Serious Adverse Events Reporting on Systemic Terbinafine: A Danish Register-based Study

Bangsgaard, Nannie; Saunte, Ditte Marie Lindhardt; Folkenberg, Maja; Zachariae, Claus

doi:10.2340/00015555-1041

Cited by 18 publications

(22 citation statements)

References 7 publications

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“…Oral antifungal agents often fail to achieve sustainable cures even at the cost of long-term treatment. AEs associated with systemic antifungal agents may reduce compliance [13][14][15][16] . Controlled studies on the effectiveness of topical drugs alone are rare and provide low cure rates [16,26] .…”

Section: Discussionmentioning

confidence: 99%

“…AEs associated with systemic antifungal agents may reduce compliance [13][14][15][16] . Controlled studies on the effectiveness of topical drugs alone are rare and provide low cure rates [16,26] . Debridement alone was shown to be ineffective in achieving mycological cure [27] .…”

Section: Discussionmentioning

confidence: 99%

“…Although oral antifungals are generally well tolerated, liver impairment has been observed, ranging from mild elevation of transaminases to fulminant liver failure [12,13] . Premature ventricular contractions and congestive heart failure have been reported with itraconazole [14,15] and various serious adverse events (AEs) have been related to terbinafine [16] . Altered taste perception is an AE associated with terbinafine [17] .…”

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A Multicenter, Randomized, Open-Label, Controlled Study Comparing the Efficacy, Safety and Cost-Effectiveness of a Sequential Therapy with RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-Forming Solution with Amorolfine Nail Lacquer Alone in Dermatophytic Onychomycosis

Paul

Coustou²,

Lahfa

et al. 2013

Dermatology

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Background: The efficacy of topical antifungals is controversial. Objective: To compare the efficacy and safety of a sequential (SEQ) treatment with chemical nail avulsion and topical antifungals to amorolfine nail lacquer in dermatophytic onychomycosis. Methods: This was a randomized, parallel-group, controlled study comparing a 36-week SEQ treatment with chemical nail avulsion with RV4104A ointment (class I medical device containing 40% urea) followed by ciclopirox cream for 8 weeks and ciclopirox nail lacquer for 25 weeks (SEQ group) to amorolfine nail lacquer for 36 weeks (AMO group). Patients had to have a big toenail onychomycosis, sparing the matrix. The primary efficacy criterion was complete cure at week 48. A cost-effectiveness analysis was performed. Results: A total of 142 patients were randomized. The complete cure rate at week 48 was significantly higher in the SEQ group than in the AMO group (36.6 vs. 12.7%, p = 0.001). Clinical cure at week 48 was observed in 53.5% of patients in the SEQ group versus 17% in the AMO group (p < 0.01). The cost of cure per patient was 50% lower with SEQ treatment (EUR 33) compared with amorolfine (EUR 76). Conclusion: A treatment of onychomycosis comprising chemical avulsion of the pathological nail, ciclopirox cream and nail lacquer is significantly more effective than amorolfine nail lacquer.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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A Multicenter, Randomized, Open-Label, Controlled Study Comparing the Efficacy, Safety and Cost-Effectiveness of a Sequential Therapy with RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-Forming Solution with Amorolfine Nail Lacquer Alone in Dermatophytic Onychomycosis

Paul

Coustou²,

Lahfa

et al. 2013

Dermatology

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“…In randomized controlled trials of onychomycosis, complete cure rates reflecting both mycological and clinical cures for terbinafine and itraconazole range from approximately 35 to 50% (10). Moreover, both drug classes carry safety warnings pertaining to liver toxicity (11,12) and drug-drug interactions (13), with a small but significant percentage of more serious side effects (14)(15)(16). As a consequence, many patients choose not to pursue oral therapy.…”

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confidence: 99%

VT-1161 Dosed Once Daily or Once Weekly Exhibits Potent Efficacy in Treatment of Dermatophytosis in a Guinea Pig Model

Garvey

Hoekstra

Moore

et al. 2015

Antimicrob Agents Chemother

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c Current therapies used to treat dermatophytoses such as onychomycosis are effective but display room for improvement in efficacy, safety, and convenience of dosing. We report here that the investigational agent VT-1161 displays potent in vitro antifungal activity against dermatophytes, with MIC values in the range of <0.016 to 0.5 g/ml. In pharmacokinetic studies supporting testing in a guinea pig model of dermatophytosis, VT-1161 plasma concentrations following single oral doses were dose proportional and persisted at or above the MIC values for at least 48 h, indicating potential in vivo efficacy with once-daily and possibly once-weekly dosing. Subsequently, in a guinea pig dermatophytosis model utilizing Trichophyton mentagrophytes and at oral doses of 5, 10, or 25 mg/kg of body weight once daily or 70 mg/kg once weekly, VT-1161 was statistically superior to untreated controls in fungal burden reduction (P < 0.001) and improvement in clinical scores (P < 0.001). The efficacy profile of VT-1161 was equivalent to those for doses and regimens of itraconazole and terbinafine except that VT-1161 was superior to itraconazole when each drug was dosed once weekly (P < 0.05). VT-1161 was distributed into skin and hair, with plasma and tissue concentrations in all treatment and regimen groups ranging from 0.8 to 40 g/ml (or g/g), at or above the MIC against the isolate used in the model (0.5 g/ml). These data strongly support the clinical development of VT-1161 for the oral treatment of onychomycosis using either once-daily or once-weekly dosing regimens. F ungal infections of the skin, nails, and hair by dermatophytes, yeasts, and nondermatophyte molds are a common occurrence (1-3), with an estimated worldwide prevalence of 20% to 25% (1). In a survey of ambulatory records in the United States, these infections necessitated an average of 4 million physician visits per year from 1995 to 2004 (4), and the majority of these infections were caused by dermatophytes. The worldwide distribution of causative fungi and types of infection are dependent on geography, environment, and cultural factors (1, 2). Consistent with most of Europe and the United States (1, 2), a recent retrospective study found that onychomycosis (also referred to as tinea unguium) was the most common dermatophyte infection and that the absolute number of onychomycosis cases increased 10-fold over a 40-year period (5). This increase can be partly explained by the increases of two at-risk populations, the elderly (6) and diabetics (7). The most common species causing onychomycosis in Europe and the United States are Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum (8).Current oral treatment options for superficial fungal infections include allylamines, such as terbinafine, and azole-based fungal sterol 14␣-demethylase (CYP51) inhibitors (8, 9). The azoles fall into two classes defined by the moiety that binds the heme iron within the active site of CYP51, the imidazoles (e.g., ketoconazole), which are rarely used orally due...

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“…Two large-scale postmarketing surveillance studies showed that the incidence of serious side effects was <1% [4,5]. In contrast, 2 studies of registry data from Austria and Denmark drew attention to blood dyscrasias associated with terbinafine [6,7]. Notable adverse events have been reported, including hepatitis requiring liver transplantation [8], drug-induced lupus reactions, severe skin reactions such as Stevens-Johnson syndrome, and, much less often, neutropenia/agranulocytosis and thrombocytopenia [9,10,11,12,13,14,15,16,17].…”

Section: Discussion and Review Of The Literaturementioning

confidence: 99%

Aplastic Anemia Associated with Oral Terbinafine: A Case Report and Review of the Literature

Kantarcıoğlu¹,

Türköz²,

Yılmaz³

et al. 2014

Tjh

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Onychomycosis (OM) is a common fungal infection of the toenails and/or fingernails that is highly prevalent in the general population and also responsible for significant morbidity. OM is caused by dermatophytes, nondermatophytic molds, or yeast. Today systemic antifungal agents are considered as the gold standard for all types of OM. Here we report a case of aplastic anemia associated with oral terbinafine use and a review of the literature on hematological toxicities associated with terbinafine.

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Serious Adverse Events Reporting on Systemic Terbinafine: A Danish Register-based Study

Cited by 18 publications

References 7 publications

A Multicenter, Randomized, Open-Label, Controlled Study Comparing the Efficacy, Safety and Cost-Effectiveness of a Sequential Therapy with RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-Forming Solution with Amorolfine Nail Lacquer Alone in Dermatophytic Onychomycosis

A Multicenter, Randomized, Open-Label, Controlled Study Comparing the Efficacy, Safety and Cost-Effectiveness of a Sequential Therapy with RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-Forming Solution with Amorolfine Nail Lacquer Alone in Dermatophytic Onychomycosis

VT-1161 Dosed Once Daily or Once Weekly Exhibits Potent Efficacy in Treatment of Dermatophytosis in a Guinea Pig Model

Aplastic Anemia Associated with Oral Terbinafine: A Case Report and Review of the Literature

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