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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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Naldemedine (drug)
• Lubiprostone (drug)
• Naloxegol (drug)

Sponsor: BioDelivery Sciences International · Participants: 34,532 · Started: Jan 4, 2019

Contact the study team

• Todd Kunkel · Phone: 913-940-1789

Official record on ClinicalTrials.gov — NCT03720613

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.