Discussion
AKI, renal failure, diabetic nephropathy, prerenal failure
DISEASE, RENAL FAILURE, DIABETIC NEPHROPATHY, AML
In this EAS, venetoclax in combination with LDAC showed a similar safety profile to that in the VIALE-C study. Regarding patient characteristics, the venetoclax plus LDAC arm of the VIALE-C study (The patient with AKI developed renal failure and decreased blood pressure after changing the antifungal prophylaxis to fluconazole. Fluconazole, which is a moderate cytochrome P450 3A (CYP3A) inhibitor, may have increased the blood concentration of nifedipine, which is a substrate of CYP3A, and decreases blood pressure and could have resulted in prerenal failure. Additionally, the patient’s history of diabetic nephropathy may have contributed to the development of AKI. In the VIALE-C study, 7 out of 142 patients (4.9%) in the venetoclax + LDAC group had AKI (including 1 with SAE) compared with 5 of 68 patients (7.4%) in the placebo + LDAC group, with no increase in venetoclax treatment, although no SAEs were reported in the latter group (G-CSF was used in 5 out of 14 patients (35.7%), including for prophylactic purposes (This study did not include efficacy endpoints because this was an EAS focusing on ‘early access’ for patients with no effective therapy; however, bone marrow assessment after Cycle 1 was performed to evaluate the disease condition at the discretion of each investigator. The rates of CR and CRi appeared to be similar to the outcomes of the VIALE-C study. Additionally, the achievement rate of transfusion independence suggested efficacy of venetoclax plus LDAC, which is comparable with that in the VIALE-C study (The VIALE-C study confirmed the benefit–risk balance of venetoclax treatment in combination with LDAC among patients with untreated AML who are ineligible for intensive chemotherapy and for whom treatment options are limited (In conclusion, the AEs reported in this EAS were consistent with the known safety profile of venetoclax plus LDAC and were successfully managed with standard medical care. The findings of this EAS further support the benefit–risk profile of venetoclax plus LDAC shown in the VIALE-C study.