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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Age range

65 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5ARI

Drug

dutasteride or finasteride

Other names: Proscar® (finasteride), Avodart® (dutasteride)

Primary outcomes

  1. Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery

    Time frame: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)

    AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP)

Secondary outcomes

  1. Adjusted benign prostatic hyperplasia (BPH)-related costs

    Time frame: 1 year following the first therapy date

    Differences in cost will be compared across cohorts. BPH-related costs include those associated with ICD-9-CM codes 222.2x or 600.xx

  2. Medication Possession Ratio (MPR)

    Time frame: 1 year following the first therapy date

    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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2011
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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