Abstract
BACKGROUND: Azole-refractory mucosal candidiasis is a debilitating disease frequently seen in patients who are immunosuppressed as a result of HIV, malignancy, posttransplant immunosuppressive therapy, persistent neutropenia, steroid use, or diabetes. Anidulafungin has potent activity against a broad spectrum of Candida species, including strains resistant to azoles and amphotericin B. We performed an open-label, noncomparative study to examine efficacy and safety of anidulafungin in patients with azole-refractory oropharyngeal and esophageal candidiasis. METHODS: Patients enrolled met diagnostic criteria for azole-refractory mucosal candidiasis. They received intravenous anidulafungin 100 mg on day 1 followed by daily 50-mg doses on day 2 through day 14 or for a maximum of 21 days. Primary efficacy variables were clinical response (for oropharyngeal candidiasis) and endoscopic and clinical response (for esophageal candidiasis) at the end of therapy. RESULTS: Nineteen patients were enrolled; 89% had advanced HIV infection. Clinical success was observed in 95% of patients at end of therapy, and endoscopic success was observed in 92% of patients with esophageal candidiasis. At follow-up, clinical success was maintained in 47% of patients. The most common adverse event, experienced by 4 patients, was nausea and/or vomiting. CONCLUSIONS: Anidulafungin was well tolerated and efficacious in the treatment of patients with azole-refractory esophageal and oropharyngeal candidiasis.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 304-309 |
| Number of pages | 6 |
| Journal | Journal of Acquired Immune Deficiency Syndromes |
| Volume | 48 |
| Issue number | 3 |
| DOIs | |
| State | Published - Jul 1 2008 |
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Keywords
- Anidulafungin
- Azole-refractory candidiasis
- Mucosal candidiasis
ASJC Scopus subject areas
- Infectious Diseases
- Pharmacology (medical)
Cite this
A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis. / Vazquez, José A.; Schranz, Jennifer A.; Clark, Kay; Goldstein, Beth P.; Reboli, Annette; Fichtenbaum, Carl.
In: Journal of Acquired Immune Deficiency Syndromes, Vol. 48, No. 3, 01.07.2008, p. 304-309.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis
AU - Vazquez, José A.
AU - Schranz, Jennifer A.
AU - Clark, Kay
AU - Goldstein, Beth P.
AU - Reboli, Annette
AU - Fichtenbaum, Carl
PY - 2008/7/1
Y1 - 2008/7/1
N2 - BACKGROUND: Azole-refractory mucosal candidiasis is a debilitating disease frequently seen in patients who are immunosuppressed as a result of HIV, malignancy, posttransplant immunosuppressive therapy, persistent neutropenia, steroid use, or diabetes. Anidulafungin has potent activity against a broad spectrum of Candida species, including strains resistant to azoles and amphotericin B. We performed an open-label, noncomparative study to examine efficacy and safety of anidulafungin in patients with azole-refractory oropharyngeal and esophageal candidiasis. METHODS: Patients enrolled met diagnostic criteria for azole-refractory mucosal candidiasis. They received intravenous anidulafungin 100 mg on day 1 followed by daily 50-mg doses on day 2 through day 14 or for a maximum of 21 days. Primary efficacy variables were clinical response (for oropharyngeal candidiasis) and endoscopic and clinical response (for esophageal candidiasis) at the end of therapy. RESULTS: Nineteen patients were enrolled; 89% had advanced HIV infection. Clinical success was observed in 95% of patients at end of therapy, and endoscopic success was observed in 92% of patients with esophageal candidiasis. At follow-up, clinical success was maintained in 47% of patients. The most common adverse event, experienced by 4 patients, was nausea and/or vomiting. CONCLUSIONS: Anidulafungin was well tolerated and efficacious in the treatment of patients with azole-refractory esophageal and oropharyngeal candidiasis.
AB - BACKGROUND: Azole-refractory mucosal candidiasis is a debilitating disease frequently seen in patients who are immunosuppressed as a result of HIV, malignancy, posttransplant immunosuppressive therapy, persistent neutropenia, steroid use, or diabetes. Anidulafungin has potent activity against a broad spectrum of Candida species, including strains resistant to azoles and amphotericin B. We performed an open-label, noncomparative study to examine efficacy and safety of anidulafungin in patients with azole-refractory oropharyngeal and esophageal candidiasis. METHODS: Patients enrolled met diagnostic criteria for azole-refractory mucosal candidiasis. They received intravenous anidulafungin 100 mg on day 1 followed by daily 50-mg doses on day 2 through day 14 or for a maximum of 21 days. Primary efficacy variables were clinical response (for oropharyngeal candidiasis) and endoscopic and clinical response (for esophageal candidiasis) at the end of therapy. RESULTS: Nineteen patients were enrolled; 89% had advanced HIV infection. Clinical success was observed in 95% of patients at end of therapy, and endoscopic success was observed in 92% of patients with esophageal candidiasis. At follow-up, clinical success was maintained in 47% of patients. The most common adverse event, experienced by 4 patients, was nausea and/or vomiting. CONCLUSIONS: Anidulafungin was well tolerated and efficacious in the treatment of patients with azole-refractory esophageal and oropharyngeal candidiasis.
KW - Anidulafungin
KW - Azole-refractory candidiasis
KW - Mucosal candidiasis
UR - http://www.scopus.com/inward/record.url?scp=47049108146&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=47049108146&partnerID=8YFLogxK
U2 - 10.1097/QAI.0b013e31817af47a
DO - 10.1097/QAI.0b013e31817af47a
M3 - Article
C2 - 18545153
AN - SCOPUS:47049108146
VL - 48
SP - 304
EP - 309
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
SN - 1525-4135
IS - 3
ER -