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Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332435
First received: April 7, 2011
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).


Condition Intervention
Prostatic Hyperplasia
 Drug: 5ARI + AB

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Resource links provided by NLM:

Drug Information available for: Dutasteride
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Clinical Progression [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.

  • Number of Participants With Acute Urinary Retention [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.

  • Number of Participants Who Needed Prostate-Related Surgery [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.


Secondary Outcome Measures:
  • Total BPH-related Costs [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

  • BPH-related Medical Costs [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

  • BPH-related Pharmacy Costs [ Time Frame: Day 1 of a 1-day study ] [ Designated as safety issue: No ]
    Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).


Enrollment: 6896
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Early 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
 Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Late 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (more than 30 days but less than 6 months after initiation of AB)
 Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study aims to identify eligible patient data between July 1, 2000, and December 31, 2006, and allows for patient data to be followed for 6 months prior to and up to 1 year following index prescription date.

Criteria

Inclusion Criteria:

  • Male patients aged 50 years or older
  • a medical claim of EP
  • a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)
  • continuously eligible for 6 months prior to and at least 12 months after index prescription date.

Exclusion Criteria:

  • diagnosis of prostate or bladder cancer
  • any prostate-related surgical procedure within 5 months of index date
  • prescription claim for finasteride indicative of male pattern baldness
  • 5ARI therapy initiated prior to initiating AB therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332435

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: NCT01332435     History of Changes
Other Study ID Numbers: 113984
Study First Received: April 7, 2011
Results First Received: April 14, 2011
Last Updated: August 4, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
 Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013