Prognosis of Patients with Chronic Obstructive Pulmonary Disease Not Eligible for Major Clinical Trials
Research output: Contribution to journal › Journal article › Research › peer-review
Rationale: Randomized controlled trials only include a subset of patients with chronic obstructive pulmonary disease (COPD) fulfilling strict inclusion criteria. Thus, most patients with COPD in a real-world setting do not have the necessary evidence to support treatment effectiveness.
Objectives: To test the hypotheses that most individuals with COPD in the general population are not represented in major clinical trials despite clinically significant disease with exacerbations and early death.
Methods: In 105,630 adults from a Danish contemporary population-based cohort, we defined COPD as age 40 or more years, chronic respiratory symptoms, history of smoking exposure, and airflow limitation with FEV1/FVC, 0.70. Outcomes included acute exacerbations and all-cause mortality. Symptomatic smokers without COPD were used as a reference group.
Measurements and Main Results: Of all, 7,516 (7%) and 16,079 (15%) were symptomatic smokers with and without COPD. Only 44% of those with COPD were eligible for major clinical trials when applying FEV1,80% predicted, smoking history of 10 or more pack-years, and no comorbid asthma as common inclusion criteria. During the median 8.9 years of follow-up, we observed 2,130 acute exacerbations and 3,973 deaths in symptomatic smokers. Compared with symptomatic smokers without COPD, multivariable-adjusted hazard ratios for exacerbations were 7.45 (95% confidence interval, 5.41-10.3) and 29.0 (21.1-39.8) in those with COPD, respectively, excluded and eligible for clinical trials. Corresponding hazard ratios for all-cause mortality were 1.21 (1.11-1.31) and 1.67 (1.54-1.81), respectively.
Conclusions: More than half of individuals with COPD in the general population are excluded from major clinical trials; however, these individuals have a clinically significant disease with exacerbations and early death compared with symptomatic smokers without COPD.
Original language | English |
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Journal | American Journal of Respiratory and Critical Care Medicine |
Volume | 206 |
Issue number | 3 |
Pages (from-to) | 271-280 |
Number of pages | 10 |
ISSN | 1073-449X |
DOIs | |
Publication status | Published - 2022 |
- pulmonary disease, chronic obstructive, clinical trials, randomized, asthma, spirometry, forced expiratory volume, TIME-COURSE, COPD, EXACERBATIONS, POPULATION, ASTHMA, INDIVIDUALS, UPDATE, RISK
Research areas
Links
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9890252/pdf/rccm.202110-2441OC.pdf
Final published version
ID: 317356387