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The long-term visual safety of voriconazole

Abstract number: 1134_02_308

Tomaszewski K., Laties A., Goodrich J.M.

Objectives:

Long Term Visual Safety of Voriconazole (VORI) is an extended-spectrum antifungal agent, with activity against Candida and moulds such as Aspergillus, Fusarium, and Scedosporium. While displaying an overall favorable safety profile, VORI is associated with transient visual adverse events (VAEs). In clinical trials, between 23–35% of VORI-treated subjects reported VAEs, including blurred vision and altered light perception. Over 28 days of treatment with VORI, the VAE was non-progressive and fully reversible following discontinuation. The objective of this study was to investigate and better understand the visual safety of VORI beyond 28 days.

Methods:

In a multicentre, open-label, comparative study, 53 patients with paracoccidioidomycosis were randomized to receive VORI (po 200 mg bid) or itraconazole (ITRA) (po 100 mg bid) in a 2:1 ratio over a period of at least 6 months. Visual function tests (VFTs) and safety assessments were performed at baseline, Week 12, Week 24, end of treatment (EOT) and at 8 weeks post EOT. The VFTs included color vision (Farnsworth-Munsell 15 Hue), visual acuity (ETDRS), contrast sensitivity (Pelli-Robson), visual field (Humphrey), funduscopy and slit lamp examination. Other adverse events and laboratory evaluations were recorded at the same visits as VFTs.

Results:

32/35 VORI and 17/18 ITRA patients completed 3 months treatment, with 14/35 and 11/18 respectively receiving >6 months treatment. 1 subject receiving VORI prematurely discontinued due to unrelated sarcoidosis and 2 due to elevated liver enzymes. 16/35 VORI and 0/18 ITRA subjects experienced drug-related VAEs; none were considered serious or severe or resulted in discontinuation. There were 22 separate VAEs in the 16 subjects reporting eye findings. 19 o 22 VAEs started on day 1 of dosing and had resolved by day 3.No VORI or ITRA subject had a significant deterioration (>2 lines) in visual acuity at anytime whilst on drug. There were no differences in other VFTs between the two groups. VORI had no long-term effect on ocular structure, as assessed by funduscopy and slit lamp. There was therefore no relationship of visual function to occurrence of VAEs in either treatment group.

Conclusions:

Clinical assessment of the results of VFTs in this study found no evidence of an effect of VORI on long term visual function or new concerns about VORI's effect on the eye.

Session Details

Date: 01/08/2007
Time: 00:00-00:00
Session name: XXIst ISTH Congress
Subject:
Location: Oxford, UK
Presentation type:
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