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
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 April 17, 2014