Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
- Conditions
- Prostatic Hyperplasia
- Interventions
- Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapyDrug: Non-adherent to 5ARI therapy
- Registration Number
- NCT01334723
- Lead Sponsor
- GlaxoSmithKline
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 35032
- 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.
- prostate cancer
- any prostate-related surgical procedure prior to index date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute Urinary Retention Non-adherent to 5ARI therapy 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. Acute Urinary Retention Adherent with 5-alpha-reductase inhibitor (5ARI) therapy 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. Prostate Surgery Adherent with 5-alpha-reductase inhibitor (5ARI) therapy This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. Prostate Surgery Non-adherent to 5ARI therapy This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
- Primary Outcome Measures
Name Time Method Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% 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% 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% 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 = 80%.
- Secondary Outcome Measures
Name Time Method Mean Length of 5-ARI Therapy 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% 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% 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% 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 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).