Metoprolol for the Prevention of Acute Exacerbations of COPD

Autor: Sarah M Lindberg, Stephen C. Lazarus, Robert J. Kaner, Elizabeth Westfall, MeiLan K. Han, Allison A. Lambert, David A. Kaminsky, Barry J. Make, Jeffrey L. Curtis, Ken M. Kunisaki, Paul D. Scanlon, Charlene McEvoy, Umur Hatipoğlu, Keith Brenner, Ralph J. Panos, Helen Voelker, Jeremy A. Weingarten, Mark T. Dransfield, John E. Connett, J. Michael Wells, Gerard J. Criner, J. D.Allen Cooper, P. S. Sriram, Richard Casaburi, Carolyn E. Come, Vipul V. Jain, Anthony Smith, Robert M. Reed, Fernando J. Martinez, Matthew R. Lammi, Erika S. Helgeson, Surya P. Bhatt, Ravi Kalhan, Frank C. Sciurba, William W. Stringer
Rok vydání: 2019
Předmět:
Male
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
Medical and Health Sciences
law.invention
Pulmonary Disease
Chronic Obstructive

0302 clinical medicine
Randomized controlled trial
law
Forced Expiratory Volume
80 and over
030212 general & internal medicine
Prospective Studies
Treatment Failure
Prospective cohort study
Lung
Metoprolol
Aged
80 and over

COPD
General Medicine
Middle Aged
Adrenergic beta-1 Receptor Antagonists
Hospitalization
6.1 Pharmaceuticals
Respiratory
Disease Progression
Female
BLOCK COPD Trial Group
medicine.drug
medicine.medical_specialty
Chronic Obstructive
Chronic Obstructive Pulmonary Disease
Clinical Trials and Supportive Activities
MEDLINE
Severe chronic obstructive pulmonary disease
Pulmonary Disease
03 medical and health sciences
Clinical Research
Internal medicine
General & Internal Medicine
medicine
Humans
In patient
Aged
business.industry
Evaluation of treatments and therapeutic interventions
medicine.disease
Observational study
business
Zdroj: The New England journal of medicine, vol 381, iss 24
ISSN: 1533-4406
0258-7351
Popis: BackgroundObservational studies suggest that beta-blockers may reduce the risk of exacerbations and death in patients with moderate or severe chronic obstructive pulmonary disease (COPD), but these findings have not been confirmed in randomized trials.MethodsIn this prospective, randomized trial, we assigned patients between the ages of 40 and 85 years who had COPD to receive either a beta-blocker (extended-release metoprolol) or placebo. All the patients had a clinical history of COPD, along with moderate airflow limitation and an increased risk of exacerbations, as evidenced by a history of exacerbations during the previous year or the prescribed use of supplemental oxygen. We excluded patients who were already taking a beta-blocker or who had an established indication for the use of such drugs. The primary end point was the time until the first exacerbation of COPD during the treatment period, which ranged from 336 to 350 days, depending on the adjusted dose of metoprolol.ResultsA total of 532 patients underwent randomization. The mean (±SD) age of the patients was 65.0±7.8 years; the mean forced expiratory volume in 1 second (FEV1) was 41.1±16.3% of the predicted value. The trial was stopped early because of futility with respect to the primary end point and safety concerns. There was no significant between-group difference in the median time until the first exacerbation, which was 202 days in the metoprolol group and 222 days in the placebo group (hazard ratio for metoprolol vs. placebo, 1.05; 95% confidence interval [CI], 0.84 to 1.32; P = 0.66). Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83). The frequency of side effects that were possibly related to metoprolol was similar in the two groups, as was the overall rate of nonrespiratory serious adverse events. During the treatment period, there were 11 deaths in the metoprolol group and 5 in the placebo group.ConclusionsAmong patients with moderate or severe COPD who did not have an established indication for beta-blocker use, the time until the first COPD exacerbation was similar in the metoprolol group and the placebo group. Hospitalization for exacerbation was more common among the patients treated with metoprolol. (Funded by the Department of Defense; BLOCK COPD ClinicalTrials.gov number, NCT02587351.).
Databáze: OpenAIRE