Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain

Description

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.

Conditions

Opioid-induced Constipation

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Study Overview

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Study Details

Study 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.

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

Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain

Condition
Opioid-induced Constipation
Intervention / Treatment

-

Contacts and Locations

Wilmington

Research Site, Wilmington, Delaware, United States, 19801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioDelivery Sciences International,

Stephen Lanes, PRINCIPAL_INVESTIGATOR, HealthCore, Inc.

Study Record Dates

2030-11-01