14 research outputs found
The ultimate guide to the anti-CGRP monoclonal antibodies galaxy
No full textBackground Anti-CGRP monoclonal antibodies have represented a real revolution in the field of headaches, being the result of an extraordinary process of translation of new pathophysiological discoveries into successful therapies. Nonetheless, clinical practice is far more complex than pivotal trials setting, and real-world studies are blooming to deepen knowledge of these revolutionary medications.Objective To provide an updated guide for evidence-based clinical practice.Methods Pivotal phase 3 randomised clinical trials for each anti-CGRP(-R) monoclonal antibody were considered. We evaluated prospective real-world studies and summarised evidence on anti-CGRP mAbs use beyond episodic and chronic migraine.Results All phase 3 RCTs showed an unprecedented profile of efficacy and safety in migraine prevention for the four anti-CGRP mAbs. However, plenty of questions remained open after the approval process. Real-world studies filled the gap and effectiveness results equalled or unexpectedly outperformed RCTs figures in most cases; safety results showed a lower incidence of adverse events, but a higher frequency of reported constipation compared to RCTs. Almost all studies displayed a rapid and progressive headache worsening following treatment suspension. Several positive response predictors were suggested, such as unilateral pain, allodynia in episodic migraineurs, response to triptans, and a lower number of failed prophylaxes. Comparable effectiveness was observed in resistant/ refractory patients. In medication overuse headache patients, a clear clinical benefit was observed irrespective of any possible detoxification program.Conclusions Our narrative review restates the remarkable efficacy, effectiveness, and safety profile in both RCTs and realworld settings and provides scientific evidence for clinical practice
sj-pdf-1-cep-10.1177_03331024211067791 - Supplemental material for Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache
No full textSupplemental material, sj-pdf-1-cep-10.1177_03331024211067791 for Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache by Umberto Pensato, Carlo Baraldi, Valentina Favoni, Davide Mascarella, Eleonora Matteo, Giorgia Andrini, Maria Michela Cainazzo, Pietro Cortelli, Giulia Pierangeli, Simona Guerzoni and Sabina Cevoli in Cephalalgia</p
Greater occipital nerve blockade in cluster headache: effectiveness and safety of a combined injection protocol
No full textCluster headache (CH) is the most common disorder among trigeminal autonomic cephalalgia (TACs). It is characterized by attacks of harrowing unilateral pain associated with cranial autonomic symptoms and a restless and agitated behavior, occurring in bouts or clusters. Optimal management includes acute, prophylactic, and transitional treatments.
Acute therapy is aimed to interrupt a single attack, while prophylaxes are intended to reduce intensity and frequency of pain as well as to shorten cluster duration. However, preventive dosage titration can cause a delayed pain relief, overuse of triptans, and poor quality of life.
Greater occipital nerve blockade (GONB) has proved to be an effective and safe transitional treatment option. This interventional, open-label study aimed to evaluate the effectiveness and safety of the GONB protocol with methylprednisolone and lidocaine in CH Thirty days after the injection, ten patients (31%) were attack-free, reaching the primary outcome, while a total amount of 19 patients (59%) showed a reduction of at least 50% of daily attacks reaching the secondary outcome
Prevalence, natural history and dynamic nature of chronic headache and medication overuse headache in Italy: The SPARTACUS study
No full textBackgroundChronic headaches and medication overuse headache are common and burdening conditions. No studies have evaluated the prevalence of chronic headache and medication overuse headache in an unselected Italian population. MethodsWe performed a three-year cross-sectional and longitudinal population-based study to investigate prevalence, natural history, and prognostic factors of chronic headache. We delivered a self-administered questionnaire to 25,163 subjects. Chronic headache patients were interviewed by General Practitioners. After three years, medication overuse headache patients were invited to undergo a neurological evaluation at our Center. Results16,577 individuals completed the questionnaire; 6878 (41,5%) were episodic headache sufferers and 636 (3.8%) were chronic headache subjects. 239 (1.4%) patients were acute medication over-users. All medication overuse headache patients had migraine or headache with migrainous features. At the three-year follow-up of 98 patients, we observed conversion to episodic headaches in 53 (54.1%) patients. 27 (50.9%) patients remitted spontaneously. ConclusionsWe present the first prevalence data on chronic headache and medication overuse headache in an unselected Italian population and a high rate of spontaneous remission. These data support the interpretation of medication overuse headache as a specific migraine-related disorder that may reflect chronic migraine's dynamic nature, the need for more specific medication overuse headache diagnostic criteria, and highlight the priority of targeted public health policies
Spontaneous Intracranial Hypotension and Subdural Hematomas Treatment Management Using MMA Embolization and Target Blood Patch: A Case Report
No full textWe report a patient suffering from spontaneous intracranial hypotension (SIH) who, following a non-selective lumbar blood patch, returned to his healthcare provider with severe symptoms of neurological deficits. It was subsequently discovered that the aforementioned deficits were due to a bilateral subdural hematoma, and an emergency surgical drainage of the hematoma has been performed. However, the hematoma reformed and potential cerebrospinal fluid leakage was consequently investigated through myelography. Following the diagnostic finding of a venous diverticulum, a selective blood patch was executed in the affected area, and in order to stabilize the hematoma, an embolization of the middle meningeal arteries was performed. The combination of such operations allowed for the resorption of the hematoma and the improvement of neurological symptoms
Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache
No full textBackground: Medication overuse headache significantly contributes to the chronification process and treatment refractoriness of migraine. Currently, abrupt discontinuation of the overused medication still represents the best management strategy for these patients, challenging public health system resources. Methods: In this prospective study, chronic migraine and medication overuse headache sufferers with at least 28 days of analgesic consumption per month were included. Assessment of efficacy outcomes at three months were compared among patients who underwent in-hospital abrupt discontinuation of overused acute medication (YES-DETOX group) and patients who did not (NO-DETOX group) before starting an anti-CGRP monoclonal antibody. Results: Of 401 patients who received either erenumab or galcanezumab, 28% (n = 111) satisfied inclusion criteria (YES-DETOX n = 28; NO-DETOX n = 83). After three months of treatment, 59% (n = 65; 47/83 YES-DETOX; 18/28 NO-DETOX) patients reverted from medication overuse headache and 51% (n = 57; 42/83 YES-DETOX; 15/28 NO-DEOTX) achieved ≥50% reduction in monthly headache days; yet no statistical differences were observed between the two groups (p = 0.4788 and p = 0.8393, respectively). Monthly consumption of pain medication was the only baseline prognostic factor in multivariate analysis in the overall cohort (p = 0.016). Conclusion: Our results support the emerging evidence that anti-CGRP monoclonal antibodies may be effective in medication overuse headache patients irrespective of detoxification, yet further studies are needed to draw definitive conclusions
Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study
No full textBackground 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
DTI-ALPS Scoping Review
No full textThis project outlines the protocol for a scoping review aiming to systematically map the scientific literature on the use of Diffusion Tensor Image-Analysis Along the Perivascular Space (DTI-ALPS) as a non-invasive imaging technique to assess glymphatic function in human neurological disorders.
DTI-ALPS quantifies directional diffusivity along perivascular spaces on diffusion MRI and has been proposed as a proxy marker of glymphatic activity. However, its physiological validity remains debated, and methodological inconsistencies across studies hinder its clinical interpretation.
The review follows PRISMA-ScR guidelines and will include peer-reviewed human studies published between January 2016 and June 2024. It will address six research questions regarding methodological consistency, multimodal validation, reported findings in neurological conditions, and handling of confounding factors such as brain atrophy or microvascular disease.
A comprehensive PubMed search will be conducted, and data extraction will focus on study design, ALPS calculation methods, associated clinical and radiological variables, and reporting of outcomes. The results will help clarify the current role, limitations, and future perspectives of the DTI-ALPS method in clinical neuroscience
Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study)
No full textBackground: Rimegepant, a novel oral calcitonin gene-related peptide receptor antagonist, has been recently approved for the acute migraine treatment. While its efficacy was confirmed in randomized clinical trials, no data is available regarding real-life effectiveness and tolerability. GAINER, a prospective, multicentric study, aimed to evaluate rimegepant effectiveness and tolerability in the real-world setting. Methods: Our study involved 16 headache centers across Italy. The main outcomes were: i) 2 h pain freedom, and ii) occurrence of treatment-emergent adverse events after administration. Participants were instructed to treat one migraine attack with rimegepant 75 mg orally disintegrating tablet. Using an ad hoc diary, participants prospectively collected migraine attack features at baseline and every 30 min after rimegepant administration, up to 2 h post dose. A 24 h follow up was also collected. Results: We enrolled 103 participants with migraine (74.8% female, mean age 44.4 [42.0 – 46.7] years, 24.3% with chronic migraine of whom 44.0% presented a concomitant diagnosis of medication overuse headache). The number of previously failed preventive classes was 2.7 [2.3 – 3.2]. Participants presented a mean of 9.6 [8.2 – 10.9] monthly migraine days at baseline. At rimegepant intake, 40.8% of patients rated migraine intensity as severe. Pain freedom 2 h post dose was reported in 44.7% (46/103) of individuals. Pain freedom 2 h post dose was not influenced by baseline pain severity (p = 0.316), but it was associated with timing of intake (p = 0.032) with a higher rate of 2 h pain freedom when rimegepant was taken within 1 h from pain onset. Mild adverse events were reported in 15.5% total attacks (16/103), predominantly fatigue (n = 6), gastrointestinal symptoms (n = 6), somnolence (n = 4), and transient cognitive difficulties (n = 3). Tolerability was rated as good-to-excellent in 85.4% cases (88/103). Conclusions: Our data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants that includes subjects with episodic or chronic migraine, medication overuse and a high number of prior preventive treatment failures. Trial registration: The study was preregistered on clinicaltrial.gov, NCT05903027
A 24‐week prospective, multicenter, real‐world study on eptinezumab’s effectiveness and safety in migraine prevention (EMBRACE II)
No full textIntroduction: We evaluated the effectiveness, tolerability, and safety of eptinezumab in preventing high-frequency episodic migraine (HFEM) and chronic migraine (CM) over 24 weeks in real-world. We also assessed its impact during the first treatment week, in patients failing monoclonal antibodies targeting the calcitonin gene-related peptide (anti-CGRP mAbs), and the effects of dose escalation to 300 mg in patients requiring enhanced control. Methods: EMBRACE II is a multicenter (n = 22), prospective, 24-week, real-world study involving consecutive patients with HFEM or CM who had failed > 3 preventive treatments. Eptinezumab (100 mg, with the option for escalation to 300 mg at week 12) was administered quarterly. Primary endpoint: change in monthly migraine days (MMD), for HFEM or monthly headache days (MHD), for CM, between weeks 21–24 and baseline. Secondary endpoints: changes in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), Migraine Disability Assessment Scale (MIDAS), Migraine Interictal Burden Scale (MIBS-4), and responder rates. Results: Of the 215 participants who had received ≥ 1 eptinezumab dose, 74 were treated for ≥ 24 weeks and considered for effectiveness analysis. Eptinezumab significantly (p < 0.001) reduced MMD/MHD (− 10.5), MAI (− 15.6), NRS (− 2.2), HIT-6 (− 9.9), MIDAS (− 48.7), and MIBS-4 (− 4.3). ≥ 50% responders were 69%, ≥ 75% responders 39.2%, and 100% responders 4.1%. Comparing the first week with the last baseline week, a significant reduction in migraine days was observed (− 3.7; p < 0.001). Significant improvements were seen in patients failing anti-CGRP mAbs (32.4%) and in those escalating to 300 mg (33.8%). Half of the subjects reported being “very much improved” or “much improved”. The adverse events were infrequent (2.8%). Conclusions: This real-world study documents that 24-week eptinezumab treatment is rapidly effective and well tolerated in migraine patients with multiple therapeutic failures (including anti-CGRP mAbs). One-third of patients escalated to 300 mg at week 12, achieving further significant migraine-related disability reduction
