In randomized, double-blind trial, no difference seen in scores for agitated behaviors at 12 weeks with mirtazapine versus placebo
WEDNESDAY, Nov. 3, 2021 (HealthDay News) — Among patients with dementia, agitated behaviors are not reduced with mirtazapine versus placebo at 12 weeks, according to a study published online Oct. 23 in The Lancet.
Sube Banerjee, M.D., from the University of Plymouth in the United Kingdom, and colleagues randomly assigned adults with probable or possible Alzheimer disease and agitation unresponsive to nondrug treatment in a 1:1 ratio to either mirtazapine or placebo. The analysis included 204 participants treated at one of 26 U.K. centers.
The researchers found that the mean Cohen-Mansfield Agitation Inventory scores at 12 weeks did not differ significantly between the participants receiving mirtazapine and those receiving placebo (adjusted mean difference, –1.74; 95 percent confidence interval, –7.17 to 3.69, P = 0.53). Adverse events were similar between the groups, but there were more deaths in the mirtazapine group than the placebo group at week 16 (seven versus one). In a post hoc analysis, the difference in mortality between the groups was not statistically significant (P = 0.065).
“Dementia affects 46 million people worldwide — a figure set to double over the next 20 years. Poor life quality is driven by problems like agitation and we need to find ways to help those affected,” Banerjee said in a statement. “This study shows that a common way of managing symptoms is not helpful — and could even be detrimental. It’s really important that these results are taken into account and mirtazapine is no longer used to treat agitation in people with dementia. This study has added important information to the evidence base, and we look forward to investigating further treatments that may help to improve people’s quality of life.”
Several authors disclosed financial ties to pharmaceutical and medical device companies.
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