Randomized, double-blind, multicenter study of caspofungin versus amphotericin B for treatment of oropharyngeal and esophageal candidiases.

Abstract

Caspofungin is an antifungal agent of the novel echinocandin class. We investigated its efficacy, safety, and tolerability as therapy for oropharyngeal and/or esophageal candidiasis in a phase II dose-ranging study. Patients were randomized in a double-blind manner to receive either caspofungin acetate (35, 50, or 70 mg) or amphotericin B (0.5 mg/kg of body weight) intravenously once daily for 7 to 14 days. A favorable response required both complete resolution of symptoms and quantifiable improvement of mucosal lesions 3 to 4 days after discontinuation of study drug. Efficacy was assessed using a modified intent-to-treat analysis. No hypothesis testing of efficacy was planned or performed. Of 140 enrolled patients, 63% had esophageal involvement and 98% were infected with the human immunodeficiency virus (HIV) (median CD4 count, 30/mm(3)). A modestly higher proportion of patients in each of the caspofungin groups (74 to 91%) achieved favorable responses compared to amphotericin B recipients (63%), but there was considerable overlap in the 95% confidence intervals surrounding these point estimates. Similar trends were found in the subgroups with esophageal involvement, a history of fluconazole failure, and CD4 counts of < or =50/mm(3). A smaller proportion of patients receiving any dose of caspofungin experienced drug-related adverse events compared to patients given standard doses of conventional amphotericin B (P < 0.01). Caspofungin provided a generally well-tolerated parenteral therapeutic option for HIV-infected patients with oropharyngeal and/or esophageal candidiasis in this study.

• Authors: Eduardo G Arathoon, Eduardo Gotuzzo, L Miguel Noriega, Rayanne S Berman, Mark J DiNubile, Carole A Sable
• Journal: Antimicrobial agents and chemotherapy (Antimicrob Agents Chemother) Vol. 46 Issue 2 Pg. 451-7 (Feb 2002) ISSN: 0066-4804 [Print] United States
• PMID: 11796357 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Antifungal Agents
• Echinocandins
• Lipopeptides
• Peptides
• Peptides, Cyclic
• Amphotericin B
• Caspofungin

Topics

• Adolescent
• Adult
• Aged
• Amphotericin B (adverse effects, therapeutic use)
• Anti-Bacterial Agents (adverse effects, therapeutic use)
• Antifungal Agents (adverse effects, therapeutic use)
• Candidiasis (drug therapy)
• Caspofungin
• Double-Blind Method
• Drug Tolerance
• Echinocandins
• Esophageal Diseases (drug therapy, microbiology)
• Female
• Humans
• Lipopeptides
• Male
• Middle Aged
• Peptides
• Peptides, Cyclic
• Pharyngeal Diseases (drug therapy, microbiology)
• Treatment Outcome