Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database
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|ClinicalTrials.gov Identifier: NCT01376258|
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (EP) and lower health care related costs.
The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and length of therapy and the likelihood of acute urinary retention (AUR), prostate-related surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and Medicare population. The null hypothesis is that no differences will be observed in the outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period of time will experience significantly fewer adverse outcomes and significantly lower treatment costs.
The data source for this analysis is the MarketScan database, which contains medical and pharmacy claims for commercial health plan members and Medicare recipients. Medical and pharmacy claims data are sourced directly from health plans and employers. The database represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid enrollees from multiple states. The database includes the Medicare-covered portion of payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary.
The study design is a retrospective cohort analysis. Each patient's index date was defined as the date of the first fill for a 5ARI prescription.
|Condition or disease||Intervention/treatment|
|Prostatic Hyperplasia||Drug: 5ARI|
|Study Type :||Observational|
|Actual Enrollment :||28903 participants|
|Official Title:||Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Patients adherent to 5-alpha reductase inhibitor (5ARI)
Patients with benign prostate hyperplasia (BPH) who are adherent (as measured by a medication possession ratio (MPR)) based on 3 MPR threshold values of 70%, 75% and 80%
dutasteride or finasteride
Patients who are non-adherent to 5ARI therapy
Patients with BPH who are not adherent to 5ARI therapy as measured by 3 MPR threshold values of 70%, 75%, and 80%
dutasteride or finasteride
- Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery [ Time Frame: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first) ]AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP)
- Adjusted benign prostatic hyperplasia (BPH)-related costs [ Time Frame: 1 year following the first therapy date ]Differences in cost will be compared across cohorts. BPH-related costs include those associated with ICD-9-CM codes 222.2x or 600.xx
- Medication Possession Ratio (MPR) [ Time Frame: 1 year following the first therapy date ]A measure of medication adherence (compliance and discontinuation) in patients taking monotherapy versus early combination therapy. Discontinuation is defined as a 30-day gap in therapy
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): NCT01376258
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|