Randomized, Double-Blind, Multicenter Study of Caspofungin versus Amphotericin B for Treatment of Oropharyngeal and Esophageal Candidiases

Arathoon, Eduardo G.; Gotuzzo, Eduardo; Noriega, L. Miguel; Berman, Rayanne S.; DiNubile, Mark J.; Sable, Carole A.

doi:10.1128/aac.46.2.451-457.2002

Cited by 254Antifungal resistance and susceptibilityFungal Infections and StudiesHIV/AIDS oral health manifestations

Randomized, Double-Blind, Multicenter Study of Caspofungin versus Amphotericin B for Treatment of Oropharyngeal and Esophageal Candidiases

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Arathoon, Eduardo G., Gotuzzo, Eduardo, Noriega, L. Miguel, Berman, Rayanne S., DiNubile, Mark J., Sable, Carole A.·2002·Antimicrobial Agents and Chemotherapy

DOI 10.1128/aac.46.2.451-457.2002PMC PMC127070

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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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Caspofungin has been shown to be as effective as both amphotericin B deoxycholate and fluconazole when used as therapy for oropharyngeal and esophageal candidiasis.
“Caspofungin has been shown to be as effective as both amphotericin B deoxycholate and fluconazole when used as therapy for oropharyngeal and esophageal candidiasis [57][58][59][60].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [58]

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A randomized double-blind study of caspofungin versus fluconazole for the treatment of esophageal candidiasis
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Authors: Arathoon, E. G., Gotuzzo, E., Noriega, L. M., Berman, R. S., DiNubile, M. J., & Sable, C. A.
Affiliations: Hospital General San Juan de Dios (GT)
Hospital Nacional Cayetano Heredia (PE)
Complejo Asistencial Sótero del Río (CL)
Merck Research Laboratories, West Point, Pennsylvania
Corresponding author: DiNubile, Mark J.
ORCID: Arathoon, Eduardo G.
Gotuzzo, Eduardo
Venue: Antimicrobial Agents and Chemotherapy
Publisher: American Society for Microbiology
Published: 2002-02
Volume: 46
Issue: 2
Pages: 451-457
ISSN: 0066-4804 (ISSN-L)
1098-6596
DOI: 10.1128/aac.46.2.451-457.2002
PMC: PMC127070
OpenAlex: W2156228013
Cited by: 254
References: 46
Citations by year: 2026: 1 · 2025: 2 · 2024: 2 · 2023: 1 · 2022: 1 · 2021: 3 · 2020: 6 · 2019: 1 · 2018: 2 · 2017: 4 · 2016: 1 · 2015: 8 · 2014: 8 · 2013: 4 · 2012: 7
FWCI: 18.98
Type: journal article
Language: en
Open access: green
europepmc.org
Licence: journals.asm.org/non-commercial-tdm-license (tdm)
Locations: Antimicrobial Agents and Chemotherapy (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › HIV/AIDS oral health manifestations
Keywords: caspofungin, amphotericin B, oropharyngeal candidiasis, esophageal candidiasis, HIV infection, CD4 count, drug safety and tolerability, dose-ranging
MeSH terms: Caspofungin, Adolescent, Adult, Aged, Amphotericin B, Anti-Bacterial Agents, Antifungal Agents, Candidiasis, Double-Blind Method, Drug Tolerance, Esophageal Diseases, Female, Humans, Male, Middle Aged, Peptides, Peptides, Cyclic, Pharyngeal Diseases, Treatment Outcome, Echinocandins, Lipopeptides

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Randomized, Double-Blind, Multicenter Study of Caspofungin versus Amphotericin B for Treatment of Oropharyngeal and Esophageal Candidiases

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