusion: This substudy analysis supplements previous findings that revefenacin provides sustained bronchodilation over 24 hours. Assessing additional complementary COPD clinical trial endpoints can help clinicians make treatment decisions.
期刊介绍:
An international, peer-reviewed journal of therapeutics and pharmacology focusing on concise rapid reporting of clinical studies and reviews in COPD. Special focus will be given to the pathophysiological processes underlying the disease, intervention programs, patient focused education, and self management protocols. This journal is directed at specialists and healthcare professionals