Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 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 clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
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
- •medical claim of EP
- •prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
- •continuously eligible for 3 months prior to and at least 5 months after their index prescription date.
排除标准
- •Patients with prostate or bladder cancer
- •any prostate-related surgical procedure within 5 months of index date
- •prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB
研究组 & 干预措施
Early 5ARI Initiation
Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
干预措施: 5ARI (Drug)
Early 5ARI Initiation
Patients with EP receiving either 5ARI monotherapy or 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 (within 31 to 180 days after initiation of AB)
干预措施: 5ARI (Drug)
Late 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days 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: 3 months prior to and 12 months following index date
Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.
次要结局
- Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month(3 months prior to and 12 months following index date)