Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy
NCT ID: NCT01435954
Last Updated: 2017-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13551 participants
OBSERVATIONAL
2010-08-31
2011-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with Benign Prostatic Hyperplasia (BPH)
Insured male patients age 50 or older with BPH but no evidence of acute urinary retention (AUR) or prostate surgery at the index date
Early combination therapy
If index drug was an alpha-blocker (AB) (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claims for a 5-alpha reductase inhibitor (5ARI) (dutasteride, finasteride) on or within 30 days after the index date or if index drug was 5ARI, fill for an AB on or within 30 days after the index date
Delayed combination therapy
If index drug was an AB (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claim for a 5ARI (dutasteride, finasteride) more than 30 days but less than or equal to 180 days of the index date
Interventions
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Early combination therapy
If index drug was an alpha-blocker (AB) (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claims for a 5-alpha reductase inhibitor (5ARI) (dutasteride, finasteride) on or within 30 days after the index date or if index drug was 5ARI, fill for an AB on or within 30 days after the index date
Delayed combination therapy
If index drug was an AB (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claim for a 5ARI (dutasteride, finasteride) more than 30 days but less than or equal to 180 days of the index date
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Other Identifiers
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113908
Identifier Type: -
Identifier Source: org_study_id
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