Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Study Overview
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Brief Summary
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This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).

Official Title
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Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: 5ARI
* Drug: 5ARI + AB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged 50 years or older medical claim of EP prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date) continuously eligible for 3 months prior to and at least 5 months after their index prescription date. Exclusion Criteria: Patients with prostate or bladder cancer any prostate-related surgical procedure within 5 months of index date prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB

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 |
| --- | --- |
| Early 5ARI Initiation<br>Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB) | Drug: 5ARI<br>* Dutasteride or Finasteride<br>* Other names: Proscar® is a registered trademark of Merck;Drug: 5ARI + AB<br>* 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin<br>* Other names: Uroxatral® is a registered trademark of Sanofi-Aventis;|
| Late 5ARI Initiation<br>Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB) | Drug: 5ARI<br>* Dutasteride or Finasteride<br>* Other names: Proscar® is a registered trademark of Merck;Drug: 5ARI + AB<br>* 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin<br>* Other names: Uroxatral® is a registered trademark of Sanofi-Aventis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Progression | Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery. | 3 months prior to and 12 months following index date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month | EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample. | 3 months prior to and 12 months following index date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, acute urinary retention, surgery, early, costs, benign prostatic hyperplasia