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

NCT ID: NCT01381510

Last Updated: 2012-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54459 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-08-31

Brief Summary

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.

Conditions

Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia; Adherence; Acute urinary retention; Enlarged prostate; 5-alpha reductase inhibitor; Surgery; Cost and cost analysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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%

5-alpha Reductase Inhibitor (5ARI)

Intervention Type: DRUG

A 5ARI: Either dutasteride or finisteride

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%

5-alpha Reductase Inhibitor (5ARI)

Intervention Type: DRUG

A 5ARI: Either dutasteride or finisteride

Interventions

5-alpha Reductase Inhibitor (5ARI)

A 5ARI: Either dutasteride or finisteride

Intervention Type: DRUG

Other Intervention Names

Proscar ® (finasteride); Avodart ® (dutasteride)

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

113909

Identifier Type: -

Identifier Source: org_study_id