A K Gupta1, M D Gover, C W Lynde. 1. Division of Dermatology, Department of Medicine, Sunnybrook and Women's College Health Sciences Center (Sunnybrook site), University of Toronto and Toronto General Hospital, Canada. agupta@execulink.com
Abstract
BACKGROUND:Oral terbinafine and oral itraconazole are two of the most common agents used for the treatment of toenail dermatophyte onychomycosis. Despite the fact that diabetic patients are more likely to have onychomycosis than normal individuals are, there is little research into the efficacy of standard oral regimens of terbinafine and itraconazole for onychomycosis in the diabetic population. STUDY DESIGN: We present a prospective, randomized, single-blind, parallel group, comparator-controlled, multi-centre study designed to assess the efficacy of the pulse itraconazole (200 mg twice daily, 1 week on, 3 weeks off, for 12 weeks) vs. continuous terbinafine (250 mg once daily for 12 weeks) oral therapies in the treatment of dermatophyte toenail distal and lateral subungual onychomycosis (DLSO) in the diabetic population. EFFICACY PARAMETERS: Primary efficacy measures included mycological cure rate (negative KOH and culture) and effective cure (mycological cure plus nail plate involvement of 10% or less) at Week 48. RESULTS: At Week 48, mycological cure was attained by 88.2% (30 of 34) and 79.3% (23 of 29) of patients in the itraconazole and terbinafine groups, respectively (P not significant). Effective cure (mycological cure with <or=10% of nail plate involvement) was attained by 52.9% (18 of 34) of the itraconazole group and 51.7% (15 of 29) of the terbinafine group (P not significant). Three itraconazole patients experienced side effects in the form of gastrointestinal problems. There were no serious adverse events and no interactions with concomitant medications recorded. DISCUSSION: Both continuous terbinafine and itraconazolepulse therapy are effective and safe in the management of dermatophyte toenail onychomycosis in people with diabetes.
RCT Entities:
BACKGROUND: Oral terbinafine and oral itraconazole are two of the most common agents used for the treatment of toenail dermatophyte onychomycosis. Despite the fact that diabeticpatients are more likely to have onychomycosis than normal individuals are, there is little research into the efficacy of standard oral regimens of terbinafine and itraconazole for onychomycosis in the diabetic population. STUDY DESIGN: We present a prospective, randomized, single-blind, parallel group, comparator-controlled, multi-centre study designed to assess the efficacy of the pulse itraconazole (200 mg twice daily, 1 week on, 3 weeks off, for 12 weeks) vs. continuous terbinafine (250 mg once daily for 12 weeks) oral therapies in the treatment of dermatophyte toenail distal and lateral subungual onychomycosis (DLSO) in the diabetic population. EFFICACY PARAMETERS: Primary efficacy measures included mycological cure rate (negative KOH and culture) and effective cure (mycological cure plus nail plate involvement of 10% or less) at Week 48. RESULTS: At Week 48, mycological cure was attained by 88.2% (30 of 34) and 79.3% (23 of 29) of patients in the itraconazole and terbinafine groups, respectively (P not significant). Effective cure (mycological cure with <or=10% of nail plate involvement) was attained by 52.9% (18 of 34) of the itraconazole group and 51.7% (15 of 29) of the terbinafine group (P not significant). Three itraconazolepatients experienced side effects in the form of gastrointestinal problems. There were no serious adverse events and no interactions with concomitant medications recorded. DISCUSSION: Both continuous terbinafine and itraconazole pulse therapy are effective and safe in the management of dermatophyte toenail onychomycosis in people with diabetes.
Authors: Sanne Kreijkamp-Kaspers; Kate Hawke; Linda Guo; George Kerin; Sally Em Bell-Syer; Parker Magin; Sophie V Bell-Syer; Mieke L van Driel Journal: Cochrane Database Syst Rev Date: 2017-07-14