Comparative evaluation of the efficacy and safety of two doses of terbinafine (500 and 1000 mg day(-1)) in the treatment of cutaneous or lymphocutaneous sporotrichosis

Mycoses. 2004 Feb;47(1-2):62-8. doi: 10.1046/j.1439-0507.2003.00953.x.

Abstract

The aim of this study was to evaluate the safety and efficacy of oral terbinafine (500 and 1000 mg day(-1)) in the treatment of cutaneous or lymphocutaneous sporotrichosis. A culture for Sporothrix schenckii was required for inclusion into this multicentre, randomized, double-blind, parallel-group study. Patients received either 250 mg b.i.d. or 500 mg b.i.d. oral terbinafine for up to a maximum of 24 weeks and were assessed up to 24 weeks post-treatment. The main efficacy outcome measure was cure, defined as no lesion and absence of adenopathy at the end of follow-up. Adverse events (AEs), laboratory tests, vital signs and ophthalmological examinations were also assessed. Sixty-three patients (14-85 years of age) were treated with 500 mg day(-1) (n = 28) or 1000 mg day(-1) terbinafine (n = 35). The majority of patients were cured after 12-24 weeks of treatment, and the response was dose-dependent throughout the study and at the end of follow-up. The cure rate was significantly higher in patients treated with 1000 mg day(-1) terbinafine compared with those treated with 500 mg day(-1) terbinafine (87% vs. 52%, respectively; P = 0.004). There were no cases of relapse after 24 weeks of follow-up in the 1000 mg day(-1) terbinafine group, compared with six relapses in the terbinafine 500 mg day(-1) group. Terbinafine was well tolerated and the frequency of drug-related AEs was slightly higher in the 1000 mg treatment group. Both doses of terbinafine were well-tolerated and effective for the treatment of sporotrichosis. The 1000 mg day(-1) terbinafine dose was more efficacious than 500 mg day(-1) in the treatment of cutaneous or lymphocutaneous sporotrichosis.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antifungal Agents / administration & dosage*
  • Antifungal Agents / adverse effects
  • Antifungal Agents / pharmacology
  • Antifungal Agents / therapeutic use
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Lymphatic Diseases / drug therapy*
  • Lymphatic Diseases / microbiology
  • Lymphatic Diseases / pathology
  • Male
  • Middle Aged
  • Naphthalenes / administration & dosage*
  • Naphthalenes / adverse effects
  • Naphthalenes / pharmacology
  • Naphthalenes / therapeutic use
  • Recurrence
  • Sporothrix / isolation & purification
  • Sporotrichosis / drug therapy*
  • Sporotrichosis / microbiology
  • Sporotrichosis / pathology
  • Terbinafine
  • Treatment Outcome

Substances

  • Antifungal Agents
  • Naphthalenes
  • Terbinafine