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Abstract Background Migraine clinical profile may change with age, making it necessary to verify that migraine treatments are equally safe and effective in older patients. These analyses evaluated the effects of patient age on the pharmacokinetics (PK), efficacy, and safety of galcanezumab for prevention of migraine. Methods Analyses included efficacy data from three double-blind phase 3 clinical trials: two 6-month studies in episodic migraine (EVOLVE-1, EVOLVE-2: N = 1773) and one 3-month study in chronic migraine (REGAIN:N = 1113). Patients were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. Safety and PK data included additional phase 2 and phase 3 trials for a larger sample size of patients > 60 years (range = 18–65 for all studies). Subgroup analyses assessed efficacy measures, adverse event (AE) occurrence, and cardiovascular measurement changes by patient age group. Galcanezumab PK were evaluated using a population analysis approach, where age was examined as a potential covariate on apparent clearance (CL/F) and apparent volume of distribution (V/F) of galcanezumab. Results Numbers of baseline monthly migraine headache days were similar across age groups. There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use. Age (18–65) had a minimal effect on CL/F, and no effect on V/F. Galcanezumab-treated patients ≥60 years experienced no clinically meaningful increases in blood pressure and no increased frequency in treatment-emergent AEs, discontinuations due to AEs, serious adverse events (SAEs) overall, or cardiovascular SAEs, compared to age-matched placebo-treated patients. Conclusions Age (up to 65 years) does not affect efficacy in migraine prevention and has no clinically meaningful influence on galcanezumab PK to warrant dose adjustment. Furthermore, older galcanezumab-treated patients experienced no increases in frequency of AEs or increases in blood pressure compared with age-matched placebo-treated patients. Trial registrations EVOLVE-1 ( NCT02614183 , registered 23 November 2015), EVOLVE-2 ( NCT02614196 , 23 November 2015), REGAIN ( NCT02614261 , 23 November 2015), ART-01 ( NCT01625988 , 20 June 2012, ), I5Q-MC-CGAB ( NCT02163993 , 12 June 2014, ), I5Q-MC-CGAJ ( NCT02614287 , 23 November 2015, ), all retrospectively registered.

Abstract Objective To study the efficacy and safety of lasmiditan for acute treatment of migraine in patients using migraine preventive medications. Background While lasmiditan has been proven to be an effective acute treatment for migraine, its effectiveness has not been examined when used concurrently with migraine preventives. Methods SAMURAI and SPARTAN were similarly designed, double-blind, phase 3, placebo-controlled studies of patients 18 years or older with 3 to 8 migraine attacks per month. Patients were randomized to treat a migraine attack with oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo. Migraine preventives were allowed as long as doses were stable for 3 months prior to screening and were unchanged during the study. Preventive medications with established or probable efficacy, as recommended by the American Academy of Neurology, the American Headache Society, and the European Headache Federation, plus botulinum toxin type A and candesartan, were included. Within the subgroups of patients using and not using preventive therapies, lasmiditan and placebo groups were analyzed for the outcome of pain-free at 2 h and other efficacy outcomes. The subgroups of patients using and not using preventive therapies were compared and interaction p-values were calculated for safety and efficacy outcomes. Results In these trials, 698 of 3981 patients (17.5%) used migraine preventive treatments. Among patients using preventives, all lasmiditan doses resulted in significantly more patients being pain-free at 2 h, compared to placebo (p

Este estudo objetiva analisar a percepção de estudantes de cursos de graduação da saúde sobre a dinâmica do jogo InterRaps, identificando os seus limites e suas potencialidades. O jogo oferece uma imersão digital simulada da experiência de trabalho interprofissional nos equipamentos de saúde da Rede de Atenção Psicossocial. Estudo qualitativo, exploratório e descritivo. A coleta de dados ocorreu entre fevereiro e abril de 2021, durante quatro partidas do jogo InterRaps, com a participação de nove estudantes da área da saúde de uma universidade do sul do Brasil. Os dados foram submetidos à análise de conteúdo, com o apoio do Software MaxQDA. Os resultados apontaram reflexões acerca da dinâmica do jogo, jogabilidade, interprofissionalidade e do uso de plataformas online para o ensino remoto durante a pandemia de COVID-19. Constatou-se que o jogo se apresenta como alternativa para o ensino remoto, pois utiliza a metodologia ativa de gamificação do ensino na perspectiva da interprofissionalidade.