Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database

NCT ID: NCT01376258

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28903 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2010-12-31

Brief Summary

Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (EP) and lower health care related costs.

The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and length of therapy and the likelihood of acute urinary retention (AUR), prostate-related surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and Medicare population. The null hypothesis is that no differences will be observed in the outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period of time will experience significantly fewer adverse outcomes and significantly lower treatment costs.

The data source for this analysis is the MarketScan database, which contains medical and pharmacy claims for commercial health plan members and Medicare recipients. Medical and pharmacy claims data are sourced directly from health plans and employers. The database represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid enrollees from multiple states. The database includes the Medicare-covered portion of payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary.

The study design is a retrospective cohort analysis. Each patient's index date was defined as the date of the first fill for a 5ARI prescription.

Conditions

Prostatic Hyperplasia

Study Design

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

Study Groups

Patients adherent to 5-alpha reductase inhibitor (5ARI)

Patients with benign prostate hyperplasia (BPH) who are adherent (as measured by a medication possession ratio (MPR)) based on 3 MPR threshold values of 70%, 75% and 80%

5ARI

Intervention Type: DRUG

dutasteride or finasteride

Patients who are non-adherent to 5ARI therapy

Patients with BPH who are not adherent to 5ARI therapy as measured by 3 MPR threshold values of 70%, 75%, and 80%

5ARI

Intervention Type: DRUG

dutasteride or finasteride

Interventions

5ARI

dutasteride or finasteride

Intervention Type: DRUG

Other Intervention Names

Proscar® (finasteride); Avodart® (dutasteride)

Eligibility Criteria

Inclusion Criteria

• Male
• Age 65 or older
• A diagnostic claim of BPH (ICD-9-CM code 222.2x or 600.xx)
• A prescription claim for a 5ARI for at least 60 days during the observation period
• Continuous eligibility for 6 months prior to and at least 91 days after the index date

Exclusion Criteria

• A prostate cancer diagnosis
• A procedure cost for any prostate-related surgical procedure prior to the index date

• Minimum Eligible Age: 65 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

113907

Identifier Type: -

Identifier Source: org_study_id