Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35,032
- 主要终点
- Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •prostate cancer
- •any prostate-related surgical procedure prior to index date
研究组 & 干预措施
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.
干预措施: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy (Drug)
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.
干预措施: Non-adherent to 5ARI therapy (Drug)
Prostate Surgery
This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
干预措施: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy (Drug)
Prostate Surgery
This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
干预措施: Non-adherent to 5ARI therapy (Drug)
结局指标
主要结局
Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%
时间窗: 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%
时间窗: 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%
时间窗: 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%.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)