Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies

Gabriele Sganga, Minggui Wang, M Rita Capparella, Margaret Tawadrous, Jean L Yan, Jalal A Aram, Philippe Montravers, Gabriele Sganga, Minggui Wang, M Rita Capparella, Margaret Tawadrous, Jean L Yan, Jalal A Aram, Philippe Montravers

Abstract

The incidence of nosocomial invasive fungal infections involving Candida spp. has increased markedly in recent years in patients undergoing abdominal surgery. This post hoc analysis aimed to determine the efficacy and safety of anidulafungin treatment in patients with intra-abdominal candidiasis (IAC) from five prospective studies (one comparative and four open-label) of adult surgical patients with microbiologically confirmed Candida intra-abdominal infection. Patients received an intravenous (IV) loading dose of anidulafungin 200 mg, followed by a daily 100-mg maintenance dose. Per study protocols, some patients could be switched to an oral azole after ≥ 5 or ≥ 10 days of IV treatment. Antifungal treatment was maintained for ≥ 14 days after the last positive Candida culture and resolution of symptoms. The global response rate (GRR) at the end of IV treatment (EOIVT) was the primary endpoint. GRR at the end of therapy (EOT), all-cause mortality at days 14 and 28, and safety was also evaluated. Seventy-nine patients had IAC from peritoneal fluid or hepatobiliary tract. C. albicans (72.2%) and C. glabrata (32.9%) were the most common pathogens. Overall GRR was 73.4% and 67.1% at EOIVT and EOT, respectively. All-cause mortality was 17.7% at day 14 and 24.1% at day 28 in the modified intent-to-treat population. Anidulafungin was well tolerated in this population, with most adverse events mild or moderate in severity. In these patients with IAC, anidulafungin showed a GRR at EOIVT similar to the anidulafungin registrational trial, and the results of our analysis confirmed the known safety profile of anidulafungin. ClinicalTrials.gov registration number NCT00496197, registered July 3, 2007, https://ichgcp.net/clinical-trials-registry/NCT00496197 ; ClinicalTrials.gov registration number NCT00548262, registered October 19, 2007, https://ichgcp.net/clinical-trials-registry/NCT00548262 ; ClinicalTrials.gov registration number NCT00537329, registered September 25, 2007, https://ichgcp.net/clinical-trials-registry/NCT00537329 ; ClinicalTrials.gov registration number NCT00689338, registered May 29, 2008, https://ichgcp.net/clinical-trials-registry/NCT00689338 ; ClinicalTrials.gov registration number NCT00805740, registered November 26, 2008, https://ichgcp.net/clinical-trials-registry/NCT00805740.

Keywords: Anidulafungin; Efficacy; Intra-abdominal candidiasis; Patient-level data; Pooled analysis; Safety.

Conflict of interest statement

G. Sganga is an employee of Catholic University of the Sacred Heart, Fondazione Agostino Gemelli University Hospital, Rome, Italy. M. Wang is an employee of Huashan Hospital, Fudan University, Shanghai, China. M.R. Capparella is an employee and shareholder of Pfizer PIO, Paris, France. M. Tawadrous, J.L. Yan and J.A. Aram are employees and shareholders of Pfizer Inc, USA. P. Montravers has no conflict of interest to declare.

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