Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Naldemedine, Lubiprostone, Naloxegol.
- Who it may be relevant to
- Registry conditions: Opioid-induced Constipation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- Drug Naldemedine
0.2 mg tablet once a day at any time with or without food - Drug Lubiprostone
0.024 mg twice a day \[adjust dose based on liver function\] - Drug Naloxegol
25 mg tablet once a day in morning, 1 hour before or 2 hours after food
Primary outcome measures
- Number of Participants with a Major Adverse Cardiovascular Event [Time frame: 5 years]
Secondary outcome measures (3)
- Number of Participants with Cardiovascular Death [Time frame: 5 years]
- Number of Participants with Nonfatal Myocardial Infarction [Time frame: 5 years]
- Number of Participants with Nonfatal Stroke [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Research Site — Wilmington
Identifiers
NCT: NCT03720613 · 1711V9241