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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376258
First received: June 16, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Prostatic Hyperplasia
Drug: 5ARI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP)


Secondary Outcome Measures:
  • Adjusted benign prostatic hyperplasia (BPH)-related costs [ Time Frame: 1 year following the first therapy date ] [ Designated as safety issue: No ]
    Differences in cost will be compared across cohorts. BPH-related costs include those associated with ICD-9-CM codes 222.2x or 600.xx

  • Medication Possession Ratio (MPR) [ Time Frame: 1 year following the first therapy date ] [ Designated as safety issue: No ]
    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


Enrollment: 28903
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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%
Drug: 5ARI
dutasteride or finasteride
Other Names:
  • Proscar® (finasteride)
  • Avodart® (dutasteride)
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%
Drug: 5ARI
dutasteride or finasteride
Other Names:
  • Proscar® (finasteride)
  • Avodart® (dutasteride)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376258

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01376258     History of Changes
Other Study ID Numbers: 113907
Study First Received: June 16, 2011
Last Updated: June 16, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
benign prostatic hyperplasia
acute urinary retention
adherence
5-alpha reductase inhibitor
enlarged prostate
surgery

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Finasteride
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014