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

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy; Drug: Non-adherent to 5ARI therapy

• Study Type: Observational
• Enrollment (Actual): 35032

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck; 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: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck
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: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck; 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: Avodart® is a registered trademark of GlaxoSmithKline; Proscar® is a registered trademark of Merck

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%	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%.	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%	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%.	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%	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%.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Length of 5-ARI Therapy	In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery.	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%	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).	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%	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).	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%	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).	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	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).	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (ESTIMATE): April 13, 2011

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Benign prostatic hyperplasia, enlarged prostate, 5-alpha-reductase inhibitor, adherence, surgery, acute urinary retention
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Dutasteride; Finasteride; 5-alpha Reductase Inhibitors
• Other Study ID Numbers: 114482