Clinical trial NCT01376258: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia
acute urinary retention
adherence
5-alpha reductase inhibitor
enlarged prostate
surgery
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 28903
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include retrospective data from male patients aged 65 years and older with continuous health plan enrollment from July 1, 2003 and June 30, 2009. Patient records will be reviewed for data from the 6-months prior to and 1-year following the index date, which represents the first prescription fill for a 5ARI

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.


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

Primary outcomes:
measure: Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery
timeFrame: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)
Secondary outcomes:
measure: Adjusted benign prostatic hyperplasia (BPH)-related costs
timeFrame: 1 year following the first therapy date
measure: Medication Possession Ratio (MPR)
timeFrame: 1 year following the first therapy date
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: