Naloxegol Health Outcome Post Authorisation Safety Study
Lykilorð
Útdráttur
Lýsing
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.
Dagsetningar
| Síðast staðfest: | 08/31/2019 |
| Fyrst lagt fram: | 06/06/2016 |
| Áætluð skráning lögð fram: | 06/21/2016 |
| Fyrst sent: | 06/26/2016 |
| Síðasta uppfærsla lögð fram: | 09/18/2019 |
| Síðasta uppfærsla sett upp: | 09/22/2019 |
| Raunverulegur upphafsdagur náms: | 06/30/2016 |
| Áætlaður aðallokunardagur: | 11/30/2023 |
| Áætlaður dagsetningu rannsóknar: | 11/30/2023 |
Ástand eða sjúkdómur
Íhlutun / meðferð
Drug: naloxegol
Drug: non-PAMORA laxative
Stig
Armhópar
| Armur | Íhlutun / meðferð |
|---|---|
| naloxegol patients exposed to naloxegol | Drug: naloxegol non-interventional study where patients are exposed to naloxegol during normal clinical practice |
| non-PAMORA laxative patient exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative | Drug: non-PAMORA laxative non-interventional study where patients are exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative |
Hæfniskröfur
| Kyn sem eru hæf til náms | All |
| Sýnatökuaðferð | Non-Probability Sample |
| Tekur við heilbrigðum sjálfboðaliðum | Já |
| Viðmið | Inclusion Criteria: 1. 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: 1. Patients <18 years of age on cohort entry date 2. Patients with <1 year of continuous data available prior to cohort entry date 3. 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 4. Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date 5. Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date |
Útkoma
Aðal niðurstöður ráðstafanir
1. Presence (yes/no) of bowel perforation [can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years]
2. Presence (yes/no) of acute MI [can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years]
3. Presence (yes/no) of stroke [can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years]
4. Presence (yes/no) of all-cause mortality [can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years]
5. Presence (yes/no) of hypertension [can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years]
Aðrar útkomuaðgerðir
1. 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]
2. 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]
3. 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]
4. 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]
5. 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]
6. 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]
