title: Candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) and resource utilization and costs in Italy.
abstract: Chronic heart failure (HF) is a major cause of morbidity and mortality particularly in the elderly and a growing healthcare burden in Italy. The objective was to assess the cost-effectiveness of candesartan cilexetil, an angiotensin II type 1 receptor blocker (ARB) for the treatment of HF. A pre-specified economic evaluation was conducted on resource utilization (cardiovascular drug treatment, cardiovascular and non-cardiovascular hospital admission, cardiovascular procedures/operations) prospectively collected alongside the CHARM program, a series of parallel randomized clinical trials comparing candesartan with placebo (standard therapy) in patients with NYHA Class II-IV HF: CHARM-Alternative (LVEF < or =40% patients not receiving ACE inhibitors because of previous intolerance); CHARM-Added (LVEF < or =40% patients currently receiving ACE inhibitors); or CHARM-Preserved (LVEF > or =40% patients). The primary outcome for the component trials was the composite of cardiovascular death or worsening hospital admission for HF and of the overall program all-cause mortality. Adjunctive treatment with candesartan in CHARM-Alternative and CHARM-Added led to clinical benefits and to either cost-savings or a small additional cost, depending on the trial. The less certain clinical benefit in CHARM-Preserved was obtained at modest extra cost. The incremental cost-effectiveness ratios (ICERs) were estimated to range from euro713 per life year gained for CHARM-Alternative to dominant for CHARM-Added and the pooled reduced LVEF trials.
authors.affiliation: S.A.V.E Studi Analisi Valutazioni Economiche, Milana, Italy. giorgio.colombo@savestudi.it
authors.forename: Giorgio L
authors.initials: GL
authors.lastname: Colombo
authors.forename: Mauro
authors.initials: M
authors.lastname: Caruggi
authors.forename: Chiara
authors.initials: C
authors.lastname: Ottolini
authors.forename: Aldo P
authors.initials: AP
authors.lastname: Maggioni
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000191:economics* / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000191:economics* / Q000627:therapeutic use*; D001713:Biphenyl Compounds; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality; D017721:Hospital Costs; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D012307:Risk Factors; D016019:Survival Analysis; D013777:Tetrazoles / Q000191:economics* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; C081643:candesartan