Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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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).

Official Title
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Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy
* Drug: Non-adherent to 5ARI therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Urinary Retention<br>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. | Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy<br>* 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.)<br>* Other names: Avodart® is a registered trademark of GlaxoSmithKline;Drug: Non-adherent to 5ARI therapy<br>* 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.)<br>* Other names: Avodart® is a registered trademark of GlaxoSmithKline;|
| Prostate Surgery<br>This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. | Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy<br>* 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.)<br>* Other names: Avodart® is a registered trademark of GlaxoSmithKline;Drug: Non-adherent to 5ARI therapy<br>* 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.)<br>* Other names: Avodart® is a registered trademark of GlaxoSmithKline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, enlarged prostate, 5-alpha-reductase inhibitor, adherence, surgery, acute urinary retention