Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia.
This study evaluated the safety and efficacy of anidulafungin, a novel echinocandin, in patients with invasive candidiasis, including candidemia. A total of 123 eligible patients were randomized to one of three intravenous regimens, 50, 75, or 100 mg once daily. Treatment continued for 2 weeks beyond resolution or improvement of signs and symptoms. The primary efficacy criterion was a successful global response rate (i.e., clinical and microbiological success) in the evaluable population at the follow-up (FU) visit, 2 weeks after end of therapy (EOT). One hundred twenty (120) patients received at least one dose of anidulafungin; 68 were evaluable. Review of adverse events and laboratory data indicated no dose response for safety parameters. Non-albicans Candida species accounted for approximately one-half of all isolates. Success rates at EOT were 84, 90, and 89% in the 50-, 75-, and 100-mg groups, respectively. At FU, the success rates were 72, 85, and 83%. Phase 3 studies of anidulafungin for the treatment of invasive candidiasis and candidemia are warranted.
Krause
David S
DS
Vicuron Pharmaceuticals Inc., 455 S. Gulph Rd., Suite 310, King of Prussia, PA 19406, USA. dkrause@vicuron.com
Reinhardt
John
J
Vazquez
Jose A
JA
Reboli
Annette
A
Goldstein
Beth P
BP
Wible
Michele
M
Henkel
Timothy
T
D018806:APACHE; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077612:Anidulafungin; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002177:Candidiasis / Q000188:drug therapy* / Q000382:microbiology; D004305:Dose-Response Relationship, Drug; D054714:Echinocandins; D005260:Female; D016469:Fungemia / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies
D000935:Antifungal Agents; D054714:Echinocandins; D010456:Peptides, Cyclic; D000077612:Anidulafungin