mallefet_edit1.qxp 28/5/09 2:11 pm Page 24
Tinea Pedis
Table 2: Indirect Comparisons of Terbinafine 1% Film-forming Solution versus Other Topical Treatments –
Comparisons of the Differences in Mycological Cure Rates from Vehicle
Indirect Effect of Terbinafine 1% Film-forming Solution versus Active Comparator
Active Comparator Indirect Effect 95% CI Conclusion Concerning Terbinafine FFS**
Terbinafine cream -0.8±9.2% -18.9–17.3% Non-inferior descriptively
Terbinafine cream, gel, solution -4.4±7.0% -18.2–9.4% Non-inferior descriptively
Butenafine 8.7±9.6% -10.1–27.5% Non-inferior statistically
Naftifine (1) 6.6±6.4% -6.0–19.2% Non-inferior statistically
Naftifine (2) -2.1±13.5% -28.6–24.4% Non-inferior descriptively
Naftifine (1) and butenafine 7.7±5.9% -4.0–19.4% Non-inferior statistically
Naftifine (2) and butenafine 1.9±10.0% -17.7–21.5% Non-inferior descriptively
Econazole 3.9±9.3% -14.3–22.1% Non-inferior descriptively
Bifonazole 9.6±11.0% -12.0–31.2% Non-inferior descriptively
Miconazole -5.3±21.4% -47.2–36.6% Non-inferior descriptively
Clotrimazole 24.1±6.8% 10.7–37.5% Superior statistically
Tioconazole -3.2±11.1% -25.0–18.6% Non-inferior descriptively
Oxiconazole 15.8±6.9% 2.3–29.3% Superior statistically
Azoles 9.0±7.0% -4.8–22.8% Non-inferior statistically
Ciclopiroxolamine 13.2±20.2% -26.4–52.8% Superior descriptively
A positive treatment effect is to the advantage of Terbinafine 1% FFS..
Naftifine (1) = meta-analysis excluding Klaschka study; Naftifine (2) = meta-analysis including Klaschka study.
• Non-inferiority can be claimed on a descriptive basis when the indirect effect is ≥-10%.
• Non-inferiority can be claimed on a statistical basis when the 95% confdence interval [CI] lower bound is ≥-10%.
• Superiority can be claimed on a descriptive basis when the indirect effect is ≥10%.
• Superiority can be claimed on a statistical basis when, in addition, the 95% CI lower bound is >0%.
Figure 2: Indirect Treatment Effects Between Terbinafine 1% Film-forming Solution and Other Topical Treatments
(Difference Between Terbinafine Film-forming Solution Effect and Other Active Treatments Effects)
Meta-analysis Name Point Estimate* Standard Error Point Estimate
TERBINAFINE
Terbinafine cream -0.008 0.092
Terbinafine cream, gel or solution -0.044 0.070
OTHER ALLYLAMINES
Butenafine 0.087 0.096
Naftifine -0.021 0.135
Total other allylamines 0.019 0.100
(butenafine plus naftifine)
AZOLES
Bifonaloze 0.096 0.110
Econazole 0.039 0.093
Miconazole -0.053 0.214
Clotrimazole 0.241 0.068
Tioconazole -0.032 -0.111
Oxiconazole 0.158 0.069
Total azoles 0.090 0.070
Ciclopiroxolamine 0.132 0.202
-100% -50% 0% 50% 100%
Favours active treatment Favours
terbinafine 1% FFS
Econazole mainly by the low number of studies involved in this indirect
The indirect comparison between terbinafine 1% FFS and econazole comparison (three).
1% cream results in an effect of 3.9±9.3% to the advantage of
terbinafine 1% FFS. This effect is clinically insignificant (less than Miconazole
10%) and not statistically significant (p=0.675). The lower bound of The indirect comparison between terbinafine 1% FFS and miconazole
the 95% CI is -14.3%, less than -10%, and therefore statistical non- cream results in an effect of -5.3±21.4% to the disadvantage of
inferiority cannot be claimed. The size of the 95% CI can be explained terbinafine 1% FFS. This effect is clinically insignificant (<10%) and not
24 EUROPEAN DERMATOLOGY
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