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

N/ARecruitingNCT03720613

BioDelivery Sciences International34,532 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

34,532

Conditions

Opioid-induced Constipation

Interventions

NaldemedineDRUG

0.2 mg tablet once a day at any time with or without food

LubiprostoneDRUG

0.024 mg twice a day \[adjust dose based on liver function\]

NaloxegolDRUG

25 mg tablet once a day in morning, 1 hour before or 2 hours after food

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Wilmington, Delaware, United States

RECRUITING

Outcomes

Primary Outcomes

Number of Participants with a Major Adverse Cardiovascular Event

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.

Time frame: 5 years

Secondary Outcomes

Number of Participants with Cardiovascular Death

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.

Time frame: 5 years

Number of Participants with Nonfatal Myocardial Infarction

Participants with nonfatal myocardial infarction will be identified using claims data.

Time frame: 5 years

Number of Participants with Nonfatal Stroke

Participants with nonfatal stroke will be identified using claims data.

Time frame: 5 years

Central Contacts

Todd Kunkel

CONTACT

913-940-1789 tkunkel@bdsi.com

Tom Smith

CONTACT

tsmith@bdsi.com

Data from ClinicalTrials.gov

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