Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis

Alan M. Laties, Frederick (Fritz) Fraunfelder, Konrad Tomaszewski, James Goodrich, Ana Tereza Moreira, Mario T. Sato, Flâvio de Queiroz-Telles

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2207-2217
Number of pages11
JournalClinical Therapeutics
Volume32
Issue number13
DOIs
StatePublished - Dec 2010

Fingerprint

Paracoccidioidomycosis
Safety
Itraconazole
Therapeutics
Fungi
Paracoccidioides
Voriconazole
Color Vision
Contrast Sensitivity
Antifungal Agents
Visual Fields
Visual Acuity
Yeasts
Research Personnel

Keywords

  • Antifungal
  • Paracoccidioidomycosis
  • Safety
  • Visual
  • Voriconazole

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Laties, A. M., Fraunfelder, F. F., Tomaszewski, K., Goodrich, J., Moreira, A. T., Sato, M. T., & de Queiroz-Telles, F. (2010). Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis. Clinical Therapeutics, 32(13), 2207-2217. https://doi.org/10.1016/S0149-2918(10)80024-4

Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis. / Laties, Alan M.; Fraunfelder, Frederick (Fritz); Tomaszewski, Konrad; Goodrich, James; Moreira, Ana Tereza; Sato, Mario T.; de Queiroz-Telles, Flâvio.

In: Clinical Therapeutics, Vol. 32, No. 13, 12.2010, p. 2207-2217.

Research output: Contribution to journalArticle

Laties, AM, Fraunfelder, FF, Tomaszewski, K, Goodrich, J, Moreira, AT, Sato, MT & de Queiroz-Telles, F 2010, 'Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis', Clinical Therapeutics, vol. 32, no. 13, pp. 2207-2217. https://doi.org/10.1016/S0149-2918(10)80024-4
Laties, Alan M. ; Fraunfelder, Frederick (Fritz) ; Tomaszewski, Konrad ; Goodrich, James ; Moreira, Ana Tereza ; Sato, Mario T. ; de Queiroz-Telles, Flâvio. / Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis. In: Clinical Therapeutics. 2010 ; Vol. 32, No. 13. pp. 2207-2217.
@article{59e165ad5b564e67bdb5d844e26be497,
title = "Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis",
abstract = "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.",
keywords = "Antifungal, Paracoccidioidomycosis, Safety, Visual, Voriconazole",
author = "Laties, {Alan M.} and Fraunfelder, {Frederick (Fritz)} and Konrad Tomaszewski and James Goodrich and Moreira, {Ana Tereza} and Sato, {Mario T.} and {de Queiroz-Telles}, Fl{\^a}vio",
year = "2010",
month = "12",
doi = "10.1016/S0149-2918(10)80024-4",
language = "English (US)",
volume = "32",
pages = "2207--2217",
journal = "Clinical Therapeutics",
issn = "0149-2918",
publisher = "Excerpta Medica",
number = "13",

}

TY - JOUR

T1 - Long-term visual safety of voriconazole in adult patients with paracoccidioidomycosis

AU - Laties, Alan M.

AU - Fraunfelder, Frederick (Fritz)

AU - Tomaszewski, Konrad

AU - Goodrich, James

AU - Moreira, Ana Tereza

AU - Sato, Mario T.

AU - de Queiroz-Telles, Flâvio

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

UR - http://www.scopus.com/inward/record.url?scp=79951528924&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79951528924&partnerID=8YFLogxK

U2 - 10.1016/S0149-2918(10)80024-4

DO - 10.1016/S0149-2918(10)80024-4

M3 - Article

VL - 32

SP - 2207

EP - 2217

JO - Clinical Therapeutics

JF - Clinical Therapeutics

SN - 0149-2918

IS - 13

ER -