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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Purpose
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 | Intervention |
|---|---|
|
Prostatic Hyperplasia |
Drug: 5ARI |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| 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 |
- 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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Enrollment: | 28903 |
| Study Start Date: | October 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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%
|
Drug: 5ARI
dutasteride or finasteride
Other Names:
|
|
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%
|
Drug: 5ARI
dutasteride or finasteride
Other Names:
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study will include retrospective data from male patients aged 65 years and older with continuous health plan enrollment from July 1, 2003 and June 30, 2009. Patient records will be reviewed for data from the 6-months prior to and 1-year following the index date, which represents the first prescription fill for a 5ARI
Inclusion Criteria:
- Male
- Age 65 or older
- A diagnostic claim of BPH (ICD-9-CM code 222.2x or 600.xx)
- A prescription claim for a 5ARI for at least 60 days during the observation period
- Continuous eligibility for 6 months prior to and at least 91 days after the index date
Exclusion Criteria:
- A prostate cancer diagnosis
- A procedure cost for any prostate-related surgical procedure prior to the index date
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01376258 History of Changes |
| Other Study ID Numbers: | 113907 |
| Study First Received: | June 16, 2011 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
benign prostatic hyperplasia acute urinary retention adherence |
5-alpha reductase inhibitor enlarged prostate surgery |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes Finasteride |
Dutasteride 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013