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

NCT01381510 COMPLETED

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.

Details

Lead sponsor	GlaxoSmithKline
Status	COMPLETED
Enrolment	54459
Start date	2010-06
Completion	2010-08

Conditions

• Prostatic Hyperplasia

Interventions

• 5-alpha Reductase Inhibitor (5ARI)

Primary outcomes

• The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery — 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)