Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: Early combination therapy (Drug); Delayed combination therapy (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

In patients with benign prostatic hyperplasia (BPH), combination therapy with an alpha-blocker (AB) and a 5 alpha-reductase inhibitor (5ARI) has been shown to reduce the progression of acute urinary retention (AUR) and the incidence of prostate surgery, and also provides symptom relief. The objective of this study is to compare the likelihood of clinical progression (defined as AUR and/or prostate-related surgery) and costs in BPH patients who were treated with delayed combination therapy to BPH patients who were treated with early combination therapy using data from a United States (US) healthcare claims database. The hypothesis of this study is that patients who are prescribed combination therapy early in their BPH treatment will experience better clinical outcomes and lower healthcare costs compared with patients treated with delayed combination therapy. The null hypothesis is that no difference will be observed in outcomes or direct medical costs for patients treated with early combination therapy and patients treated with delayed combination therapy. The US healthcare claims database includes data from patients with Medicare Advantage as well as private health plan coverage including the Impact health plan. About 14 million people were covered by this set of health plans in 2007 and were geographically diverse across the US. Data from 2000 through 2009 were utilized. The study is a retrospective cohort analysis.

Official title: Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Number of participants with a code that indicates clinical progression

Secondary outcome: Mean BPH-related medical costs

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male

- Age 50 or older at the index date (the date of the first filled prescription for an

AB or 5ARI during the enrollment period)

- At least one claim with an ICD-9 diagnosis code for BPH (222. 2 or 600. xx) in any

position and at least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) or at least one fill for a 5ARI (dutasteride or finasteride) (with or without a diagnosis for BPH)

- Continuous enrollment with medical and pharmacy benefits for 6 months prior to the

index date (i. e., baseline period) and 12 months after the index date (follow-up period) Exclusion Criteria:

- At least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or

terazosin) any time during the pre-index period prior to the index date

- At least one fill for a 5ARI (dutasteride or finasteride) any time during the

pre-index period prior to the index date

- A diagnosis code for prostate cancer (ICD-9 = 185, 198. 82, 233. 4, 236. 5, 239. 5,

V10. 46) or bladder cancer (ICD-9 =188, 198. 1, 223. 3, 233. 7, 239. 4, V10. 51) in any position during the pre-index or follow-up period

- A pharmacy claim for finasteride 1 mg tablets (i. e., treatment of male-pattern

baldness) during the pre-index or follow-up period

- Prostate surgery anytime during the pre-index period or 5 months after the index date

Starting date: August 2010
Last updated: September 15, 2011