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This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Urinary Retention | This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome. |
| |
| Prostate Surgery | This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherent with 5-alpha-reductase inhibitor (5ARI) therapy | Drug | Patient with BPH who are adherent to 5ARI therapy (Adherence will be calculated using a medication possession ratio (MPR); 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%. | The 5 and a half year period from January 1, 2000 to June 30, 2006 |
| Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%. | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
| Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%. | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Length of 5-ARI Therapy | In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery. | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients aged 50 years or older with a diagnostic claim of BPH and prescription claim for a 5ARI for at least 60 days during the observation period. Patients will be required to be continuously eligible for 6 months prior to and at least 6 months after index date.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
The study utilized retrospective claims data from the Integrated Healthcare HealthCare Information Services, Inc. (IHCIS) database, a nationally representative managed care database that represents over 30 healthplans and more than 25 million lives.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Urinary Retention Outcomes Cohort | This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome. |
| FG001 | Prostate Surgery Outcomes Cohort | This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Urinary Retention Outcomes Cohort | This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome. |
| BG001 | Prostate Surgery Outcomes Cohort |
| 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 Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%. | Enrolled Population: participants in the IHCIS database with a diagnosis of benign prostate hyperplasia or enlarged prostate as indicated by ICD-9-CM code on claims (222.2x or 600.xx). Participants were included if they had at least 60 days of 5-ARI therapy during the enrollment period, 6 months of continuous enrollment, and no prior surgery. | Posted | Number | participants | The 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
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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 | Acute Urinary Retention Outcomes Cohort | This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome. |
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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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| ID | Term |
|---|---|
| D058891 | 5-alpha Reductase Inhibitors |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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|
| Non-adherent to 5ARI therapy | Drug | Patients with BPH non-adherent to 5ARI therapy (Adherence will be calculated using a MPR; 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.) |
|
|
| Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% | In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
| Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% | In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
| Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% | In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
| BPH-Related Costs for Every 30 Days of 5-ARI Therapy | In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Acute Urinary Retention Outcomes Cohort, MPR <=70% | Participants in the acute urinary retention outcomes cohort with an MPR <=70% |
| OG001 | Acute Urinary Retention Outcomes Cohort, MPR >70% | Participants in the acute urinary retention outcomes cohort with an MPR >70% |
| OG002 | Prostate Surgery Outcomes Cohort, MPR <=70% | Participants in the prostate surgery outcomes cohort with an MPR <=70% |
| OG003 | Prostate Surgery Outocomes Cohort, MPR >70% | Participants in the prostate surgery outcomes cohort with an MPR >70% |
|
|
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| Primary | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%. | Enrolled Population | Posted | Number | participants | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
|
|
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| Primary | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%. | Enrolled Population | Posted | Number | participants | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
|
|
|
| Secondary | Mean Length of 5-ARI Therapy | In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery. | Enrolled Population | Posted | Mean | Standard Deviation | days | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
|
|
| Secondary | Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% | In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Enrolled Population | Posted | Mean | Standard Deviation | United States dollars per month | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
|
|
| Secondary | Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% | In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Enrolled Population | Posted | Mean | Standard Deviation | United States dollars per month | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
|
|
| Secondary | Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% | In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Enrolled Population | Posted | Mean | Standard Deviation | United States dollars per month | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
|
|
| Secondary | BPH-Related Costs for Every 30 Days of 5-ARI Therapy | In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx). | Enrolled Population | Posted | Mean | Standard Deviation | United States dollars per month | Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Prostate Surgery Outcomes Cohort | This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. | 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 |
| D020164 | Chemical Actions and Uses |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| Number of Participants without AUR and surgery |
|
| Hazard Ratio (HR) |
| 0.542 |
| 95 |
| 0.427 |
| 0.689 |
A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery. |
| Superiority or Other |
| Number of Participants without AUR and surgery |
|
| Hazard Ratio (HR) |
| 0.436 |
| 95 |
| 0.333 |
| 0.570 |
A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery. |
| Superiority or Other |