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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: 5-alpha Reductase Inhibitor (5ARI)

• Study Type: Observational
• Enrollment (Actual): 54459

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

The study is populated with claims data from male health plan members and Medicare patients age 50 and older who were continuously enrolled in a health plan that feeds into the MarketScan database between July 1, 2003 and May 1, 2009. Patient records were analyzed for 6 months prior to and at least 150 days following the index date for the first 5-alpha reductase inhibitor (5ARI) treatment

Description

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

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
Adherent BPH patients; 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); A 5ARI: Either dutasteride or finisteride; Other Names: Proscar ® (finasteride); Avodart ® (dutasteride)
Non-adherent BPH patients; 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); A 5ARI: Either dutasteride or finisteride; Other Names: Proscar ® (finasteride); Avodart ® (dutasteride)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): August 27, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Adherence; Surgery; Benign prostatic hyperplasia; Enlarged prostate; 5-alpha reductase inhibitor; Acute urinary retention; Cost and cost analysis
• 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; Dutasteride; Finasteride; 5-alpha Reductase Inhibitors
• Other Study ID Numbers: 113909