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Efeitos da vildagliptina sobre o controle da glicose em 24 semanas em pacientes com diabetes do tipo II inadequadamente controlados com metformina

Bosi E, Camisasca RP, Garber AJ et al. Effects of Vildagliptin on Glucose Control Over 24 Weeks in Patients With Type 2 Diabetes Inadequately Controlled With Metformin. Diabetes Care. April, 2007;30(4):890-895.

Conhecimento prévio ao estudo: A vildagliptina é uma nova classe de medicamentos para o tratamento e prevenção do Diabetes Mellitus do tipo II, os inibidores da dipeptil peptidase-4 (DPP-4), provocando o aumento plasmático da incretina com conseqüente estímulo à liberação de insulina e inibição da produção de glucagon.

Objetivo do estudo: Avaliar a eficácia e a segurança da vildagliptina adicionada à metformina durante 24 semanas de tratamento em pacientes com diabetes do tipo II.

Metodologia: Ensaio clínico prospectivo, longitudinal, randomizado, multicêntrico, duplo cego, controlado, com grupos paralelos, sem cruzamentos, com duração de 24 semanas. Os pacientes permaneceram com a dosagem estável da metformina (=/> 1.500mg/dia) e com controle glicêmico inadequado (Hemoglobina A1C 7,5 – 11%) e receberam 50mg/dia de vildagliptina (n= 177), 100mg/dia de vildagliptina (n= 185) ou placebo (n= 182).

Resumo dos resultados: A diferença entre os tratamentos (vildagliptina – placebo) na mudança média ajustada (AM{Delta}) ± DP na A1C do basal para o final do estudo foi de –0,7 ± 0,1% (P <>P <> pacientes recebendo 50 ou 100 mg de vildagliptina diariamente, respectivamente. A diferença entre tratamento na AM{Delta} da glicose plasmática em jejum foi de –0,8 ± 0,3 mmol/l (P = 0,003) e –1,7 ± 0,3 mmol/l (P <> ou 100 mg de vildagliptina diariamente, respectivamente.

Eventos adversos foram relatados em 63,3, 65,0 e 63,5% dos pacientes recebendo 50 mg de vildagliptina diariamente, 100 mg de vildagliptina diariamente ou placebo, respectivamente. Eventos adversos gastrintestinais foram relatados em 9,6 (P = 0,022 vs. placebo), 14,8 e 18,2% dos pacientes recebendo 50 mg de vildagliptina diariamente, 100 mg de vildagliptina diariamente ou placebo, respectivamente. Um paciente em cada grupo de tratamento experimentou um leve evento hipoglicêmico.

Conhecimento adquirido com o estudo: A vildagliptina é bem tolerada e produz clinicamente significante redução dose-relacionada na hemoglobina glicada A1C e na glicose plasmática de jejum, como terapia adjuvante em pacientes com diabetes do tipo II inadequadamente controlados pela metformina.

Força de evidência: (A)* - Ensaio clínico prospectivo, longitudinal, randomizado, multicêntrico, duplo cego, controlado, com grupos paralelos, sem cruzamentos, com duração de 24 semanas. Excelente metodologia e tratamento estatístico. Mínima perda de seguimento e resultados de acordo com as conclusões apresentadas. Um dos pesquisadores é funcionário da indústria que pesquisou a vildagliptina, mas não interferiu nos resultados do estudo e nem na discussão e conclusão do trabalho. Excelente aplicabilidade clínica.

Os autores principais são membros da Diabetes and Endocrinology Unit, Department of General Medicine, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy e do Baylor College of Medicine, Houston, Texas. Autor responsável: Alan J. Garber, MD, PhD – agarber@bmc.tmc.edu.

84 comentários:

putaveia disse...

Grato pela publicação do Estudo
Estou usando o galvus (vildagliptina) à 4 dias e meus niveis de glicemia agora variam de 120-195, mas não fogem mais dessa faixa
Estava utilizando Glibemclamida + metformina e ela estava se descontrolando, chegando a picos de 380
Não sou insulino-dependente
Grato

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Gostei da Publicação:
EStou usando a vidagliptina conjuntamente com a metformina e reduzi de 120mg para 97 mg.
Importante usar a fidagliptina antes do café da manhâ e antes da janta, pois eu usava incorretamente e não surtiu efeito.
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Estou usando o medicamento há alguns dias e estou sentindo muito desconforto. Mal estar generalizado, dor de cabeça constante e o pior de todos, enjoo. Meus níveis de glicemia abaixaram consideravelmente, chegando a 84 em jejum e 104 pós almoço, porém os desconfortos do remédio são péssimos.

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Estou usando galvus Met(50mg +850mg),sinto taquicardia, tremor,rosto quente, não consigo dormir direito.Não sei se a dose esta certa um comprimido de manhã e outro a noite. A hemoglobina glicosilada é de 7,5- tenho 54 anos.Pode responder.Arlei Aparecida Gomeiro

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