Department of Neurology, Danish Headache Center, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Brain and Spinal Cord Injury, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Headache. 2024 May;64(5):509-515. doi: 10.1111/head.14715. Epub 2024 Apr 22.
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).
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.
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).
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.
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.
在这项来自丹麦头痛中心（DHC）的回顾性横断面真实世界证据研究中，我们试图确定治疗新的每日持续性头痛（NDPH）的潜在药物。
NDPH 是一种突发性和慢性头痛的神秘头痛障碍，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，病因仍为特发性。对这种疾病的稀疏研究尚未产生病理生理学基础，也没有发现治疗 NDPH 的有效方法。
DHC 所有患有 NDPH 诊断的患者均被纳入研究（n=64）。首先，我们回顾了所有患有 NDPH 诊断的患者的记录，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试用的急性和预防性药物干预措施。然后，对≥20 名患者尝试过的药物干预措施进行事后分析，以疗效为结果，并分为五个效果类别（“无效”、“部分有效”、“完全有效”、“部分有效并因不良反应停药”和“完全有效并因不良反应停药”）。进行描述性统计分析，并以图表形式呈现结果（见表 2）。
64 名患者中有 51 名被发现符合 NDPH 标准，并被纳入研究。尝试过≥20 名患者的药物有阿米替林（n=34）、坎地沙坦（n=27）和米氮平（n=20）。这些药物没有患者出现完全疗效，而分别有 9%（3/34）、26%（7/27）和 15%（3/20）的患者出现无不良反应停药的部分疗效。其余患者则出现无疗效或有不良反应停药的部分疗效。
在这项研究中，我们增加了真实世界的证据，表明常规用于治疗慢性偏头痛和慢性紧张型头痛的预防性药物对治疗 NDPH 的效果有限；然而，坎地沙坦和米氮平分别有 26%和 15%的患者出现部分反应，这值得进一步在随机双盲安慰剂对照试验中进行研究。
