PANCREATIC TOXICITY AS AN ADVERSE EFFECT INDUCED BY MEGLUMINE ANTIMONIATE THERAPY IN A CLINICAL TRIAL FOR CUTANEOUS LEISHMANIASIS.

November 28, 2016 at 8:39 pm

Rev Inst Med Trop Sao Paulo. 2016 Sep 22;58:68.

Lyra MR1, Passos SR2,3, Pimentel MI1, Bedoya-Pacheco SJ1, Valete-Rosalino CM1,4,3, Vasconcellos EC1, Antonio LF1, Saheki MN1, Salgueiro MM1, Santos GP1, Ribeiro MN1, Conceição-Silva F5, Madeira MF1,3, Silva JL1, Fagundes A1, Schubach AO1,6,7.

Author information

1Fundação Oswaldo Cruz (FIOCRUZ), Instituto Nacional de Infectologia Evandro Chagas (INI), Laboratório de Pesquisa Clínica e Vigilância em Leishmanioses. Rio de Janeiro, RJ, Brazil. E-mails: marcelo.lyra@ini.fiocruz.br; maria.pimentel@ini.fiocruz.br; sandro.bedoya@ensp.fiocruz.br; claudia.valete@ini.fiocruz.br; erimedi@hotmail.com; lilianedefatima@gmail.com; mauricio.saheki@ini.fiocruz.br; marizasalgueiro@hotmail.com; ginelza.santos@ini.fiocruz.br;  madelon.novato@ini.fiocruz.br; fatima.madeira@ini.fiocruz.br; jorge.silva@ini.fiocruz.br;  aline.fagundes@ini.fiocruz.br; armando.schubach@ini.fiocruz.br

2Fundação Oswaldo Cruz (FIOCRUZ) Instituto Nacional de Infectologia Evandro Chagas (INI), Laboratório de Pesquisa Clínica em Epidemiologia. Rio de Janeiro, RJ, Brazil. E-mail: sonialambert@gmail.com

3Fellow researcher (“Jovem Cientista do Nosso Estado”) of Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ). Rio de Janeiro, RJ, Brazil. E-mails: sonialambert@gmail.com; claudia.valete@ini.fiocruz.br; fatima.madeira@ini.fiocruz.br

4Universidade Federal do Rio de Janeiro (UFRJ). Rio de Janeiro, RJ, Brazil. E-mail: claudia.valete@ini.fiocruz.br

5Fundação Oswaldo Cruz (FIOCRUZ), Instituto Oswaldo Cruz (IOC), Laboratório de Imunoparasitologia. Rio de Janeiro, RJ, Brazil. E-mail: fconei@ioc.fiocruz.br

6Fellow researcher of Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Rio de Janeiro, RJ, Brazil. E-mail: armando.schubach@ini.fiocruz.br

7Fellow researcher (“Cientista do Nosso Estado”) of Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ), Rio de Janeiro, RJ, Brazil. E-mail: armando.schubach@ini.fiocruz.br

Abstract

American tegumentary leishmaniasis is an infectious disease caused by a protozoan of the genus Leishmania. Pentavalent antimonials are the first choice drugs for cutaneous leishmaniasis (CL), although doses are controversial.

In a clinical trial for CL we investigated the occurrence of pancreatic toxicity with different schedules of treatment with meglumine antimoniate (MA).

Seventy-two patients were allocated in two different therapeutic groups: 20 or 5 mg of pentavalent antimony (Sb5+)/kg/day for 20 or 30 days, respectively. Looking for adverse effects, patients were asked about abdominal pain, nausea, vomiting or anorexia in each medical visit.

We performed physical examinations and collected blood to evaluate serum amylase and lipase in the pre-treatment period, and every 10 days during treatment and one month post-treatment. Hyperlipasemia occurred in 54.8% and hyperamylasemia in 19.4% patients.

Patients treated with MA 20 mg Sb5+ presented a higher risk of hyperlipasemia (p = 0.023). Besides, higher MA doses were associated with a 2.05 higher risk ratio (p = 0.003) of developing more serious (moderate to severe) hyperlipasemia. The attributable fraction was 51% in this group.

Thirty-six patients presented abdominal pain, nausea, vomiting or anorexia but only 47.2% of those had hyperlipasemia and/ or hyperamylasemia. These findings suggest the importance of the search for less toxic therapeutic regimens for the treatment of CL.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5048639/pdf/1678-9946-rimtsp-58-00068.pdf

Entry filed under: Antiparasitarios, Biología Molecular, Epidemiología, FIEBRE en el POSTOPERATORIO, Infecciones emergentes, Infecciones parasitarias, Medicina del viajero, Metodos diagnosticos, Sepsis, Update, Zoonosis. Tags: .

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