Micafungin is not inferior in efficacy and safety to caspofungin in the treatment of invasive candidiasis and candida
Micafungin has shown no less clinical and microbiological efficacy than caspofungin with the same safety profile and good tolerance in the treatment of invasive candidiasis and candida.
The aim of a prospective multicentre, double-blind, randomized, phase III comparative study by B. Dupont et al. (France, Belgium, United States, Canada, Brazil), was to evaluate the efficacy and safety of intravenous micafungin therapy at a dose of 100 mg and 150 mg per day compared to intravenous therapy with caspofungin at a dose of 70 mg on the 1st day with a subsequent transition to 50 mg per day in patients with invasive candidiasis and candidaemia. Treatment continued for 4 weeks, followed by follow-up for 6 weeks.
The study included data from 593 patients over the age of 18 with a confirmed diagnosis of invasive candidiasis or candidaemia, with the exception of patients with endocarditis, osteomyelitis and meningitis. Patients were randomized to one of three groups (MIKA100, n = 199; MIKA150, n = 202 and CASPO, n = 192), when there was no significant difference between patients in the groups of comparison, with one exception: patients in the MIKA100 group received concomitant therapy in a larger volume than representatives of the MIKA150 and CASPO groups (20% vs 11.9% vs 10.4% , respectively; p = 0.01).
According to the results of the analysis, according to the protocol, there were no significant differences between the patients of the three groups in the overall effectiveness of the treatment (MIKA100 - 70.4%, MIKA150 - 68.8% and CASPO - 70.3%). When assessing clinical and microbiological efficacy, no difference expressed separately between the groups was also observed (84.4% vs 86.1% vs 85.9% and 85.4% vs 82.2% vs 82.8%, respectively).
During the works, the absence of a significant effect on the effectiveness of the treatment as a type of strains at the origin of the infectious process was highlighted (76.3% vs 69 , 6% vs 73.8% for Candida albicans and 75.2% vs 70.9% vs 71.1% for non albicans strains), therefore in nosological form of candidiasis (76.2% vs 74% vs 73.5 % with candidaemia and 75.9% vs 53.3% vs 65.2% for invasive candidiasis). In addition, the incidence of relapse during the follow-up period (19.6% vs 15.2% vs 19.8%, respectively), including confirmed cultural differences (4.5% vs 2.9% vs 5%), as well as the persistence of a fungal infection (9.8% vs 13% vs 13.6%) in the comparison groups did not differ significantly.
In summarizing the safety data, the authors note that the incidence of adverse events was similar in the three groups of patients. The frequency of death from fungal infection was relatively low (3.5% vs 4.5% vs 3.6%, respectively) and the episodes of death due when taking the drugs sought were not recorded.
Thus, the use of mikafungin at a daily dose of 100 mg and 150 mg was accompanied by the same efficacy, no less than that of caspofungin, with a similar safety profile. The data obtained during the study allowed the authors to envisage an optimal intravenous administration of micafungin at a dose of 100 mg / day.