What is the best oral monotherapy for toenail onychomycosis in adults?
Based on efficacy, safety, and cost, a regimen of terbinafine 250 mg once daily for 12 weeks, followed by a 12-week period of no therapy, and then a 4-week booster of terbinafine 250 mg was preferred for onychomycosis in adults for the outcome of complete cure at 1 year. (LOE = 1a-)
This POEM aligns with the Canadian Dermatology Association’s Choosing Wisely Canada recommendation: Don’t prescribe systemic anti-fungals for suspected onychomycosis without mycological confirmation of dermatophyte infectionem.
Meta-analysis (randomized controlled trials)
Self-funded or unfunded
The goal of this network meta-analysis was to compare individual oral antifungal regimens directly and indirectly for onychomycosis in adults. The surface under the cumulative ranking curve (SUCRA), a measure of the likelihood that a regimen was more likely to be effective or to cause harms, was calculated for each study and outcome. The researchers identified a total of 21 studies. The study quality was mixed, with many studies failing to mask participants and/or physicians. An overall assessment of the quality of each study was not provided, though by my review they were mostly at moderate to high risk of bias. The highest complete cure rates at one year were found for 250 mg terbinafine once daily for 12 weeks, followed by no treatment for 12 weeks, followed by 250 mg terbinafine once daily for another 4 weeks (SUCRA = 82.7%); the same regimen, but with an initial treatment period of 8 weeks (SUCRA = 80.4%); and 400 mg albaconazole once weekly for 36 weeks (SUCRA = 80.4%). Terbinafine 250 mg once daily for 24 weeks had the highest likelihood of mycological cure (SUCRA = 92.4%). In terms of adverse events, terbinafine 250 mg daily for 12 weeks was found to be significantly safer than albaconazole 400 mg weekly for 36 weeks; oteseconazole 600 mg daily for 2 weeks, then 600 mg weekly for 10 weeks; fluconazole 300 mg once weekly for 12 months; and posaconazole 200 mg daily for 24 weeks. Terbinafine costs pennies compared with $1000 or more for the newer agents like albaconazole and posaconazole.
Mark H. Ebell, MD, MS
University of Georgia