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

Recruiting
18 years of age
Both
Phase N/A

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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.

Eligibility

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

Study details

Opioid-induced Constipation

NCT03720613

BioDelivery Sciences International

27 January 2024

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