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Amorolfine nail lacquer Rationale for combination therapy

Amorolfine nail lacquer Rationale for combination therapy. Amorolfine nail lacquer Rationale for combination therapy. Oral antifungal - via nail bed Topical antifungal - penetration from surface. Topical. Oral. Polak A., J Eur Acad Dermatol Venereol, 1995.

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Amorolfine nail lacquer Rationale for combination therapy

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  1. Amorolfine nail lacquerRationale for combination therapy

  2. Amorolfine nail lacquerRationale for combination therapy Oral antifungal - via nail bed Topical antifungal - penetration from surface Topical Oral Polak A., J Eur Acad Dermatol Venereol, 1995

  3. Amorolfine nail lacquerRationale for combination therapy Antifungal convergence Increased efficacy at lower concentration of both drugs Antagonism Additive DRUG A Synergy Concentration DRUG B Concentration Polak A., Mycoses, 1993

  4. Amorolfine nail lacquerCombination therapy studies • Can Combination therapyimprove the cure rates and reduce the duration of systemic treatment ?

  5. Amorolfine lacquer & oral Terbinafine A randomised trial of amorolfine 5% solution nail lacquer associated with oral terbinafine compared with terbinafine alone in the treatment of dermatophytic toenail onychomycoses affecting the matrix region. Baran R, Feuilhade M, Datry A, Goettmann S, Pietrini P, Viguie C, Badillet G, Larnier C, Czernielewski J. Br J Dermatol, 2000

  6. Amorolfine lacquer & oral Terbinafine Study Design • 147 patients (83 male + 64 female patients; 47 ± 14 years) with severe dermatophyte toenail onychomycosis with matrix involvement • Efficacy criteria Primary: Negative culture and microscopy at 3 months Secondary: • Negative culture and microscopy at visits up to 18 months • Clinical cure (<10% disease remaining) • Combined mycological-clinical clearing Baran et al, Br J Dermatology 2000

  7. Amorolfine lacquer & oral Terbinafine Study Design 0 1.5M 3 M 9 M 15 M 18M Terbinafine * AT-6 n=50 Amorolfine # n=40 n=25 Terbinafine AT-12 n=48 n=40 n=33 Amorolfine T-12 n=49 Terbinafine n=41 n=21 * 250mg daily # 5% lacquer once weekly Baran et al, Br J Dermatology 2000

  8. Amorolfine lacquer & oral Terbinafine Mycological results Baran et al, Br J Dermatology 2000

  9. Amorolfine lacquer & oral Terbinafine Combinedclinical-mycological response at 18 months P < 0.05 Baran et al, Br J Dermatology 2000

  10. Amorolfine lacquer & oral Terbinafine Amorolfine nail lacquer once a week + Terbinafine 250 mg/d 12 weeks BASELINE 6-MONTH TREATMENT 18-MONTH TREATMENT Baran et al, Br J Dermatology 2000

  11. Amorolfine lacquer & oral Terbinafine Pharmacoeconomic analysis Group AT-6 AT-12 T-12 Cure Rate (%) Cost per patient treated (FF) Cost per patient cured (FF) 44.0 1118 2541 72.3 1678 2320 37.5 1131 3016 4000 T-12 3000 AT-6 AT-12 (FF) 2000 1000 0 Baran et al, Br J Dermatology 2000

  12. Amorolfine lacquer & oral Terbinafine Conclusions (1) • More rapid mycological cure • Slightly increased clinical cure rate • Lower cost per patient cured Amorolfine x 15 months + Terbinafine x 1.5 months Terbinafine x 3 months vs Baran et al, Br J Dermatology 2000

  13. Amorolfine lacquer & oral Terbinafine Conclusions (2) • More rapid mycological cure • Significantly increased clinical cure rate • Lower cost per patient cured Amorolfine x 15 months + Terbinafine x 3 months Terbinafine x 3 months vs Baran et al, Br J Dermatology 2000

  14. Amorolfine lacquer & Itraconazole A randomised trial of amorolfine 5% solution nail lacquer associated with oral itraconazole compared with itraconazole alone in the treatment of onychomycosis affecting the matrix region Lecha M, Torres Rodriguez JM, Moragas J, Gimenez J, Garcia Diez A, Iglesias L, Casado J, Armijo M, Toribio J, Aliaga A, Sanches J, Naranjo R, Quintanilla E, Diaz JL, Herrera A, Riz de Erechum F

  15. Amorolfine lacquer & Itraconazole Study Design • 131 patients (69 male + 62 female patients; 49 ± 12 years) with severe toenail onychomycosis 80% nail surface and/or matrix involvement • Efficacy criteria Primary: Negative culture and microscopy at 3 months Secondary: Combined mycological-clinical clearing at 6months (Mycological clearing=negative microscopy & culture + Clinical clearing = < 5% of original disease remaining) Lecha et al, Data on file. Galderma Laboratories

  16. Amorolfine lacquer & Itraconazole Study Design 0 1.5 M 3 M 6 M Itraconazole * AI-6 AI-6 n=51 Amorolfine # n=45 n=43 Itraconazole AI-12 n=37 n=35 n=33 Amorolfine I-12 n=43 Itraconazole n=34 n=32 * 200mg daily # 5% lacquer once weekly Lecha et al, Data on file. Galderma Laboratories

  17. Amorolfine lacquer & Itraconazole Mycological results p < 0.05 p < 0.001 p < 0.001 p < 0.05 At 3 months At 6 months Lecha et al, Data on file. Galderma Laboratories

  18. Amorolfine lacquer & Itraconazole CombinedMycological & Clinical results p < 0.05 Lecha et al, Data on file. Galderma Laboratories At 6 months

  19. Amorolfine lacquer & Itraconazole Amorolfine nail lacquer once a week + Itraconazole 200 mg/d 6 weeks TOENAIL AT BASELINE TOTAL DYSTROPHIC ONYCHOMYCOSIS TOENAIL AFTER 6 MONTHS TREATMENT

  20. Amorolfine lacquer & Itraconazole Amorolfine nail lacquer once a week + Itraconazole 200 mg/d 12 weeks BASELINE 3-MONTH TREATMENT 6-MONTH TREATMENT

  21. Amorolfine lacquer & Itraconazole Pharmacoeconomic analysis Lecha et al, Data on file. Galderma Laboratories

  22. Amorolfine lacquer & Itraconazole Conclusions (1) Amorolfine x 6 months + Itraconazole x 1.5 months Itraconazole x 3 months vs • More rapid and greater mycological cure • Increased combined clinical-mycological cure rate • Lower cost per patient cured Lecha et al, Data on file. Galderma Laboratories

  23. Amorolfine lacquer & Itraconazole Conclusions (2) Amorolfine x 6 months + Itraconazole x 3 months Itraconazole x 3 months vs • More rapid and greater mycological cure • Significantly increased combined clinical-mycological cure rate • Lower cost per patient cured Lecha et al, Data on file. Galderma Laboratories

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