Clinical trial NCT03720613: Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid-induced Constipation
Keywords: naloxegol
major adverse cardiovascular event (MACE)
opioid induced constipation (OIC)
lubiprostone
naldemedine
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
Collaborators: name: HealthCore, Inc.
First posted: 2018-10-25
Enrollment: 34532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include new users of naldemedine or one of the comparator OIC medications (lubiprostone or naloxegol) who satisfy all of the inclusion criteria and none of the exclusion criteria.

Brief 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.

Detailed description: This is a prevalent new user cohort study conducted using multiple databases linkable to medical records and the National Death Index (NDI) to assess MACE risk among adult patients with chronic non-cancer pain receiving naldemedine or a comparator OIC medication. The uptake of naldemedine and comparator OIC medications will be monitored for each database annually until a sufficient number of patients to support the comparative analyses in the safety assessment phase is accrued. The safety assessment phase will commence at the conclusion of the monitoring phase.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with a Major Adverse Cardiovascular Event
timeFrame: 5 years
Secondary outcomes:
measure: Number of Participants with Cardiovascular Death
timeFrame: 5 years
measure: Number of Participants with Nonfatal Myocardial Infarction
timeFrame: 5 years
measure: Number of Participants with Nonfatal Stroke
timeFrame: 5 years
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Research Site
state: Delaware
Study officials:
affiliation: HealthCore, Inc.
name: Stephen Lanes
role: PRINCIPAL_INVESTIGATOR
References: