Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial

Drake, Lynn A.; Shear, Neil H.; Arlette, Jon P.; Cloutier, Richard; Danbye, Frederick W.; Elewski, Boni E.; Garnis‐Jones, Sylvia; Giroux, Jean-Mario; Gratton, David; Gulliver, Wayne; Hull, Peter; Jones, Henry E.; Journet, Michel; Krol, Alfons; Leyden, James J.; Maddin, Stuart; Ross, J.Barrie; Savin, Ronald C.; Scher, Richard K.; Sibbald, Gary; Tawfik, Naji H.; Zaias, Nardo; Tolpin, Mark D.; Evans, Sandra; Marsolais, Christian; Chinv, Thomas; Lin, Tsuang-Hua; Maher, Thomas D.; Birnbaum, Jay E.

doi:10.1016/s0190-9622(97)70111-7

Cited by 110 publications

(79 citation statements)

References 14 publications

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“…An updated search of the PubMed, Scopus and OVID, and clinical trials.gov databases yielded 7, 72, and 6 articles, respectively, and two clinicaltrials.gov records (n = 85). Of these, only the two clinicaltrials.gov records met the inclusion criteria; thus, a total of 19 trials (n = 5,551 patients) were included for the NMA (table 1) [20,21,22,23,24,25,26,27,28,29,30,31,32,33]. The evidence network consisted of five topical treatments [amorolfine 5% nail lacquer, ciclopirox nail lacquer 8%, efinaconazole 10% topical solution, terbinafine nail solution (TNS), and tavaborole topical solution 5%] and four oral treatment regimens (fluconazole 150-450 mg, itraconazole 200 mg continuous dosing, itraconazole 400 mg pulse, and terbinafine 250 mg continuous dosing; fig.…”

Section: Resultsmentioning

confidence: 99%

Network Meta-Analysis of Onychomycosis Treatments

Gupta

Daigle

Foley

2015

Skin Appendage Disord

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Background: Many onychomycosis treatments have not been directly compared in head-to-head clinical trials. Objective: To determine the relative efficacy of onychomycosis treatments using network meta-analysis (NMA). Methods: We conducted a systematic review and NMA of mycological cure rates. Results: Nineteen trials were included in the network. Terbinafine 250 mg was significantly superior to all treatments except itraconazole 400 mg pulse therapy. The itraconazole 400 mg pulse regimen was significantly superior to all topicals except efinaconazole 10% nail solution. Itraconazole 200 mg was significantly superior to all topical treatments, while fluconazole 150-450 mg, efinaconazole 10% nail solution, tavaborole 5% nail solution, ciclopirox nail lacquer 8%, terbinafine nail solution, and amorolfine 5% nail lacquer were significantly superior to placebo. Conclusions: Newly developed topicals have improved the odds ratios (ORs) of mycological cure, yet these ORs were not significantly greater than preexisting topical treatments. Further experience with these agents will reveal their clinical significance, and head-to-head trials are warranted.

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Section: Resultsmentioning

confidence: 99%

Network Meta-Analysis of Onychomycosis Treatments

Gupta

Daigle

Foley

2015

Skin Appendage Disord

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“…165,[182][183][184] Most terbinafine related adverse events are mild or moderate and include gastrointestinal complaints (eg, nausea, abdominal pain, vomiting, diarrhea), cutaneous eruptions, weight gain, appetite changes, headaches, and vertigo. 43,152,165,185,186 Those adverse reactions involving the gastrointestinal system and skin are most commonly associated with discontinuation of therapy, 165,186 with the risk of discontinuation estimated at 3.4%. 187 Serious adverse drug reactions, most commonly involving the liver and the hematologic system, are only rarely reported with terbinafi ne use (0.04%).…”

Section: Adverse Effectsmentioning

confidence: 99%

Update on terbinafine with a focus on dermatophytoses

Newland¹,

Abdel‐Rahman

2009

CCID

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Since terbinafi ne was introduced on the world market 17 years ago, it has become the leading antifungal for the treatment of superfi cial fungal infections, aided by unique pharmacologic and microbiologic profi les. This article reviews mode of action, antimycotic spectrum and disposition profi le of terbinafi ne. It examines the data, accumulated over 15 years, on the comparative effi cacy of terbinafi ne (vs griseofulvin, itraconazole, fl uconazole) in the management of the infections for which it is primarily indicated (eg, dermatophytoses) and provides a brief discussion on its use for the treatment of non-dermatophyte infections. Finally, the available data on the newest topical and systemic formulations are introduced.

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“…Percentage area, onycholysis, hyperkeratosis, discoloration Incomplete Drake et al, 22 1997 Unaffected nail length (millimeters and percentages), patients' assessment Incomplete Van der Shroeff et al, 23 1992 Onycholysis, hyperkeratosis, and paronychial inflammation Incomplete Ling et al, 24 1998…”

Section: Incompletementioning

confidence: 99%

“…The frequency of adverse events was not significantly different between treatment and placebo arms for terbinafine, itraconazole, and fluconazole. [12][13][14][15][22][23][24][25][26] The data from dosefinding studies do not suggest that shorter treatment times (including intermittent regimens) result in fewer reported adverse events. No trials with placebo controls were identified for evaluations of griseofulvin and ketoconazole.…”

Section: Adverse Eventsmentioning

confidence: 99%