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Onychomycosis is a common problem. The desired outcome of treatment for patients and clinicians is complete cure (negative culture and negative potassium hydroxide examination results plus a completely normal nail). This cost analysis sought to determine the cost-effectiveness of treatments for onychomycosis using complete cure as a unit of effectiveness. A simplified cost-effectiveness analysis was conducted using complete cure rates from randomized, blinded clinical trials involving at least 50 participants. Trials were identified by searching the literature, manually searching for review articles, and reviewing medication package inserts. For each trial that met the entry criteria, three levels of cost were used to calculate medication cost per complete cure: commercial price, average wholesale price, and Veterans Affairs pharmacy price. In addition, a computerized economic model was used to determine total cost per complete cure, including all medical costs. The most cost-effective treatments were those that involved terbinafine: pulse, continuous, or in combination with other agents. Itraconazole, griseofulvin, and fluconazole were less cost-effective. Ciclopirox nail lacquer was at least three times more expensive than all other agents when evaluating total costs per complete cure. Overall, the lowest cost per complete cure resulted from terbinafine treatment, with most evidence supporting 3 months of continuous therapy. (J Am Podiatr Med Assoc 96(1): 38–52, 2006)
OBJECTIVE: To assess the daily treatment costs and the average cost-effectiveness of three topical onychomycosis therapies - amorolfine 5% and ciclopirox 8% nail lacquers and tioconazole 28% nail solution - when used as indicated in France, the UK, Germany and Italy.
METHODS: The quantity of drug required and nail size measurements were investigated and, knowing the cost per bottle of each study drug, used to calculate the average treatment cost per patient. Using the prevalence of infection data, the weighted average total treatment cost per patient and hence the weighted average daily treatment cost and cost per patient cured, were calculated.
RESULTS: Amorolfine was consistently more cost-effective in terms of weighted average daily treatment cost and cost per patient cured than ciclopirox and tioconazole, when all therapies were used as indicated to treat onychomycosis. In France, for example, the weighted average daily treatment cost of amorolfine was found to be euro 0.23 and euro 0.40 when used once and twice a week, respectively; the cost per patient cured for amorolfine was euro 84. By comparison, the weighted average daily treatment cost of ciclopirox was found to be euro 0.81; the cost per patient cured was euro 252.
CONCLUSIONS: When used as indicated, amorolfine 5% nail lacquer is more cost-effective than ciclopirox 8% and tioconazole 28% for onychomycosis of toenail, fingernail or both in males and females in France, UK, Germany and Italy.
BACKGROUND: Fungal infections of the feet normally occur in the outermost layer of the skin (epidermis). The skin between the toes is a frequent site of infection which can cause pain and itchiness. Fungal infections of the nail (onychomycosis) can affect the entire nail plate.
OBJECTIVES: To assess the effects of topical treatments in successfully treating (rate of treatment failure) fungal infections of the skin of the feet and toenails and in preventing recurrence. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE and EMBASE (from inception to January 2005). We screened the Science Citation Index, BIOSIS, CAB - Health and Healthstar, CINAHL DARE, NHS Economic Evaluation Database and EconLit (March 2005). Bibliographies were searched. SELECTION CRITERIA: Randomised controlled trials (RCTs) using participants who had mycologically diagnosed fungal infections of the skin and nails of the foot. DATA COLLECTION AND ANALYSIS: Two authors independently summarised the included trials and appraised their quality of reporting using a structured data extraction tool.
MAIN RESULTS: Of the 144 identified papers, 67 trials met the inclusion criteria. Placebo-controlled trials yielded the following pooled risk ratios (RR) of treatment failure for skin infections: allylamines RR 0.33 (95% CI 0.24 to 0.44); azoles RR 0.30 (95% CI 0.20 to 0.45); ciclopiroxolamine RR 0.27 (95% CI 0.11 to 0.66); tolnaftate RR 0.19 (95% CI 0.08 to 0.44); butenafine RR 0.33 (95% CI 0.24 to 0.45); undecanoates RR 0.29 (95% CI 0.12 - 0.70). Meta-analysis of 11 trials comparing allylamines and azoles showed a risk ratio of treatment failure RR 0.63 (95% CI 0.42 to 0.94) in favour of allylamines. Evidence for the management of topical treatments for infections of the toenails is sparser. There is some evidence that ciclopiroxolamine and butenafine are both effective but they both need to be applied daily for prolonged periods (at least 1 year). The 6 trials of nail infections provided evidence that topical ciclopiroxolamine has poor cure rates and that amorolfine might be substantially more effective but more research is required.
AUTHORS' CONCLUSIONS: Placebo-controlled trials of allylamines and azoles for athlete's foot consistently produce much higher percentages of cure than placebo. Allylamines cure slightly more infections than azoles and are now available OTC. Further research into the effectiveness of antifungal agents for nail infections is required.