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Use of low dose naltrexone and change in use of prescription drugs in patients with inflammatory bowel disease – A drug utilization cohort study based on the Norwegian prescription register

Title
Use of low dose naltrexone and change in use of prescription drugs in patients with inflammatory bowel disease – A drug utilization cohort study based on the Norwegian prescription register
Publication Type
Journal Article
Research Type
Human
Reported as
Case Report/Series/Restrospective Study
Date
June 01, 2017
Authors
Pia Simonsen, Lars Småbrekke, Guttorm Raknes
Institution
The Arctic University of Norway; University Hospital of North Norway; Uni Research Health;
Link
Abstract

INTRODUCTION: Naltrexone is a non-selective opioid antagonist traditionally used to treat opioid and alcohol addiction. Low Dose Naltrexone (LDN), 3-5 mg/day, has gained popularity as an off-label adjunctive therapy for several autoimmune diseases, including inflammatory bowel disease (IBD). Studies have shown improved quality of life, reduced area of inflamed intestine, reduced C-reactive protein and lower Crohn’s Disease Activity Index.

OBJECTIVES: The aim of this study was to investigate whether there is an association between the use of LDN and change in use of other prescription drugs in patients with IBD.

METHODS: We obtained data on dispensed drugs (762 patients, 34 417 prescriptions) from the Norwegian Prescription Register. All patients received at least one LDN prescription in 2013, and the first prescription was used as index date. We captured retrieval of all other prescription drugs two years before and two years after (observation period) the index date. Selected drugs were collated in ATC-groups chosen based on Norwegian Guidelines for treatment of IBD and clinical relevance. The number of Defined Daily Doses (DDD) for each group were summarized per week, and the weekly number of DDDs during the observation period were analysed using interrupted time series.

RESULTS: We analysed 20 ATC-groups. Weak opioids showed a statistical significant drop in number of DDD per week after index date (p < 0,001), but increased to the same level as before index date at the end of the observation period. We found a lesser immediate drop for strong opioids, but an increase in consumption during the observation period resulted in a net increase compared to the level at the index date (p < 0,001). For systemic glucocorticoids, we found a significant drop in level after index date, but no change in slope. Statistical significant differences were also found in use of TNF-α-inhibitors and some other ATC-groups for sub-groups of LDN users.

DISCUSSION AND CONCLUSIONS: This study demonstrated a minor reduction in use of weak and strong opioids after starting LDN. However, the initial reduction was not sustainable, and may be related to advice on refraining from simultaneous use of LDN and opioids. We also found evidence for temporary change in use for a number of other ATC-groups. Assuming consumption of drugs related to treatment of IBD is a proxy for possible LDN effects, our results suggest further investigation of possible effects of LDN in a randomized controlled trial.