Common Questions and Answers about Metoprolol copd. Third, in part because the trial was stopped early, we had limited power to detect differences in the risk of severe exacerbation between subgroups and could not identify specific factors that predisposed patients to adverse outcomes when treated with metoprolol. Patients diagnosed with both heart failure (HF) and chronic obstructive pulmonary disease (COPD) treated with carvedilol may have a higher risk for hospitalization for HF compared with patients treated with metoprolol/bisoprolol/nebivolol, according to a … 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 … This led to the current BLOCK-COPD trial which (spoiler alert) shows that metoprolol isn’t beneficial for COPD. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure, Bupropion and Naltrexone in Methamphetamine Use Disorder. 10. study was designed to test the concept that beta-blockers could reduce the spirometry Yancy CW, Jessup M, Bozkurt B, et al. I have COPD and something was aggravating my breathing problems. S1B). Premature termination increases the there are a lot of secondary endpoints. Columbus’s voyage was negative, because he failed to reach China (his 9. Criner GJ, Connett JE, Aaron SD, et al. Fihn SD, Gardin JM, Abrams J, et al. EMCrit is a trademark of Metasin LLC. 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. pre-specified endpoint). December 12, 2019N Engl J Med 2019; 381:2304-2314 My preference is to use some judgement in these studies, based on numerous factors (e.g. 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. Hjalmarson A, Goldstein S, Fagerberg B, et al. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. No commercial entity was involved in the trial. For a long time, there was a belief that beta-blockers were contraindicated in COPD. § Scores for dyspnea on the modified Medical Research Council scale range from 0 to 4, with higher scores indicating more severe breathlessness. Etminan M, Jafari S, Carleton B, FitzGerald JM. Clinicians also need to monitor these patients carefully, since drug-drug interactions may cause beta-blockers to lose their cardio-selectivity. I’m surprised that you didn’t mention the higher rate of active smokers in the Metoprolol group (35% vs 27%), which is known to result in more and more severe COPD exacerbations. 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. 20. First, although the investigators and patients were unaware of trial-group assignments, it was not possible to fully blind the effects of beta blockade, which resulted in reductions in heart rate and blood pressure. seriously: The authors presented these results in a rather dark light: The Interim analysis: the alpha spending function approach. There was no significant between-group difference in the median time until the first exacerbation, which was 202 days (95% confidence interval [CI], 162 to 282) in the metoprolol group and 222 days (95% CI, 189 to 295) in the placebo group (Figure 2A). Information, resources, and support needed to approach rotations - and life as a resident. 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. Vogelmeier CF, Criner GJ, Martinez FJ, et al. For example, a few weeks ago, I made an argument that for CRASH-3 the secondary endpoints might be considered positive. On the basis of data from previous clinical trials of a similar design,25,26 we estimated that 65% of the patients in the placebo group would have an exacerbation during the 1-year trial and that metoprolol would reduce this risk to 55%. 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). 4. Bhatt SP, Wells JM, Kinney GL, et al. A complete list of the BLOCK COPD trial group members is provided in the Supplementary Appendix, available at NEJM.org. DeMets DL, Lan KK. 27. COPD and Beta-blockers: another myth dispensed…, IBCC chapter – Disseminated Intravascular Coagulation (DIC), PulmCrit- RCTs don't justify using convalescent plasma or antibody cocktails. Beta-blockers shouldn’t be prescribed to patients without any indication for them. primary endpoint was time to first COPD exacerbation. Chen W, Thomas J, Sadatsafavi M, FitzGerald JM. In pts with CAD on BB, ie., metoprolol, with newly diagnosed severe COPD, what is the appropriate recommendation for BB therapy. Patientswere enrolled if they had COPD and lackedany indication for beta-blockers (e.g., prior myocardial infarction or systolicheart failure). 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. * Listed are adverse events that were reported as serious by the investigator. Am J Respir Crit Care Med 2017;195:557-582. 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. Severe or very severe exacerbations occurred in 26.1% of the patients in the metoprolol group and in 14.8% of those in the placebo group. Patients in the metoprolol group may have been sicker (with a substantially higher rate of COPD exacerbation in the year. Hospitalization for exacerbation was more common among the patients treated with metoprolol. Effect on mortality of metoprolol in acute myocardial infarction: a double-blind randomised trial. Thorax 2008;63:301-305. 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. This article was published on October 20, 2019, at NEJM.org. Cardioselective beta-blockers are generally safe among patients with COPD. BMJ Open 2016;6(6):e012292-e012292. Cardiovascular disease is a frequent comorbidity in patients with COPD. First, although the investigators and patients were unaware of trial-group assignments, it was not possible to fully blind the effects of beta blockade, which resulted in reductions in heart rate and blood pressure. vast majority of these secondary endpoints were negative. S8). He is an associate professor of Pulmonary and Critical Care Medicine at the University of Vermont. — both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) Our trial has several limitations. ); and North Florida–South Georgia Veterans Health System, Gainesville (P.S.S.). to give in patients with COPD. likelihood that the trial could possibly show benefit from metoprolol) and some concerns regarding safety. The most trusted, influential source of new medical knowledge and clinical best practices in the world. J Am Coll Cardiol 2006;47:2554-2560. There was no difference in the risk of COPD exacerbation between the metoprolol and the placebo groups, although the use of metoprolol was associated with a higher risk of exacerbation leading to hospitalization. The primary end point was the median time until the first COPD exacerbation of any severity during the treatment period, which was defined as the period from randomization to day 336 for the patients receiving a final dose of 25 mg of metoprolol or placebo or until day 350 for those receiving a dose of 50 mg or 100 mg. Characteristics of the Patients at Baseline. (Scores on the St. George’s Respiratory Questionnaire range from 0 to 100, with lower scores indicating better functioning and with a minimal clinically important difference [MCID] of 4 points.30 Scores on the COPD Assessment Test range from 0 to 40, with lower scores indicating better functioning and with a MCID of 2 points.31 Scores for dyspnea on the mMRC scale range from 0 to 4, with higher scores indicating more severe breathlessness.32 Scores on the San Diego Shortness of Breath Questionnaire range from 0 to 120, with higher scores indicating more severe breathlessness and with an MCID of 5 points.33), The data and safety monitoring committee met approximately every 6 months to review recruitment, follow-up rates, safety, and efficacy results. Spirometric reference values from a sample of the general U.S. population. incidence of COPD exacerbation. We’ve come full circle on the beta-blocker roller coaster. 12. S7). Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Westerik JA, Metting EI, van Boven JF, Tiersma W, Kocks JW, Schermer TR. The demographic and clinical characteristics of the patients at baseline are provided in Table 1, with a full list provided in Table S1 in the Supplementary Appendix. The would have regressed towards the mean, had the study been completed). Dransfield MT, Rowe SM, Johnson JE, Bailey WC, Gerald LB. and the Minneapolis VA Medical Center (K.M.K. Recent evidence suggests that using cardio-selective beta-blockers in COPD … β-Blockers are associated with a reduction in COPD exacerbations. 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. 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. Beta blockade may adversely affect pulmonary function by counteracting the bronchodilation produced by catecholamine stimulation of beta-2 receptors. Suissa S, Ernst P. Beta-blockers in COPD: a methodological review of the observational studies. Beta-blockers aren’t completely benign medications:  they do have some side-effects. The hypothesis was based on non-causal associations of better outcome among patients who used beta-blockers, which, as usual, were then subject to further hypothetical pathophysiological explanations. N Engl J Med 2011;365:689-698. interpretation is that any study with a negative primary endpoint is negative, Beta-blockers best avoided in COPD patients without cardiovascular disease. In your case, individual circumstances may deem othe ... Read More NEW! Sample-size calculations that included a two-sided alpha level of 0.05 and a trial power of 90% indicated we would need to enroll 1028 patients on the assumption of a loss to follow-up of approximately 12%. If beta-blocker therapy is necessary in thes… ), VISUAL ABSTRACTBeta-Blockers for COPD Exacerbations, Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD executive summary. 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. Josh is the creator of PulmCrit.org. Lancet Respir Med 2014;2:195-203. Randomization was performed by a computer algorithm by means of an interactive website linked to the data coordinating center. Beta-blockers are safe for most patients with asthma and COPD? 8. I went to the doctor yesterday and he took me off the Metoprolol and put me on 100 mg of Losartan. 7. 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]. In the BLOCK COPD (Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease) trial, we investigated the effect of the beta-blocker metoprolol, as compared with placebo, on the risk of COPD exacerbations among patients who were at high risk for such events.22 We hypothesized that the use of metoprolol would lower the risk of exacerbations in these patients without having an adverse effect on lung function, results on a 6-minute walk test, dyspnea, or quality of life. Azithromycin for prevention of 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. Stat Med 1994;13:1341-1356. Supported by a grant (W81XWH-15-1-0705) from the Department of Defense. Effect of beta-blockade on mortality among high-risk and low-risk patients after myocardial infarction. This study Quint JK, Herrett E, Bhaskaran K, et al. Metoprolol was purchased for use in the trial; matching placebo was manufactured at the Current Good Manufacturing Practices Facility at the Temple University School of Pharmacy. 25. 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. Am J Respir Crit Care Med 2002;166:111-117. Thus, we do not know whether our results would apply to patients with mild airflow obstruction or a lower exacerbation risk.

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