We discussed current pharmacoeconomic issues on the management of onychomycosis. Consensus was reached on the following issues: * Published pharmacoeconomic studies concerning onychomycosis are flawed. Future studies should be based on internationally validated principles and appropriate models. The fact that costs of different drugs, laboratory examinations and physician visits vary worldwide should be considered. Cost-benefit studies are required. * The National Institute for Clinical Excellence (NICE) recommendations are often considered in countries other than the UK, even when not adapted to the country in question. * Generic drugs might reduce costs, but this depends on their effectiveness (bioavailability). * Sampling requests affect the economic cost (dependent on methodology, which depends on country) and physicians often trust their instincts even when tests are repeatedly negative. * The cost of adverse event management is usually considered to be 10%; this may be too high for onychomycosis, as treatments are relatively safe without severe side-effects. * Probability of recurrence for each drug should be determined. * Need for disease severity standardization, definition of diagnostic criteria and successful treatment (mycological and clinical cure).
Background: In recent years, itraconazole pulse therapy for onychomycosis has been developed [three 1-week pulses with itraconazole 400 (2 × 200) mg daily every month]. This has proved an effective and safe regimen which requires only 50% of the medication used for continuous dosing schedules. Parallel to the development of the new dosage schedule, additional studies were conducted to further document the safety and efficacy of itraconazole 200 mg once daily for 3 months to treat onychomycosis. Objective: To compare the safety of itraconazole 200 mg once daily for 3 months, with or without itraconazole 200 mg once weekly for a further 3 months, with that of miconazole cream twice daily for 6 months, in the treatment of onychomycosis. Treatment efficacy was compared as a secondary objective. Methods: In this multicenter, double-blind study, patients were randomized to receive itraconazole 200 mg once daily for 3 months followed by either itraconazole 200 mg once weekly for 3 months (ITR-ITR group, n = 599) or oral placebo once weekly for 3 months (ITR-PLAC group, n = 613), or to receive miconazole cream twice daily for 6 months (MIC-MIC group, n = 396). The primary variable was elevation of alanine aminotransferase (ALT) concentration above 50 U/l. Results: Overall incidence of elevation of ALT concentration above 50 U/l, adverse events and rate of withdrawal because of adverse events were low and similar in the three treatment groups. Efficacy was significantly greater in the ITR groups than the MIC-MIC group. Conclusion: Itraconazole and miconazole were well tolerated and had no significant effect on liver function, but itraconazole was significantly more effective.
The ultrastructural morphology of localized skin calcifications without associated diseases and with normal serum calcium and phosphate ion values is still unknown. In a case of superficial dystrophic calcinosis cutis (DCC) the role of collagen elastin and ground substance in the process of calcification and the organization of the apatite crystals could be studied by light and electron microscopy despite technical difficulties in sectioning the hard tissue. Ultrastructural investigation revealed the nucleation of calcification being related to collagen and elastic fibers. No intracellular calcification was found. A flower-like arrangement of pleomorphic crystals was found around single collagen fibrils resembling the calcification of collagen seen in bone tissue. The elastic fibers showed a different pattern of calcification compared with other diseases (e.g. pseudoxanthoma elasticum) with known calcification of the elastic fibers. The process of mineralization was initially linked to the microfibrils of the elastic fiber.
Background: The strategies for the management of onychomycosis have changed since the availability of the newer generation of antifungal agents, particularly, itraconazole and terbinafine. Itraconazole (1-week pulse) therapy may have higher efficacy and an improved adverse-effects profile compared to the continuous therapy regimen. Objective: We performed a pharmacoeconomic evaluation of the most commonly used treatments in Germany for toenail onychomycosis from a health care payer perspective. Methods: A 5-step approach was used. Firstly, the purpose of the study, the comparator drugs, their dosage regimens and the time frame of the analysis were defined. Next, the medical practice and resource consumption patterns associated with the treatment of onychomycosis were identified. In step III, a meta-analysis was used to determine the relative efficacy of the comparator drugs. In step IV, a decision tree of the treatment algorithms was constructed for each comparator. The expected cost analysis and cost-effectiveness analysis were also performed. Finally, a sensitivity analysis was carried out. Results: For the four main comparator drugs used to treat toenail onychomycosis in Germany, the clinical response rates (clinical cure plus marked improvement) at the end of the follow-up period (month 12 after starting therapy) were, for itraconazole (1-week pulse dosing): 89.8 ± 3% (mean ± SE), terbinafine: 79.4 ± 10%, itraconazole (continuous dosing): 77.5 ± 9%, and ciclopirox nail varnish: 55 ± 5%. Itraconazole (1-week pulse dosing) was most cost-effective at DM 1,107 per successful treatment, followed by oral terbinafine at DM 1,224, ciclopirox nail varnish and itraconazole (continuous dosing). Sensitivity analyses indicated that itraconazole (1-week pulse dosing) and terbinafine had similar cost-effectiveness ratios. Conclusion: Itraconazole is an effective, broad-spectrum triazole used as continuous or pulse therapy in the treatment of onychomycosis. Itraconazole (1-week pulse) and terbinafine are the most cost-effective therapies for toenail onychomycosis.
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