Last updated: 11/07/2018 07:02:14

Clinical progression and costs in benign prostatic hyperplasia patients treated with early versus delayed combination therapy

GSK study ID
113908
See study documents
Clinicaltrials.gov ID
NCT01435954
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical progression and costs in benign prostatic hyperplasia patients treated with early versus delayed combination therapy
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with a code that indicates clinical progression

Timeframe: Data collected over a 9-year time period from 2000 to 2009.

Secondary outcomes:

Mean BPH-related medical costs

Timeframe: Data collected over a 9-year time period from 2000 to 2009

Interventions:
Drug: Early combination therapy
Drug: Delayed combination therapy
Enrollment:
13551
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Michael T. Eaddy, Bridgett Goodwin, Gabriel Gomez Rey, Robert Morlock. A Retrospective Analysis Comparing Clinical Progression, Acute Urinary Retention, Prostate-related Surgeries, and Costs in Patients with Benign Prostatic Hyperplasia Taking Early versus Delayed Combination 5<alpha>-reductase Inhibitor Therapy and <alpha>-blocker Therapy. Clin Ther.
Medical condition
Benign Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
August 2010 to April 2011
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Male
Age
50+ years
Accepts healthy volunteers
No
  • 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 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
Inclusion and exclusion 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

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-25-04

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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