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Efficacy and safety of combination antifungal therapy in Korean haematological patients with invasive aspergillosis
Author(s) -
Lee DongGun,
Lee HyeJung,
Yan Jean Li,
Lin Stephen ShengFong,
Aram Jalal A.
Publication year - 2019
Publication title -
mycoses
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.13
H-Index - 69
eISSN - 1439-0507
pISSN - 0933-7407
DOI - 10.1111/myc.12972
Subject(s) - medicine , combination therapy , tolerability , voriconazole , placebo , aspergillosis , population , adverse effect , gastroenterology , surgery , immunology , dermatology , antifungal , pathology , alternative medicine , environmental health
Summary This randomised, double‐blind, placebo‐controlled trial assessed the efficacy, safety and tolerability of voriconazole+anidulafungin (combination) or voriconazole+placebo (monotherapy) for invasive aspergillosis ( IA ; NCT 00531479). We present a post hoc analysis of Korean and non‐Korean patients with IA (including baseline positive serum galactomannan [ GM ]). Immunocompromised patients ≥ 16 years with IA were randomised 1:1, combination or monotherapy, for ≥ 2 weeks’ treatment. The primary endpoint was 6‐ and 12‐week all‐cause mortality (Korean modified intent‐to‐treat [ mITT ] population). Overall, 454 patients enrolled (Koreans: 56 [combination: 28, monotherapy: 28], non‐Koreans: 398 [combination: 200, monotherapy: 198]). The mITT population comprised 40 Koreans (combination: 23; monotherapy: 17) and 237 non‐Koreans (combination: 112; monotherapy: 125). Week 6 treatment difference in mortality rate between combination and monotherapy was −6.4% in non‐Koreans. This reduction was more marked in Koreans (−22.4%). Week 12 difference in all‐cause mortality between combination and monotherapy was −17.7% (Koreans) and −20.2% at Week 6 (Koreans; positive baseline GM ). Week 6 mortality (Koreans [ mITT ]; baseline GM >0.5‐2.0) was 0/13 (combination) and 2/6 (monotherapy). Serious adverse events were numerically higher for combination than monotherapy (Koreans: 57.1%, 46.4%; non‐Koreans: 49.5%, 46.0%). In Koreans, combination therapy was associated with marginally better outcomes than monotherapy and more so than in non‐Koreans.