Anidulafungina versus complexo lipídico de anfotericina B (desoxicolato ou formulação lipídica) no tratamento de candidemia e outras formas de candidíase invasiva

Abstract

INTRODUCTION: Candidemia is considered one of the main causes of mortality in ICUs, with a death rate of around 40%. In addition, it is responsible for raising the cost of hospitalizations. In this sense, the optimization of therapeutics is relevant, to have a better adjustment and cost reduction in health. This project is following the line of research on quality in adult health care and was developed at the request of the Health Surveillance Secretariat of the Ministry of Health, in partnership with the research project of the Evidence-Based Health Laboratory of the Escola Superior in Sciences of Health, Brasília, Federal District. OBJECTIVE: To evaluate the efficacy and safety of anidulafungin compared to amphotericin B (deoxycholate and lipid formulations) in the treatment of candidemia and other forms of invasive candidiasis. METHODS: A scoping review was performed, searching for clinical trials and systematic reviews in Medline (PUBMED), EMBASE, The Cochrane Library, Latin American and Caribbean Literature on Health Sciences (LILACS), Scopus and Web of Science until October 31, 2021, without restriction on language or publication date. A search was also carried out in the gray literature using the Google Scholar and Open Gray platforms. In addition, a manual search was performed in the references of the included articles. The Rayyan Online Platform for Systematic Reviews was used as a tool for screening and selecting the studies identified by the search. Articles considered eligible were included in the risk of bias assessment step using the Cochrane Collaboration Tool to assess the risk of bias in randomized clinical trials (RoB 2) in the case of clinical trials or by the tool The MeaSurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) in the case of systematic reviews. The evaluation of the quality of the evidence was performed using the GRADE instrument (Grading of Recommendations Assessment, Development and Evaluation). RESULTS/PRODUCTS: 918 studies were found in the databases used, of which 310 were duplicates, leaving 608 for screening by title and abstract. This step excluded 542 studies, leaving 66 studies for full text analysis. In this last stage, 64 studies that did not answer the research question were excluded, and two scientific articles were included, which correspond to two systematic reviews that compare anidulafungin and amphotericin B formulations from clinical trials that included these drugs in the treatment of people with invasive candidiasis. It was observed that there is moderate evidence favorable to the use of anidulafungin technology for absolute efficacy / chance of being the best drug (anidulafungin - 77.49% / 0.345, liposomal amphotericin B - 72.98% / 0.070 and amphotericin B deoxycholate: 65, 40% / 0.000). There was no significant difference in terms of mortality. In adverse events, there was a lower incidence of elevation of liver enzymes without the need to discontinue the drug in the treatment with anidulafungin compared to treatments with amphotericin B formulations. adverse event treatment. A randomized clinical trial comparing another drug of the same class with amphotericin B showed that micafungin was as effective and better tolerated (lower incidence of renal dysfunction and adverse events leading to discontinuation of treatment) than liposomal amphotericin B. However, it should be noted that no clinical trials were found directly comparing anidulafungin and amphotericin B formulations in people with invasive candidiasis. As products, a scientific article was developed to be sent for publication in the journal ESCS-EDU and a Scientific Technical Opinion sent to the Ministry of Health, which composed the Recommendation Report “Anidulafungin for the treatment of patients with candidemia and other forms of invasive candidiasis” presented the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC), being the drug unanimously recommended for incorporation into the Unified Health System (SUS) by the members of CONITEC in June 2021 after the inclusion of the analyzes of economic and budgetary impact and public consultation. On 07/28/2022, the Ministry of Health published SCTIE Ordinance No. 55, deciding to incorporate anidulafungin into the SUS for the treatment of candidemia and other forms of invasive candidiasis. CONCLUSION: There is moderate evidence favorable to the use of anidulafungin technology for absolute efficacy/chance of being the best drug. There was no significant difference in terms of mortality. In adverse events, there was a lower incidence of elevation of liver enzymes without the need to suspend the drug in treatment with anidulafungin compared to treatments with amphotericin B formulations. SUS for the treatment of candidemia and other forms of invasive candidiasis.