Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

Study Overview
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Brief Summary
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Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs. The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters. The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009. This study is a retrospective cohort analysis of medical claims data.

Official Title
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Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: 5-alpha Reductase Inhibitor (5ARI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Aged 50 years or older A diagnostic claim of benign prostatic hyperplasia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 222.2x or 600.xx) A prescription claim for a 5-alpha reductase inhibitor (5ARI) for at least 60 days during the observation period Continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ARI prescription Exclusion Criteria: A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46) A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51), A procedure code for any prostate-related surgery prior to the index date or 150 days after the index date A diagnosis code for acute urinary retention (AUR) prior to the index date or 150 days after the 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 |
| --- | --- |
| Adherent BPH patients<br>Patients with benign prostatic hyperplasia (BPH) who are adherent to 5-alpha reductase inhibitor (5ARI) therapy based on a medication possession ratio (MPR). Analyses will be conducted with threshold adherence levels of 70%, 75% and 80% | Drug: 5-alpha Reductase Inhibitor (5ARI)<br>* A 5ARI: Either dutasteride or finisteride<br>* Other names: Avodart ® (dutasteride);|
| Non-adherent BPH patients<br>Patients with BPH who are not adherent to 5ARI therapy based on an MPR and threshold levels of less than 70%, less than 75% and less than 80% | Drug: 5-alpha Reductase Inhibitor (5ARI)<br>* A 5ARI: Either dutasteride or finisteride<br>* Other names: Avodart ® (dutasteride);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery | The occurence of a code for either AUR or prostate surgery will be identified for patients who were adherent with 5ARI therapy as measured with a medication possession ratio (MPR) | One year following the first date of 5ARI therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean costs associated with AUR or prostate surgery | The mean costs of outpatient and inpatient visits associated with the diagnosis code for AUR or the procedure codes for prostate surgery will be compared between patients who were compliant with 5ARI therapy and those who were not | One year following the first date of 5ARI therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, Adherence, Acute urinary retention, Enlarged prostate, 5-alpha reductase inhibitor, Surgery, Cost and cost analysis