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REPATHA (evolocumabe): primeiro medicamento de uma classe inédita, para tratar colesterol alto de difícil controle, a ser aprovado pela Anvisa

O medicamento acaba de chegar a mercado brasileiro e possibilita, aos pacientes que antes não conseguiam atingir níveis recomendados de colesterol, alcançá-los em até 94% dos casos, quando associado ao tratamento padrão


News provided by

Amgen

Aug 18, 2016, 08:30 ET

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SÃO PAULO, 18 de agosto de 2016 /PRNewswire/ -- Aprovado pela Anvisa em abril, RepathaTM (evolocumabe), acaba de ser lançado no mercado brasileiro. Trata-se do primeiro medicamento de uma nova classe para tratar colesterol alto de difícil controle: a dos inibidores de PCSK9 (pró-proteína convertase subtilisina/kexina tipo 9). Ele atua em uma proteína específica, a PCSK9, envolvida na degradação do colesterol. O evolocumabe é indicado para o tratamento de pacientes que necessitam de redução adicional intensa do colesterol LDL.

RepathaTM é um anticorpo monoclonal totalmente humano, que inibe a proteína PCSK9, responsável pela redução da capacidade do fígado de remover o LDL-C, ou o colesterol "ruim", do sangue. O colesterol alto é reconhecido como um importante fator de risco relacionado às doenças cardiovasculares, principal causa de morte no Brasil.

O medicamento representa um grande avanço no tratamento de pacientes com alto risco de doenças cardiovasculares que, até então, não conseguiam atingir as metas de LDL-C, mesmo em uso adequado das opções convencionais de tratamento para hipercolesterolemia. Em estudos clínicos, RepathaTM reduziu, de forma intensa, em até 75% o nível de LDL-C em adição às estatinas – tratamento padrão – assegurando que até 94% dos pacientes atingissem as metas preconizadas, finalmente atendendo a uma necessidade importante no tratamento da dislipidemia.

"A taxa de LDL-C considerada ideal para os pacientes de alto risco é bastante rigorosa, menor do que 70mg/dL, e estudos mais recentes têm sugerido valores ainda menores para pacientes de muito alto risco (menor do que 50 mg/dL), enquanto para a população sem fatores de risco, valores mais elevados, numa faixa entre 100 e 160 mg/dL, são considerados aceitáveis", contextualiza o cardiologista Francisco Antonio Helfenstein Fonseca, ex-presidente da Sociedade de Cardiologia de São Paulo (SOCESP).

Muitos pacientes, inclusive brasileiros, vêm se beneficiando com RepathaTM, por meio da participação em estudos clínicos, que abrangem diferentes situações em que há necessidade de redução intensa do colesterol. Outros tantos pacientes estão em uso rotineiro deste medicamento na Europa, nos Estados Unidos, no Canadá e em outros países em que RepathaTM já é comercializado.

O grupo de pacientes de alto risco para doenças cardiovasculares inclui aqueles indivíduos com hipercolesterolemia familiar (HF), uma condição hereditária causada por mutações genéticas e que expõe o paciente, desde a infância, a altos níveis de LDL-C, causando, por exemplo, infarto em pessoas muito jovens. Essa doença, apesar de ser genética, não é rara, mas muitos pacientes não são diagnosticados. No Brasil, estima-se que até 300.000 pessoas tenham essa condição, no entanto menos de 10% são diagnosticadas e tratadas corretamente.

"É uma grande satisfação trazer, para a população brasileira, um medicamento tão inovador, especialmente no que se refere ao combate ao colesterol alto, principal fator de risco para as doenças que mais matam no país", comenta Mauro Loch, Gerente Geral da Amgen.

A Amgen também está comprometida com a educação e o apoio para transformar os resultados clínicos em benefícios para pacientes que necessitam de RepathaTM, por meio de colaborações relevantes com foco nas necessidades médicas não atendidas, programas de pacientes e discussões sobre o tema, com a sociedade e com o governo, visando tornar essa inovação acessível àqueles que necessitam.

Contato para a Imprensa:
Adriana Toledo
+55 (11) 3529-3470

FONTE Amgen

SOURCE Amgen

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