Opioid Induced Constipation
Conditions
Brief summary
This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.
Detailed description
The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) What are the treatment patterns of naloxegol utilization during follow-up? Primary objectives: 1. To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics). 2. To describe any of the following treatment patterns: * Discontinuation of naloxegol (permanently during the observation period) * Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC) * Prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed (augmentation) * Restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday) * Continuous treatment with naloxegol during the study period * Change in dosing Exploratory objective: 1\. To identify predictors of length of naloxegol use
Interventions
DRUGNaloxegol
Non-interventional study of drug utilization
Sponsors
Kyowa Kirin Pharmaceutical Development Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period. 2. The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date)
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| discontinuation | can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years | Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period) |
| Switching | can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years | Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC) |
| Augmentation | can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years | Presence (yes/no) of a patient augmenting therapy with a prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed |
| Restart | can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years | Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday) |
| Continuous Use | can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years | Presence (yes/no) of a patient continuously treated with naloxegol during the study period |
| Dose Change | can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years | Presence (yes/no) of a patient changing dosing of naloxegol |
Countries
Germany, Norway, Sweden, United Kingdom
Outcome results
None listed