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
Overview
- Phase
- Not Applicable
- Intervention
- Naldemedine
- Conditions
- Opioid-induced Constipation
- Sponsor
- BioDelivery Sciences International
- Enrollment
- 34532
- Locations
- 1
- Primary Endpoint
- Number of Participants with a Major Adverse Cardiovascular Event
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Naldemedine
Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.
Intervention: Naldemedine
Lubiprostone
Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.
Intervention: Lubiprostone
Naloxegol
Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.
Intervention: Naloxegol
Outcomes
Primary Outcomes
Number of Participants with a Major Adverse Cardiovascular Event
Time Frame: 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.
Secondary Outcomes
- 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)