Gupta Aditya K, Elewski Boni E, Sugarman Jeffrey L, Ieda Chikara, Kawabata Hideki, Kang Robert, Pillai Radhakrishnan, Olin Jason T, Watanabe Shinichi
J Drugs Dermatol. 2014 Jul;13(7):815-20.
Onychomycosis is a fungal infection of the nail apparatus that can be challenging to treat due to the modest efficacy of existing antifungal therapies and a high rate of relapse and recurrence.
To investigate the efficacy and safety of efinaconazole 10% solution in pooled Phase III clinical trial participants with mild to moderate onychomycosis.
Phase III clinical trials data from NCT01008033 and NCT01007708 were pooled. Efficacy analysis for the primary and secondary outcome variables was conducted using the mITT population and analysed using Cochran-Mantel-Haenszel tests. Subgroup analysis was conducted for prognostic factors that may affect drug efficacy. Safety analysis was conducted on all recipients of a single drug dose.
Efinaconazole 10% nail solution was superior to vehicle for all primary and secondary outcome measures assessed. Complete cure was 18.5% vs 4.7% P< 0.001 [mITT] and mycological cure was 56.3% vs 16.6%, P< 0.001 [mITT]. Complete or almost complete cure and treatment success were achieved in 27.7% and 47.2% compared to 7.9% and 18.2% with vehicle, respectively (P< 0.001 [mITT]). In all subgroups, efinaconazole 10% solution had statistically higher cures rates compared to vehicle. Higher complete cure rates were observed in women and individuals with mild disease (≤33% involvement), but not in any other subgroup assessed. Treatment associated adverse events in the efinaconazole 10% solution group were similar to vehicle and limited to local site reactions (2%).
The findings from this pooled analysis suggest that efinaconazole 10% solution may become the preferred topical agent for mild to moderate onychomycosis.
甲癣是一种甲器真菌感染，由于现有抗真菌疗法疗效一般且复发率高，治疗颇具挑战性。
在合并的III期临床试验参与者中，研究10%艾氟康唑溶液治疗轻至中度甲癣的疗效和安全性。
汇总来自NCT01008033和NCT01007708的III期临床试验数据。使用意向性分析（mITT）人群对主要和次要结局变量进行疗效分析，并采用 Cochr an-Mantel-Haenszel检验进行分析。对可能影响药物疗效的预后因素进行亚组分析。对所有接受单剂量药物的受试者进行安全性分析。
对于所有评估的主要和次要结局指标，10%艾氟康唑甲溶液均优于赋形剂。完全治愈为18.5%对4.7%，P<0.001 [mITT]，真菌学治愈为56.3%对16.6%，P<0.001 [mITT]。完全或几乎完全治愈以及治疗成功的比例分别为27.7%和47.2%，而赋形剂组分别为7.9%和18.2%（P<0.001 [mITT]）。在所有亚组中，10%艾氟康唑溶液的治愈率在统计学上均高于赋形剂。女性和轻度疾病（受累≤33%）个体的完全治愈率较高，但在其他评估亚组中未观察到。10%艾氟康唑溶液组的治疗相关不良事件与赋形剂组相似，且仅限于局部部位反应（2%）。
该汇总分析结果表明，10%艾氟康唑溶液可能成为轻至中度甲癣的首选局部用药。
