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

Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376258
• Other study ID #: 113907
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: May 19, 2017
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28903
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• 5ARI
dutasteride or finasteride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery	AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP)	1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)
Secondary	Adjusted benign prostatic hyperplasia (BPH)-related costs	Differences in cost will be compared across cohorts. BPH-related costs include those associated with ICD-9-CM codes 222.2x or 600.xx	1 year following the first therapy date
Secondary	Medication Possession Ratio (MPR)	A measure of medication adherence (compliance and discontinuation) in patients taking monotherapy versus early combination therapy. Discontinuation is defined as a 30-day gap in therapy	1 year following the first therapy date