Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study)
Abstract Background 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. GAIN...
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2025-01-01
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| Series: | The Journal of Headache and Pain |
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| Online Access: | https://doi.org/10.1186/s10194-024-01935-8 |
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| author | Luigi Francesco Iannone Gloria Vaghi Gabriele Sebastianelli Francesco Casillo Antonio Russo Marcello Silvestro Francesca Pistoia Giorgio Dalla Volta Matteo Cortinovis Alberto Chiarugi Danilo Antonio Montisano Maria Pia Prudenzano Sabina Cevoli Edoardo Mampreso Gianluca Avino Marina Romozzi Mariarosaria Valente Carla Fasano Stefania Battistini Antonio Granato Elisa Maria Piella Innocenzo Rainero Raffaele Ornello Roberto De Icco On behalf of the Italian Headache Registry (RICe) Study Group |
| author_facet | Luigi Francesco Iannone Gloria Vaghi Gabriele Sebastianelli Francesco Casillo Antonio Russo Marcello Silvestro Francesca Pistoia Giorgio Dalla Volta Matteo Cortinovis Alberto Chiarugi Danilo Antonio Montisano Maria Pia Prudenzano Sabina Cevoli Edoardo Mampreso Gianluca Avino Marina Romozzi Mariarosaria Valente Carla Fasano Stefania Battistini Antonio Granato Elisa Maria Piella Innocenzo Rainero Raffaele Ornello Roberto De Icco On behalf of the Italian Headache Registry (RICe) Study Group |
| author_sort | Luigi Francesco Iannone |
| collection | DOAJ |
| description | Abstract Background 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. |
| format | Article |
| id | doaj-art-d0e904bf83054869871be7cac88b158b |
| institution | Kabale University |
| issn | 1129-2377 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | The Journal of Headache and Pain |
| spelling | doaj-art-d0e904bf83054869871be7cac88b158b2025-01-12T12:33:10ZengBMCThe Journal of Headache and Pain1129-23772025-01-0126111110.1186/s10194-024-01935-8Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study)Luigi Francesco Iannone0Gloria Vaghi1Gabriele Sebastianelli2Francesco Casillo3Antonio Russo4Marcello Silvestro5Francesca Pistoia6Giorgio Dalla Volta7Matteo Cortinovis8Alberto Chiarugi9Danilo Antonio Montisano10Maria Pia Prudenzano11Sabina Cevoli12Edoardo Mampreso13Gianluca Avino14Marina Romozzi15Mariarosaria Valente16Carla Fasano17Stefania Battistini18Antonio Granato19Elisa Maria Piella20Innocenzo Rainero21Raffaele Ornello22Roberto De Icco23On behalf of the Italian Headache Registry (RICe) Study GroupDepartment of Health Sciences, University of FlorenceDepartment of Brain and Behavioral Sciences, University of PaviaDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo PontinoDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo PontinoHeadache Centre, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”Headache Centre, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”Department of Biotechnological and Applied Clinical Sciences, University of L’AquilaHeadache Center of Clinical Neurology of Istituto Clinico Città Di BresciaHeadache Center of Clinical Neurology of Istituto Clinico Città Di BresciaDepartment of Health Sciences, University of FlorenceNeuroalgology Unit and Headache Center, Fondazione IRCCS Istituto Neurologico Carlo BestaHeadache Center, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of BariIRCCS Istituto Di Scienze Neurologiche Di Bologna, Programma Cefalee e Algie FaccialiHeadache Centre, Neurology - Euganea, Health UnitNeurology UnitFondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro CuoreClinical Neurology, Azienda Sanitaria Universitaria Friuli CentraleHeadache and Facial Pain Center Neurology, AOU CareggiDepartment of Medical, Surgical and Neurological Sciences, University of SienaHeadache Centre, Clinical Unit of Neurology, School of Neurology, Department of Medicine, Surgery and Health Sciences, University Hospital and Health Services of Trieste, ASUGI, University of TriesteDepartment of Neurosciences “Rita Levi Montalcini”, University of TurinDepartment of Neurosciences “Rita Levi Montalcini”, University of TurinDepartment of Biotechnological and Applied Clinical Sciences, University of L’AquilaDepartment of Brain and Behavioral Sciences, University of PaviaAbstract Background 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.https://doi.org/10.1186/s10194-024-01935-8Acute treatmentsGepantsTriptansCGRP |
| spellingShingle | Luigi Francesco Iannone Gloria Vaghi Gabriele Sebastianelli Francesco Casillo Antonio Russo Marcello Silvestro Francesca Pistoia Giorgio Dalla Volta Matteo Cortinovis Alberto Chiarugi Danilo Antonio Montisano Maria Pia Prudenzano Sabina Cevoli Edoardo Mampreso Gianluca Avino Marina Romozzi Mariarosaria Valente Carla Fasano Stefania Battistini Antonio Granato Elisa Maria Piella Innocenzo Rainero Raffaele Ornello Roberto De Icco On behalf of the Italian Headache Registry (RICe) Study Group Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study) The Journal of Headache and Pain Acute treatments Gepants Triptans CGRP |
| title | Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study) |
| title_full | Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study) |
| title_fullStr | Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study) |
| title_full_unstemmed | Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study) |
| title_short | Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study) |
| title_sort | effectiveness and tolerability of rimegepant in the acute treatment of migraine a real world prospective multicentric study gainer study |
| topic | Acute treatments Gepants Triptans CGRP |
| url | https://doi.org/10.1186/s10194-024-01935-8 |
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