Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBioDelivery Sciences International

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

34,532 Participants
are divided into 3 treatment groups

Sponsors and collaborators