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This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early 5ARI Initiation | Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB) |
| |
| Late 5ARI Initiation | Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5ARI | Drug | Dutasteride or Finasteride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Progression | Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery. | 3 months prior to and 12 months following index date |
| Measure | Description | Time Frame |
|---|---|---|
| Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month | EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample. |
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Inclusion Criteria:
Exclusion Criteria:
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This study will identify eligible patient data between April 1, 2000, and December 31, 2007, and allows for patient data to be followed for 3 months prior to and up to 1 year following index prescription date.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Cohort | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) |
| FG001 | Delayed Cohort | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Cohort | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Progression | Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery. | Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID. | Posted | Number | participants | 3 months prior to and 12 months following index date |
|
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This was a retrospective database study, and adverse event/serious adverse event information was not captured in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Cohort | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 5ARI + AB | Drug | 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin |
|
|
| 3 months prior to and 12 months following index date |
| Delayed Cohort |
Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Delayed Cohort | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) |
|
|
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| Secondary | Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month | EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample. | Enrolled Population | Posted | Mean | 95% Confidence Interval | dollars | 3 months prior to and 12 months following index date |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Delayed Cohort | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) | 0 | 0 | 0 | 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D052801 |
| Male Urogenital Diseases |