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Alteration of prescription-only drug utilization by low dose naltrexone users with hypothyroidism. A cohort study based on the Norwegian prescription database from 2011-2015

Title
Alteration of prescription-only drug utilization by low dose naltrexone users with hypothyroidism. A cohort study based on the Norwegian prescription database from 2011-2015
Publication Type
Journal Article
Research Type
Human
Reported as
Case Report/Series/Restrospective Study
Date
June 01, 2017
Authors
Kim Phung Khong, Lars Småbrekke, Guttorm Raknes
Institution
The Arctic University of Norway; University Hospital of North Norway; Uni Research Health;
Link
Abstract

INTRODUCTION: In recent years, Low Dose Naltrexone (LDN) (<5 mg / day) has increasingly been used as supportive treatment in chronic pain, fibromyalgia, multiple sclerosis, inflammatory bowel disease, Sjögren’s syndrome and other autoimmune diseases. There are no studies on LDN in hypothyroidism.

OBJECTIVES: The aim was to examine whether use of LDN was associated with change in the prescription pattern for other drugs in patients with hypothyroidism.

METHODS: We obtained information from the Norwegian Prescription Database on dispensed drugs during 2011-2015 for patients (n= 1779) who got their first LDN-prescription in 2013. The date for the first prescription was defined as the index date. Our observation period for all other prescription drugs was two years before and two years after the index date. We aggregated prescription drugs into ATC-groups based on treatment guidelines and clinical relevance, and summarized the number of DDDs of each ATC-group per week. We used interrupted time series to investigate possible change in drug utilization over the period.

RESULTS: We analysed 14 ATC group. Consumption strong opioids (ketobemidone, pethidine, fentanyl, buprenorphine, ketobemidone (with spasmolyticand) and tapentadol) (p= 0.031) and codeine (p= 0.026) decreased significantly after starting LDN. We found an increased level for codeine to almost the same level as before the index date at the end of the observation period. For strong opioids, it showed a less immediate drop, but increased to a higher level than index date. The consumption of benzodiazepines increased significantly after starting LDN (p= 0.018), and the slope increased slowly after the index date. We also found a statistical significant difference in antidepressant (not tricyclic antidepressants, selective serotonin reuptake inhibitors or monoamine oxidase inhibitors) (p= 0,007), but no change in consumption of other ATC-groups.

DISCUSSION AND CONCLUSIONS: This study demonstrated a minor but significant immediate drop in consumption of strong opioids and codeine after starting LDN. The initial fall was not sustainable, and may relate to advice on refraining from simultaneous use of LDN and opioids. We found evidence for temporary change in consumption for some ATC-groups related to treatment of hypothyroidism. Our findings suggest for further observation of possible effects of LDN in a randomized controlled trial.