Background The broad spectrum of activity of itraconazole in vitro man
ifests itself clinically with the drug being effective for the treatme
nt of onychomycosis caused by dermatophytes, Candida and some non-derm
atophyte molds. The pharmacokinetics of itraconazole in the nail resul
ts in drug remaining at therapeutic levels for 6-9 months after comple
tion of therapy. Methods An overview of studies where continuous or pu
lse itraconazole therapy has been used in the treatment of fingernail
and toenail onychomycosis. Results Following continuous therapy at 200
mg/day for 3 months for toenail onychomycosis (n = 1741), the rates o
f clinical cure, clinical response and mycologic cure were: (meta-aver
age +/- 95% standard error (SE)), 52 +/- 9%, 86 +/- 2%, and 74 +/- 3%,
respectively, at follow-up 12 months following start of therapy. In f
ingernail onychomycosis (n = 211), the duration of therapy was 6 weeks
acid the corresponding efficacy rates at follow-up, 9 months after st
art of therapy, were meta-average (+/- S.E.) 82 +/- 5%, 90 +/- 2%, and
86 +/- 3%, respectively. In toenail onychomycosis treated with 3 puls
es of therapy (n = 1389), the clinical response, clinical cure and myc
ologic cure were observed in meta-average (+/- S.E.) 58 +/- 10%, 82 +/
- 3%, and 77 +/- 5% patients, respectively, at follow-up 12 months aft
er the start of therapy. In fingernail onychomycosis treated with 2 pu
lses of therapy (n = 210), at follow-up 9 months after the start of th
erapy, the corresponding efficacy rates were meta-average (+/- S.E.) 7
8 +/- 10%, 89 +/- 6%, and 87 +/- 8%, respectively. Conclusions Both th
e continuous and pulse therapy regimens are safe with few adverse effe
cts. Compared to continuous therapy, the pulse regimen has an improved
adverse effects profile, is more cost-effective, and is preferred by
many patients.