Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381510
First received: June 23, 2011
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs.

The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters.

The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009.

This study is a retrospective cohort analysis of medical claims data.


Condition Intervention
Prostatic Hyperplasia
Drug: 5-alpha Reductase Inhibitor (5ARI)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery [ Time Frame: One year following the first date of 5ARI therapy ] [ Designated as safety issue: No ]
    The occurence of a code for either AUR or prostate surgery will be identified for patients who were adherent with 5ARI therapy as measured with a medication possession ratio (MPR)


Secondary Outcome Measures:
  • Mean costs associated with AUR or prostate surgery [ Time Frame: One year following the first date of 5ARI therapy ] [ Designated as safety issue: No ]
    The mean costs of outpatient and inpatient visits associated with the diagnosis code for AUR or the procedure codes for prostate surgery will be compared between patients who were compliant with 5ARI therapy and those who were not


Enrollment: 54459
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adherent BPH patients
Patients with benign prostatic hyperplasia (BPH) who are adherent to 5-alpha reductase inhibitor (5ARI) therapy based on a medication possession ratio (MPR). Analyses will be conducted with threshold adherence levels of 70%, 75% and 80%
Drug: 5-alpha Reductase Inhibitor (5ARI)
A 5ARI: Either dutasteride or finisteride
Other Names:
  • Proscar ® (finasteride)
  • Avodart ® (dutasteride)
Non-adherent BPH patients
Patients with BPH who are not adherent to 5ARI therapy based on an MPR and threshold levels of less than 70%, less than 75% and less than 80%
Drug: 5-alpha Reductase Inhibitor (5ARI)
A 5ARI: Either dutasteride or finisteride
Other Names:
  • Proscar ® (finasteride)
  • Avodart ® (dutasteride)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study is populated with claims data from male health plan members and Medicare patients age 50 and older who were continuously enrolled in a health plan that feeds into the MarketScan database between July 1, 2003 and May 1, 2009. Patient records were analyzed for 6 months prior to and at least 150 days following the index date for the first 5-alpha reductase inhibitor (5ARI) treatment

Criteria

Inclusion Criteria:

  • Male
  • Aged 50 years or older
  • A diagnostic claim of benign prostatic hyperplasia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 222.2x or 600.xx)
  • A prescription claim for a 5-alpha reductase inhibitor (5ARI) for at least 60 days during the observation period
  • Continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ARI prescription

Exclusion Criteria:

  • A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46)
  • A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51),
  • A procedure code for any prostate-related surgery prior to the index date or 150 days after the index date
  • A diagnosis code for acute urinary retention (AUR) prior to the index date or 150 days after 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: NCT01381510

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381510     History of Changes
Other Study ID Numbers: 113909
Study First Received: June 23, 2011
Last Updated: August 23, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Benign prostatic hyperplasia
Adherence
Acute urinary retention
Enlarged prostate
5-alpha reductase inhibitor
Surgery
Cost and cost analysis

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

ClinicalTrials.gov processed this record on August 28, 2014