An application of Atorvastatin to anti - fungal effects in acute myeloid leukemia: a multicenter, triple-blinded, randomized clinical trial

Author:

Saber-moghaddam Niloufar1,nodeh Mohammad Moeini1,Ghavami Vahid1,Rahimi Hossein1,azimi Sajjad Ataei1,Seddigh-shamsi Mohsen1,Kamandi Mostafa1,Allahyari Abolghasem1,maghani Somayeh Shariat1,Elyasi Sepideh1,Arasteh Omid1

Affiliation:

1. Mashhad University of Medical Sciences

Abstract

Abstract Background: The development of invasive fungal infections (IFIs) is a serious complication in Acute myeloid leukemia (AML) patients who undergo an induction to remission chemotherapy. Given the increased mortality in AML patients with IFI despite prophylaxis, we need to solve this problem. Statins have traditionally been employed in the clinical setting as agents for reducing lipid levels. Nonetheless, recent investigations have brought to light their antifungal properties in animals, as well as in-vitro studies. Objectives: The objective of this study was to assess the effectiveness of Atorvastatin in the treatment of invasive fungal infections in patients diagnosed with acute myeloid leukemia. Methods: A randomized, multicenter, triple-blind study was conducted on 76 AML patients aged 18-70, who received either placebo or Atorvastatin in addition to Fluconazole. Patients were followed for 30 days in case of developing IFIs, patients’ survival and Atorvastatin related adverse drug reactions. Data have been analyzed with SPSS version 26.0. A level of significance of 0.05 was utilized as the threshold for all statistical tests. Results: The data were analyzed by adjusting for the effect of age, regarding that there was a significant difference between the two groups, and showed that Atorvastatin reduced the development of both probable and proven IFI (based on EORTC/MSGERC criteria) compared to placebo. IFI-free survival was also significantly better in the Atorvastatin group. The incidence of developing Aspergillosis did not differ between the two groups. No serious adverse events related to Atorvastatin were seen. Conclusion: The present investigation has substantiated the antecedent in-vitro and animal research on the fungicidal impact of statins and has suggested the need for additional research involving larger sample sizes and an extended duration of follow-up.

Publisher

Research Square Platform LLC

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