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

BioDelivery Sciences International

Status: Enrolling

Conditions: Opioid-induced Constipation

Treatments: Drug: Naloxegol; Drug: Lubiprostone; Drug: Naldemedine

Study type: Observational

Funder types: Industry

Identifiers

NCT03720613

1711V9241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34,532 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

34,532 participants in 3 patient groups

Naldemedine

Description:

Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.

Treatment:

Drug: Naldemedine

Lubiprostone

Description:

Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.

Treatment:

Drug: Lubiprostone

Naloxegol

Description:

Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.

Treatment:

Drug: Naloxegol