Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,896
- 主要终点
- Number of Participants With Clinical Progression
研究概览
简要总结
This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).
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
- •Male patients aged 50 years or older
- •a medical claim of EP
- •a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)
- •continuously eligible for 6 months prior to and at least 12 months after index prescription date.
排除标准
- •diagnosis of prostate or bladder cancer
- •any prostate-related surgical procedure within 5 months of index date
- •prescription claim for finasteride indicative of male pattern baldness
- •5ARI therapy initiated prior to initiating AB therapy
研究组 & 干预措施
Early 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
干预措施: 5ARI + AB (Drug)
Late 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (more than 30 days but less than 6 months after initiation of AB)
干预措施: 5ARI + AB (Drug)
结局指标
主要结局
Number of Participants With Clinical Progression
时间窗: Day 1 of a 1-day study
Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.
Number of Participants With Acute Urinary Retention
时间窗: Day 1 of a 1-day study
Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Number of Participants Who Needed Prostate-Related Surgery
时间窗: Day 1 of a 1-day study
Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
次要结局
- Total BPH-related Costs(Day 1 of a 1-day study)
- BPH-related Medical Costs(Day 1 of a 1-day study)
- BPH-related Pharmacy Costs(Day 1 of a 1-day study)