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

Recruiting

• Conditions: Opioid-induced Constipation
• Interventions: Drug: Naldemedine; Drug: Lubiprostone; Drug: Naloxegol

• Registration Number: NCT03720613
• Lead Sponsor: BioDelivery Sciences International

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.

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-01-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2030-11-01
• Study Completion: 2030-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34532

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Naldemedine	Naldemedine	Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.
Lubiprostone	Lubiprostone	Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.
Naloxegol	Naloxegol	Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.

Primary Outcome Measures

Name	Time	Method
Number of Participants with a Major Adverse Cardiovascular Event	5 years	A composite of major adverse cardiovascular events, cardiovascular (CV) death, nonfatal myocardial infarction (MI), and non-fatal stroke; participants with major adverse cardiovascular events will be identified using claims data and the national death index.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Cardiovascular Death	5 years	Cardiovascular death is defined by the underlying cause of death and will include death from acute MI, sudden cardiac death, heart failure, stroke, cardiovascular procedure, cardiovascular hemorrhage, and other cardiovascular causes. Cardiovascular death will be identified using claims data and the national death index.
Number of Participants with Nonfatal Stroke	5 years	Participants with nonfatal stroke will be identified using claims data.
Number of Participants with Nonfatal Myocardial Infarction	5 years	Participants with nonfatal myocardial infarction will be identified using claims data.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Wilmington, Delaware, United States