title: Self-rated health predicts adverse events during β-blocker treatment: the CIBIS-ELD randomised trial analysis.
abstract: BACKGROUND
  Self-rated health (SRH) predicts outcome in patients with heart failure. Beta-blockers are known to improve health-related quality of life and reduce mortality in such patients. We aimed to evaluate the relation between SRH and adverse events during titration of beta-blockers in elderly patients with heart failure.
  
  
  METHODS
  The cardiac insufficiency bisoprolol study in the elderly (CIBIS-ELD) is a multicentre, double-blind trial, in which 883 patients aged ≥ 65 years with chronic heart failure (73 ± 6 years, 38% women, left ventricular ejection fraction [LVEF] 42% ± 14%) were randomised to bisoprolol or carvedilol. SRH was assessed at baseline and after 12 weeks, using a 5-grade descriptive scale: excellent, very good, good, fair, and poor.
  
  
  RESULTS
  Median SRH at baseline and follow-up was good, but more patients reported fair/poor SRH at baseline (36% vs. 30%, p = 0.012). Women, beta-blocker-naïve patients, patients in NYHA class III/IV and those with PHQ-9 score ≥ 12 were more likely to report fair/poor baseline SRH (p < 0.001 for all). During follow-up, SRH improved in 34% of patients and worsened in 8% (p < 0.001). Adverse events were experienced by 64% patients and 38% experienced > 1 adverse event or serious adverse event, with higher prevalence in lower SRH categories. In a multivariate logistic regression model, SRH, age, distance achieved on the 6-min walk test and LVEF >45% predicted adverse events (p < 0.05 for all).
  
  
  CONCLUSIONS
  SRH is an independent predictor of adverse events during titration of beta-blockers and correlates with the proportion and number of adverse events per patient.
authors.affiliation: Division of Cardiology, University Clinic Golnik, Golnik, Slovenia. mitja.lainscak@guest.arnes.si
authors.forename: Mitja
authors.initials: M
authors.lastname: Lainscak
authors.forename: Jerneja
authors.initials: J
authors.lastname: Farkas
authors.forename: Simone
authors.initials: S
authors.lastname: Inkrot
authors.forename: Götz
authors.initials: G
authors.lastname: Gelbrich
authors.forename: Aleksandar N
authors.initials: AN
authors.lastname: Neskovic
authors.forename: Thomas
authors.initials: T
authors.lastname: Rau
authors.forename: Elvis
authors.initials: E
authors.lastname: Tahirovic
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Töpper
authors.forename: Svetlana
authors.initials: S
authors.lastname: Apostolovic
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Haverkamp
authors.forename: Christoph
authors.initials: C
authors.lastname: Herrmann-Lingen
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.forename: Hans-Dirk
authors.initials: HD
authors.lastname: Düngen
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000009:adverse effects*; D000368:Aged; D017298:Bisoprolol / Q000009:adverse effects; D002227:Carbazoles / Q000009:adverse effects; D000077261:Carvedilol; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011412:Propanolamines / Q000009:adverse effects; D057566:Self Report; D016896:Treatment Outcome
chemical_list: D000319:Adrenergic beta-Antagonists; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol; D017298:Bisoprolol