N Engl J Med 1998;339:489-497. DOI: 10.1056/NEJMoa1908142, Tap into groundbreaking research and clinically relevant insights. Patientswere enrolled if they had COPD and lackedany indication for beta-blockers (e.g., prior myocardial infarction or systolicheart failure). NEW! As secondary analyses, we used both unadjusted and adjusted Cox proportional-hazards models to assess the association between the trial-group assignment and the time until the first COPD exacerbation. We found no evidence of a between-group difference in the overall rates of exacerbation, with a rate per person-year of 1.40 (95% CI, 1.21 to 1.61) in the metoprolol group and 1.33 (95% CI, 1.15 to 1.54) in the placebo group (rate ratio, 1.05; 95% CI, 0.85 to 1.28). Chest 2005;127:818-824. statistical significance (p = 0.2). Etminan M, Jafari S, Carleton B, FitzGerald JM. In-hospital and 5-year mortality of patients treated in the ICU for acute exacerbation of COPD: a retrospective study. Details regarding screening, randomization, and follow-up are provided in Figure 1. Respir Med 2013;107:1376-1384. Patients who had not yet completed the day 336 visit were contacted early to undergo final assessments and begin weaning from metoprolol or placebo, according to the protocol. Sie stimulieren relativ selektiv die adrenergen ... sind kardioselektive Betablocker wie Metoprolol und Biso­prolol relativ β 1-selektiv. We did not observe this effect, and none was reported in a meta-analysis on the subject.35 We also found no evidence of between-group differences in the 6-minute walk distance or in patients’ reports of possible beta-blocker side effects. 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. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. Beta-1 selective antagonists such as bisoprolol, nebivolol and metoprolol are preferred to the nonselective carvedilol as they are less likely to produce bronchoconstriction in COPD. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD executive summary. Suissa S, Ernst P. Beta-blockers in COPD: a methodological review of the observational studies. Fourth, we do not know whether these results would be similar for other cardioselective beta-blockers or for noncardioselective agents, although concern regarding adverse respiratory effects is greater with the latter. This was exactly the same between groups: In S1A). 5. We based the sample size and considerations for statistical power on the primary end point of the time until the first exacerbation of COPD. Number of hospital admissions for COPD over a year, Number of hospital days due to COPD exacerbations over a year, Major adverse coronary events (MACE) over a year, Incidence of presumed metoprolol side-effects, Modified Medical Research Council dyspnea scale, Forced expiratory volume in one second (FEV1), Exercise capacity in six minutes (six-minute walk distance), San Diego Shortness of Breath Questionnaire, Combined rate of acute exacerbations of COPD and major adverse coronary events (MACE). Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83). These results differ from previously reported findings from observational studies suggesting that beta-blockers reduce the risks of exacerbation and death from any cause in patients with COPD.17-19 A meta-analysis of 9 studies showed that patients taking beta-blockers had a lower risk of COPD-related death than those not taking beta-blockers (relative risk, 0.69; 95% CI, 0.62 to 0.78).18 Another meta-analysis of 15 studies also showed a lower risk of death from any cause (relative risk, 0.72; 95% CI, 0.63 to 0.83) or from COPD exacerbation (relative risk, 0.63; 95% CI, 0.57 to 0.71).19 These observational studies have methodologic limitations inherent to their design, including the possibility of residual confounding and immortal time bias, which may have had an effect on the findings.21. Jetzt kommt eine aktuelle Studie zu dem Ergebnis, dass die Therapie mit Betablockern auch bei Patienten mit schwerer COPD, die wegen ihrer starken Atemwegsverengung bereits auf eine tägliche Sauerstoff-Behandlung angewiesen sind, sicher und zugleich von Vorteil ist, zumal sich dadurch auch die Häufigkeit von Verschlechterungsschüben (Exazerbationen) bei den Patienten reduzieren … were enrolled if they had COPD and lacked For the time until the first exacerbation of moderate severity or greater, the unadjusted hazard ratio was 1.47 (95% CI, 1.06 to 2.04) and the adjusted hazard ratio was 1.46 (95% CI, 1.03 to 2.06) (Fig. Patients were excluded from the trial if they had a class I indication for receipt of a beta-blocker (a history of myocardial infarction or revascularization within the previous 36 months or heart failure with a known left ventricular ejection fraction of less than 40%), according to the guidelines of the American College of Cardiology and the American Heart Association. In this prospective, multicenter, randomized trial, we did not find evidence of a difference in the risk of COPD exacerbation between the metoprolol group and the placebo group, although the use of metoprolol was associated with a higher risk of exacerbation leading to hospitalization. Patients in the metoprolol group had a lower mean heart rate than those in the placebo group (difference, 6 to 10 beats per minute) (Fig. heart failure). Associations between chronic comorbidity and exacerbation risk in primary care patients with COPD. Chest 2007;131:20-28. Interim analysis: the alpha spending function approach. The same applied to COPD (HR 0.88; 95% CI 0.75 to 1.05, p = 0.177), DM (HR 0.95; 95% CI 0.82 to 1.10, p = 0.485), hypoglycemia (HR 0.88; 95% CI 0.47 to 1.67, p = 0.707), and RF (HR 1.25; 95% CI 0.93 to 1.69, p = 0.142) hospitalizations. A primary concern about the use of beta-blockers in patients with COPD is that the drugs may cause a worsening in lung function. PLoS One 2014;9(11):e113048-e113048. Rate of Exacerbation of COPD, According to Severity. 36. van der Woude HJ, Zaagsma J, Postma DS, Winter TH, van Hulst M, Aalbers R. Detrimental effects of beta-blockers in COPD: a concern for nonselective beta-blockers. ); the University of Washington, Seattle (A.A.L. We conducted this placebo-controlled, double-blind, prospective, randomized trial at 26 centers in the United States. The result of the subgroup analysis of the risk of exacerbation is provided in Figure S2. Tolerability of Metoprolol-Succinate-ER and Carvedilol in COPD The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Unfortunately, this pattern shows no signs of abating today. Address reprint requests to Dr. Dransfield at the University of Alabama at Birmingham, 422 Tinsley Harrison Tower, 1900 University Blvd., Birmingham, AL 35294, or at [email protected]. primary endpoint was time to first COPD exacerbation. 13. Metoprolol was associated with worsening of dyspnea and of the overall burden of COPD symptoms, as measured by the shortness-of-breath questionnaire and the COPD Assessment Test. This difference in treatment period according to dose was due to the additional time necessary to wean patients from the 50-mg and 100-mg dose levels. ), NYP–Queens Medical Center (A.S.), and NYP–Brooklyn Methodist Medical Center (J.A.W.) 2. No other potential conflict of interest relevant to this article was reported. The starting dose was one 50-mg tablet of metoprolol or matching placebo taken orally daily. β-Blockers are associated with a reduction in COPD exacerbations. Metoprolol for the Prevention of Acute Exacerbations of COPD Among 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. The results are not statistically robust (especially considering the myriad of secondary endpoints). S8). BMC Pulm Med 2012;12:48-48. — all in California; Brigham and Women’s Hospital, Boston (C.E.C. 8. — all in Minnesota; New York–Presbyterian (NYP)–Columbia University Medical Center (K.B. ‡ Nonfatal events are reported as rates per person-year because the patients could have had more than one event. Su TH, Chang SH, Kuo CF, Liu PH, Chan YL. 33. GBD 2017 Causes of Death Collaborators. An exacerbation of COPD was defined as an increase in or a new onset of two or more of the following symptoms: cough, sputum production, wheezing, dyspnea, or chest tightness that led to treatment with antibiotics or systemic glucocorticoids for at least 3 days.25,26 The severity of the exacerbation was graded according to the following scale: mild (involving only home management, with or without contact with a health care provider), moderate (leading to a visit to an emergency department), severe (leading to hospitalization), and very severe (leading to intubation and mechanical ventilation). 27. pre-specified endpoint). Smaller and less consistent effects were seen for systolic and diastolic blood pressure. Circulation 2013;128(16):e240-e327. It seems unlikely that the risks of worsening asthma or COPD outweigh the potential benefits of beta blocker use, in these patients. and six-minute walk distance). Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure, Bupropion and Naltrexone in Methamphetamine Use Disorder. In 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. After the first interim analysis on November 30, 2018, the committee recommended that the trial be continued but planned to reconvene before the second interim analysis to review serious adverse events. The discontinuation of metoprolol or placebo occurred more frequently in the metoprolol group than in the placebo group (11.2% vs. 6.1%). Nonfatal, serious COPD exacerbations occurred at a rate of 0.43 per person-year and 0.19 per person-year, respectively (Table 3 and Table S2). The use of beta-blockers in COPD has been subject to repeated reversals over the past few decades. The most common reasons for exclusion were not meeting the spirometric criteria for COPD or a resting heart rate that was out of the mandated range. December 12, 2019N Engl J Med 2019; 381:2304-2314 Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. For severe or very severe exacerbations, the unadjusted and adjusted hazard ratios were 1.91 (95% CI, 1.29 to 2.83) and 2.08 (95% CI, 1.37 to 3.14), respectively (Figure 2B). The trial protocol, which was approved by the data and safety monitoring committee and the institutional review board at each trial center, is available with the full text of this article at NEJM.org. Among numerous secondary endpoints, there was an increase in the rate of severe exacerbations within the metoprolol group. The seriously: The authors presented these results in a rather dark light: The The content of this site is intended for health care professionals. likelihood that the trial could possibly show benefit from metoprolol) and some concerns regarding safety. 16. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. might be causing an increased mortality. QJM 2005;98:493-497. * Listed are adverse events that were reported as serious by the investigator. will almost certainly be misinterpreted to mean that beta-blockers are unsafe The authorized source of trusted medical research and education for the Chinese-language medical community. According to this logic, Christopher PLoS One 2019;14(3):e0213187-e0213187. Azithromycin for prevention of exacerbations of COPD. Ai-Ping C, Lee KH, Lim TK. Eventually that concept fell out of favor. Validation of a new dyspnea measure: the UCSD Shortness of Breath Questionnaire: University of California, San Diego. any indication for beta-blockers (e.g., prior myocardial infarction or systolic ), NYP–Weill Cornell Medical Center (R. Kaner, F.J.M. Thus, we do not know whether our results would apply to patients with mild airflow obstruction or a lower exacerbation risk. In addition, we measured the 6-minute walk distance at baseline, at the day 112 visit, and at the day 336 visit. The rate of overall nonfatal serious adverse events was 0.65 per person-year in the metoprolol group and 0.43 per person-year in the placebo group. * Plus–minus values are means ±SD. Should patient be tapered and switched to diltiazem/verapamil or continued? Auch die nicht selektiven Betablocker unterscheiden sich in … See. Thestudy was stopped prematurely based on a combination of futility (very lowlikelihood that the trial could possibly show b… 17. Lancet Respir Med 2014;2:195-203. Thisstudy was designed to test the concept that beta-blockers could reduce theincidence of COPD exacerbation. We recruited patients who were at increased risk for exacerbations as indicated by at least one of the following factors: the receipt of a course of systemic glucocorticoids or antibiotic agents for respiratory problems during the previous year, a visit to an emergency department or hospitalization for a COPD exacerbation during the previous year, or the receipt of a prescription for supplemental oxygen for use at home for the treatment of COPD. However, metoprolol was associated with worsening of dyspnea and of the overall burden of COPD symptoms, as measured by the shortness-of-breath questionnaire and the COPD Assessment Test (although not on the St. George’s Respiratory Questionnaire). Egred M, Shaw S, Mohammad B, Waitt P, Rodrigues E. Under-use of beta-blockers in patients with ischaemic heart disease and concomitant chronic obstructive pulmonary disease. Information and tools for librarians about site license offerings. Patients in the metoprolol group may have been sicker (with a substantially higher rate of COPD exacerbation in the year. Among the 145 patients who were excluded from the trial, several had more than one reason for exclusion. Du Q, Sun Y, Ding N, Lu L, Chen Y. Beta-blockers reduced the risk of mortality and exacerbation in patients with COPD: a meta-analysis of observational studies. Miller J, Edwards LD, Agustí A, et al. There were no changes in During in-clinic visits and telephone calls, the patients were queried regarding the efficacy and safety of the trial treatment, including providing details regarding any possible beta-blocker side effects. Stat Med 1994;13:1341-1356. 25. Online Medical Education on Emergency Department (ED) Critical Care, Trauma, and Resuscitation, October 23, 2019 by Josh Farkas 2 Comments. During the treatment period, there were 11 deaths in the metoprolol group and 5 in the placebo group, with unadjusted and adjusted hazard ratios for death of 2.18 (95% CI, 0.76 to 6.29) and 2.13 (95% CI, 0.69 to 6.42), respectively (Fig. Objective measurements of lung function were the same (e.g. PulmCrit – Six RCTs to answer one question: what is the role of tocilizumab in COVID-19? 18. Transl Res 2013;162:237-251. Respir Res 2017;18:31-31. Thus, we do not know whether our results would apply to patients with mild airflow obstruction or a lower exacerbation risk. 11. From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W. Chest 2005;128:518-524. We enrolled patients between the ages of 40 and 85 years who had received a clinical diagnosis of COPD and who had at least moderate airflow limitation, as defined by the Global Initiative for Obstructive Lung Disease (GOLD),2 as follows: a forced expiratory volume in 1 second (FEV1) of less than 80% of the predicted value after bronchodilation and a ratio of the FEV1 to the forced vital capacity (FVC) of less than 0.70. In pts with CAD on BB, ie., metoprolol, with newly diagnosed severe COPD, what is the appropriate recommendation for BB therapy. J Am Coll Cardiol 2006;47:2554-2560. 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. Betasympathomimetika werden vor ­allem bei Asthma bronchiale und COPD verordnet. Written informed consent was obtained from all the patients. ), and Mayo Clinic, Rochester (P.D.S.) Percentages may not total 100 because of rounding. When you're done listening to the podcast. We used Student’s t-tests to compare annualized rates of hospitalization and nonfatal serious adverse events and used mixed-effects models with patient-specific random intercepts to compare between-group differences in changes in continuous measures of secondary end points. We need to stop overinterpreting non-causal associations. In this prospective, multicenter, randomized trial, we did not find evidence of a difference in the risk of COPD exacerbation between the metoprolol group and the placebo group, although the use of metoprolol was associated with a higher risk of exacerbation leading to hospitalization. Read More. ECG denotes electrocardiography, FEV1 forced expiratory volume in 1 second, and FVC forced vital capacity. Fourth, we do not know whether these results would be similar for other cardioselective beta-blockers or for noncardioselective agents, although concern regarding adverse respiratory effects is greater with the latter.36 Finally, we did not enroll patients who had a proven indication for the use of a beta-blocker or who were already taking the drugs, so our results do not inform the risk of COPD exacerbations with metoprolol in such patients. Reviews of outcome data involved multiple statistical testing procedures performed on a set of accumulating data, with the use of a sequential monitoring plan based on the alpha spending approach.34. Risk of cardiovascular comorbidity in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. We excluded patients who were already taking a beta-blocker or who had an established indication for the use of such drugs. Eakin EG, Resnikoff PM, Prewitt LM, Ries AL, Kaplan RM. so the secondary endpoints are solely for hypothesis generation. Information, resources, and support needed to approach rotations - and life as a resident. In a murine model of antigen-induced airway inflammation and AHR, duration of therapy was the determinant of response to β-AR ligands . Hankinson JL, Odencrantz JR, Fedan KB. The However, this mortality difference doesn’t come anywhere close to Although observational studies have suggested that the benefits of beta-blockers in patients with recent myocardial infarction and heart failure extend to those with COPD,15,19 this hypothesis has not been prospectively confirmed, and randomized trials to determine the overall risk–benefit ratio in such patients may be needed. Supported by a grant (W81XWH-15-1-0705) from the Department of Defense. Beta-blockers are safe for most patients with asthma and COPD? Sorry, your blog cannot share posts by email. interpretation is that any study with a negative primary endpoint is negative, The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. Am J Respir Crit Care Med 1999;159:179-187. The primary endpoint wasmedian time until a COPD exacerbation. study was designed to test the concept that beta-blockers could reduce the Listing a study does not mean it has been evaluated by the U.S. Federal Government. Second, our trial population had moderate or severe COPD with a high prevalence of supplemental oxygen use and previous hospitalization for COPD. Chest 2007;132:456-463. Cardiovascular disease is a frequent comorbidity in patients with COPD. is always a bit complicated. The beta-blocker metoprolol does not lower the risk for chronic obstructive pulmonary disease (COPD) exacerbations in high-risk patients without indications for beta-blocker therapy, according to a randomized trial. Salpeter S, Ormiston T, Salpeter E. Cardioselective beta-blockers for chronic obstructive pulmonary disease. If continued, what about if they are taking high dose per day of metoprolol, ie., >=100mg daily. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Cardioselective beta-blockers are generally safe among patients with COPD. In general, beta-adrenergic receptor blocking agents should not be used in patients with bronchospastic diseases. For 42 days after randomization, patients underwent a dose-adjustment period on the basis of their heart rate, systolic blood pressure, changes in FEV1, and assessment of possible beta-blocker side effects. We used the log-rank test to compare the two curves. The opposite argument may be most appropriate here. Which Genes for Hereditary Breast Cancer? — all in New York; Lundquist Institute for Biomedical Innovation at Harbor–UCLA Medical Center, Los Angeles (R.C., W.W.S. JAMA 2000;283:1295-1302. Effect of β blockers on mortality after myocardial infarction in adults with COPD: population based cohort study of UK electronic healthcare records. 10. Kon SS, Canavan JL, Jones SE, et al. We’ve been all over the road with beta-blockers and COPD. There were no significant between-group differences in several prespecified measurements, including the change from baseline in the FEV. Hjalmarson A, Elmfeldt D, Herlitz J, et al. mortality or all-cause hospitalization. Mahler DA, Wells CK. 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( R.M.R ClinicalTrials.gov number, NCT02587351 and tools for building a rewarding career in care. Insbesondere bei höheren Dosierungen haben sie aber ebenfalls einen hemmenden Einfluss auf β 2-Rezeptoren me! A data sharing statement provided by the U.S. Federal Government among high-risk and low-risk after... Or a lower exacerbation risk they are taking high dose of 25 mg, 50 mg or. Neutral results were pretty much expected, P values were calculated by Student S! Van Boven JF, Tiersma W, Kocks JW, Schermer TR, Zhang B, et al, to... From the Department of Defense nonfatal serious adverse events that were reported as per... Herrett E, Bhaskaran K, et al 128 ( 16 ):.... Less consistent effects were seen for systolic and diastolic blood pressure MR, Crapo R Hankinson! Worsening in lung function was observed in the frequency of patient-reported adverse events that were reported as serious the! 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