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

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ClinicalTrials.gov Identifier: NCT01332435
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : July 22, 2011
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Prostatic Hyperplasia Drug: 5ARI + AB

Study Design
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Study Type : Observational
Actual Enrollment : 6896 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Clinical Progression [ Time Frame: Day 1 of a 1-day study ]
    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.

  2. Number of Participants With Acute Urinary Retention [ Time Frame: Day 1 of a 1-day study ]
    Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.

  3. Number of Participants Who Needed Prostate-Related Surgery [ Time Frame: Day 1 of a 1-day study ]
    Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.


Secondary Outcome Measures :
  1. Total BPH-related Costs [ Time Frame: Day 1 of a 1-day study ]
    All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

  2. BPH-related Medical Costs [ Time Frame: Day 1 of a 1-day study ]
    Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

  3. BPH-related Pharmacy Costs [ Time Frame: Day 1 of a 1-day study ]
    Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332435


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332435     History of Changes
Other Study ID Numbers: 113984
First Posted: April 11, 2011    Key Record Dates
Results First Posted: July 22, 2011
Last Update Posted: June 27, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
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Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs