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临床试验/NCT01376258
NCT01376258已完成不适用

Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database

GlaxoSmithKline0 个研究点目标入组 28,903 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28,903
主要终点
Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery

研究概览

简要总结

Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (EP) and lower health care related costs.

The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and length of therapy and the likelihood of acute urinary retention (AUR), prostate-related surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and Medicare population. The null hypothesis is that no differences will be observed in the outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period of time will experience significantly fewer adverse outcomes and significantly lower treatment costs.

The data source for this analysis is the MarketScan database, which contains medical and pharmacy claims for commercial health plan members and Medicare recipients. Medical and pharmacy claims data are sourced directly from health plans and employers. The database represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid enrollees from multiple states. The database includes the Medicare-covered portion of payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary.

The study design is a retrospective cohort analysis. Each patient's index date was defined as the date of the first fill for a 5ARI prescription.

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
65 Years 至 —(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 65 or older
  • A diagnostic claim of BPH (ICD-9-CM code 222.2x or 600.xx)
  • A prescription claim for a 5ARI for at least 60 days during the observation period
  • Continuous eligibility for 6 months prior to and at least 91 days after the index date

排除标准

  • A prostate cancer diagnosis
  • A procedure cost for any prostate-related surgical procedure prior to the index date

研究组 & 干预措施

Patients adherent to 5-alpha reductase inhibitor (5ARI)

Patients with benign prostate hyperplasia (BPH) who are adherent (as measured by a medication possession ratio (MPR)) based on 3 MPR threshold values of 70%, 75% and 80%

干预措施: 5ARI (Drug)

Patients who are non-adherent to 5ARI therapy

Patients with BPH who are not adherent to 5ARI therapy as measured by 3 MPR threshold values of 70%, 75%, and 80%

干预措施: 5ARI (Drug)

结局指标

主要结局

Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery

时间窗: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)

AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP)

次要结局

  • Adjusted benign prostatic hyperplasia (BPH)-related costs(1 year following the first therapy date)
  • Medication Possession Ratio (MPR)(1 year following the first therapy date)

研究者

申办方类型
Industry
责任方
Sponsor

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