Opioids are a type of drug that are primarily used to relieve pain. However, opioids can also cause significant side effects. One common side effect is opioid induced constipation (OIC). OIC is often not adequately controlled by using traditional laxatives and to counter OIC some patients may stop or reduce their opioid use. This therefore risks exposing the patient to uncontrolled pain which may lead to increased healthcare contacts. Naldemedine is a newly available drug that has been shown to help improve control of OIC in patients taking opioids. In this study we wish to select patients with a prescription for naldemedine in the Clinical Practice Research Datalink, and to describe the characteristics of these patients such as their age and gender, what medical conditions they have and how many times they access general practitioner and hospital services before and after starting naldemedine. This study will provide valuable information about the impact of naldemedine on NHS services which may help reduce overall healthcare burden in the National Health Service.
Opioid-induced constipation (OIC) is a common adverse event of opioid analgesia. Naldemedine is one of a new class of peripherally-acting mu-opioid receptor antagonists (PAMORAs) which have shown proven efficacy in the treatment of OIC. In this study we wish to describe the demographic and clinical profile of patients initiating naldemedine and to compare healthcare resource use and associated costs before and after naldemedine initiation. Patients of acceptable research quality will a prescription for naldemedine will be selected from the CPRD GOLD and Aurum databases. For those patients that can be linked, we will request HES admitted patient care, outpatient and accident and emergency datasets to provide additional baseline clinical data and to allow the resource use analyses. Date of first prescription will define index date. Discrete naldemedine regimens will be identified by overlapping sequences of prescriptions. Episodes will be characterized by duration of therapy and medical possession ratio, calculated as the total distinct days’ supply prescribed over the course of the naldemedine episode divided by the duration of that episode from initiation to end of exposure. Baseline characteristics at index date will be provided and primary and secondary care resource use and associated costs presented prior and subsequent to index date. This study will provide important data on the early users of naldemedine and their impact on NHS service provision for the treatment of OIC.
Patient characteristics; Comorbidities; Healthcare resource use; Healthcare costs;
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Andrew Cooper - Collaborator - Shionogi BV
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
peter conway - Collaborator - Shionogi BV
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation