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Zydus explora novas opções de tratamento com seu medicamento revolucionário, Lipaglyn(TM)
  • Latin America - español

Iniciados os ensaios de fase 3 para Lipaglyn[TM] (Saroglitazar) em pacientes com lipodistrofia


News provided by

Zydus

May 29, 2014, 11:50 ET

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AHMEDABAD, Índia, 29 de maio de 2014 /PRNewswire/ -- Ao explorar novos usos terapêuticos de seu medicamento revolucionário, Lipaglyn[TM] (Saroglitazar), o Zydus Group iniciou os ensaios de fase 3 da molécula para pacientes com lipodistrofia. O medicamento já foi aprovado na Índia para o tratamento da dislipidemia diabética e hipertrigliceridemia. O objetivo desse ensaio é avaliar a segurança e a eficácia de Lipaglyn 4 mg, comparado com o padrão de cuidados com placebo no tratamento da lipodistrofia.

A lipodistrofia é um problema na forma como o corpo produz, utiliza e armazena gordura. A lipodistrofia hereditária é causada por mutações em um gene. A lipodistrofia adquirida é causada por medicamentos, mecanismos de autoimunidade ou mecanismos desconhecidos. Os pacientes com lipodistrofia sofrem de distúrbios metabólicos que incluem dislipidemia e resistência à insulina, o que leva à diabetes. Esses distúrbios também podem aumentar o risco de outros problemas, como doenças cardíacas e hepáticas.

Ao falar sobre o novo desenvolvimento, o presidente e diretor administrativo do Zydus Group, o Sr. Pankaj R. Patel, afirmou: "Após lançar Lipaglyn[TM] na Índia, continuamos a buscar outros desenvolvimentos clínicos em casos com necessidades não atendidas, como a lipodistrofia. Os resultados dos estudos de fase 2 realizados anteriormente em pacientes com lipodistrofia foram encorajadores, e esperamos ampliar o desenvolvimento de Lipaglyn[TM] para o tratamento da lipodistrofia".

Lançado em setembro de 2013, Lipaglyn[TM] (Saroglitazar) é um tratamento revolucionário no tratamento da dislipidemia diabética e o primeiro NCE a chegar ao mercado indiano. Desde então, milhares de pacientes já foram tratados com Lipaglyn[TM] no país. É um medicamento vendido sob prescrição médica, disponível em toda a Índia, prescrito por cardiologistas, diabetologistas e clínicos gerais. Como duplo agonista de PPAR, Lipaglyn[TM] possui afinidade predominante com PPAR alfa e afinidade moderada com PPAR gama. Essa ação dupla reduz o triglicérides e o colesterol (ruim) LDL, além de aumentar o colesterol (bom) HDL. Além disso, mostrou redução da glicemia de jejum e hemoglobina glicada (HbA1c), o que confirma seus efeitos benéficos tanto para o controle lipídico como glicêmico. Com uma rota de eliminação não renal, Lipaglyn[TM] não apresenta eventos adversos como edema, aumento de peso, miopatias ou transtornos de funções do fígado e/ou dos rins, o que o torna seguro e eficaz.

Sobre a Zydus 

Com sede em Ahmedabad, Índia, a Zydus Cadila é uma empresa farmacêutica global e inovadora que descobre, fabrica e comercializa uma ampla gama de tratamentos para o cuidado com a saúde. O grupo conta com mais de 16.000 funcionários em todo o mundo, entre eles mais de 1100 cientistas envolvidos em P&D, e dedica-se a criar comunidades mais saudáveis no mundo todo. Como fornecedora líder de cuidados com a saúde, seu objetivo é se tornar uma empresa farmacêutica global baseada em pesquisa até 2020. O grupo possui um canal de pesquisa sólido de NCEs, produtos biológicos e vacinas em várias fases de ensaios clínicos, inclusive a última fase.

Sobre o Zydus Research Centre 

O Zydus Research Centre conta com mais de 20 programas de descoberta nas áreas de distúrbios cardiometabólicos, dores, inflamações e oncologia. O Zydus possui capacidades internas para realizar pesquisas de descoberta desde o conceito até o desenvolvimento pré-clínico de medicamentos em fase experimental e ensaios clínicos de prova de conceito com humanos.

  

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