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This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early 5ARI Initiation | Patients with EP receiving 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 (more than 30 days but less than 6 months after initiation of AB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5ARI + AB | Drug | 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Progression | Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes. | Day 1 of a 1-day study |
| Number of Participants With Acute Urinary Retention | Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. | Day 1 of a 1-day study |
| Number of Participants Who Needed Prostate-Related Surgery | Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. | Day 1 of a 1-day study |
| Measure | Description | Time Frame |
|---|---|---|
| Total BPH-related Costs | All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Day 1 of a 1-day study |
| BPH-related Medical Costs |
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Inclusion Criteria:
Exclusion Criteria:
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This study aims to identify eligible patient data between July 1, 2000, and December 31, 2006, and allows for patient data to be followed for 6 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 | IHCIS; Early 5ARI Initiation | Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]). |
| FG001 | IHCIS; Late 5ARI Initiation | Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| FG002 | PharMetrics; Early 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| FG003 | PharMetrics; Late 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IHCIS; Early 5ARI Initiation | Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes. | Enrolled Population: Men aged >=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy | Posted | Number | participants | Day 1 of a 1-day study |
|
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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 | IHCIS; Early 5ARI Initiation | Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]). |
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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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Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
| Day 1 of a 1-day study |
| BPH-related Pharmacy Costs | Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Day 1 of a 1-day study |
| BG001 | IHCIS; Late 5ARI Initiation | Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| BG002 | PharMetrics; Early 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| BG003 | PharMetrics; Late 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | IHCIS; Late 5ARI Initiation | Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| OG002 | PharMetrics; Early 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
| OG003 | PharMetrics; Late 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). |
|
|
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| Primary | Number of Participants With Acute Urinary Retention | Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. | Enrolled Population | Posted | Number | participants | Day 1 of a 1-day study |
|
|
|
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| Primary | Number of Participants Who Needed Prostate-Related Surgery | Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. | Enrolled Population | Posted | Number | participants | Day 1 of a 1-day study |
|
|
|
|
| Secondary | Total BPH-related Costs | All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Enrolled Population | Posted | Mean | Standard Deviation | United States dollars | Day 1 of a 1-day study |
|
|
|
|
| Secondary | BPH-related Medical Costs | Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Enrolled Population | Posted | Mean | Standard Deviation | United States dollars | Day 1 of a 1-day study |
|
|
|
|
| Secondary | BPH-related Pharmacy Costs | Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Enrolled Population | Posted | Mean | Standard Deviation | United States dollars | Day 1 of a 1-day study |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | IHCIS; Late 5ARI Initiation | Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). | 0 | 0 | 0 | 0 |
| EG002 | PharMetrics; Early 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). | 0 | 0 | 0 | 0 |
| EG003 | PharMetrics; Late 5ARI Initiation | Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). | 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 |
| 95 |
| Superiority or Other |
| 95 |
| Superiority or Other |
| 95 |
| Superiority or Other |
| 95 |
| Superiority or Other |