Skip to main content
OpenTrials
Completed

NCT Number: NCT01381510

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 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
  • 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

Treatment and study plan

5-alpha Reductase Inhibitor (5ARI)

Drug

A 5ARI: Either dutasteride or finisteride

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

Primary outcomes

  1. 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

    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 outcomes

  1. Mean costs associated with AUR or prostate surgery

    Time frame: One year following the first date of 5ARI therapy

    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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 27, 2011
Registry last updated
Aug 27, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.