Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database
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ClinicalTrials.gov Identifier: NCT01381510 |
Recruitment Status
:
Completed
First Posted
: June 27, 2011
Last Update Posted
: August 27, 2012
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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 or disease | Intervention/treatment |
---|---|
Prostatic Hyperplasia | Drug: 5-alpha Reductase Inhibitor (5ARI) |
Study Type : | Observational |
Actual Enrollment : | 54459 participants |
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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Group/Cohort | Intervention/treatment |
---|---|
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%
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Drug: 5-alpha Reductase Inhibitor (5ARI)
A 5ARI: Either dutasteride or finisteride
Other Names:
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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:
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- 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)
- 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

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381510
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01381510 History of Changes |
Other Study ID Numbers: |
113909 |
First Posted: | June 27, 2011 Key Record Dates |
Last Update Posted: | August 27, 2012 |
Last Verified: | August 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 |