Fondazione ReS (Ricerca e Salute) - Research and Health Foundation, Via Magnanelli 6/3, Casalecchio di Reno, 40033, Bologna, Italy.
IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
J Headache Pain. 2019 Jun 27;20(1):74. doi: 10.1186/s10194-019-1027-7.
Although migraine is a disabling neurological condition that causes important disability, it remains an area of underdiagnosis and undertreatment worldwide. The aim of this study was to depict the burden of the unmet medical needs in migraine treated with triptans in a large Italian population.
A 2-year longitudinal analysis of migraineurs with unmet medical needs on treatment with triptans was performed. The studied cohort consisted of subjects with ≥4 triptan dose units per month, selected from the general population These patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4-9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10-14 triptan dose units per month) and possible Chronic Migraine (pCM:> 14 triptan dose units per month). The first follow-up year was analysed to describe the use of preventive therapies, the second year to describe the ≥50% reduction in triptan use.
Of 10,270,683 adults, 8.0 per 1000 were triptan users and, of these, 38.2% were migraineurs with unmet medical needs, corresponding to 3.1 per 1000 adults. By stratifying for the number of triptan dose units per month, 72.3% were affected by pLF-EM, 17.4% by pHF-EM, and 10.3% by pCM. In this cohort, 19.1% of individuals used oral preventive drugs and 0.1% botulinum toxin. Triptan use reduction was found in 22.3% individuals of the cohort, decreasing with the intensification of need levels (25.8% pLF-EM, 13.6% pHF-EM, 12.0% pCM).
This real-life analysis underlined that the unmet medical needs concern a large part of patients treated with triptans and there is an undertreatment with preventive therapies whose benefit is insufficient, which may be due to the lack of effective preventive strategies, probably still reserved to severe patients. This study allows forecasting the actual impact of newest therapeutic strategies aimed to fill this gap.
偏头痛是一种致残性神经系统疾病,会导致严重残疾,但在全球范围内,其仍存在诊断不足和治疗不足的情况。本研究旨在描述在意大利大型人群中,使用曲坦类药物治疗偏头痛时未满足的医疗需求的负担。
对每月使用曲坦类药物治疗但仍存在未满足医疗需求的偏头痛患者进行了为期 2 年的纵向分析。该研究队列由每月使用≥4 个曲坦类药物剂量的患者组成,这些患者选自普通人群。将这些患者分为:可能的低频发作性偏头痛(pLF-EM:每月使用 4-9 个曲坦类药物剂量)、可能的高频发作性偏头痛(pHF-EM:每月使用 10-14 个曲坦类药物剂量)和可能的慢性偏头痛(pCM:每月使用>14 个曲坦类药物剂量)。分析了第一年的随访结果以描述预防性治疗的使用情况,第二年的随访结果以描述曲坦类药物使用减少≥50%的情况。
在 10270683 名成年人中,有 8.0 人/1000 人使用曲坦类药物,其中 38.2%为偏头痛患者且存在未满足的医疗需求,相当于 3.1 人/1000 人。按照每月曲坦类药物剂量的数量进行分层,72.3%为 pLF-EM,17.4%为 pHF-EM,10.3%为 pCM。在该队列中,有 19.1%的个体使用口服预防性药物,0.1%的个体使用肉毒毒素。发现该队列中有 22.3%的个体减少了曲坦类药物的使用,且随着需求水平的增加而减少(25.8% pLF-EM、13.6% pHF-EM、12.0% pCM)。
这项真实世界的分析强调,使用曲坦类药物治疗的患者中存在很大一部分存在未满足的医疗需求,而且预防性治疗的使用率较低,其获益不足,这可能是由于缺乏有效的预防性治疗策略,可能仅限于严重的患者。本研究可以预测旨在填补这一空白的最新治疗策略的实际影响。