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.
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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)
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Chemical References |
- Anti-Bacterial Agents
- Antifungal Agents
- Echinocandins
- Lipopeptides
- Peptides
- Peptides, Cyclic
- Amphotericin B
- Caspofungin
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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
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