Abstract：
BACKGROUND: Effectiveness of candesartan in migraine prevention is supported by two randomized controlled trials. We aimed to assess the effectiveness, tolerability, and response predictors of candesartan in the preventive treatment of migraine.
METHODS: Observational, multicenter, prospective cohort study. The 50%, 75% and 30% responder rates, between weeks 8-12 and 20-24, were compared with the baseline. Treatment emergent adverse effects were systematically evaluated. Response predictors were estimated by multivariate regression models.
RESULTS: Eighty-six patients were included, 79.1% females, aged 39.5 (inter-quartile range [IQR] 26.3-50.3), with chronic migraine (43.0%), medication overuse headache (55.8%) and a median of two (inter-quartile range: 0.75-3) prior preventive treatments. At baseline patients had 14 (10-24) headache and 8 (5-11) migraine days per month. The 30%, 50% and 75% responder rates were 40%, 34.9% and 15.1% between weeks 8-12, and 48.8%, 36%, and 18.6% between weeks 20-24. Adverse effects were reported by 30 (34.9%) and 13 (15.1%) patients between weeks 0-12 and 12-24, leading to discontinuation in 15 (17.4%) patients. Chronic migraine, depression, headache days per month, medication overuse headache, and daily headache at baseline predicted the response between weeks 20-24.
CONCLUSIONS: Candesartan effectiveness and tolerability in migraine prevention was in line with the clinical trials\' efficacy.Trial registration: The study protocol is registered in ClinicalTrials.gov (NCT04138316).
METHODS: Observational, multicenter, prospective cohort study. The 50%, 75% and 30% responder rates, between weeks 8-12 and 20-24, were compared with the baseline. Treatment emergent adverse effects were systematically evaluated. Response predictors were estimated by multivariate regression models.
RESULTS: Eighty-six patients were included, 79.1% females, aged 39.5 (inter-quartile range [IQR] 26.3-50.3), with chronic migraine (43.0%), medication overuse headache (55.8%) and a median of two (inter-quartile range: 0.75-3) prior preventive treatments. At baseline patients had 14 (10-24) headache and 8 (5-11) migraine days per month. The 30%, 50% and 75% responder rates were 40%, 34.9% and 15.1% between weeks 8-12, and 48.8%, 36%, and 18.6% between weeks 20-24. Adverse effects were reported by 30 (34.9%) and 13 (15.1%) patients between weeks 0-12 and 12-24, leading to discontinuation in 15 (17.4%) patients. Chronic migraine, depression, headache days per month, medication overuse headache, and daily headache at baseline predicted the response between weeks 20-24.
CONCLUSIONS: Candesartan effectiveness and tolerability in migraine prevention was in line with the clinical trials\' efficacy.Trial registration: The study protocol is registered in ClinicalTrials.gov (NCT04138316).
摘要：
背景：两项随机对照试验支持坎地沙坦预防偏头痛的有效性。我们的目的是评估有效性，耐受性,坎地沙坦在偏头痛预防性治疗中的反应预测因子。
方法：观察性，多中心，前瞻性队列研究。50%,75%和30%的响应率，在第8-12周和第20-24周,与基线进行比较.系统评价治疗中出现的不良反应。通过多元回归模型估计反应预测因子。
结果：纳入86例患者，79.1%女性，年龄39.5（四分位数间距[IQR]26.3-50.3），慢性偏头痛（43.0%），药物过度使用头痛（55.8％）和两次（四分位数间范围：0.75-3）之前的预防性治疗的中位数。在基线时，患者每月有14(10-24)天头痛和8(5-11)天偏头痛。30%,50%和75%的应答率为40%，第8-12周的34.9%和15.1%，以及48.8%，36%,20-24周之间的18.6%。在0-12周和12-24周之间，有30例（34.9％）和13例（15.1％）患者报告了不良反应，导致15例（17.4％）患者停药。慢性偏头痛,抑郁症,每月头痛天数，药物过度使用头痛，基线时的每日头痛预测了20-24周之间的反应。
结论：坎地沙坦预防偏头痛的有效性和耐受性与临床试验疗效一致。试验注册:研究方案在ClinicalTrials.gov(NCT04138316)中注册。
方法：观察性，多中心，前瞻性队列研究。50%,75%和30%的响应率，在第8-12周和第20-24周,与基线进行比较.系统评价治疗中出现的不良反应。通过多元回归模型估计反应预测因子。
结果：纳入86例患者，79.1%女性，年龄39.5（四分位数间距[IQR]26.3-50.3），慢性偏头痛（43.0%），药物过度使用头痛（55.8％）和两次（四分位数间范围：0.75-3）之前的预防性治疗的中位数。在基线时，患者每月有14(10-24)天头痛和8(5-11)天偏头痛。30%,50%和75%的应答率为40%，第8-12周的34.9%和15.1%，以及48.8%，36%,20-24周之间的18.6%。在0-12周和12-24周之间，有30例（34.9％）和13例（15.1％）患者报告了不良反应，导致15例（17.4％）患者停药。慢性偏头痛,抑郁症,每月头痛天数，药物过度使用头痛，基线时的每日头痛预测了20-24周之间的反应。
结论：坎地沙坦预防偏头痛的有效性和耐受性与临床试验疗效一致。试验注册:研究方案在ClinicalTrials.gov(NCT04138316)中注册。
