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| |  Posaconazole Compares With Standard Onychomycosis Treatments: Presented at AAD By Perrie Susman MIAMI BEACH, Fla -- March 11, 2010 -- The antifungal posaconazole appears to combat onychomycosis as well as standard treatments and better than placebo, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). More than half of the patients in the study who were treated with posaconazole 200 mg achieved a complete cure -- this was statistically significant when compared with placebo (P > .05). “Collectively, these data suggest that posaconazole warrants further consideration as a new treatment for onychomycosis,” said Boni Elewski, MD, University of Alabama at Birmingham, Birmingham, Alabama, during a poster presentation here on March 9. Although terbinafine is effective and well tolerated, about two-thirds of the patients treated with the agent do not achieve a complete cure, noted Dr. Elewski. In the study, researchers evaluated 4 doses of posaconazole, 1 dose of terbinafine, and placebo, in patients (mainly men) diagnosed with clinical and mycologic onychomycosis that affected at least 25% and at most 75% of at least 1 great toenail. Patients were treated with oral suspension posaconazole 100 mg (n = 37), 200 mg (n = 37), or 400 mg QD for 24 weeks (n = 36); posaconazole 400 mg QD for 12 weeks (n = 36); terbinafine 250 mg tablet for 12 weeks (n = 36); or placebo for 24 weeks (n = 36). Effects of treatment were observed through 48 weeks for all patients. Complete cure, defined as negative mycology and 0% nail involvement, was significantly higher than placebo in all posaconazole and terbinafine regimens (P < .05). There were no complete cures among the 36 placebo-treated patients, and 37.1% of the patients on terbinafine achieved a complete cure. Among the posaconazole arms, the complete cure rate was highest with the 200-mg/24-week posaconazole regimen, at 54.1%. Nearly half (45.5%) of all patients treated with posaconazole 400 mg for 24 weeks also achieved a complete cure. Complete cures also were observed in 22.9% of the patients on the 100 mg/24-week posaconazole regimen and in 20% of the patients on the 400 mg/12-week posaconazole regimen. More people taking posaconazole discontinued the trial due to transient abnormal liver function tests, Dr. Elewski said. AST elevations were reported in the posaconazole 200-mg/24-week arm (3%) and in the terbinafine arm (3%). ALT elevations were reported by 9% of patients in the posaconazole 400-mg/24-week treatment group and in 3% of patients in each of the other treatment groups. Funding for this study was provided by Schering-Plough (now Merck & Co.) [Presentation title: A Randomized, Placebo- and Active-Controlled, Parallel-Group, Multicenter, Investigator-Blinded Study of Four Treatment Regimens of Posaconazole in Adults With Toenail Onychomycosis. Abstract P2106]
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