Efficacy & Safety of Pulse vs Continuous Therapy for Toenail Onychomycosis
Journal of the European Academy of Dermatology and Venereology (JEADV): Published
on March, 2020
Onychomycosis refers to persistent
fungal nail and adjacent skin infection by dermatophyte fungi, non-dermatophyte
fungi or yeast. It is the most common nail disease accounting for 90% of toe
nail infections worldwide.
Dermatophytes are the most
frequently implicated causative agents with Trichophyton rubrum and Trichophyton
mentagrophytes var. interdigitale being responsible for nearly 90% of
toenail and at least 50% of fingernail onychomycosis.
Complete cure remains challenging,
but oral antifungal medications have been successful in managing the fungus for
a significant proportion of patients. Treatment with these drugs can be
continuous or intermittent, albeit the evidence on their relative efficacies
remains unclear.
Study aim
to determine the relative effectiveness and safety of pulse
versus continuous administration, of three common oral therapies for
dermatophyte onychomycosis, by conducting multiple-treatment meta-analysis.
TAKE-HOME MESSAGE
This systematic review and network
meta-analysis showed that continuous daily and pulse regimens of terbinafine
and itraconazole were similar in mycological cure.
Continuous terbinafine 250 mg daily
for 24 weeks was significantly more likely to produce mycological cure than continuous
itraconazole 200 mg for 12 weeks and weekly fluconazole (150-450 mg).
Compared with placebo, the most
successful treatments were continuous terbinafine 250 mg daily for 24
weeks (mycologic cure 95.97%) and continuous terbinafine 250 mg daily for
16 weeks (mycologic cure 70.71%).
The FDA dose of continuous
terbinafine 250 mg daily for 12 weeks was not significantly different from
continuous terbinafine 250 mg for (16 and 24 weeks), pulsed terbinafine 500 mg,
weekly fluconazole, or pulsed and continuous itraconazole regimens in
mycological cure.
Continuous and pulsed regimens of terbinafine and itraconazole for onychomycosis had similar efficacies and adverse events.
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Background: Onychomycosis
is a chronic, fungal infection of the nails. Complete cure remains challenging,
but oral antifungal medications have been successful in managing the fungus for
a significant proportion of patients. Treatment with these drugs can be
continuous or intermittent, albeit the evidence on their relative efficacies
remains unclear.
Objective: To
determine the relative effectiveness and safety of pulse versus continuous
administration, of three common oral therapies for dermatophyte onychomycosis,
by conducting multiple-treatment meta-analysis.
Methods: This
systematic review and network meta-analysis compared the efficacy (as per
mycological cure) and adverse event rates of three oral antifungal medications
in the treatment of dermatophyte toenail onychomycosis, namely terbinafine,
itraconazole and fluconazole. A total of 30 studies were included in the
systematic review, while 22 were included in the network meta-analysis.
Results: The
likelihood of mycological cure was not significantly different between
continuous and pulse regimens for each of terbinafine and itraconazole. Use of
continuous terbinafine for 24 weeks - but not 12 weeks - was significantly more
likely to result in mycological cure than continuous itraconazole for 12 weeks
or weekly fluconazole for 9-12 months. Rank probabilities demonstrated that
24-week continuous treatment of terbinafine was the most effective. There were
no significant differences in the likelihood of adverse events between any
continuous and pulse regimens of terbinafine, itraconazole and fluconazole.
Drug treatments were similar to placebo in terms of their likelihood of
producing adverse events.
Conclusion: More knowledge about the fungal life cycle and drugs' pharmacokinetics in nail and plasma could further explain the relative efficacy and safety of the pulse and continuous treatment regimens. Study results indicate that in the treatment of dermatophyte toenail onychomycosis, the continuous and pulse regimens for terbinafine and itraconazole have similar efficacies and rates of adverse events.
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