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Randomized, Double-Blind, Multicenter Study of Caspofungin versus Amphotericin B for Treatment of Oropharyngeal and Esophageal Candidiases
Open accessAbstract
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 [57][58][59][60].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [58]
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Practice Guidelines for the Treatment of Candidiasis
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Lipid Formulations of Amphotericin B: Recent Progress and Future Directions
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Andriole, V. T. (1999) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/44.2.151 · Cited by 191
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Guidelines for Treatment of Candidiasis
Pappas, P. G., Rex, J. H., Sobel, J. D., Filler, S. G., Dismukes, W. E., Walsh, T. J., & Edwards, J. E. (2004) · Clinical Infectious Diseases · doi:10.1086/380796 · Cited by 1,440
Comparison of Caspofungin and Amphotericin B for Invasive Candidiasis
Mora-Duarte, J., Betts, R., Rotstein, C., Colombo, A. L., Thompson-Moya, L., Smietana, J., Lupinacci, R., Sable, C., Kartsonis, N., & Perfect, J. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa021585 · Cited by 1,380
Self-citationDenning, D. W. (2003) · The Lancet · doi:10.1016/s0140-6736(03)14472-8 · Cited by 1,131
Walsh, T. J., Teppler, H., Donowitz, G. R., Maertens, J. A., Baden, L. R., Dmoszyńska, A., Cornely, O. A., Bourque, M. R., Lupinacci, R. J., Sable, C. A., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa040446 · Cited by 907
Self-citationMaertens, J., RAAD, I. I., Petrikkos, G. L., Boogaerts, M., Selleslag, D., Petersen, F. B., Sable, C. A., Kartsonis, N. A., Ngai, A. L., Taylor, A., et al. (2004) · Clinical Infectious Diseases · doi:10.1086/423381 · Cited by 651
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Metadata
- 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.
- 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
- 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
- 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 › Infectious Diseases › Fungal Infections and Studies
- Health Sciences › Dentistry › General Dentistry › 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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