Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01334723
First received: April 7, 2011
Last updated: December 8, 2011
Last verified: November 2011
  Purpose

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).


Condition Intervention
Prostatic Hyperplasia
Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy
Drug: Non-adherent to 5ARI therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% [ Time Frame: The 5 and a half year period from January 1, 2000 to June 30, 2006 ] [ Designated as safety issue: No ]
    Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.

  • Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.

  • Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.


Secondary Outcome Measures:
  • Mean Length of 5-ARI Therapy [ Time Frame: 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 ] [ Designated as safety issue: No ]
    In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery.

  • Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% [ Time Frame: 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 ] [ Designated as safety issue: No ]
    In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).

  • Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% [ Time Frame: 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 ] [ Designated as safety issue: No ]
    In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).

  • Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% [ Time Frame: 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 ] [ Designated as safety issue: No ]
    In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).

  • BPH-Related Costs for Every 30 Days of 5-ARI Therapy [ Time Frame: 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 ] [ Designated as safety issue: No ]
    In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).


Enrollment: 35032
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute Urinary Retention
This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy
Patient with BPH who are adherent to 5ARI therapy (Adherence will be calculated using a medication possession ratio (MPR); 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)
Other Names:
  • Proscar® is a registered trademark of Merck
  • Avodart® is a registered trademark of GlaxoSmithKline
Drug: Non-adherent to 5ARI therapy
Patients with BPH non-adherent to 5ARI therapy (Adherence will be calculated using a MPR; 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)
Other Names:
  • Proscar® is a registered trademark of Merck
  • Avodart® is a registered trademark of GlaxoSmithKline
Prostate Surgery
This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy
Patient with BPH who are adherent to 5ARI therapy (Adherence will be calculated using a medication possession ratio (MPR); 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)
Other Names:
  • Proscar® is a registered trademark of Merck
  • Avodart® is a registered trademark of GlaxoSmithKline
Drug: Non-adherent to 5ARI therapy
Patients with BPH non-adherent to 5ARI therapy (Adherence will be calculated using a MPR; 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)
Other Names:
  • Proscar® is a registered trademark of Merck
  • Avodart® is a registered trademark of GlaxoSmithKline

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334723

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: NCT01334723     History of Changes
Other Study ID Numbers: 114482
Study First Received: April 7, 2011
Results First Received: April 14, 2011
Last Updated: December 8, 2011
Health Authority: United States: No Health Authority

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

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 July 29, 2014