Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications Used for Opioid Induced Constipation in Adult Patients With Chronic Non-Cancer Pain in a Healthcare Claims Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34,532
- 试验地点
- 1
- 主要终点
- Number of Participants with a Major Adverse Cardiovascular Event
研究概览
简要总结
The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.
详细描述
This is a prevalent new user cohort study conducted using multiple databases linkable to medical records and the National Death Index (NDI) to assess MACE risk among adult patients with chronic non-cancer pain receiving naldemedine or a comparator OIC medication. The uptake of naldemedine and comparator OIC medications will be monitored for each database annually until a sufficient number of patients to support the comparative analyses in the safety assessment phase is accrued. The safety assessment phase will commence at the conclusion of the monitoring phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one dispensing of naldemedine or lubiprostone or naloxegol without prior use in the database of either medication (index date)
- •At least two dispensings of opioids within six months prior to and including the index date, with at least a combined 31 cumulative days supply
- •At least 18 years of age or older on the index date
- •At least six months of continuous health plan coverage that includes medical and pharmacy benefits prior to and including the index date
排除标准
- •Any acute MACE (non-fatal MI or non-fatal stroke) within six months before or on the index date
- •Any cancer treatment or cancer pain diagnosis within six months before or on the index date
- •Prior use of methylnaltrexone, alvimopan or naloxegol within six months before or on the index date
研究组 & 干预措施
Naldemedine
Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.
干预措施: Naldemedine (Drug)
Lubiprostone
Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.
干预措施: Lubiprostone (Drug)
Naloxegol
Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.
干预措施: Naloxegol (Drug)
结局指标
主要结局
Number of Participants with a Major Adverse Cardiovascular Event
时间窗: 5 years
A composite of major adverse cardiovascular events, cardiovascular (CV) death, nonfatal myocardial infarction (MI), and non-fatal stroke; participants with major adverse cardiovascular events will be identified using claims data and the national death index.
次要结局
- Number of Participants with Cardiovascular Death(5 years)
- Number of Participants with Nonfatal Stroke(5 years)
- Number of Participants with Nonfatal Myocardial Infarction(5 years)