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Cost-effectiveness of mirtazapine for agitated behaviors in dementia: findings from a randomized controlled trial
International Psychogeriatrics ( IF 7 ) Pub Date : 2022-07-19 , DOI: 10.1017/s1041610222000436
Catherine Henderson 1 , Martin Knapp 1 , Susan Stirling 2 , Lee Shepstone 2 , Juliet High 2 , Clive Ballard 3 , Peter Bentham 4 , Alistair Burns 5 , Nicolas Farina 6 , Chris Fox 2 , Julia Fountain 7 , Paul Francis 3 , Robert Howard 8 , Iracema Leroi 9 , Gill Livingston 8 , Ramin Nilforooshan 10 , Shirley Nurock 11 , John T O'Brien 12 , Annabel Price 13 , Ann Marie Swart 2 , Naji Tabet 6 , Tanya Telling 14 , Alan J Thomas 15 , Sube Banerjee 16
Affiliation  

Objectives:

To examine the costs and cost-effectiveness of mirtazapine compared to placebo over 12-week follow-up.

Design:

Economic evaluation in a double-blind randomized controlled trial of mirtazapine vs. placebo.

Setting:

Community settings and care homes in 26 UK centers.

Participants:

People with probable or possible Alzheimer’s disease and agitation.

Measurements:

Primary outcome included incremental cost of participants’ health and social care per 6-point difference in CMAI score at 12 weeks. Secondary cost-utility analyses examined participants’ and unpaid carers’ gain in quality-adjusted life years (derived from EQ-5D-5L, DEMQOL-Proxy-U, and DEMQOL-U) from the health and social care and societal perspectives.

Results:

One hundred and two participants were allocated to each group; 81 mirtazapine and 90 placebo participants completed a 12-week assessment (87 and 95, respectively, completed a 6-week assessment). Mirtazapine and placebo groups did not differ on mean CMAI scores or health and social care costs over the study period, before or after adjustment for center and living arrangement (independent living/care home). On the primary outcome, neither mirtazapine nor placebo could be considered a cost-effective strategy with a high level of confidence. Groups did not differ in terms of participant self- or proxy-rated or carer self-rated quality of life scores, health and social care or societal costs, before or after adjustment.

Conclusions:

On cost-effectiveness grounds, the use of mirtazapine cannot be recommended for agitated behaviors in people living with dementia. Effective and cost-effective medications for agitation in dementia remain to be identified in cases where non-pharmacological strategies for managing agitation have been unsuccessful.



中文翻译:

米氮平治疗痴呆症激越行为的成本效益:一项随机对照试验的结果

目标:

在 12 周的随访期间,与安慰剂相比,检查米氮平的成本和成本效益。

设计:

米氮平与安慰剂的双盲随机对照试验的经济评估。

环境:

26 个英国中心的社区环境和护理院。

参加者:

可能或可能患有阿尔茨海默病和情绪激动的人。

测量:

主要结果包括参与者在 12 周时 CMAI 评分每 6 分差异的健康和社会护理成本增量。二次成本效用分析从健康和社会护理以及社会角度检查了参与者和无偿护理人员在质量调整生命年(源自 EQ-5D-5L、DEMQOL-Proxy-U 和 DEMQOL-U)中的收益。

结果:

每组分配一百零两名参与者;81 名米氮平参与者和 90 名安慰剂参与者完成了为期 12 周的评估(分别有 87 名和 95 名参与者完成了为期 6 周的评估)。在研究期间、中心和生活安排(独立生活/护理院)调整之前或之后,米氮平和安慰剂组在平均 CMAI 分数或健康和社会护理成本方面没有差异。在主要结果方面,米氮平和安慰剂都不能被视为具有高置信度的成本效益策略。在调整之前或之后,各组在参与者自我评价或代理评价或照顾者自我评价的生活质量得分、健康和社会关怀或社会成本方面没有差异。

结论:

出于成本效益的考虑,不建议将米氮平用于痴呆症患者的激越行为。在控制躁动的非药物策略不成功的情况下,仍有待确定有效且具有成本效益的治疗痴呆症躁动的药物。

更新日期:2022-07-19
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