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

Antimicrob Agents Chemother. 2002 Feb;46(2):451-7. doi: 10.1128/AAC.46.2.451-457.2002.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

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

Substances

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