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.
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
Study Type
OBSERVATIONAL
Enrollment
17,254
Non-interventional study of drug utilization
Research Site
Frankfurt am Main, Germany
Research Site
Oslo, Norway
Research Site
Mölndal, Sweden
Research Site
London, United Kingdom
discontinuation
Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period)
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Switching
Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Augmentation
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
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Restart
Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday)
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Continuous Use
Presence (yes/no) of a patient continuously treated with naloxegol during the study period
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Dose Change
Presence (yes/no) of a patient changing dosing of naloxegol
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
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