TY - JOUR
T1 - Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis
AU - Laties, Alan M.
AU - Fraunfelder, Frederick T.
AU - Tomaszewski, Konrad
AU - Goodrich, James
AU - Moreira, Ana Tereza
AU - Sato, Mario T.
AU - de Queiroz-Telles, Flâvio
N1 - Funding Information:
The original study and the analyses described in this article were supported by Pfizer Inc. Employees of the study sponsor participated in study design and data analysis and interpretation.
Funding Information:
Dr. Laties was a paid consultant to Pfizer in connection with this study. Dr. Fraunfelder has acted as a consultant to Pfizer and Boehringer Ingelheim. Dr. Tomaszewski is a full-time employee of Pfizer. Dr. Goodrich was a full-time employee of Pfizer at the time of the study. Drs. Moreira and Sato have received research grants from Pfizer. Dr. de Queiroz-Telles has received research grants from Astellas Pharma US, Inc., Janssen-Cilag, Merck Sharpe & Dohme, and Pfizer; is a member of the speakers’ bureau for Pfizer; and is a consultant to Astellas, Merck, and Pfizer. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
Funding Information:
Editorial support (editing for language, spelling, grammar, and consistent style; formatting tables; coordinating manuscript review and incorporating author comments; fact checking; and assistance with submission) was provided by Dominik Wolf, MSc, and Susanne Gilbert, MA, of PAREXEL International (Stamford, Connecticut), and was funded by Pfizer Inc.
PY - 2010/12
Y1 - 2010/12
N2 - Background: Voriconazole is an antifungal agent with in vitro activity and clinical efficacy against yeasts, molds, and dimorphic fungi (eg, Paracoccidioides brasiliensis). The safety profile of voriconazole includes transient visual adverse events (VAEs) that resolve while undergoing treatment or after its discontinuation.Objective: The goal of this study was to assess the long-term (ie, 6-12 months) visual safety of voriconazole in adult patients with paracoccidioidomycosis.Methods: Ophthalmic data were prospectively collected as part of a multicenter, open-label, comparative study. Patients aged ≥18 years with paracoccidioidomycosis were randomized in a 2:1 ratio to receive either voriconazole (200 mg BID orally, after the loading dose of 400 mg BID on day 1) or itraconazole (100 mg BID orally, with no loading dose). Patients were expected to receive treatment for a minimum of 6 months, or longer if needed as determined by the investigator (maximum duration, 1 year). Visual function tests and safety assessments were performed at baseline, week 12, week 24, end of treatment (EOT), and 8 weeks post-EOT. Ophthalmic examinations included visual acuity, color vision, contrast sensitivity, visual field, funduscopy, and slit lamp biomicroscopy. Treatment compliance was monitored via pill counts at each study visit.Results: Thirty-five patients (mean age, 48 years; 96.2% male; 83.0% white) were randomized to receive voriconazole and 18 to receive itraconazole. Fourteen voriconazole-treated patients received >6 months of treatment (median, 169 days). Efficacy and overall safety results have been published previously. Sixteen voriconazole-treated patients and 2 itraconazole-treated patients experienced drug-related VAEs; none was considered serious or severe or led to dose reductions or resulted in discontinuation. Overall, visual examination results were not clinically significantly different between patients treated with voriconazole or itraconazole. There was no apparent relationship between changes in visual function test results and the occurrence of VAEs in either treatment group.Conclusion: Clinical assessment in this study found no evidence of an effect of voriconazole on long-term visual function in these adult patients with paracoc-cidioidomycosis.
AB - Background: Voriconazole is an antifungal agent with in vitro activity and clinical efficacy against yeasts, molds, and dimorphic fungi (eg, Paracoccidioides brasiliensis). The safety profile of voriconazole includes transient visual adverse events (VAEs) that resolve while undergoing treatment or after its discontinuation.Objective: The goal of this study was to assess the long-term (ie, 6-12 months) visual safety of voriconazole in adult patients with paracoccidioidomycosis.Methods: Ophthalmic data were prospectively collected as part of a multicenter, open-label, comparative study. Patients aged ≥18 years with paracoccidioidomycosis were randomized in a 2:1 ratio to receive either voriconazole (200 mg BID orally, after the loading dose of 400 mg BID on day 1) or itraconazole (100 mg BID orally, with no loading dose). Patients were expected to receive treatment for a minimum of 6 months, or longer if needed as determined by the investigator (maximum duration, 1 year). Visual function tests and safety assessments were performed at baseline, week 12, week 24, end of treatment (EOT), and 8 weeks post-EOT. Ophthalmic examinations included visual acuity, color vision, contrast sensitivity, visual field, funduscopy, and slit lamp biomicroscopy. Treatment compliance was monitored via pill counts at each study visit.Results: Thirty-five patients (mean age, 48 years; 96.2% male; 83.0% white) were randomized to receive voriconazole and 18 to receive itraconazole. Fourteen voriconazole-treated patients received >6 months of treatment (median, 169 days). Efficacy and overall safety results have been published previously. Sixteen voriconazole-treated patients and 2 itraconazole-treated patients experienced drug-related VAEs; none was considered serious or severe or led to dose reductions or resulted in discontinuation. Overall, visual examination results were not clinically significantly different between patients treated with voriconazole or itraconazole. There was no apparent relationship between changes in visual function test results and the occurrence of VAEs in either treatment group.Conclusion: Clinical assessment in this study found no evidence of an effect of voriconazole on long-term visual function in these adult patients with paracoc-cidioidomycosis.
KW - Antifungal
KW - Paracoccidioidomycosis
KW - Safety
KW - Visual
KW - Voriconazole
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U2 - 10.1016/S0149-2918(10)80024-4
DO - 10.1016/S0149-2918(10)80024-4
M3 - Article
C2 - 21316537
AN - SCOPUS:79951528924
SN - 0149-2918
VL - 32
SP - 2207
EP - 2217
JO - Clinical therapeutics
JF - Clinical therapeutics
IS - 13
ER -