Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01386983
First received: February 28, 2011
Last updated: August 11, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
| Condition | Intervention |
|---|---|
|
Prostatic Hyperplasia |
Drug: 5ARI Drug: 5ARI + AB |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of Participants With Clinical Progression [ Time Frame: 3 months prior to and 12 months following index date ] [ Designated as safety issue: No ]Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.
Secondary Outcome Measures:
- Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month [ Time Frame: 3 months prior to and 12 months following index date ] [ Designated as safety issue: No ]EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.
| Enrollment: | 332 |
| Study Start Date: | March 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Early 5ARI Initiation
Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
|
Drug: 5ARI
Dutasteride or Finasteride
Other Names:
Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Other Names:
|
|
Late 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)
|
Drug: 5ARI
Dutasteride or Finasteride
Other Names:
Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Other Names:
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
This study will identify eligible patient data between April 1, 2000, and December 31, 2007, and allows for patient data to be followed for 3 months prior to and up to 1 year following index prescription date.
Criteria
Inclusion Criteria:
- Males
- aged 50 years or older
- medical claim of EP
- prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
- continuously eligible for 3 months prior to and at least 5 months after their index prescription date.
Exclusion Criteria:
- Patients with prostate or bladder cancer
- any prostate-related surgical procedure within 5 months of index date
- prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01386983 History of Changes |
| Other Study ID Numbers: | 112599 |
| Study First Received: | February 28, 2011 |
| Results First Received: | February 28, 2011 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, acute urinary retention, surgery, early, costs benign prostatic hyperplasia |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013