An Observational Post-Authorisation Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated With Opioids Chronically
Overview
- Phase
- Not Applicable
- Intervention
- naloxegol
- Conditions
- Opioid Induced Constipation
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Presence (yes/no) of stroke
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity. This study is part of a broader post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in clinical practice.
Detailed Description
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in the indicated population, grouped by cancer or non-cancer, and within at-risk vulnerable non-cancer populations identified in the naloxegol risk management plan (RMP) by describing type and frequency of identified and potential risks (including bowel perforation, acute MI, stroke, CV-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity) in patients ≥18 years of age who were treated with opioids chronically and subsequently treated with naloxegol in routine post-authorization use. The primary objective of the study is to assess the incidence risk of bowel perforation, acute MI, stroke, all-cause mortality, and hypertension in patients treated with naloxegol (Naloxegol Inception Cohort, (NIC)), grouped by cancer or non cancer, a Concurrent Reference Cohort (CRC) by cancer or non-cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior CV, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of cytochrome P450 (CYP) 3A inhibitors/inducer or P-glycoprotein (Pgp) modulators. An exploratory objective of the study is to assess the incidence risk of CV-specific mortality, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity in patients treated with naloxegol (NIC) grouped by cancer and non cancer, a CRC grouped by cancer or non cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior cardiovascular risk, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of CYP3A inhibitors/inducer or Pgp modulators.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient receives a new prescription for naloxegol or a non-PAMORA laxative. (Note: Only non-PAMORA laxatives that are approved/marketed in the European Union at the time naloxegol is authorized are permitted.)
Exclusion Criteria
- •Patients \<18 years of age on cohort entry date
- •Patients with \<1 year of continuous data available prior to cohort entry date
- •Patients without exposure to current regular opioid use defined by \>30 days of opioid exposure within the 180 days prior to and inclusive of the cohort entry date
- •Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date
- •Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date
Arms & Interventions
naloxegol
patients exposed to naloxegol
Intervention: naloxegol
non-PAMORA laxative
patient exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative
Intervention: non-PAMORA laxative
Outcomes
Primary Outcomes
Presence (yes/no) of stroke
Time Frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic code for cerebral, cerebellar haemorrhage or infarction, cerebral embolism, stroke or cerebrovascular accident
Presence (yes/no) of bowel perforation
Time Frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic or procedure code
Presence (yes/no) of acute MI
Time Frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic code for acute MI, a diagnostic code for electrocardiogram supportive of MI or cardiac enzyme lab tests with positive results
Presence (yes/no) of all-cause mortality
Time Frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Record of death
Presence (yes/no) of hypertension
Time Frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a hypertension (HT) diagnostic code where no record of HT or treatment for HT was observed in the baseline, or a record of change in HT treatment type or dose from baseline was observed.
Secondary Outcomes
- Presence of (yes/no) opioid withdrawal(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) diarrhea(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) CV-specific mortality(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) abdominal pain(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) syncope(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)
- Presence of (yes/no) change in pain severity(Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years)