Prostatic Hyperplasia
Conditions
Keywords
Benign prostatic hyperplasia, enlarged prostate, 5-alpha-reductase inhibitor, adherence, surgery, acute urinary retention
Brief summary
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).
Interventions
DRUGAdherent with 5-alpha-reductase inhibitor (5ARI) therapy
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.)
DRUGNon-adherent to 5ARI therapy
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.)
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male * aged 50 years or older * a diagnostic claim of BPH * prescription claim for a 5ARI for at least 60 days during the observation period. * continuously eligible for 6 months prior to and at least 6 months after index date.
Exclusion criteria
* prostate cancer * any prostate-related surgical procedure prior to index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | The 5 and a half year period from January 1, 2000 to June 30, 2006 | 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%. |
| Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 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 | 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%. |
| Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 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 | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean BPH-Related Costs for Participants With an MPR >=80% Versus <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 | 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). |
| Mean Length of 5-ARI Therapy | 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 | In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery. |
| BPH-Related Costs for Every 30 Days of 5-ARI Therapy | 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 | 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). |
| Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% | 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 | 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). |
| Mean BPH-Related Costs for Participants With an MPR >=75% Versus <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 | 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). |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17,293 |
| Prostate Surgery Outcomes Cohort This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. | 17,739 |
| Total | 35,032 |
Baseline characteristics
| Characteristic | Acute Urinary Retention Outcomes Cohort | Prostate Surgery Outcomes Cohort | Total |
|---|---|---|---|
| Age, Customized Age < 50 | 0 participants | 0 participants | 0 participants |
| Age, Customized Age >= 50 | 17293 participants | 17739 participants | 35032 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17293 Participants | 17739 Participants | 35032 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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%.
Time frame: The 5 and a half year period from January 1, 2000 to June 30, 2006
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants with AUR and Surgery | 2140 participants |
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants without AUR and Surgery | 5511 participants |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants without AUR and Surgery | 8055 participants |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants with AUR and Surgery | 1587 participants |
| Prostate Surgery Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants with AUR and Surgery | 481 participants |
| Prostate Surgery Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants without AUR and Surgery | 6905 participants |
| Prostate Surgery Outocomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants with AUR and Surgery | 331 participants |
| Prostate Surgery Outocomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% | Number of Participants without AUR and Surgery | 10022 participants |
95% CI: [0.35, 0.412]
95% CI: [0.235, 0.368]
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%.
Time frame: 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
Population: Enrolled Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants with AUR and surgery | 2755 participants |
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants without AUR and surgery | 7658 participants |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants without AUR and surgery | 5603 participants |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants with AUR and surgery | 1277 participants |
| Prostate Surgery Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants with AUR and surgery | 627 participants |
| Prostate Surgery Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants without AUR and surgery | 10480 participants |
| Prostate Surgery Outocomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants with AUR and surgery | 185 participants |
| Prostate Surgery Outocomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% | Number of Participants without AUR and surgery | 6447 participants |
95% CI: [0.562, 0.668]
95% CI: [0.427, 0.689]
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%.
Time frame: 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
Population: Enrolled Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants with AUR and surgery | 2812 participants |
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants without AUR and surgery | 8975 participants |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants without AUR and surgery | 4591 participants |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants with AUR and surgery | 915 participants |
| Prostate Surgery Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants with AUR and surgery | 627 participants |
| Prostate Surgery Outcomes Cohort, MPR <=70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants without AUR and surgery | 11326 participants |
| Prostate Surgery Outocomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants with AUR and surgery | 185 participants |
| Prostate Surgery Outocomes Cohort, MPR >70% | Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% | Number of Participants without AUR and surgery | 5601 participants |
95% CI: [0.472, 0.57]
95% CI: [0.333, 0.57]
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).
Time frame: 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
Population: Enrolled Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | BPH-Related Costs for Every 30 Days of 5-ARI Therapy | 28.08 United States dollars per month | Standard Deviation 145.4 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | BPH-Related Costs for Every 30 Days of 5-ARI Therapy | 29.89 United States dollars per month | Standard Deviation 156.22 |
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).
Time frame: 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
Population: Enrolled Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% | MPR >=70% | 23.56 United States dollars per month | Standard Deviation 10.45 |
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% | MPR <70% | 35.25 United States dollars per month | Standard Deviation 15.64 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% | MPR >=70% | 24.40 United States dollars per month | Standard Deviation 10.64 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% | MPR <70% | 38.59 United States dollars per month | Standard Deviation 16.83 |
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).
Time frame: 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
Population: Enrolled Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% | MPR >=75% | 27.12 United States dollars per month | Standard Deviation 12.05 |
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% | MPR <75% | 29.64 United States dollars per month | Standard Deviation 13.17 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% | MPR >=75% | 27.14 United States dollars per month | Standard Deviation 12.11 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% | MPR <75% | 32.37 United States dollars per month | Standard Deviation 14.44 |
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).
Time frame: 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
Population: Enrolled Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% | MPR >=80% | 24.24 United States dollars per month | Standard Deviation 10.8 |
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% | MPR <80% | 30.83 United States dollars per month | Standard Deviation 13.73 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% | MPR >=80% | 23.02 United States dollars per month | Standard Deviation 10.19 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% | MPR <80% | 33.95 United States dollars per month | Standard Deviation 15.03 |
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.
Time frame: 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
Population: Enrolled Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Urinary Retention Outcomes Cohort, MPR <=70% | Mean Length of 5-ARI Therapy | 276.8 days | Standard Deviation 89.1 |
| Acute Urinary Retention Outcomes Cohort, MPR >70% | Mean Length of 5-ARI Therapy | 289.5 days | Standard Deviation 85.1 |