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

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: 5ARI; Drug: 5ARI + AB

• Study Type: Observational
• Enrollment (Actual): 332

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

This study will identify eligible patient data between April 1, 2000, and December 31, 2007, and allows for patient data to be followed for 3 months prior to and up to 1 year following index prescription date.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early 5ARI Initiation; 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; Dutasteride or Finasteride; Other Names: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck; Drug: 5ARI + AB; 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin; Other Names: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck; Hytrin® is a registered trademark of Abbott Laboratories; Flomax® is a registered trademark of Astellas Pharma; Cardura® is a registered trademark of Pfizer Inc; Uroxatral® is a registered trademark of Sanofi-Aventis
Late 5ARI Initiation; Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)	Drug: 5ARI; Dutasteride or Finasteride; Other Names: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck; Drug: 5ARI + AB; 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin; Other Names: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck; Hytrin® is a registered trademark of Abbott Laboratories; Flomax® is a registered trademark of Astellas Pharma; Cardura® is a registered trademark of Pfizer Inc; Uroxatral® is a registered trademark of Sanofi-Aventis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): July 1, 2011

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: benign prostatic hyperplasia; Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, acute urinary retention, surgery, early, costs
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride; Finasteride
• Other Study ID Numbers: 112599