Assessing cardiovascular risks of naldemedine and other medications for opioid-induced constipation
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
This study is testing whether using naldemedine for opioid-induced constipation has different heart risks compared to other medications like lubiprostone and naloxegol.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 34532 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BioDelivery Sciences International Industry-sponsored |
| Locations | 1 site (Wilmington, Delaware) |
| Trial ID | NCT03720613 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the risk of major adverse cardiovascular events (MACE) among new users of naldemedine compared to users of lubiprostone and naloxegol, which are also used for opioid-induced constipation (OIC). The study will utilize multiple databases linked to medical records and the National Death Index to monitor the uptake of these medications and assess safety outcomes. The monitoring phase will continue until a sufficient number of patients is accrued for comparative analyses in the safety assessment phase.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic non-cancer pain who are new users of naldemedine, lubiprostone, or naloxegol.
Not a fit: Patients with a history of major adverse cardiovascular events or cancer treatment within the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the cardiovascular safety of naldemedine compared to other OIC treatments, potentially guiding safer medication choices for patients.
How similar studies have performed: While this study focuses on a specific comparison of medications, similar observational studies have previously assessed cardiovascular risks associated with various treatments, indicating a potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wilmington, Delaware
- Research Site — Wilmington, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Lanes — HealthCore, Inc.
- Study coordinator: Todd Kunkel
- Email: tkunkel@bdsi.com
- Phone: 913-940-1789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.