The Clinical and Economic Benefit of Early Avodart Use vs Early Finasteride Use

Trial description: Current guidelines recommend alpha blockers (ABs) and/or 5-alpha reductase inhibitors (5ARIs) as first-line pharmacologic treatment for men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). ABs provide symptomatic relief by decreasing the smooth muscle tone in the prostate, urethra, and bladder. However, they do not affect the prostate size. 5ARIs are considered to be disease-modifying, as they reduce prostate size, thereby reducing the subject’s likelihood of developing prostate-related complications, such as acute urinary retention (AUR) and prostate surgery, in addition to providing long-term symptom control. Dutasteride and finasteride are the only 5ARI therapies currently available in the United States (US). The objective of this study is to assess the impact of early combination with dutasteride or finasteride in subjects treated with alpha blockers (ABs). The null hypothesis is that there is no difference in rates of AUR or prostate-related surgery for subjects adding dutasteride or finasteride to AB therapy. Additional analyses will compare and contrast the BPH-related costs incurred by subjects treated with dutasteride and finasteride. Data sources include i3 Impact, IMS LifeLink, and MarketScan databases. The Ingenix Impact National Benchmark database (formerly IHCIS) is a comprehensive, de-identified US medical claims database that is generally representative of the insured US population <65 years old. It does not include Medicaid or Medicare information. The database contains inpatient/outpatient and pharmacy claims, lab results, and enrollment information on over 98 million lives from 1997 to 2010. The IMS LifeLink Health Plan Claims Database is a claims database that contains data from over 90 different managed healthcare plans, encompassing over 60 million lives. The database includes inpatient and outpatient diagnoses (in International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] format) and procedures (in Current Procedural Terminology [CPT-4] and Healthcare Common Procedure Coding System [HCPCS] formats), as well as standard and mail-order prescription records. Both paid and charged amounts are available for all services rendered, as well as dates of service for all claims. The MarketScan databases capture person-specific clinical utilization, expenditures, and enrollment data across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The MarketScan databases link paid claims and encounter data to detailed patient information across sites and types of providers, as well as over time. The data are HIPAA-compliant; thus, all patients have been anonymized. This study is a retrospective, observational cohort study.