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

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:

MedlinePlus related topics: Enlarged Prostate (BPH)

Drug Information available for: Dutasteride

U.S. FDA Resources

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 ]
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 ]
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 (Adult, Senior)
Sexes 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


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

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:


Hyperplasia Prostatic Hyperplasia Pathologic Processes Prostatic Diseases Genital Diseases, Male Dutasteride 5-alpha Reductase Inhibitors	Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2017