Sabina Cevoli

Aim: Rimegepant is an effective acute migraine treatment, with limited evidence regarding its consistency across multiple migraine attacks. The primary aim is to assess rimegepant effectiveness across multiple migraine attacks. Methods: In this real-world, prospective, multicentric study we assessed participants who treated up to four different migraine attacks with rimegepant 75 mg orally disintegrating tablet. Data was collected every 30 min from migraine onset up to 2 h post dose using an electronic diary. Our primary outcome was 2-h pain freedom across all-treated attacks; secondary outcomes were: consistency of response (percentage of participants who achieved 2-h pain freedom in at least two treated attacks), safety and tolerability. Results: We enrolled 191 participants (80.1% females, age 44.8 [43.2–46.5] years, disease duration 28.4 [25.0–31.8] years, 27.7% with chronic migraine, 9.6 [8.9–10.9] baseline monthly migraine days-MMDs). We collected data from 377 migraine attacks (191 first-treated, 110 s-treated, 46 third-treated and 30 fourth-treated). Two-hour pain freedom was achieved in 44.6% (168/377) of treated attacks [39.3–49.6]. After correction for age, timing of rimegepant intake, baseline pain intensity, ongoing preventive treatment, and number of preventive drug classes that previously proved ineffective, 2-h pain freedom was associated with female sex (odds ratio (OR) = 2.3 [1.2–4.3], p = 0.012), no ongoing mAbs treatment (OR = 3.2 [1.6–6.4], p = 0.001), and lower MMDs (OR = 1.05 [1.0–1.1], p = 0.002). Consistency of response was 36.4% [27.3–45.5] (40/110). Participants reporting at least one adverse event were 11.5% (22/191). Conclusion: Our study confirms the effectiveness of rimegepant in nearly half of treated attacks and describe the consistency of response in a relatively large real-world population where one out of five participants achieved 2-h pain freedom in all-treated migraine attacks. No new safety signals were identified.

What are the main findings?Migraine care in Italy is characterized by a mismatch between healthcare resource utilization and clinical needs, with limited primary-care involvement, repeated specialist consultations, and healthcare nomadism.Healthcare resource utilization is substantial, including extensive diagnostic testing—predominantly brain imaging—as well as emergency department visits, detoxification cycles, and repeated access to headache centers.

Background/Objectives: Migraine is a common, disabling neurological disorder disproportionately affecting women during hormonally sensitive phases like menarche, pregnancy, and menopause. Despite awareness of sex-specific risk factors, management remains fragmented and predominantly neurologist-led, with limited coordination. To address these gaps, this project aimed to develop a national expert consensus, endorsed by scientific societies, on multidisciplinary migraine management in women across the lifespan, integrating perspectives from neurology, gynecology, endocrinology, cardiology, and general medicine. Methods: A two-round Delphi survey was conducted among 145 Italian clinicians representing the five specialties. The Scientific Board formulated 50 questions, each consisting of a variable number of statements, covering diagnostic approaches, hormonal therapies, comorbidities, and organizational care pathways. Statements were rated on a nine-point Likert scale, and consensus was defined using pre-specified criteria based on median scores and agreement. Results: Overall, 79 of 145 statements (54%) achieved consensus. High-level agreement emerged on sex-informed diagnostic strategies, including systematic gynecological and endocrinological evaluation and hormonal profiling in women with migraine. Round 2 facilitated consensus on contentious issues, such as avoiding estrogen-containing contraceptives in migraine with aura, individualized thrombotic risk assessment during menopause, and structured interdisciplinary coordination—particularly among neurologists, gynecologists, and general practitioners—during fertility planning and assisted reproduction. Qualitative feedback emphasized the need to update clinical pathways, implement standardized referral models, and strengthen interprofessional communication. However, persistent divergence remained on selected topics, particularly the role of hormonal contraceptives as a first-line approach to migraine management in women of reproductive age, reflecting different priorities between gynecologists and neurologists. Conclusions: This Delphi initiative provides the first national multidisciplinary consensus on migraine management in women in Italy. The findings support the development of sex- and life-stage-specific clinical guidance and integrated care models tailored to the complex needs of women with migraine.

Medication overuse headache (MOH) causes substantial disability in suffering patients, significantly reducing the quality of life. It may lead to structura

The aim of this study was to describe the long-term effectiveness and treatment persistence of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (MAbs) in migraine and to identify baseline factors associated with 2-year treatment continuation. A prospective observational multicenter registry-based study of anti-CGRP MAbs was conducted. We analyzed changes in monthly headache days (MHDs) at 24 months (M24) compared with baseline in those who reached M24 (ON-group). We analyzed patterns of response at 4 time points (6, 12, 18, and 24 months). We defined sustained response (SR) as a ≥50% reduction in MHDs at ≥3 of 4 time points. We compared baseline characteristics of the ON-group with those of the discontinuation group because of lack of effectiveness (OFF-group). A total of 1,340 individuals reached M24 (ON-group: median age 48.0 [41.0-55.0] years; 81.7% female). The median MHD at baseline was 20.0 (13.0-28.0) days. At M24, 60.4% of patients demonstrated ≥50% reduction in MHDs (809/1,340). The proportion of participants achieving SR at M24 was 53.8% (142/264). When compared with the ON-group (n = 1,340), the OFF-group (n = 1,057) showed statistically significant higher baseline MHDs (ON: 20.0 [13.0-28.0] vs OFF: 25.0 [16.0-28.0]) and a greater proportion of patients with aura (ON: 16.2% vs OFF: 22.9%), depression (ON: 22.8% vs OFF: 37.9%), and obesity (ON: 7.2% vs OFF: 19.1%) (p < 0.001). Sustained reductions in MHDs to anti-CGRP treatment at 2 years was observed. Delayed treatment onset, migraine with aura, depression, and obesity may negatively affect treatment persistence. This study provides Class IV evidence that, in patients with migraine, treatment with anti-CGRP MAbs is associated with sustained reductions in MHDs over a 24-month period.

Migraine is the most frequent primary disorder of medication overuse headache (MOH). As MOH progresses, patients tend to increase medication doses, which p

We here present evidence-based guidelines for the pharmacological treatment of migraine. These guidelines, created by the Italian Society for the Study of Headache and the International Headache Society, aim to offer clear, actionable recommendations to healthcare professionals. They incorporate evidence-based recommendations from randomized controlled trials and expert-based opinions. The guidelines follow the GRADE approach for assessing the quality of evidence. The guideline development involved a systematic review of literature across multiple databases, adherence to Cochrane review methods, and a structured framework for data extraction and interpretation. Although the guidelines provide a robust foundation for migraine treatment, they also highlight gaps in current research, such as the paucity of head-to-head drug comparisons and the need for long-term outcome studies. These guidelines serve as a resource to standardize migraine treatment and promote high-quality care across different healthcare settings.

Background: While monoclonal antibodies (mAbs) targeting the CGRP pathway have revolutionized migraine management due to their improved tolerance and adherence, concerns remain about their potential impact on blood pressure (BP), especially in older patients, due to CGRP-mediated vasodilation blockade. Given the growing use of these therapies in older populations, assessing their cardiovascular (CV) safety is of paramount importance. Methods: This multicentric observational prospective study focused on migraine sufferers aged ≥ 60 who began erenumab, galcanezumab, or fremanezumab for prevention. Baseline, three-month, and twelve-month BP measurements were collected. Changes in antihypertensive medication and "Newly or Worsened Hypertensive" patients (NWHP) were assessed. Results: Among 155 patients receiving anti-CGRP mAbs (40 Erenumab, 47 Galcanezumab, 68 Fremanezumab), 42.5% had hypertension history and 39% were on antihypertensive treatment. No significant systolic or diastolic BP changes occurred at any time point compared to baseline (all p > 0.05), with no differences between the three groups. After one year, 20/155 (12.9%) patients were considered NWHP; 11/20 had prior hypertension, and 5/11 adjusted antihypertensive therapy. Among 9/20 newly hypertensive patients, 5/9 had a single measurement above the normal threshold with no requirement for new pharmacological therapy. A higher baseline BP value was associated with increased BP (p = 0.002). Conclusions: The study concludes that treatment with anti-CGRP mAbs over one year does not significantly affect BP in patients aged ≥ 60, nor does it increase the incidence of hypertension compared to general population trends. Nonetheless, continuous monitoring and further long-term studies are necessary to fullya scertain the cardiovascular safety of these medications in the elderly.