Lancet study: Pfizer's Vfend equals two-drug candidemia regimen, with fewer serious side effects

11/03/05

New York, November 4, 2005 – Using Vfend® (voriconazole) for the treatment of nonneutropenic patients with candidemia, an often-fatal hospital-acquired bloodstream infection, is as effective as a regimen of two older antifungals and carries fewer serious side effects than that regimen. This is based on a study published in The Lancet in October.

The study highlights Vfend, Pfizer's antifungal treatment, as an important treatment option for candidemia in nonneutropenic patients (those who do not have low white blood cell counts). Vfend is the only treatment available in oral and IV formulations that is approved as first-line therapy against both mould and yeast infections.

"This study proves the effectiveness of Vfend for the treatment of candidemia, an often-deadly fungal infection for which we need multiple treatment options," said Dr. Jack D. Sobel, study investigator and professor and chief of the Division of Infectious Diseases at Wayne State University School of Medicine. "Because of Vfend's broad spectrum of activity against infections caused by yeasts and moulds, it is a good first-choice treatment option for immunocompromised patients who are at risk for those types of infection."

Candidemia is a systemic fungal infection in the blood that can lead to other body organ infections. Surgical patients and patients with compromised immune systems are at high risk for candidemia.

This study was the first ever to compare Vfend versus amphotericin B followed by fluconazole, both of which are approved treatments for candidemia. However, amphotericin B is commonly associated with toxic effects, including a risk of kidney failure. In addition, the prevalence of fluconazole-resistant Candida is increasing.

The study used a non-inferiority study design in which the trial objective was to evaluate the comparability of differing treatment options. Results showed that the treatment regimens were comparable in terms of effectiveness, including time required to clear Candida from the blood. Investigators concluded that Vfend is an effective alternative to this regimen and that it is among the most useful treatment options for candidemia in non-neutropenic patients due to its efficacy, tolerability and broad spectrum, and also due to the availability of IV and oral formulations.

Treatment discontinuations due to all-cause adverse events were more frequent in the Vfend group, although most discontinuations in this group were due to non-drug-related events. Patients taking Vfend experienced fewer serious adverse events, such as renal toxicity.

Study details
The study included 370 patients who had at least one positive blood culture for Candida within 96 hours of entering the study, and who did not suffer from neutropenia. Patients were randomly assigned (in a 2-to-1 ratio) to receive either Vfend or amphotericin B followed by fluconazole.

In the Vfend group, patients received IV Vfend for three days followed by oral Vfend for as long as needed, while the combination group received IV amphotericin B for three to seven days followed by oral fluconazole for as long as needed. Success was judged by improved clinical signs and symptoms and a negative blood culture for Candida 12 weeks after each patient's treatment ended.

In both treatment groups, 41 percent of patients reported a successful response when assessed at 12 weeks after the end of treatment. In the secondary analysis, which included all evaluable patients, including those whose last assessment was sooner than 12 weeks, about two-thirds of patients in both groups reported success – 65 percent of Vfend patients and 71 percent of amphotericin B/fluconazole patients, a difference that was not statistically significant.

Treatment with Vfend was able to clear Candida from the blood as quickly as amphotericin B plus fluconazole. The median time to attain a negative blood culture was two days in both groups. The adverse event rates were comparable between treatment groups. However, significantly more serious adverse events (57 percent in the amphotericin B/fluconazole group versus 46 percent in the Vfend group) and cases of renal toxicity (21 percent for the amphotericin B/fluconazole group versus 8 percent for the Vfend group) were reported in the amphotericin B/fluconazole group.

There were more reports of visual events in the Vfend arm. The mortality rate was similar at 42 percent for the amphotericin B/fluconazole group and 36 percent for the Vfend group.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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