title: Hospital resource use of patients receiving isavuconazole vs voriconazole for invasive mold infections in the phase III SECURE trial.
abstract: OBJECTIVE
  In the phase III SECURE trial, isavuconazole was non-inferior to voriconazole for all-cause mortality for the primary treatment of invasive mold disease (IMD) caused by Aspergillus spp. and other filamentous fungi. This analysis assessed whether hospital resource utilization was different between patients treated with isavuconazole vs voriconazole in SECURE.
  
  
  METHODS
  The analysis population comprised adults with proven/probable/possible IMD enrolled in SECURE. The primary endpoint was hospital length of stay (LOS) in the overall trial population. Patients were also stratified by estimated glomerular filtration rate-modification of diet in renal disease category (< 60 mL/min/1.73 m(2) [moderate-to-severe impairment] and ≥60 mL/min/1.73 m(2) [mild or no impairment]), body mass index (BMI; <25, ≥25-<30, and ≥30 kg/m(2)), and age (≤45, >45-≤65, and >65 years).
  
  
  RESULTS
  Data from 516 patients (258 per arm) were evaluated. Overall, median LOS was not statistically significantly different between the isavuconazole (15.0 days) and voriconazole (16.0 days; p = 0.607) arms. Median LOS was statistically significantly shorter in patients with moderate-to-severe renal impairment treated with isavuconazole (9.0 days) vs voriconazole (19.0 days; hazard ratio [HR]: 3.44; 95% confidence interval [CI] = 1.51-7.83). Median LOS was shorter, but not significantly, in patients with a BMI ≥30 kg/m(2) (isavuconazole 13.5 days vs voriconazole 22 days; HR = 1.57; 95% CI = 0.70-3.52) or aged >65 years (isavuconazole 15.0 days vs voriconazole 20.0 days; HR = 1.37; 95% CI = 0.87-2.16).
  
  
  CONCLUSIONS
  As the patient subgroups analyzed were small, sub-group findings should be interpreted with caution in light of the lack of statistical significance for each sub-group-by-treatment interaction.
  
  
  CONCLUSIONS
  Isavuconazole may reduce hospital LOS in certain subgroups of patients with IMD, especially those with moderate-to-severe renal impairment.
authors.affiliation: a David Horn, LLC , Doylestown , PA , USA ;
authors.forename: David
authors.initials: D
authors.lastname: Horn
authors.affiliation: b The Ohio State University Wexner Medical Center , Columbus , OH , USA ;
authors.forename: Debra
authors.initials: D
authors.lastname: Goff
authors.affiliation: c Astellas Pharma Global Development, Inc. , Northbrook , IL , USA ;
authors.forename: Nikhil
authors.initials: N
authors.lastname: Khandelwal
authors.affiliation: c Astellas Pharma Global Development, Inc. , Northbrook , IL , USA ;
authors.forename: James
authors.initials: J
authors.lastname: Spalding
authors.affiliation: c Astellas Pharma Global Development, Inc. , Northbrook , IL , USA ;
authors.forename: Nkechi
authors.initials: N
authors.lastname: Azie
authors.affiliation: c Astellas Pharma Global Development, Inc. , Northbrook , IL , USA ;
authors.forename: Fei
authors.initials: F
authors.lastname: Shi
authors.affiliation: c Astellas Pharma Global Development, Inc. , Northbrook , IL , USA ;
authors.forename: Billy
authors.initials: B
authors.lastname: Franks
authors.affiliation: d Washington Hospital Center , Washington , DC , USA.
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Shorr
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000191:economics / Q000627:therapeutic use*; D001228:Aspergillosis / Q000188:drug therapy / Q000191:economics; D015992:Body Mass Index; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate; D017722:Hospital Charges / Q000706:statistics & numerical data; D006801:Humans; D053208:Kaplan-Meier Estimate; D007902:Length of Stay / Q000191:economics*; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy* / Q000191:economics*; D009570:Nitriles / Q000191:economics / Q000627:therapeutic use*; D011725:Pyridines / Q000191:economics / Q000627:therapeutic use*; D014230:Triazoles / Q000191:economics / Q000627:therapeutic use*; D065819:Voriconazole / Q000191:economics / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D009570:Nitriles; D011725:Pyridines; D014230:Triazoles; C508735:isavuconazole; D065819:Voriconazole
keywords: Antifungal; Aspergillus; isavuconazole; mold; outcomes; voriconazole