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

RECRUITINGSponsored by BioDelivery Sciences International
Actively Recruiting
SponsorBioDelivery Sciences International
Started2019-01-04
Est. completion2030-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerOpioid-induced Constipation

Locations1 site

Research Site
Wilmington, Delaware, 19801

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