title: Drug adherence and clinical outcomes for patients under pharmacological therapy for lower urinary tract symptoms related to benign prostatic hyperplasia: population-based cohort study.
abstract: BACKGROUND
  Little is known about drug adherence in men treated for lower urinary tract symptoms (LUTS). Benign prostatic hyperplasia (BPH) is one of the causes of LUTS.
  
  
  OBJECTIVE
  To examine adherence to pharmacological therapy and its clinical value in men with LUTS.
  
  
  METHODS
  Population-based cohort study using an administrative prescription database and hospital discharge codes for 1.5 million men aged ≥40 yr treated with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) alone or in combination (CT).
  
  
  METHODS
  Therapy with ABs and/or 5ARIs.
  
  
  METHODS
  The 1-yr and long-term adherence; hospitalization rates for BPH and BPH surgery. Multivariate Cox proportional hazards regression model, propensity score matching, and sensitivity analyses.
  
  
  CONCLUSIONS
  The 1-yr adherence was 29% in patients exposed to at least 6-mo therapy. Patients on CT had a higher discontinuation rate in the first 2 yr compared to those on monotherapy (p<0.0001). Overall hospitalization rates for BPH and BPH surgery were 9.04 and 12.6 per 1000 patient-years, respectively. A lower risk of hospitalization was observed for 5ARI compared to AB therapy (hazard ratio [HR] 0.46 and 0.23; p<0.0001). CT was associated with a reduced risk of hospitalization for BPH surgery (HR 0.94; p<0.0001) compared to AB. Discontinuation of drug treatment was an independent risk factor for hospitalization for BPH and BPH surgery (HR 1.65 and 2.80; p<0.0001) regardless of therapeutic group. Limitations include the paucity of clinical measures and the absence of patient-reported outcomes.
  
  
  CONCLUSIONS
  Adherence to pharmacological therapy for BPH is low and could affect clinical outcomes. Long-term 5ARI and CT use was associated with an independent reduced risk of hospitalization for BPH surgery. Our findings suggest the need for new strategies to increase patient adherence to prescribed treatment and more appropriate prescribing by physicians.
  
  
  RESULTS
  Our research shows that adherence to prescribed pharmacological therapy is crucial in the management of patients suffering from lower urinary tract symptoms. Moreover, pharmacological therapy can prevent disease progression.
authors.affiliation: Department of Urology, S. Pio da Pietrelcina Hospital, Vasto, Italy. Electronic address: lucacindolo@virgilio.it.
authors.forename: Luca
authors.initials: L
authors.lastname: Cindolo
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Santa Maria Imbaro, Italy.
authors.forename: Luisella
authors.initials: L
authors.lastname: Pirozzi
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Santa Maria Imbaro, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Fanizza
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Santa Maria Imbaro, Italy.
authors.forename: Marilena
authors.initials: M
authors.lastname: Romero
authors.affiliation: Department of Urology, Ospedale Sant'Andrea, University La Sapienza, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Tubaro
authors.affiliation: University Hospitals, Urology Institute, Cleveland, OH, USA.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Autorino
authors.affiliation: Department of Urology, Ospedale Sant'Andrea, University La Sapienza, Rome, Italy.
authors.forename: Cosimo
authors.initials: C
authors.lastname: De Nunzio
authors.affiliation: Department of Urology, S. Pio da Pietrelcina Hospital, Vasto, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Schips
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000627:therapeutic use*; D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D016208:Databases, Factual; D004359:Drug Therapy, Combination; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D016016:Proportional Hazards Models; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D058891:5-alpha Reductase Inhibitors; D000317:Adrenergic alpha-Antagonists
keywords: 5-Alpha reductase inhibitors; Administrative database; Alpha blockers; Benign prostatic hyperplasia; Drug adherence; Drug therapy; Lower urinary tract symptoms