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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    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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