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AAP Grand Rounds 20:49-50 (2008) Terbinafine vs Griseofulvin for Tinea CapitisSource: Elewski BE, Caceres HW, DeLeon L, et al. Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. J Am Acad Dermatol. 2008;59(1):41–54; doi:10.1016/j.jaad.2008.02.019[CrossRef][Medline]
Multiple investigators from several international centers (including the US) conducted two identically designed trials to compare the efficacy and safety of a new pediatric formulation of terbinafine hydrochloride oral granules with griseofulvin microsize oral suspension for the treatment of tinea capitis in children. This study pooled data from the two trials which included 1,549 children, 4–12 years of age, with clinically diagnosed tinea capitis that was also confirmed by potassium hydroxide microscopy. Children were randomized to two identical investigator-blinded, controlled trails to either once-daily terbinafine or griseofulvin for six weeks. Patients were followed for an additional four weeks after completing therapy. Dosing of the terbinafine ranged from 5–8 mg/kg per day and griseofulvin (microsize) dosing ranged from 10–20 mg/kg/day. Efficacy variables included mycologic cure (negative fungal culture and negative microscopy) and clinical cure. Complete cure was defined as both mycologic cure and clinical cure. Complete cure rates were significantly higher for terbinafine-treated patients (45.1%) compared with griseofulvin-treated patients (39.2%). For those patients with Trichophyton tonsurans infection, terbinafine was superior to griseofulvin for complete, mycologic, and clinical cure rates (P<.001). Griseofulvin was more effective than terbinafine in achieving mycologic and clinical cure rates for Microsporum canis infections. Analysis of data from the US subsets (in which T tonsurans accounted for 92% of the dermatophytes) found that terbinafine was superior to griseofulvin in achieving both complete cure (46.2% vs 32.5%, P=.0014) and mycologic cure (61.8% vs 47.2%, P=.0007). Approximately 50% of all patients developed an adverse event during the study; however, fewer than 10% of the patients in either group developed adverse events that investigators attributed to the study drug. Frequencies of individual drug-related adverse events were similar between the two groups. The most common reported adverse events included vomiting, upper abdominal pain, diarrhea, and headache. There were no drug-related deaths, and severe adverse events were rare (0.6% in both groups). No significant variations from baseline laboratory results (hematologic or hepatic) that could be attributed to drug effects were noted in patients treated with either terbinafine or griseofulvin. The authors conclude that the safety profile of terbinafine hydrochloride granules is similar to griseofulvin administered according to labeled dosing, and that terbinafine represents an effective treatment alternative for the treatment of tinea capitis in children.
Dr. Horii has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device. Tinea capitis is a common pediatric infection most frequently caused by T tonsurans in the US.1–3 Systemic treatment is required to eradicate the infection and griseofulvin has traditionally been the antifungal therapy of choice.3 In clinical practice, effective treatment with griseofulvin often requires higher doses and a longer duration of therapy than recommended on the package labeling.1,2 Effective alternative antifungal therapies that have good oral tolerability and require a shorter course of treatment are therefore likely to be advantageous. This is the largest pediatric trial of terbinafine to date. Similar to other prior studies that evaluated terbinafine tablets, terbinafine hydrochloride granules appear to be efficacious and well-tolerated in the treatment of tinea capitis.1–3 This new pediatric formulation, which can be sprinkled on non-acidic food (such as pudding), may be easier for children to consume than the tablet formulation. A previous meta-analysis of comparative, randomized trials of griseofulvin versus terbinafine tablets also found that terbinafine was at least as effective as griseofulvin in the treatment of Trichophyton species infections.3 However, the dosing and duration of treatment of griseofulvin in that study were less than what is often used in clinical practice, and the overall cure rate of terbinafine in that trial was lower than those found in other prior studies.1,2 Contrary to usual clinical practice, no adjunctive therapy, such as antifungal shampoo, was utilized in the current study, which may have affected cure rates. Terbinafine oral granules received US approval in September 2007 to treat tinea capitis in children age four years and older.4 Recommended six-week dosing is based on body weight (<25 kg: 125 mg/day; 25–35 kg: 187.5 mg/day; >35 kg: 250 mg/day) and the granules are available in 125 mg and 187.5 mg packets.4 Since T tonsurans is the most common dermatophyte causing tinea capitis in the US, terbinafine granules are a potential alternative antifungal therapeutic option to treat tinea capitis caused by Trichophyton species. However, if Microsporum species are identified on fungal culture, griseofulvin is probably a better choice. Performing a fungal culture on patients suspected to have tinea capitis is therefore highly recommended to not only confirm infection, but also to help guide appropriate therapy. Shorter duration of therapy and the ease of administration of terbinafine hydrochloride granules are potential advantages compared to griseofulvin. Cost of terbinafine granules may be less since the duration of therapy is potentially shorter than standard treatment with griseofulvin; however, the package insert for terbinafine granules recommends baseline liver function studies prior to treatment (baseline lab work is not usually performed in healthy children treated with griseofulvin) which may increase the overall cost of therapy.4
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