Dementia is one of the most common and serious public health problems of our time. The most common cause of dementia is Alzheimer's disease. Alzheimer's disease causes irreversible and progressive impairment of memory, thinking, communication skills, and the ability to perform daily activities. Along with this cognitive and functional decline, neuropsychiatric symptoms such as agitation, sleep disturbances, depression and psychosis can occur. These symptoms are common and occur in nearly 90% of people with dementia, and agitation is one of the most persistent symptoms.
Agitation is a common symptom of dementia characterized by inappropriate verbal, vocal, or motor activity and is often associated with physical and verbal aggression. People with dementia may feel agitated or irritable, restless, tap their fingers, or make other repetitive movements. They may also try to walk back and forth, move objects, cling to tasks such as cleaning, or leave the house. This behaviour is called anxiety.
A new study shows that the drug used to treat agitation in people with dementia is no more effective than a placebo and may increase mortality. A study published in The Lancet by the University of Plymouth found that the antidepressant mirtazapine did not improve agitation in people with dementia and may be more associated with mortality than no intervention at all.
Patient-centered, drug-free treatment is the first intervention that should be provided, but if this does not work, doctors may move to drug-based alternatives. Mirtazapine is prescribed regularly as antipsychotics have been shown to increase mortality in people with dementia, along with other side effects. This study was designed to add to the database of its effects.
204 people from 20 different UK sites with possible or probable Alzheimer's disease were recruited in the study, half of whom received mirtazapine and half placebo. The trial was double-blind; meaning that neither the researcher nor the study participants knew what they were taking. It was funded by the National Institute for Health Research (NIHR).
Results showed that after 12 weeks, the mirtazapine group was less agitated than the control group. By week 16, the mirtazapine group had more deaths (7 patients) than the control group (1 patient), which was analysed to be of negligible statistical significance. Lead researcher Professor Sube Banerjee, Executive Dean of public health and professor of dementia at the University of Plymouth, explains why the results are surprising but important.
Interpretation:
This trial did not show any benefit of mirtazapine over placebo and we observed a potentially higher mortality rate with mirtazapine. Data from this study do not support the use of mirtazapine for the treatment of agitation in dementia.
Reference:
The Lancet, Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial
Blog by Shreeya Poojary
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