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Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332487
First received: April 7, 2011
Last updated: February 16, 2012
Last verified: September 2011
History of Changes
  Purpose

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).


Condition Intervention
Prostatic Hyperplasia
 Drug: 5ARI + AB

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants Who Experienced Progression of Disease [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
    The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.


Secondary Outcome Measures:
  • Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 4068
Study Start Date: August 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Early initiation of 5ARI therapy
Patients starting 5ARI therapy within 30 days of initiating AB therapy
 Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Delayed initiation of 5ARI therapy
Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy
 Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, 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

Male patients aged 50 years or older with a diagnostic claim for BPH; prescription claim for an AB and a 5ARI in the observation period

Criteria

Inclusion Criteria:

  • Male
  • aged 50 years or older
  • diagnostic claim for BPH
  • prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
  • continuously eligible for 6 months prior to and 12 months after index prescription date

Exclusion Criteria:

  • prostate or bladder cancer during the study period
  • any prostate-related surgical procedure within 5 months of the index prescription date
  • prescription claim for finasteride 1 mg for male pattern baldness during the study period
  • 5ARI therapy prior to initiation of AB therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332487

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: NCT01332487     History of Changes
Other Study ID Numbers: 114461
Study First Received: April 7, 2011
Results First Received: February 16, 2012
Last Updated: February 16, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
5-alpha-reductase inhibitor
prostate surgery
alpha-blocker
 enlarged prostate
acute urinary retention
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 16, 2013