The results of an phase III clinical trial which compared the combination of Voriconazole ( Vfend ) and Anidulafungin ( Eraxis ) to Voriconazole monotherapy for primary therapy of invasive aspergillosis, a life-threatening invasive fungal infection that can develop as a complication in patients with compromised immune systems, have been reported.
The primary analysis of this double-blinded prospective randomized clinical trial was to compare mortality rates at six weeks after initiation of study treatment in patients with a diagnosis of proven or probable invasive aspergillosis.

In the primary analysis, treatment with the combination of Voriconazole and Anidulafungin resulted in a lower all-cause mortality rate at six weeks compared to Voriconazole alone. However, this difference in mortality did not achieve the pre-specified threshold for statistical superiority. The safety and tolerability of the combination of Voriconazole and Anidulafungin in this study was similar to that of Voriconazole monotherapy.

This was a prospective double-blind clinical trial conducted in cooperation with the international Mycoses Study Group, a consortium of academic Centers with the expressed purpose of investigating the epidemiology, diagnosis and treatment of invasive fungal infections. Patients were randomized at study entry to receive initial treatment with either the combination of Voriconazole and Anidulafungin or Voriconazole and an inactive placebo. After completing two to four weeks of blinded combination treatment, patients were allowed to continue treatment with Voriconazole monotherapy. A total of 454 patients from 24 countries were enrolled into the study during the period from July 2008 to February 2011. A diagnosis of proven or probable invasive aspergillosis at study entry was confirmed in 277 patients by an independent blinded Data Review Committee managed by the Mycoses Study Group. The primary objective of the study was to compare all-cause mortality at six weeks from study entry.

Invasive aspergillosis usually manifests as a severe pulmonary infection that is often accompanied by chest pain, fever and coughing or breathlessness. The infection may spread throughout the body and can settle in numerous organs, including the brain. If left untreated, invasive aspergillosis can be fatal.

Voriconazole iv/oral is the only broad-spectrum iv/oral triazole antifungal medication specifically indicated for the first-line treatment of both mould and yeast infections.
Vfend is indicated for use in the treatment of the following fungal infections: invasive aspergillosis; candidemia in nonneutropenic patients and other forms of Candida infections ( disseminated infections in skin and infections in the abdomen, kidney, bladder wall, and wounds ); esophageal candidiasis; and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp, including F. solani, in patients intolerant of, or refractory to, other therapy.

Anidulafungin for injection belongs to the echinocandin class of antifungal drugs and is used to treat serious fungal infections caused by Candida, a yeast commonly found on the skin, in the digestive tract, or as a contaminant on medical equipment and devices.
Eraxis is indicated for the treatment of the following fungal infections caused by Candida: candidemia and other forms of Candida infections ( intra-abdominal abscess and peritonitis ); esophageal candidiasis.
Eraxis has not been studied in endocarditis, osteomyelitis, or meningitis due to Candida, and has not been studied in sufficient numbers of neutropenic patients with Candida infections to determine efficacy in this group. Eraxis is not indicated for the treatment of invasive aspergillosis.

Source: Pfizer, 2011

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