Abstract：
OBJECTIVE: In this retrospective cross-sectional real-world evidence study from the Danish Headache Center (DHC), a national tertiary headache center in Denmark, we sought to identify potential pharmacological agents for the treatment of new daily persistent headache (NDPH).
BACKGROUND: NDPH is an enigmatic headache disorder with abrupt onset and chronic duration for which evidence-based treatments are lacking. NDPH is a diagnosis of exclusion, for which secondary headaches must be ruled out and the etiology remains idiopathic. The sparse investigations of this disorder have not yielded a pathophysiological basis and no effective treatment for NDPH has been found.
METHODS: All patients with an NDPH diagnosis at the DHC were enrolled (n = 64). First, we reviewed the records of all patients with an NDPH diagnosis to evaluate whether they fulfilled the diagnostic criteria. Next, we extracted all the trialled acute and prophylactic pharmacological interventions for the included patients. Then, pharmacological interventions that had been tried in ≥ 20 patients were analyzed post hoc with efficacy as the outcome, which was stratified in five effect categories (\"no effect,\" \"partial effect,\" \"full effect,\" \"partial effect and cessation due to adverse events,\" and \"full effect and cessation due to adverse events\"). Descriptive statistical analysis was performed, and the results were schematically presented (see Table 2).
RESULTS: Fifty-one patients out of 64 were found to fulfill NDPH criteria and were included in the study. The drugs tried by ≥ 20 patients were amitriptyline (n = 34), candesartan (n = 27), and mirtazapine (n = 20). No patients experienced a complete effect with these drugs while 9% (3/34), 26% (7/27), and 15% (3/20) experienced a partial effect with no adverse events that led to treatment discontinuation, respectively. The remaining patients experienced either no effect or a partial effect with adverse events leading to treatment discontinuation.
CONCLUSIONS: In this study we add real-world evidence to suggest that prophylactic drugs conventionally used for treating chronic migraine and chronic tension-type headache have limited utility for treating NDPH; however, a partial response in 26% of patients using candesartan and 15% of patients using mirtazapine warrants further investigation in randomized double-blinded placebo-controlled trials.
BACKGROUND: NDPH is an enigmatic headache disorder with abrupt onset and chronic duration for which evidence-based treatments are lacking. NDPH is a diagnosis of exclusion, for which secondary headaches must be ruled out and the etiology remains idiopathic. The sparse investigations of this disorder have not yielded a pathophysiological basis and no effective treatment for NDPH has been found.
METHODS: All patients with an NDPH diagnosis at the DHC were enrolled (n = 64). First, we reviewed the records of all patients with an NDPH diagnosis to evaluate whether they fulfilled the diagnostic criteria. Next, we extracted all the trialled acute and prophylactic pharmacological interventions for the included patients. Then, pharmacological interventions that had been tried in ≥ 20 patients were analyzed post hoc with efficacy as the outcome, which was stratified in five effect categories (\"no effect,\" \"partial effect,\" \"full effect,\" \"partial effect and cessation due to adverse events,\" and \"full effect and cessation due to adverse events\"). Descriptive statistical analysis was performed, and the results were schematically presented (see Table 2).
RESULTS: Fifty-one patients out of 64 were found to fulfill NDPH criteria and were included in the study. The drugs tried by ≥ 20 patients were amitriptyline (n = 34), candesartan (n = 27), and mirtazapine (n = 20). No patients experienced a complete effect with these drugs while 9% (3/34), 26% (7/27), and 15% (3/20) experienced a partial effect with no adverse events that led to treatment discontinuation, respectively. The remaining patients experienced either no effect or a partial effect with adverse events leading to treatment discontinuation.
CONCLUSIONS: In this study we add real-world evidence to suggest that prophylactic drugs conventionally used for treating chronic migraine and chronic tension-type headache have limited utility for treating NDPH; however, a partial response in 26% of patients using candesartan and 15% of patients using mirtazapine warrants further investigation in randomized double-blinded placebo-controlled trials.
摘要：
目的：在丹麦头痛中心（DHC）的回顾性横断面真实世界证据研究中，丹麦的国家三级头痛中心，我们试图确定治疗新的每日持续性头痛(NDPH)的潜在药物.
背景：NDPH是一种神秘的头痛疾病，具有突然发作和慢性持续时间，缺乏基于证据的治疗方法。NDPH是一种排除性诊断，必须排除继发性头痛，病因仍然是特发性的。对这种疾病的稀疏研究尚未产生病理生理学基础，也未发现对NDPH的有效治疗方法。
方法：纳入所有在DHC诊断为NDPH的患者（n=64）。首先,我们回顾了所有诊断为NDPH的患者的记录,以评估他们是否符合诊断标准.接下来,我们提取了纳入患者的所有急性和预防性药物干预试验.然后，在≥20例患者中尝试的药物干预措施进行事后分析，以疗效作为结果，分为五个效应类别(“无效应，\"\"部分效果，\"\"完整效果,“由于不良事件导致的部分效果和停止，\"和\"由于不良事件而完全生效和停止\")。进行描述性统计分析，和结果的示意图（见表2）。
结果：64例患者中有51例符合NDPH标准，并被纳入研究。≥20例患者尝试的药物为阿米替林（n=34），坎地沙坦（n=27），和米氮平（n=20）。没有患者经历了这些药物的完全效果，而9％（3/34），26%（7/27），和15％（3/20）经历了部分效果，没有不良事件导致治疗中断，分别。其余患者经历了无效果或部分效果，不良事件导致治疗中断。
结论：在这项研究中，我们增加了现实世界的证据，表明常规用于治疗慢性偏头痛和慢性紧张型头痛的预防药物在治疗NDPH方面的效用有限；然而，26%的使用坎地沙坦的患者和15%的使用米氮平的患者出现部分缓解,需要在随机双盲安慰剂对照试验中进行进一步调查.
背景：NDPH是一种神秘的头痛疾病，具有突然发作和慢性持续时间，缺乏基于证据的治疗方法。NDPH是一种排除性诊断，必须排除继发性头痛，病因仍然是特发性的。对这种疾病的稀疏研究尚未产生病理生理学基础，也未发现对NDPH的有效治疗方法。
方法：纳入所有在DHC诊断为NDPH的患者（n=64）。首先,我们回顾了所有诊断为NDPH的患者的记录,以评估他们是否符合诊断标准.接下来,我们提取了纳入患者的所有急性和预防性药物干预试验.然后，在≥20例患者中尝试的药物干预措施进行事后分析，以疗效作为结果，分为五个效应类别(“无效应，\"\"部分效果，\"\"完整效果,“由于不良事件导致的部分效果和停止，\"和\"由于不良事件而完全生效和停止\")。进行描述性统计分析，和结果的示意图（见表2）。
结果：64例患者中有51例符合NDPH标准，并被纳入研究。≥20例患者尝试的药物为阿米替林（n=34），坎地沙坦（n=27），和米氮平（n=20）。没有患者经历了这些药物的完全效果，而9％（3/34），26%（7/27），和15％（3/20）经历了部分效果，没有不良事件导致治疗中断，分别。其余患者经历了无效果或部分效果，不良事件导致治疗中断。
结论：在这项研究中，我们增加了现实世界的证据，表明常规用于治疗慢性偏头痛和慢性紧张型头痛的预防药物在治疗NDPH方面的效用有限；然而，26%的使用坎地沙坦的患者和15%的使用米氮平的患者出现部分缓解,需要在随机双盲安慰剂对照试验中进行进一步调查.
