title: Clinical effects and economical impact of dutasteride and finasteride therapy in Italian men with LUTS.
abstract: OBJECTIVE
  To investigate differences in the risk of benign prostatic hyperplasia (BPH)- related hospitalization, for surgical and non-surgical reasons, and of new prostate cancer (PCa) diagnosis between patients under dutasteride or finasteride treatment.
  
  
  METHODS
  A retrospective cohort study was conducted using data from record-linkage of administrative databases. Men aged ≥ 40 years old who had received a prescription for at least 10 boxes/year (index years: 2004-06) were included. The association of the outcomes was assessed using a multiple Cox proportional hazard model. Propensity score matched analysis and a 5-to-1, greedy 1:1 matching algorithm were performed. The budget impact analysis of dutasteride vs finasteride in BPH-treated patient was performed.
  
  
  RESULTS
  From an initial cohort of about 1.5 million of Italian men, 19620 were selected. The overall hospitalization for BPH-non surgical reasons, for BPH-related surgery and for new detection of PCa incidence rates (IRs) were 8.20 (95% CI, 7.62-8.23), 18.0 (95% CI, 17.12-18.93) and 8.62 (95% CI, 8.03-9.26) per 1000 person-years, respectively. The multivariate analysis after the propensity score-matching showed that dutasteride was associated with an independent reduced likelihood of hospitalization for BPH-related surgery (HR 0.82; 95% CI 0.73-0.93; p = 0.0025) and of newly detected PCa (HR: 0.76,95% CI, 0.65-0.85; p = 0.0116). The IR for BPH-non surgical reasons was 8.07 (95% CI, 7.10-9.17) and 9.25 (95% CI, 8.19-10.44) per 1000 person-years, respectively. The IR for BPH-related surgery was 18.28 (95% CI, 17.17-20.32) and 21.28 (95% CI, 19.24-23.06) per 1000 person-years among patients under dutasteride compared with those under finasteride, respectively. For new-onset PCa, the IR was 8.01 (95% CI, 7.07-9.08) and 9.38 (95% CI, 8.32-10.58) per 1000 person-years The pharmacoeconomical evaluation showed that the net budget impact of the use of dutasteride vs. finasteride in 1000 BPH-treated patient for 1 year induces a saving of 3933 €.
  
  
  CONCLUSIONS
  The clinical effects of dutasteride and finasteride are slightly different. The likelihood of hospitalization for BPH-related surgery and of newly detected PCa seems to be in favor of dutasteride. The budget impact analyses showed a slightly benefit for dutasteride. Comparative prospective studies are necessary to confirm these results.
authors.affiliation: S. Pio da Pietrelcina Hospital, Dept. of Urology, Vasto. lucacindolo@virgilio.it.
authors.forename: Luca
authors.initials: L
authors.lastname: Cindolo
authors.forename: Francesco
authors.initials: F
authors.lastname: Berardinelli
authors.forename: Caterina
authors.initials: C
authors.lastname: Fanizza
authors.forename: Marilena
authors.initials: M
authors.lastname: Romero
authors.forename: Luisella
authors.initials: L
authors.lastname: Pirozzi
authors.forename: Fabiola Raffaella
authors.initials: FR
authors.lastname: Tamburro
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Pellegrini
authors.forename: Fabio
authors.initials: F
authors.lastname: Neri
authors.forename: Andrea
authors.initials: A
authors.lastname: Pitrelli
authors.forename: Luigi
authors.initials: L
authors.lastname: Schips
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001378:Azasteroids / Q000627:therapeutic use*; D015331:Cohort Studies; D000068538:Dutasteride; D018120:Finasteride / Q000627:therapeutic use*; D006801:Humans; D007558:Italy; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D058891:5-alpha Reductase Inhibitors; D001378:Azasteroids; D018120:Finasteride; D000068538:Dutasteride