Clinical Trial: Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
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).
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- 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 ]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 ]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
Original Primary Outcome: To assess differences in the occurrence of AUR or prostate surgery between adherent and non-adherent patients. [ Time Frame: Patients will be followed for up to 1 year following the first date of 5ARI therapy for a medical encounter for AUR or prostate surgery (whichever occurs first). ]
Current Secondary Outcome:
- 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 ]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 ]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 ]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 ]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 ]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).
Original Secondary Outcome: To assess differences in BPH-related costs between adherent and non-adherent patients. [ Time Frame: Baseline ]
Information By: GlaxoSmithKline
Dates:
Date Received: April 7, 2011
Date Started: April 2010
Date Completion:
Last Updated: December 8, 2011
Last Verified: November 2011
- 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 ]
