A Randomized, Double‐Blind, Double‐Dummy, Multicenter Trial of Voriconazole and Fluconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Ally, R.; Schürmann, Dirk; Kreisel, Wolfgang; Carosi, Giampiero; Aguirrebengoa, Koldo; Dupont, B.; Hodges, Michael R.; Troke, Peter F.; Romero, Alain

doi:10.1086/322653

Cited by 306 publications

(157 citation statements)

References 30 publications

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“…Literatürde karşılaştırmalı çalışmalarda hem etkinlik hem de tolere edilebilirlik açısından flukonazol ve vorikonazol benzer sonuçlar sergilemişlerdir [20][21][22] . Ancak özellikle hematolojik maligniteli hastalarda C. krusei 'de intrensenk flukonazol direncinin bulunması ve başta C. glabrata olmak üzere çeşitli Candida suşlarında flukonazole direnç saptanması, albicans dışı Candida türlerindeki sıklığın son yıllarda artışı, flukonazolun aspergillus gibi küf mantarlarına etkisiz olması göz önünde bulundurulduğunda, bu hasta grubu için mukozal kandida enfeksiyonlarının empirik tedavisinde vorikonazol daha iyi bir alternatif olabilir.…”

Section: Discussionunclassified

Evaluation of Febrile Neutropenia in Hematologic Malignancy Patients

Aslan¹,

Oz²,

Akay³

et al. 2014

Mediterr J Infect Microb Antimicrob

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ÖZETGiriş: Hematolojik malignite hastalarında gelişen febril nötropeni, hastanede yatış gerektiren ve ölümle sonuçlanabilen en sık komplikasyondur. Nedeni açıklanana kadar enfeksiyona bağlı olduğu kabul edilir. Bu nedenle multidisipliner yaklaşım gerektirmekte ve medikal bir acil olarak tedavi edilmektedir. Güncel tedavi yaklaşımlarıyla enfeksiyona bağlı ölüm oranları azaltılmaya çalışılmaktadır. Bu çalışmada merkezimizde takip edilen hematolojik maligniteli febril nötropenik hastaların klinik özelliklerinin, risk faktörlerinin, izole edilen patojenlerin dağılımının ve mortalite üzerine etkili faktörlerin prospektif olarak araştırılması amaçlandı. Materyal ve Metod:Bu çalışmada Ocak 2012-Ocak 2013 tarihleri arasında hastanemizin hematoloji servisinde takip ve tedavi edilen 99 hematolojik maligniteli hastanın 161 febril nötropeni epizodu incelendi. Hastaların yaş, cinsiyet, altta yatan hastalık, aldıkları kemoterapi, takipleri sırasındaki kan sayımı sonuçları, görüntüleme yöntemlerindeki bulgular, uygulanan antibakteriyel veya antifungal tedavileri kaydedildi. Hastalardan rutin kan ve idrar kültürü, gerektiğinde diğer steril vücut sıvılarından kültür örnekleri alındı ve mikrobiyolojik açıdan incelendi. Bulgular: Çalışmaya katılan hastaların yaş ortalaması 50.7 ± 15.9 yıl olarak bulundu. Hastaların hastanede yatış süreleri ortalama 29.7 ± 14.9 gün, ortalama nötropeni süresi ise 14.6 ± 5.7 gündü. Değerlendirilen epizodların, %21'inde mikrobiyolojik olarak kanıtlanmış enfeksiyon, %40'ında klinik olarak saptanmış enfeksiyon, %39'unda ise nedeni bilinmeyen ateş saptandı. Toplam 47 izolat elde edildi. İzole edilen mikroorganizmaların dağılımları değerlendirildiğinde; tüm kültürlerde %40 gram-pozitif, %47 gramnegatif, %13 mantar üremesi saptandı. En sık saptanan mikroorganizmalar; %31 ile koagülaz-negatif stafilokok ve %22 ile Escherichia coli idi. Kan kültürlerinde ise %58 gram-pozitif bakteriler, %32 gram-negatif bakteriler ve %10 mantar üremesi vardı.

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Section: Discussionunclassified

Evaluation of Febrile Neutropenia in Hematologic Malignancy Patients

Aslan¹,

Oz²,

Akay³

et al. 2014

Mediterr J Infect Microb Antimicrob

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“…The largest prospective clinical trial of voriconazole as primary therapy for invasive aspergillosis in adults showed better clinical response and improved survival in subjects receiving voriconazole versus those receiving amphotericin B deoxycholate [104]. A multicenter trial of voriconazole versus fluconazole in treating esophageal candidiasis in 391 immunocompromised patients showed similar success rates with voriconazole (98.3%) and fluconazole (95.1%) [105]. While overall safety and tolerability of both antifungals was acceptable in this study, fewer patients discontinued voriconazole than fluconazole due to poor clinical response, but more patients discontinued voriconazole because of laboratory abnormalities or adverse events.…”

Section: Clinical Studies In Adultsmentioning

confidence: 99%

Triazole Use in the Nursery: Fluconazole, Voriconazole, Posaconazole, and Ravuconazole

Watt¹,

Manzoni²,

Cohen‐Wolkowiez³

et al. 2013

Current Drug Metabolism

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Invasive fungal infections in infants admitted to the neonatal intensive care unit are common and often fatal. The mainstay of therapy against invasive fungal infections is antifungal agents. Over the last two decades, the development and approval of these drugs evolved tremendously, and the azole class emerged as important agents in the treatment and prevention of invasive fungal infections. Among the azoles, fluconazole has been used extensively due to its favorable pharmacokinetics, excellent activity against Candida spp, and safety profile. This drug has been well studied in children but data for its use in infants are largely limited to Candida prophylaxis studies. Voriconazole, a second generation triazole, has excellent activity against Candida and Aspergillus spp. However, data on its use in neonates are extremely limited. Posaconazole and Ravuconazole are the newest agents of the triazole family. The antimicrobial spectrum of posaconazole is similar to voriconazole, but with additional activity against zygomycetes. Experience with posaconazole in children is very limited, and there are no reports of its use in infants. Ravuconazole is not approved for use by the FDA but studies in animals and humans show that it is often fungicidal and has favorable pharmacokinetics. In conclusion, the management of invasive fungal infections has progressed greatly over the last two decades with the azole antifungals playing a significant role. Related to this class, future research is needed in order to better assess dosing, safety, schedules and areas of use of these agents in infants admitted to the neonatal intensive care unit.

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“…The first, a non-inferiority study, enrolled 391 immunocompromised adult patients with esophageal candidiasis, who were randomly assigned to receive either voriconazole or fluconazole as oral therapy. 44 On the basis of a per-protocol population analysis at the end of therapy, oral voriconazole was non-inferior to fluconazole in terms of treatment success rate (defined as patients with cure or improvement, as determined by esophagoscopy). 44 The second study, a randomized, multicentre, nonblinded, non-inferiority trial, compared voriconazole with amphotericin B for the treatment of invasive candidiasis in 422 nonneutropenic patients.…”

Section: Candidiasismentioning

confidence: 99%

“…44 On the basis of a per-protocol population analysis at the end of therapy, oral voriconazole was non-inferior to fluconazole in terms of treatment success rate (defined as patients with cure or improvement, as determined by esophagoscopy). 44 The second study, a randomized, multicentre, nonblinded, non-inferiority trial, compared voriconazole with amphotericin B for the treatment of invasive candidiasis in 422 nonneutropenic patients. 45 A modified intention-to-treat analysis showed no significant difference between the 2 groups in terms of the primary end point for efficacy, success rate at 12 weeks after the end of therapy.…”

Section: Candidiasismentioning

confidence: 99%

Role of Therapeutic Drug Monitoring of Voriconazole in the Treatment of Invasive Fungal Infections

Kuo

Ensom

2009

CJHP

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Background: Voriconazole is a broad-spectrum, second-generation triazole antifungal agent with demonstrated efficacy in the treatment of invasive fungal infections caused by Aspergillus spp. and Candida spp. Given the characteristically poor prognosis of patients with invasive fungal infections and the protracted duration of treatment required, therapeutic monitoring of voriconazole is, in theory, an attractive method to optimize antifungal therapy. Objective:To determine the utility of therapeutic drug monitoring for voriconazole. Methods:A previously published decision-making algorithm was used to assess the currently available literature on therapeutic drug monitoring of voriconazole.Results: Several analytical methods can be used to quantify plasma or serum concentrations of voriconazole. Reasons for therapeutic monitoring of this drug include wide variability both within and between individuals secondary to drug properties, drug-drug interactions, and disease states. Furthermore, voriconazole follows nonlinear pharmacokinetics with saturable hepatic clearance. Another potential factor in favour of therapeutic drug monitoring for voriconazole is genetic polymorphism of CYP2C19, whereby patients who are homozygous for poor metabolism (about 19% of non-Indian Asians) can have 4-fold greater exposure to voriconazole. The concentrations of this drug are also greater in patients with hepatic impairment. Drug-drug interactions with other substrates of CYP2C9, CYP2C19, and CYP3A4 can also alter voriconazole concentrations. However, the correlations between plasma concentrations of voriconazole and its efficacy and toxicity are not well defined. Although lower and upper target thresholds of 0.25-2 mg/L and 4-6 mg/L, respectively, have been suggested, studies to date have not been appropriately designed or powered to reveal any definitive association. Conclusions:Routine therapeutic drug monitoring of voriconazole is not recommended except in certain circumstances, such as lack of response to therapy or evidence of toxicity, in which case selective monitoring of voriconazole concentrations may be of clinical utility. Méthodes : Un algorithme de prise de décision publié a été utilisé pour évaluer la documentation actuellement disponible sur le suivi thérapeutique pharmacologique du voriconazole. Résultats :Plusieurs méthodes analytiques peuvent servir à quantifier les concentrations sériques ou plasmatiques de voriconazole. Les raisons de recourir au suivi thérapeutique pharmacologique de ce médicament sont notamment la grande variabilité intra et interindividuelle attribuable aux propriétés du médicament, aux interactions médicament-médicament et aux affections. De plus, le voriconazole a un comportement pharmacocinétique non linéaire en raison d'une clairance hépatique saturable. Un autre facteur potentiellement en faveur du suivi thérapeutique pharmacologique du voriconazole est le polymorphisme génétique du CYP2C19 qui, chez les patients homozygotes ayant un faible métabolisme (environ 19 % des Asiatiques ...

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A Randomized, Double‐Blind, Double‐Dummy, Multicenter Trial of Voriconazole and Fluconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Cited by 306 publications

References 30 publications

Evaluation of Febrile Neutropenia in Hematologic Malignancy Patients

Evaluation of Febrile Neutropenia in Hematologic Malignancy Patients

Triazole Use in the Nursery: Fluconazole, Voriconazole, Posaconazole, and Ravuconazole

Role of Therapeutic Drug Monitoring of Voriconazole in the Treatment of Invasive Fungal Infections

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