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Comparison of Long-Term Clinical Implications of Beta-Blockade In Comparison of long-term clinical implications of beta-blockade in patients with obstructive airway diseases exposed to beta-blockers with different 1-adrenoreceptor selectivity An Italian population-based cohort study Sessa, Maurizio; Mascolo, Annamaria; Scavone, Cristina; Perone, Ilaria; Giorgio, Annalisa Di; Tari, Michele; Fucile, Annamaria; De Angelis, Antonella; Rasmussen, Daniel Bech; Jensen, Magnus Thorsten; Kragholm, Kristian; Rossi, Francesco; Capuano, Annalisa; Sportiello, Liberata Published in: Frontiers in Pharmacology DOI: 10.3389/fphar.2018.01212 Publication date: 2018 Document version Publisher's PDF, also known as Version of record Citation for published version (APA): Sessa, M., Mascolo, A., Scavone, C., Perone, I., Giorgio, A. D., Tari, M., Fucile, A., De Angelis, A., Rasmussen, D. B., Jensen, M. T., Kragholm, K., Rossi, F., Capuano, A., & Sportiello, L. (2018). Comparison of long-term clinical implications of beta-blockade in patients with obstructive airway diseases exposed to beta-blockers with different 1-adrenoreceptor selectivity: An Italian population-based cohort study. Frontiers in Pharmacology, 9, 1- 8. [1212]. https://doi.org/10.3389/fphar.2018.01212 Download date: 26. Sep. 2021 fphar-09-01212 October 23, 2018 Time: 14:25 # 1 ORIGINAL RESEARCH published: 25 October 2018 doi: 10.3389/fphar.2018.01212 Comparison of Long-Term Clinical Implications of Beta-Blockade in Patients With Obstructive Airway Diseases Exposed to Beta-Blockers With Different b1-Adrenoreceptor Edited by: Lei Xi, Selectivity: An Italian Virginia Commonwealth University, United States Population-Based Cohort Study Reviewed by: Chin Moi Chow, Maurizio Sessa1,2*†, Annamaria Mascolo2†, Cristina Scavone2, Ilaria Perone2, University of Sydney, Australia Annalisa Di Giorgio3, Michele Tari3, Annamaria Fucile3, Antonella De Angelis2, Federica del Monte, Daniel Bech Rasmussen4,5,6, Magnus Thorsten Jensen5, Kristian Kragholm7,8, Medical University of South Carolina, Francesco Rossi2, Annalisa Capuano2‡ and Liberata Sportiello2‡ United States 1 Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark, 2 Department *Correspondence: of Experimental Medicine, University of Campania “L. Vanvitelli”, Naples, Italy, 3 Caserta Local Health Service, Caserta, Italy, Maurizio Sessa 4 Respiratory Research Unit Zealand, Department of Respiratory Medicine, Naestved Hospital, Naestved, Denmark, [email protected]; 5 Department of Cardiology, Herlev and Gentofte University Hospital, Hellerup, Denmark, 6 Department of Regional Health [email protected] Research, University of Southern Denmark, Odense, Denmark, 7 Department of Cardiology, North Denmark Regional † These authors have contributed Hospital, Hjørring, Denmark, 8 Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark equally to this work as co-first authors ‡These authors have contributed equally to this work as co-lead Rationale: Long-term clinical implications of beta-blockade in obstructive airway authors diseases remains controversial. We investigated if within the first 5 years of treatment patients with heart failure and obstructive airway diseases using non b1-adrenoreceptor Specialty section: This article was submitted to selective beta-blockers have an increased risk of being hospitalized for all-causes, heart Translational Pharmacology, failure, and chronic obstructive pulmonary disease (COPD) when compared to patient a section of the journal using selective beta-blockers. Frontiers in Pharmacology Received: 02 July 2018 Methods: Carvedilol users were propensity matched 1:1 for co-treatments, age, Accepted: 05 October 2018 gender, and year of inclusion in the cohort with metoprolol/bisoprolol/nebivolol users. Published: 25 October 2018 Cox proportional hazard regression model was used to compare all causes, COPD, and Citation: Sessa M, Mascolo A, Scavone C, heart failure hospitalization or the beta-blocker discontinuation between cohorts. For Perone I, Di Giorgio A, Tari M, statistically significant associations, we computed the rate difference and the attributable Fucile A, De Angelis A, Rasmussen DB, Jensen MT, risk. Kragholm K, Rossi F, Capuano A and Results: Overall, 11,844 patients out of the 51,214 (23.1%) were exposed to carvedilol Sportiello L (2018) Comparison of Long-Term Clinical Implications and 39,370 (76.9%) to metoprolol/bisoprolol/nebivolol. Carvedilol users had a higher of Beta-Blockade in Patients With hazard for heart failure hospitalization (HR 1.29; 95% Confidence Interval [CI] 1.18– Obstructive Airway Diseases Exposed to Beta-Blockers With Different 1.40) with 106 (95%CI 76–134; p-value < 0.001) additional cases of heart failure β1-Adrenoreceptor Selectivity: An hospitalization per 10000 person-years if compared to metoprolol/bisoprolol/nebivolol Italian Population-Based Cohort users. In all, 26.8% (95%CI 22.5–30.9%; p-value 0.001) of heart failure Study. Front. Pharmacol. 9:1212. < doi: 10.3389/fphar.2018.01212 hospitalizations in the study population could be attributed to being exposed Frontiers in Pharmacology| www.frontiersin.org 1 October 2018| Volume 9| Article 1212 fphar-09-01212 October 23, 2018 Time: 14:25 # 2 Sessa et al. Long-Term Clinical Impact of Beta-Blockers Selectivity to carvedilol. Carvedilol users had a higher hazard (HR 1.06; 95%CI 1.02– 1.10) of discontinuing the pharmacological treatment with 131 (95%CI 62–201; p-value < 0.001) additional cases of beta-blocker discontinuation per 10000 person-years metoprolol/bisoprolol/nebivolol users. In all, 6.5% (95%CI 3.9–9.0%; p-value < 0.001) of beta-blocker discontinuation could be attributed to being exposed to carvedilol. Conclusion: On long-term follow-up period, carvedilol was associated with a higher risk of heart failure hospitalization and discontinuation if compared to metoprolol/bisoprolol/nebivolol users among patients with heart failure and obstructive airway diseases. Keywords: clinical epidemiology, obstructive respiratory diseases, humans, pharmacoepidemiology, pharmacology, beta-blockers, heart failure INTRODUCTION Moreover, patients with asthma or COPD could have been exposed for a long period to b2-adrenoreceptor agonist, a Beta-blockers are able to reduce mortality in patients with phenomenon promoting the development of b2-adrenoreceptor concurrent heart failure and respiratory diseases and, therefore, desensitization in the respiratory system (Hausdorff et al., 1990; the co-existence of both diseases should not discourage the Lohse et al., 1996; Chong et al., 2003). Consequently, patients clinicians from using these drugs (Rutten et al., 2010; Short could be less sensitive to acute beta-blockade effects in the et al., 2011; Du et al., 2014; Lim et al., 2017). While beta- respiratory system due to both desensitization mechanisms blockade is clinically useful for heart failure, it could induce of b2-adrenoreceptor and to the competitive binding of b2- bronchoconstriction and worsen lung function in patients with adrenoreceptor agonist that are typically co-administrated in asthma or chronic obstructive pulmonary disease (COPD) patients having both diseases. However, on long-term, the (Grieco and Pierson, 2017). Among beta-blockers approved prolonged b2-adrenoreceptor antagonism performed by beta- for heart failure, those less selective for b1-adrenoreceptor, blockers less selective for b1-adrenoreceptor receptors can such as carvedilol, were associated with a higher risk of alter pulmonary compliance leading to dynamic hyperinflation obstructive airway diseases exacerbations (van der Woude et al., even in presence of b2-adrenoreceptor agonists (Jabbal and 2005; Hawkins et al., 2009; Short et al., 2011, 2014). In fact, Lipworth, 2018). Dynamic hyperinflation, in turn, apart from European Society of Cardiology (ESC) and Global Initiative for negative respiratory outcomes, can promote impaired ventricular Chronic Obstructive Lung Disease (GOLD) clinical guidelines filling and low cardiac output along with a reduction of recommended more selective b1-adrenoreceptor antagonist in intrathoracic blood volume and pulmonary vein dimensions, patients with concurrent heart failure and respiratory diseases all phenomenon that can promote decompensation of heart (i.e., COPD and asthma) (Dickstein et al., 2008, 2010; McMurray failure (Jorgensen et al., 2007; Watz et al., 2010; Barr et al., et al., 2012; Ponikowski et al., 2016). However, the majority of 2012; Stone et al., 2016; Watz, 2016). In this clinical scenario, studies comparing b1-selective and non-selective beta-blockers b1-adrenoreceptor selectivity of beta-blockers may still play in patients with heart failure and concurrent respiratory diseases a key role for the recrudescence of both heart failure and focused on short-term follow-up period post beta-blockers obstructive airway diseases symptoms. To provide further insight initiation and only a few studies provided outcomes of public on this aspect we investigated if patients with heart failure and health interest (Salpeter et al., 2002; Hawkins et al., 2009; concurrent COPD or asthma with long-term exposure to low b1- Jabbour et al., 2010; Rutten et al., 2010; Dungen et al., 2011; adrenoreceptor selectivity beta-blockers have an increased risk Lainscak et al., 2011; Etminan et al., 2012; Kubota et al., 2015; of being hospitalized for all-causes, heart failure, and obstructive Ponikowski et al., 2016; Sessa et al., 2017a). Studies investigating airway diseases compared to non-selective beta-blockers. clinical implications
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