Last updated: 11/07/2018 07:47:37

Demonstrating the clinical and economic benefit of 5 Alpha Reductase Inhibitor adherence in Benign Prostatic Hyperplasia

GSK study ID
114482
See study documents
Clinicaltrials.gov ID
NCT01334723
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Demonstrating the clinical and economic benefit of 5 Alpha Reductase Inhibitor adherence in Benign Prostatic Hyperplasia
Trial description: This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants with Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%

Timeframe: The 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants with Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants with Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Secondary outcomes:

Mean Length of 5-ARI Therapy

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Mean BPH-Related Costs for participants with an MPR >=70% versus <70%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Mean BPH-Related Costs for participants with an MPR >=75% versus <75%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Mean BPH-Related Costs for participants with an MPR >=80% versus <80%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

BPH-Related Costs for Every 30 Days of 5-ARI Therapy

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Interventions:
  • Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy
  • Drug: Non-adherent to 5ARI therapy
    • Enrollment:
    35032
    Primary completion date:
    2010-28-04
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Gruschkus S, Poston S, Eaddy M, Chaudhari S. Copy of 114482 PM US2526 Adherence to 5ARI Therapy in the Treatment of Benign Prostatic Hyperplasia: Does Adherence Matter From a Clinical and Economic Perspective?. [P & T Pharm and Ther]. 2012;37(8):464-477.
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to April 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Male
    • aged 50 years or older
    • prostate cancer
    • any prostate-related surgical procedure prior to index date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male
    • aged 50 years or older
    • a diagnostic claim of BPH
    • prescription claim for a 5ARI for at least 60 days during the observation period.
    • continuously eligible for 6 months prior to and at least 6 months after index date.
    Exclusion criteria:
    • prostate cancer
    • any prostate-related surgical procedure prior to index date -

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-28-04
    Actual study completion date
    2010-28-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website