An observational study in Prostatic Hyperplasia, sponsored by GlaxoSmithKline. Completed. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by GlaxoSmithKline · Observational
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 54,459 is above the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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)
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
Also known as: Proscar ® (finasteride), Avodart ® (dutasteride)
The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery
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)
Time frame: One year following the first date of 5ARI therapy
Mean costs associated with AUR or prostate surgery
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
Time frame: One year following the first date of 5ARI therapy
No study locations are listed for this record.
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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