Preventive drug treatments for adults with chronic migraine: a systematic review with economic modelling.

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Health technology assessment Pub Date : 2024-10-01 DOI:10.3310/AYWA5297
Hema Mistry, Seyran Naghdi, Anna Brown, Sophie Rees, Jason Madan, Amy Grove, Saval Khanal, Callum Duncan, Manjit Matharu, Andrew Cooklin, Aiva Aksentyte, Natasha Davies, Martin Underwood
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With the introduction of expensive calcitonin gene-related peptide monoclonal antibodies, it is timely to compare the clinical effectiveness and cost-effectiveness of preventive drugs for chronic migraine.</p><p><strong>Objective: </strong>To assess the clinical effectiveness and cost-effectiveness of medications used for chronic migraine through systematic reviews and economic modelling.</p><p><strong>Eligibility criteria: </strong>Randomised controlled trials of drug treatments for efficacy with > 100 participants with chronic migraine per arm; for adverse events > 100 participants with episodic or chronic migraine per arm. 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The calcitonin gene-related peptide monoclonal antibodies were consistently the best choices for headache/migraine days and headache-related quality of life. Topiramate was very unlikely to be the best choice for headache/migraine days and headache-related quality of life when compared to calcitonin gene-related peptide monoclonal antibodies or Botox. We found no trials of the commonly used drugs, such as propranolol or amitriptyline, to include in the analysis. The adverse events review included 40 randomised controlled trials with 25,891 participants; 3 additional drugs, amitriptyline, atogepant and rimegepant, were included. There were very few serious adverse events - none of which were linked to the use of these medications. Adverse events were common. Most people using some calcitonin gene-related peptide monoclonal antibodies reported injection site issues; and people using topiramate or amitriptyline had nervous system or gastrointestinal issues. 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Abstract

Background: Chronic migraine is a disabling condition, affecting 2-4% of adults globally. With the introduction of expensive calcitonin gene-related peptide monoclonal antibodies, it is timely to compare the clinical effectiveness and cost-effectiveness of preventive drugs for chronic migraine.

Objective: To assess the clinical effectiveness and cost-effectiveness of medications used for chronic migraine through systematic reviews and economic modelling.

Eligibility criteria: Randomised controlled trials of drug treatments for efficacy with > 100 participants with chronic migraine per arm; for adverse events > 100 participants with episodic or chronic migraine per arm. Previous economic analyses of preventive drugs for chronic migraine.

Data sources: Eight databases.

Reviews methods: Systematic reviews, network meta-analysis and economic modelling.

Outcomes: Monthly headache days, monthly migraine days, headache-related quality of life, cost-effectiveness.

Results: We found 51 individual articles, reporting 11 randomised controlled trials, testing 6 drugs (topiramate, Botox, eptinezumab, erenumab, fremanezumab, galcanezumab), versus placebo, on 7352 adults with chronic migraine. Calcitonin gene-related peptide monoclonal antibodies, Botox and topiramate reduced headache/migraine days by 2.0-2.5, just under two, or by less than 1.5 days per month, respectively. In the network meta-analysis, eptinezumab 300 mg and fremanezumab monthly ranked in first place in both monthly headache day and monthly migraine day analyses. The calcitonin gene-related peptide monoclonal antibodies were consistently the best choices for headache/migraine days and headache-related quality of life. Topiramate was very unlikely to be the best choice for headache/migraine days and headache-related quality of life when compared to calcitonin gene-related peptide monoclonal antibodies or Botox. We found no trials of the commonly used drugs, such as propranolol or amitriptyline, to include in the analysis. The adverse events review included 40 randomised controlled trials with 25,891 participants; 3 additional drugs, amitriptyline, atogepant and rimegepant, were included. There were very few serious adverse events - none of which were linked to the use of these medications. Adverse events were common. Most people using some calcitonin gene-related peptide monoclonal antibodies reported injection site issues; and people using topiramate or amitriptyline had nervous system or gastrointestinal issues. The cost-effectiveness review identified 16 studies evaluating chronic migraine medications in adults. The newer, injected drugs are more costly than the oral preventatives, but they were cost-effective. Our economic model showed that topiramate was the least costly option and had the fewest quality-adjusted life-year gains, whereas eptinezumab 300 mg was more costly but generated the most quality-adjusted life-year gains. The cost-effectiveness acceptability frontier showed that topiramate was the most cost-effective medication if the decision maker is willing to pay up to £50,000 per quality-adjusted life-year. Our consensus workshop brought together people with chronic migraine and headache experts. Consensus was reached on the top three recommendations for future research on medications to prevent chronic migraine: (1) calcitonin gene-related peptide monoclonal antibodies and Botox versus calcitonin gene-related peptide monoclonal antibodies, (2) candesartan versus placebo and (3) flunarizine versus placebo.

Limitations: Topiramate was the only oral drug for which we were able to include data. We did not find sufficient quality evidence to support the use of other oral drugs.

Conclusions: We did not find evidence that the calcitonin gene-related peptide monoclonal antibodies are more clinically and cost-effective when compared to topiramate or Botox. We identified directions for future research these drugs might take.

Study registration: This study is registered as PROSPERO CRD42021265990, CRD42021265993 and CRD42021265995.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR132803) and is published in full in Health Technology Assessment; Vol. 28, No. 63. See the NIHR Funding and Awards website for further award information.

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成人慢性偏头痛的预防性药物治疗:经济模型系统综述。
背景:慢性偏头痛是一种致残性疾病,影响着全球2%-4%的成年人。随着昂贵的降钙素基因相关肽单克隆抗体的问世,比较慢性偏头痛预防药物的临床有效性和成本效益正当其时:通过系统回顾和经济建模评估慢性偏头痛药物的临床有效性和成本效益:药物治疗的随机对照试验,疗效试验每组>100名慢性偏头痛患者;不良反应试验每组>100名发作性或慢性偏头痛患者。以往对慢性偏头痛预防药物进行的经济分析:八个数据库:系统综述、网络荟萃分析和经济建模:结果:每月头痛天数、每月偏头痛天数、头痛相关生活质量、成本效益:我们找到了 51 篇文章,报告了 11 项随机对照试验,测试了 6 种药物(托吡酯、肉毒杆菌毒素、eptinezumab、erenumab、fremanezumab、galcanezumab)与安慰剂对 7352 名成人慢性偏头痛患者的疗效。降钙素基因相关肽单克隆抗体、肉毒杆菌毒素和托吡酯可使头痛/偏头痛天数每月分别减少2.0-2.5天、略少于2天或少于1.5天。在网络荟萃分析中,在每月头痛天数和每月偏头痛天数分析中,依替尼珠单抗 300 毫克和氟马尼珠单抗每月一次均排名第一。降钙素基因相关肽单克隆抗体一直是头痛/偏头痛日数和头痛相关生活质量的最佳选择。与降钙素基因相关肽单克隆抗体或肉毒杆菌毒素相比,托吡酯不太可能成为头痛/偏头痛天数和头痛相关生活质量的最佳选择。我们在分析中没有发现普萘洛尔或阿米替林等常用药物的试验。不良事件回顾包括 40 项随机对照试验,参与人数达 25,891 人;另外还包括 3 种药物,即阿米替林、阿托吉潘和利米吉潘。严重不良事件极少,没有一起与使用这些药物有关。不良事件很常见。大多数使用降钙素基因相关肽单克隆抗体的患者都报告了注射部位的问题;而使用托吡酯或阿米替林的患者则出现了神经系统或胃肠道问题。成本效益审查确定了 16 项评估成人慢性偏头痛药物的研究。较新的注射药物比口服预防药物成本更高,但它们具有成本效益。我们的经济模型显示,托吡酯是成本最低的选择,但获得的质量调整生命年收益最少,而依替珠单抗300毫克的成本较高,但获得的质量调整生命年收益最多。成本效益可接受性前沿显示,如果决策者愿意为每质量调整生命年支付高达 50,000 英镑,那么托吡酯是最具成本效益的药物。我们的共识研讨会汇集了慢性偏头痛患者和头痛专家。会议就未来预防慢性偏头痛药物研究的三大建议达成了共识:(1) 降钙素基因相关肽单克隆抗体和肉毒杆菌素与降钙素基因相关肽单克隆抗体的对比;(2) 坎地沙坦与安慰剂的对比;(3) 氟桂利嗪与安慰剂的对比:托吡酯是我们能够纳入数据的唯一一种口服药物。我们没有发现足够的高质量证据来支持使用其他口服药物:我们没有发现证据表明降钙素基因相关肽单克隆抗体与托吡酯或肉毒杆菌毒素相比更具临床效果和成本效益。我们确定了这些药物未来可能的研究方向:本研究注册为 PROSPERO CRD42021265990、CRD42021265993 和 CRD42021265995:该奖项由美国国家健康与护理研究所(NIHR)健康技术评估计划资助(NIHR奖项编号:NIHR132803),全文发表于《健康技术评估》第28卷第63期。更多奖项信息请参阅 NIHR Funding and Awards 网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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