Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01386983
First received: February 28, 2011
Last updated: August 11, 2011
Last verified: July 2011
  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:
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Proscar® is a registered trademark of Merck
Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Other Names:
  • Proscar® is a registered trademark of Merck
  • Hytrin® is a registered trademark of Abbott Laboratories
  • Flomax® is a registered trademark of Astellas Pharma
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Cardura® is a registered trademark of Pfizer Inc
  • Uroxatral® is a registered trademark of Sanofi-Aventis
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:
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Proscar® is a registered trademark of Merck
Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Other Names:
  • Proscar® is a registered trademark of Merck
  • Hytrin® is a registered trademark of Abbott Laboratories
  • Flomax® is a registered trademark of Astellas Pharma
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Cardura® is a registered trademark of Pfizer Inc
  • Uroxatral® is a registered trademark of Sanofi-Aventis

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386983

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  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 July 29, 2014