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This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early initiation of 5ARI therapy | Patients starting 5ARI therapy within 30 days of initiating AB therapy |
| |
| Delayed initiation of 5ARI therapy | Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5ARI + AB | Drug | 5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Progression of Disease | The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured. | Up to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients aged 50 years or older with a diagnostic claim for BPH; prescription claim for an AB and a 5ARI in the observation period
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Treatment | Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment |
| FG001 | Delayed Treatment | Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Treatment | Participants who started 5ARI therapy within 30 days of initiating AB treatment |
| BG001 | Delayed Treatment | Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment |
| 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, Continuous | Mean |
| 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 Who Experienced Progression of Disease | The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured. | Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP) | Posted | Number | participants | Up to 5 months |
|
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This was a survey of participants, 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 Treatment | Participants who started 5ARI therapy within 30 days of initiating AB treatment |
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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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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Mean Charlson Comorbidity Index Scores | The Charlson Comorbidity Index estimates 10-year mortality risk. Scores range from 0 - 37, with a lower score indicating a higher chance of survival. | Mean | Standard Deviation | scores on a scale |
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| Mean Benign Prostatic Hyperplasia (BPH) Disease Stage Scores | Disease staging for BPH was based on the International Classification of Diseases, 9th Revision (ICD-9), Clinical Modification codes. Scores: 0, BPH only; 1, BPH with urinary tract infection; 2, BPH with bladder outlet obstruction; 3, BPH with hydronephrosis; 4, BPH with renal failure; 5, BPH with sepsis; and 6, BPH with shock. | Mean | Standard Deviation | scores on a scale |
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| Secondary | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed. | Posted | Number | participants | 6 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Delayed Treatment | Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment | 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 |
| Within 1 month |
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| Within 2 months |
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| Within 3 months |
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| Within 4 months |
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| Within 5 months |
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| Within 6 months (182 days) |
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