Clinical trial NCT01334723: Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
Official title: Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia, enlarged prostate, 5-alpha-reductase inhibitor, adherence, surgery, acute urinary retention
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 35032
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients aged 50 years or older with a diagnostic claim of BPH and prescription claim for a 5ARI for at least 60 days during the observation period. Patients will be required to be continuously eligible for 6 months prior to and at least 6 months after index date.

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: 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
measure: 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
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: