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Comparison of the Clinical Outcome of Different Beta-Blockers in Heart Failure Patients: a Retrospective Nationwide Cohort Study

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Comparison of the Clinical Outcome of Different Beta-Blockers in Heart Failure Patients: a Retrospective Nationwide Cohort Study European Journal of Heart Failure (2014) doi:10.1002/ejhf.81 Comparison of the clinical outcome of different beta-blockers in heart failure patients: a retrospective nationwide cohort study Rasmus Bølling1*, Nikolai Madrid Scheller1,LarsKøber2, Henrik Enghusen Poulsen3,4, Gunnar H. Gislason5, and Christian Torp-Pedersen1 1Institute of Health, Science and Technology, Aalborg University, Denmark; 2Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen; 3Laboratory of Clinical Pharmacology, Rigshospitalet; 4Department of Clinical Pharmacology Bispebjerg Hospital, Copenhagen University Hospital; and 5Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark Received 31 October 2013; revised 9 February 2014; accepted 14 February 2014 Aim To compare survival on different beta-blockers in heart failure. ..................................................................................................................................................................... Methods We identified all Danish patients ≥35 years of age who were hospitalized with a first admission for heart failure and and results who initiated treatment with a beta-blocker within 60 days of discharge. The study period was 1995–2011. The main outcome was all-cause mortality and all-cause hospitalization. Cox proportional hazard models were used to compare survival. The study included 58 634 patients of whom 30.121 (51.4%) died and 46.990 (80.1%) were hospitalized during follow-up. The mean follow-up time was 4.1 years. In an unadjusted model carvedilol was associated with a lower mortality [hazard ratio (HR) 0.737, 0.714–0.761] compared with metoprolol (reference) while bisoprolol was not associated with an increased mortality (HR 1.020, 0.973–1.069). In a model adjusted for possible confounders and stratified according to beta-blocker dosages, patients that received high-dose carvedilol (≥50 mg daily) had a lower all-cause mortality risk (HR 0.873, 0.789–0.966) than patients receiving high-dose (≥200 mg daily) metoprolol (reference). High-dose bisoprolol (≥10 mg daily) was associated with a greater risk of death (HR 1.125, 1.004–1.261). High-dose carvedilol was associated with significantly lower all-cause hospitalization risk (HR 0.842, 0.774–0.915) than high-dose metoprolol (reference), while high-dose bisoprolol had insignificantly lower risk than high-dose metoprolol (HR 0.948, 0.850–1.057). ..................................................................................................................................................................... Conclusions Heart failure patients receiving high-dose carvedilol (≥50 mg daily) showed significantly lower all-cause mortality risk ..........................................................................................................and hospitalization risk, compared with other beta-blockers. Keywords Beta-blockers • Bisoprolol • Carvedilol • Heart failure • Metoprolol • Pharmacological treatment Introduction study demonstrated that carvedilol had a significant beneficial effect on all-cause mortality compared with metoprolol. The validity of Randomized clinical trials have shown that bisoprolol, carvedilol the COMET results has since been discussed on the basis of the and metoprolol improve survival and reduce hospitalizations for compared dosage regimens and formulation of metoprolol chosen 1 – 6 cardiac events in patients with chronic heart failure. The com- for the study.8 – 12 Observational studies have compared different parison of carvedilol and metoprolol on clinical outcomes in beta-blockers in heart failure patients but their conclusions have patients with chronic heart failure in the Carvedilol Or Metopro- not been consistent. A Canadian observational study of 26 787 lol European Trial (COMET) from 2003 is the only randomized patients diagnosed with heart failure found no difference in mor- clinical trial to have compared beta-blockers head to head.7 This tality rates among patients receiving metoprolol or carvedilol.13 ........................... *Corresponding author: Vølundsgade 10, 4. sal, 2200 Copenhagen N, Denmark. Tel: +45 40974899, Fax: +45 98154008. E-mail: [email protected] ©2014TheAuthors European Journal of Heart Failure ©2014 European Society of Cardiology 2 R. Bølling et al. Another study from 2008 of 26 112 north American veterans, minimum daily dosage for each tablet strength could ensure continu- found the controlled release formulation of metoprolol to be ous treatment. Daily dose during continuous treatment was calculated superior in improving survival compared with carvedilol.14 In con- as the mean dose for each patient. 19 trast, another observational study from 2005, based on a health- Based on the heart failure treatment guidelines we stratified insurance claims database in the USA, which compared metoprolol exposure groups metoprolol, carvedilol and bisoprolol into three strata (low, intermediate, and high daily dosage) according to each tartrate and carvedilol, found carvedilol to be superior in terms of patient’s estimated daily dosage, at 3 months, 6 months, and 2 years of mortality and hospitalizations.15 Equal benefit of metoprolol and treatment. For metoprolol the dosages used were ≤100 mg/day (low), 16 carvedilol was the result of a third US observational study. A 101–199 mg/day (intermediate) and ≥200 mg/day (high). For carvedilol small Japanese study found no difference in survival between biso- the dosages used were ≤12.5 mg (low), 12.6–49.9 mg (intermediate) 17 prolol and carvedilol. These studies were done on varying small and ≥50 mg (high) and for bisoprolol the dosages used were ≤5mg patient populations and as single-centre or single-region studies. (low), 6–9 mg (intermediate) and ≥10mg(high). Owing to the inconsistent results from these studies we saw a need We assessed whether patients had received any beta-blocker treat- for more and larger studies. Based on extensive Danish nationwide ment before their index hospitalization and whether they switched type patient and medicinal product dispensing registries this study’s aim of beta-blocker throughout their treatment period. was to compare short- and long-term treatment with several beta- The year of first beta-blocker prescription after index hospitalization blockers in heart failure patients, examining type of beta-blocker for all patients was divided into periods of before 2001,fromand ................................................... as well as dose. including 2001–2005 and from and including 2006–2011. Persistence of treatment was defined as the percentage of patients in each exposure group in treatment on each relative day throughout Method each of the individual treatment periods starting at the first date of dispensing of the medicine until patient death or last date of data Patient population sample. This could be assessed based on the same assumptions and calculations as done for daily dosages. Using the Danish National Patient Registry we identified all patients aged ≥35 years who were discharged after a first-time hospitalization for chronic heart failure. Patients were included from the first date on Co-morbidity and concomitant which one of the following diagnosis codes appeared in the registry [International Classification of Diseases, 10th revision (ICD10), codes treatment I50 (heart failure), I42 (cardiomyopathy), I110 (Hypertensive heart Co-morbidities diagnosed before index hospitalization were identified disease with (congestive) heart failure) and J81 (Pulmonary oedema)], directly using ICD10 codes: myocardial infarction (I21), essential hyper- between 1978 and 31. December 2011. The registry contains records tension (I109), atrial fibrillation and flutter (I48), cerebrovascular dis- of all hospitalizations and primary and secondary diagnosis in Denmark ease (I6), peripheral arterial disease (I7), chronic kidney disease (N18), since 1978. malignant condition (C), paroxysmal tachycardia (I47), chronic obstruc- Using The Danish Registry of Medicinal Product Statistics, we tive pulmonary disease (J44), and ischaemic heart disease (I25, I248, included patients who claimed at least one outpatient prescription of a I249, I200C). Treatment with a glucose-lowering anti-diabetic medica- beta-blocker of any sort (ATC code C07) 60 days following discharge. tion (ATC code A10), defined as claim of at least one prescription in Patients who claimed their first beta-blocker prescription later than a period of 90 days before, or up to 60 days after index hospitalization 60 days were excluded. The registry contains data on all prescriptions was used as indication to a pre-existing diabetic condition. dispensed in Denmark since 1995, including medicine strength, quantity Using The Danish Registry of Medicinal Product Statistics we iden- dispensed and dispensing date. Heart failure patients diagnosed before tified patients who had collected a prescription of the following drugs the initiation date of this registry were excluded. within a period of 90 days before and 60 days after their index hospi- We obtained the vital status of each patient as of 31 December talization: loop-diuretics (C03C), thiazide diuretics (C03A), spirono- 2011 (the date of last data sample) via the Central Population Registry lactone (C03DA01), ACE-inhibitors (C09A), statins (C10AA), anti- of Denmark. This registry includes data on every citizen of Denmark diabetics (A10) and organic nitrates (C01DA). based on a personal social security number. This allows us to connect
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