Low-dose naltrexone and opioid consumption: a drug utilization cohort study based on data from the Norwegian prescription database

2019

PLoS ONE

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In recent years, low dose naltrexone (LDN) has been used as an off-label therapy for several chronic diseases. Results from small laboratory and clinical studies indicate some beneficial effects of LDN in autoimmune diseases, but clinical research on LDN in rheumatic disease is limited. Using a pharmacoepidemiological approach, we wanted to test the hypothesis that starting LDN leads to reduced dispensing of medicines used in the treatment of rheumatic disease. We performed a controlled before-after study based on the Norwegian Prescription Database (NorPD) to compare prescriptions to patients one year before and one year after starting LDN in 2013. The identified patients (n = 360) were stratified into three groups based on LDN exposure. Outcomes were differences in dispensing of medicines used in rheumatic disease. In persistent LDN users, there was a 13% relative reduction in cumulative defined daily doses (DDD) of all medicines examined corresponding to -73.3 DDD per patient (95% CI -120,2 to -26.4, p = 0.003), and 23% reduction of analgesics (-21.6 DDD (95% CI -35.5 to -7.6, p<0.009)). There was no significant DDD change in patients with lower LDN exposure. Persistent LDN users had significantly reduced DDDs of NSAID and opioids, and a lower proportion of users of DMARDs (-6.7 percentage points, 95% CI -12.3 to-1.0, p = 0.028), TNF-α antagonists and opioids. There was a decrease in the number of NSAID users among patients with the least LDN exposure. Important limitations are that prescription data are proxies for clinical effects and that a control group unexposed to LDN is lacking. The results support the hypothesis that persistent use of LDN reduces the need for medication used in the treatment of rheumatic and seropositive arthritis. Randomised clinical trials on LDN in rheumatic disease are warranted.

Section: Introductionmentioning

confidence: 99%

Low dose naltrexone: Effects on medication in rheumatoid and seropositive arthritis. A nationwide register-based controlled quasi-experimental before-after study

2019

PLoS ONE

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“…In a previous study with a similar design we documented a 46% reduction in opioid use among among persistent LDN users, whereas one-time users had no change in their opioid use. 18 …”

Section: Discussionmentioning

confidence: 99%

The Effect of Low-Dose Naltrexone on Medication in Inflammatory Bowel Disease: A Quasi Experimental Before-and-After Prescription Database Study

Simonsen²,

Journal of Crohn's and Colitis

2018

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Background and AimsLow-dose naltrexone [LDN] is a controversial off-label treatment used by many Crohn’s disease [CD] and ulcerative colitis [UC] patients. A small number of preliminary studies indicate that LDN might be beneficial in CD, but evidence is too scarce to demonstrate efficacy. We sought to examine whether initiation of LDN therapy by patients with inflammatory bowel disease [IBD] was followed by changes in dispensing of relevant medication.MethodsWe performed a quasi-experimental before-and-after study following a sudden increase in LDN use in the Norwegian population in 2013. IBD patients were identified from among all the patients who had at least one LDN prescription recorded in the Norwegian Prescription Database [NorPD] in 2013. Drug dispensing 2 years before and after the first LDN prescription was compared.Results: We identified 582 IBD patients who had received LDN. Of the 256 patients who became persistent LDN users, there were reductions in the number of users for [i] all examined drugs [–12%], [ii] intestinal anti-inflammatory agents [–17%], [iii] other immunosuppressants [–29%], [iv] intestinal corticosteroids [–32%] and [v] aminosalicylates [–17%]. In subgroups of identified CD and UC patients, there were significant reductions in the number of users of intestinal corticosteroids [CD: –44%, UC: –53%] and systemic corticosteroids [UC: –24%]. No significant differences in cumulative defined daily doses were observed.Conclusions: Our findings imply that the initiation of LDN in IBD is followed by reduced dispensing of several drugs considered essential in the treatment of CD and UC.

“…The observed significant increase in the dispensing of baclofen, cannabinoids, and drugs used for urinary frequency and incontinence among the persistent LDN users further weakens the assumption that LDN is effective against a range of MS symptoms. Opioid dispensing was reduced in MS patient with persistent LDN use, but this was in the same order of magnitude as seen in the entire persistent LDN using population [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

“…This sudden increase provided an unprecedented opportunity for quasi-experimental studies to assess the effect of LDN on prescribing of other medicines in MS and other chronic conditions. Using NorPD data, we have already observed that the sudden increase in the use of LDN in Norway in 2013 was followed by a significant reduction in opioid dispensing among persistent LDN users [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Low dose naltrexone in multiple sclerosis: Effects on medication use. A quasi-experimental study

2017

PLoS ONE

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Low dose naltrexone (LDN) has become a popular off-label therapy for multiple sclerosis (MS). A few small, randomized studies indicate that LDN may have beneficial effects in MS and other autoimmune diseases. If proven efficacious, it would be a cheap and safe alternative to the expensive treatments currently recommended for MS. We investigated whether a sudden increase in LDN use in Norway in 2013 was followed by changes in dispensing of other medications used to treat MS. We performed a quasi-experimental before–and–after study based on population data from the Norwegian Prescription Database (NorPD). We included all patients that collected at least one LDN prescription in 2013, and had collected at least two medications with a reimbursement code for MS, or collected a medication with MS as the only indication in 2009 or 2010. Outcomes were differences in cumulative dispensed doses and incidence of users of disease modifying MS therapies, and medications used to treat MS symptoms two years before and two years after dispensing the initial LDN prescription. The eligible 341 patients collected 20 921 prescriptions in the observation period. Apart from changes in line with general trends in MS therapy in Norway, there was no difference in neither dispensed cumulative doses or number of prevalent users of MS specific medication. Initiation of LDN was not followed by reductions of other medications used to treat symptoms associated with MS.