Transdermal Buprenorphine Not Well Tolerated in Dementia
The primary outcomes was time and reasons for discontinuation, and secondary outcomes included change in daytime activity and intensity.
|The following article is part of conference coverage from the 2018 Alzheimer's Association International Conference in Chicago, Illinois. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAIC 2018.|
CHICAGO – At the 2018 Alzheimer's Association International Conference, Clive Ballard, MD, of the University of Exeter Medical School in the United Kingdom, and colleagues presented data from the first randomized, placebo-controlled trial examining safety of the buprenorphine transdermal system for pain management in people with dementia.
The researchers conducted a 13-week study that included 162 individuals with advanced dementia and considerable depression residing in nursing homes in Norway. Study participants were randomly assigned to receive paracetamol, buprenorphine, or placebo for the length of the study. The primary outcome was time and reasons for discontinuation, and secondary outcomes included change in daytime activity and intensity.
Ultimately, 44 patients received buprenorphine 5 μg/hour; of those, 52.3% discontinued treatment due to adverse events compared with 13.3% of patients in the placebo group (P <.001). Among those who discontinued use, nearly 70% experienced psychiatric and neurological adverse events. The researchers noted that concomitant use of antidepressants significantly increased the likelihood of discontinuation (hazard ratio 23.2; 95% CI, 2.95-182; P =.003).
After adjusting for age, sex, cognitive function, and pain, patients taking buprenorphine were 20.9 times more likely to discontinue drug use (95% CI, 2.12-206; P =.009). The researchers also noted that daytime activity levels decreased significantly by the second day of treatment, and decreased by 12.9% within the first week (P =.053).
The researchers concluded that buprenorphine was not well tolerated in patients with dementia and depression. “More work is urgently needed to develop a specific pain treatment pathway for the treatment of pain in people with dementia.”
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Erdal A, Flo E, Aarsland D, Ballard C, Husebø BS. A randomized, placebo-controlled trial to investigate safety in people with dementia of buprenorphine transdermal system for pain management. Presented at: 2018 Alzheimer's Association International Conference. July 22-26, 2018; Chicago, IL. Abstract 24392.