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Therapeutic drug monitoring of voriconazole improved outcomes
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Discontinuation of voriconazole treatment may occur less frequently when routine therapeutic drug monitoring is utilized, according to researchers of Seoul National University, College of Medicine, in South Korea.
“Recently, several observational studies demonstrated that the blood trough level is associated with adverse events and treatment response,” the researchers wrote. “However, there have been no controlled trials that have evaluated the clinical utility of routine voriconazole therapeutic drug monitoring.”
The researchers conducted a randomized, assessor-blinded, controlled, single-center trial that included 110 patients receiving voriconazole (Vfend, Pfizer) for invasive fungal infections. The patients were randomly assigned to receive therapeutic drug monitoring or not. For those in the therapeutic drug monitoring group, blood samples were analyzed every 4 days, and the voriconazole dose was adjusted according to the trough levels (target range, 1 mg/L to 5.5 mg/L). Patients in the non-therapeutic drug monitoring group received the standard dosage of voriconazole.
The initial trough levels were within the target range in 51% of patients. In the therapeutic drug monitoring group, 26 of 53 patients had initial levels within the range. Of the other patients, six were not given a dose adjustment because of drug discontinuation or death. In the remainder, 16 patients received a dose decrease and five a dose increase. Forty-one patients in this group reached the target range.
There were no differences in adverse events between groups. Two patients in the therapeutic drug monitoring group discontinued treatment vs. nine patients in the non-therapeutic drug monitoring group. At 6 weeks, the overall mortality was 11 in the therapeutic drug monitoring group and 18 in the non-therapeutic drug monitoring group. In the therapeutic drug monitoring group, treatment success was observed in 86% of the patients vs. 63% of patients in the non-therapeutic drug monitoring group.
“Routine therapeutic drug monitoring of voriconazole may not reduce the incidence of drug-related adverse events because of the early occurrence of adverse events compared with the time needed for optimizing voriconazole levels based on therapeutic drug monitoring,” the researchers wrote. “However, voriconazole therapeutic drug monitoring did reduce drug discontinuations due to adverse events and improved the treatment response in invasive fungal infections.”
Disclosure: The researchers report no relevant financial disclosures.
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