About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Naldemedine
- Lubiprostone
- Naloxegol
Treatment groups
Sponsors and collaborators
BioDelivery Sciences International
Lead sponsor
HealthCore, Inc.
Collaborator