Browsing by Author "Ornello, Raffaele"
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- European Headache Federation (EHF) consensus on the definition of effective treatment of a migraine attack and of triptan failurePublication . Sacco, Simona; Lampl, Christian; Amin, Faisal Mohammad; Braschinsky, Mark; Deligianni, Christina; Uludüz, Derya; Versijpt, Jan; Ducros, Anne; Gil-Gouveia, Raquel; Katsarava, Zaza; Martelletti, Paolo; Ornello, Raffaele; Raffaelli, Bianca; Boucherie, Deirdre M.; Pozo-Rosich, Patricia; Sanchez-Del-Rio, Margarita; Sinclair, Alexandra; Maassen van den Brink, Antoinette; Reuter, UweBACKGROUND: Triptans are migraine-specific acute treatments. A well-accepted definition of triptan failure is needed in clinical practice and for research. The primary aim of the present Consensus was to provide a definition of triptan failure. To develop this definition, we deemed necessary to develop as first a consensus definition of effective treatment of an acute migraine attack and of triptan-responder. MAIN BODY: The Consensus process included a preliminary literature review, a Delphi round and a subsequent open discussion. According to the Consensus Panel, effective treatment of a migraine attack is to be defined on patient well-being featured by a) improvement of headache, b) relief of non-pain symptoms and c) absence of adverse events. An attack is considered effectively treated if patient's well-being, as defined above, is restored within 2 hours and for at least 24 hours. An individual with migraine is considered as triptan-responder when the given triptan leads to effective acute attack treatment in at least three out of four migraine attacks. On the other hand, an individual with migraine is considered triptan non-responder in the presence of failure of a single triptan (not matching the definition of triptan-responder). The Consensus Panel defined an individual with migraine as triptan-resistant in the presence of failure of at least 2 triptans; triptan refractory, in the presence of failure to at least 3 triptans, including subcutaneous formulation; triptan ineligibile in the presence of an acknowledged contraindication to triptan use, as specified in the summary of product characteristics. CONCLUSIONS: The novel definitions can be useful in clinical practice for the assessment of acute attack treatments patients with migraine. They may be helpful in identifying people not responding to triptans and in need for novel acute migraine treatments. The definitions will also be of help in standardizing research on migraine acute care.
- European Headache Federation (EHF) critical re-appraisal and meta-analysis of oral drugs in migraine prevention - part 2: flunarizinePublication . Deligianni, Christina I.; Sacco, Simona; Ekizoglu, Esme; Uluduz, Derya; Gil-Gouveia, Raquel; MaassenVanDenBrink, Antoinette; Ornello, Raffaele; Sanchez-del-Rio, Margarita; Reuter, Uwe; Versijpt, Jan; Vries, Tessa de; Hussain, Muizz; Zeraatkar, Dena; Lampl, ChristianObjective: Novel disease-specific and mechanism-based treatments sharing good evidence of efficacy for migraine have been recently marketed. However, reimbursement by insurers depends on treatment failure with classic anti-migraine drugs. In this systematic review and meta-analysis, we aimed to identify and rate the evidence for efficacy of flunarizine, a repurposed, first- or second-line treatment for migraine prophylaxis. Methods: A systematic search in MEDLINE, Cochrane CENTRAL, and ClinicalTrials.gov was performed for trials of pharmacological treatment in migraine prophylaxis, following the Preferred Reporting Items for Systematic Reviews (PRISMA). Eligible trials for meta-analysis were randomized, placebo–controlled studies comparing flunarizine with placebo. Outcomes of interest according to the Outcome Set for preventive intervention trials in chronic and episodic migraine (COSMIG) were the proportion of patients reaching a 50% or more reduction in monthly migraine days, the change in monthly migraine days (MMDs), and Adverse Events (AEs) leading to discontinuation. Results: Five trials were eligible for narrative description and three for data synthesis and analysis. No studies reported the predefined outcomes, but one study assessed the 50% reduction in monthly migraine attacks with flunarizine as compared to placebo showing a benefit from flunarizine with a low or probably low risk of bias. We found that flunarizine may increase the proportion of patients who discontinue due to adverse events compared to placebo (risk difference: 0.02; 95% CI -0.03 to 0.06). Conclusions: Published flunarizine trials predate the recommended endpoints for evaluating migraine prophylaxis drugs, hence the lack of an adequate assessment for these endpoints. Further, modern-day, large‐scale studies would be valuable in re-evaluating the efficacy of flunarizine for the treatment of migraines, offering additional insights into its potential benefits.
- European Headache Federation (EHF) critical re-appraisal and meta-analysis of oral drugs in migraine prevention-part 1: amitriptylinePublication . Lampl, Christian; Versijpt, Jan; Amin, Faisal Mohammad; Deligianni, Christina I.; Gil-Gouveia, Raquel; Jassal, Tanvir; MaassenVanDenBrink, Antoinette; Ornello, Raffaele; Paungarttner, Jakob; Sanchez-Del-Rio, Margarita; Reuter, Uwe; Uluduz, Derya; de Vries, Tessa; Zeraatkar, Dena; Sacco, SimonaOBJECTIVE: The aim of this paper is to critically re-appraise the published trials assessing amitriptyline for migraine prophylaxis. METHODS: We report our methods and results following the Preferred Reporting Items for Systematic Reviews (PRISMA), by searching MEDLINE, EMBASE, Cochrane CENTRAL, and ClinicalTrials.gov for randomized trials of pharmacologic treatments for migraine prophylaxis. We included randomized trials that compared amitriptyline with placebo for migraine prophylaxis in adults. Our outcomes of interest were informed by the Outcome Set for preventive intervention trials in chronic and episodic migraine (COSMIG) and include the proportion of patients who experience a 50% or more reduction in migraine days per month, migraine days per month, and adverse events leading to discontinuation. We assessed risk of bias by using a modified Cochrane RoB 2.0 tool and the certainty of evidence by using the GRADE approach. RESULTS: Our search yielded 10.826 unique records, of which three trials (n = 622) were eligible for data synthesis and analysis. We found moderate certainty evidence that amitriptyline increases the proportion of patients who experience a 50% or more reduction in monthly migraine days, compared to placebo (relative risk: 1.60 (95% CI 1.17 to 2.19); absolute risk difference: 165 more per 1,000 (95% CI 47 more to 327 more). We found moderate certainty evidence that amitriptyline increases the proportion of patients who discontinue due to adverse events compared to placebo (risk difference: 0.05 (95% CI 0.01 to 0.10); absolute risk difference: 50 more per 1,000 (95% CI 10 more to 100 more). CONCLUSIONS: Our meta-analysis showed that amitriptyline may have a prophylactic role in migraine patients, however these results are far from robust. This warrants further large-scale research to evaluate the role of amitriptyline in migraine prevention.
- European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 updatePublication . Sacco, Simona; Amin, Faisal Mohammad; Ashina, Messoud; Bendtsen, Lars; Deligianni, Christina I.; Gil-Gouveia, Raquel; Katsarava, Zaza; MaassenVanDenBrink, Antoinette; Martelletti, Paolo; Mitsikostas, Dimos Dimitrios; Ornello, Raffaele; Reuter, Uwe; Sanchez-del-Rio, Margarita; Sinclair, Alexandra J.; Terwindt, Gisela; Uluduz, Derya; Versijpt, Jan; Lampl, ChristianBackground: A previous European Headache Federation (EHF) guideline addressed the use of monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway to prevent migraine. Since then, randomized controlled trials (RCTs) and real-world evidence have expanded the evidence and knowledge for those treatments. Therefore, the EHF panel decided to provide an updated guideline on the use of those treatments. Methods: The guideline was developed following the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. The working group identified relevant questions, performed a systematic review and an analysis of the literature, assessed the quality of the available evidence, and wrote recommendations. Where the GRADE approach was not applicable, expert opinion was provided. Results: We found moderate to high quality of evidence to recommend eptinezumab, erenumab, fremanezumab, and galcanezumab in individuals with episodic and chronic migraine. For several important clinical questions, we found not enough evidence to provide evidence-based recommendations and guidance relied on experts’ opinion. Nevertheless, we provided updated suggestions regarding the long-term management of those treatments and their place with respect to the other migraine preventatives. Conclusion: Monoclonal antibodies targeting the CGRP pathway are recommended for migraine prevention as they are effective and safe also in the long-term.
- Longitudinal assessment of migraine burden in resistant and refractory migraine – data from the prospective REFINE studyPublication . Pensato, Umberto; Ornello, Raffaele; Rosignoli, Chiara; Caponnetto, Valeria; Onofri, Agnese; Braschinsky, Mark; Sved, Olga; Gil-Gouveia, Raquel; Oliveira, Renato; Lampl, Christian; Paungarttner, Jakob; Martelletti, Paolo; Wells-Gatnik, William David; Martins, Isabel Pavao; Mitsikostas, Dimos D.; Apostolakopoulou, Loukia; Ozge, Aynur; Narin, Dilan Bayar; Pozo-Rosich, Patricia; Munoz-Vendrell, Albert; Prudenzano, Maria Pia; Gentile, Martino; Ryliskiene, Kristina; Vainauskiene, Jurgita; Sanchez-del-Rio, Margarita; Vernieri, Fabrizio; Iaccarino, Gianmarco; Waliszewska-Prosół, Marta; Budrewicz, Sławomir; Carnovali, Marta; Katsarava, Zaza; Sacco, SimonaBackground: Some individuals with migraine fail to respond adequately to preventive treatments, bearing most of migraine burden. The European Headache Federation (EHF) classifies these individuals into resistant migraine (ResM) or refractory migraine (RefM) according to treatment failures, debilitating headache days, and disease duration. We investigated the evolution of these categories over six months in patients treated at tertiary headache centers and whether they accurately reflect disability and burden. Methods: Participants from the multicenter, prospective REFINE study were classified into three categories of treatment responsiveness, namely RefM, ResM, and non-refractory non-resistant migraine (NRNRM). The primary objective was to determine the trajectories of category changes over six months. Secondary outcomes included changes in the 6-item Headache Impact Test (HIT-6), Headache-Attributed Lost Time (HALT), and Hospital Anxiety and Depression Scale (HADS-A and HADS-D) scores. Results: Overall, 489 participants were included with a median age of 45 years (IQR = 36–53); 389 participants (79.7%) were female; 256 (52.4%) had NRNRM, 178 (36.4%) ResM, and 55 (11.2%) RefM. At follow-up, 200/256 (78.1%) NRNRM remained stable, while 56/256 (21.9%) progressed to ResM. Among those with ResM, 98/178 (55.1%) remained stable, 72/178 (40.5%) improved to NRNRM, and 8/178 (4.5%) worsened to RefM. Among participants with RefM, 37/55 (67.3%) remained stable, while 18/55 (32.7%) improved to NRNRM. Participants with RefM and ResM presented significantly higher scores at baseline than those with NRNRM. Over time, HIT-6, HALT, and HADS-A scores improved substantially in the overall cohort (p < 0.001, p < 0.001, and p = 0.006, respectively). Improvements were observed in participants with ResM across all scores and HIT-6 and HALT for NRNRM, but no improvement was noted in participants with RefM. Conclusions: Over six months, ~ 40% of ResM and ~ 30% of RefM individuals improved to NRNRM, while ~ 20% of NRNRM developed treatment resistance after receiving care in tertiary headache centers. Participants with ResM had a better prognosis than those with RefM. While both ResM and RefM reflect high migraine disability burden, they might present relevant differences in their management and prognosis.