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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

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Abstract:

Summary Background 

Onychomycosis is common, accounting for up to 50% of all nail disorders. Toenail onychomycosis can cause nail deformity, embarrassment, pain and walking difficulties. Some populations, such as individuals with diabetes, are at higher risk for developing secondary complications such as infections. Treatment takes many months and therapeutic choices can increase clinical effectiveness, lower toxicity and minimize healthcare costs. Objectives 

Based on the results of a previous pilot study, the objective of the present study was to show, in a larger population, the enhanced efficacy of a combination of amorolfine nail lacquer and oral terbinafine in the treatment of onychomycosis with matrix involvement. In addition, a cost-effectiveness analysis was performed. Methods 

In this multicentre, randomized, open-label, parallel group study, patients were randomized to receive either a combination of amorolfine hydrochloride 5% nail lacquer once weekly for 12 months plus terbinafine 250 mg once daily for 3 months (AT group) or terbinafine alone once daily for 3 months (T group). The study duration was 18 months including a 6-month treatment-free phase following the 12-month active treatment phase for the AT group and a 15-month treatment-free phase following the 3-month active treatment phase for the T group. The primary efficacy criterion was overall response, dichotomized into success or failure, success being the combination of clinical cure and negative mycology at month 18. This criterion was used as the effectiveness measure in the pharmacoeconomic analysis, conducted from a payer perspective. Results 

In total, 249 patients were included into the study: 120 in the AT group and 129 in the T group. A significantly higher success rate was observed for patients in the AT group relative to those in the T group at 18 months (59·2% vs. 45·0%; P =0·03). Both treatment regimens were safe and well tolerated. Treatment cost per cured patient was lower for the combination than for terbinafine alone in all countries. Conclusions 

Study results confirmed that, in the treatment of dermatophytic toenail onychomycosis with matrix involvement, amorolfine nail lacquer in combination with oral terbinafine enhances clinical efficacy and is more cost-effective than terbinafine alone.

Keywords: amorolfine; combination therapy; cost-effectiveness; onychomycosis; randomized controlled trial; terbinafine

Document Type: Research Article

DOI: https://doi.org/10.1111/j.1365-2133.2007.07974.x

Affiliations: 1: Dermatology Centre, Smaratorg 1, 200 Kopavogur, Iceland 2: Department of Dermatology, Bristol Royal Infirmary, Bristol BS2 8HW, U.K. 3: Universitätsklinikum Frankfurt am Main, Dermatologie, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany 4: Hospital Clinic, Dermatologia, C/Villarroel 170, 08036 Barcelona, Spain 5: Sahlgrenska Universitetssjukhuset, Hudkliniken, Gröna Stråket 16, S-413 45 Göteborg, Sweden 6: Galderma Research & Development, 2400 route des Colles, 06902 Sophia Antipolis, France

Publication date: 2007-07-01

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