Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
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
BioDelivery Sciences International
34,532 participants
Jan 4, 2019
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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
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Interventions
0.2 mg tablet once a day at any time with or without food
0.024 mg twice a day \[adjust dose based on liver function\]
25 mg tablet once a day in morning, 1 hour before or 2 hours after food
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03720613