A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a combination therapy with amorolfine nail lacquer and oral terbinafine compared with oral terbinafine alone for the treatment of onychomycosis with matrix involvement

• DOI: 10.1111/j.1365-2133.2007.07974.x
• Publication Date: 2007-06-06T12:50:19Z
• Authors: R. Baran; B. Sigurgeirsson; D. de Berker; R. Kaufmann; M. Lecha; J. Faergemann; N. Kerrouche; F. Sidou
• Keywords: Terbinafine; Combination therapy

Background Onychomycosis is common, accounting for up to 50% of all nail disorders. Toenail onychomycosis can cause deformity, embarrassment, pain and walking difficulties. Some populations, such as individuals with diabetes, are at higher risk developing secondary complications infections. Treatment takes many months therapeutic choices increase clinical effectiveness, lower toxicity minimize healthcare costs. Objectives Based on the results a previous pilot study, objective present study was show, in larger population, enhanced efficacy combination amorolfine lacquer oral terbinafine treatment matrix involvement. In addition, cost-effectiveness analysis performed. Methods this multicentre, randomized, open-label, parallel group patients were randomized receive either hydrochloride 5% once weekly 12 plus 250 mg daily 3 (AT group) or alone (T group). The duration 18 including 6-month treatment-free phase following 12-month active AT 15-month 3-month T group. primary criterion overall response, dichotomized into success failure, being cure negative mycology month 18. This used effectiveness measure pharmacoeconomic analysis, conducted from payer perspective. Results total, 249 included study: 120 129 A significantly rate observed relative those (59·2% vs. 45·0%; P = 0·03). Both regimens safe well tolerated. cost per cured patient than countries. Conclusions Study confirmed that, dermatophytic toenail involvement, enhances more cost-effective alone.