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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

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ClinicalTrials.gov Identifier: NCT01332487
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : February 29, 2012
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Study Type : Observational
Actual Enrollment : 4068 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Participants Who Experienced Progression of Disease [ Time Frame: Up to 5 months ]
    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 :
  1. Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery [ Time Frame: 6 months ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

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): NCT01332487


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332487     History of Changes
Other Study ID Numbers: 114461
First Posted: April 11, 2011    Key Record Dates
Results First Posted: February 29, 2012
Last Update Posted: June 19, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
5-alpha-reductase inhibitor
prostate surgery
alpha-blocker
enlarged prostate
acute urinary retention
Benign prostatic hyperplasia

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
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