PMID- 11209118
OWN - NLM
STAT- MEDLINE
DCOM- 20010405
LR  - 20181130
IS  - 0190-9622 (Print)
IS  - 0190-9622 (Linking)
VI  - 44
IP  - 3
DP  - 2001 Mar
TI  - Single-blind, randomized, prospective study on terbinafine and itraconazole for 
      treatment of dermatophyte toenail onychomycosis in the elderly.
PG  - 479-84
AB  - BACKGROUND: The 2 most common agents used to treat dermatophyte onychomycosis of 
      the toe are terbinafine (continuous) and itraconazole (pulse). Although 
      comparative studies have been performed evaluating the efficacy of these 2 agents 
      in adults, no such studies have been reported specifically in the elderly subset. 
      OBJECTIVE: This prospective, randomized, single-blind, non--industry-sponsored, 
      comparative study evaluated the efficacy and safety of terbinafine (continuous) 
      and itraconazole (pulse) therapies in the treatment of dermatophyte onychomycosis 
      of the toe in the elderly population. METHODS: Elderly patients (> or =60 years 
      old) with dermatophyte onychomycosis of at least 1 great toe were randomly 
      assigned to receive either terbinafine 250 mg/day for 12 weeks or itraconazole 
      (pulse) 200 mg twice a day for 1 week, given for 3 pulses. At month 6 from the 
      start of therapy, if there was less than 50% reduction in the affected nail plate 
      area compared with baseline, or if there was less than 3 mm outgrowth of 
      unaffected nail plate as measured in midline, then patients who had been 
      administered terbinafine (continuous) therapy were given an extra 4 weeks of the 
      drug (total of 16 weeks of therapy), and those who had received itraconazole 
      (pulse) therapy were given an extra pulse (fourth pulse). Patients were evaluated 
      at 1.5, 3, 6, 12, and 18 months from the start of therapy. The efficacy measures 
      included mycologic cure rate and clinical efficacy (mycologic cure plus clinical 
      cure or clinical improvement so that 10% or less of nail plate was clinically 
      involved). RESULTS: There were 101 elderly patients enrolled in the study with 50 
      and 51 patients receiving terbinafine and itraconazole, respectively. The 
      terbinafine group consisted of 28 men and 22 women, age (mean +/- standard error 
      [SE]) 68.0 +/- 0.9 years, duration of onychomycosis (mean +/- SE) 18.2 +/- 1.4 
      years, number of nails involved (mean +/- SE) 5.5 +/- 0.5, and percent baseline 
      nail plate area involved (mean +/- SE) 67.5% +/- 4.2%. The corresponding figures 
      for the itraconazole (pulse) group were 24 men and 27 women, age (mean +/- SE) 
      68.8 +/- 0.8 years, duration of onychomycosis (mean +/- SE) 16.1 +/- 1.7 years, 
      number of nails involved (mean +/- SE) 6.0 +/- 0.7, and percent baseline nail 
      plate area involved (mean +/- SE) 74.9% +/- 3.8%, respectively, with no 
      significant difference between the groups. At month 6, the number of patients 
      that required an extra 4 weeks of terbinafine in the allylamine group or an extra 
      itraconazole pulse in the triazole group was 13 of 50 and 23 of 51, respectively. 
      The mycologic cure rate and clinical efficacy at 18 months from the start of 
      therapy for the terbinafine group were 64.0% and 62.0%, respectively. The 
      corresponding figures for the itraconazole (pulse) group were 62.7% and 60.8%, 
      respectively, with no significant difference between the 2 groups. There were no 
      dropouts during therapy. For both groups the drug appeared safe with no 
      significant adverse events (AEs) or clinically significant laboratory 
      abnormalities. All the AEs were mild and transient. There was high compliance 
      with both regimens. CONCLUSIONS: In the elderly, for the treatment of 
      dermatophyte toe onychomycosis, both terbinafine (continuous) and itraconazole 
      (pulse) therapies are effective, safe, and associated with high compliance.
FAU - Gupta, A K
AU  - Gupta AK
AD  - Department of Medicine, Sunnybrook and Women's College Health Sciences Center, 
      Toronto, Ontario, Canada. agupta@execulink.com
FAU - Konnikov, N
AU  - Konnikov N
FAU - Lynde, C W
AU  - Lynde CW
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Antifungal Agents)
RN  - 0 (Naphthalenes)
RN  - 304NUG5GF4 (Itraconazole)
RN  - G7RIW8S0XP (Terbinafine)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Antifungal Agents/administration & dosage/*therapeutic use
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Foot Dermatoses/drug therapy/pathology
MH  - Humans
MH  - Itraconazole/administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Naphthalenes/administration & dosage/*therapeutic use
MH  - Onychomycosis/*drug therapy/pathology
MH  - Patient Compliance
MH  - Prospective Studies
MH  - Single-Blind Method
MH  - Terbinafine
MH  - Treatment Outcome
EDAT- 2001/02/24 11:00
MHDA- 2001/04/06 10:01
CRDT- 2001/02/24 11:00
PHST- 2001/02/24 11:00 [pubmed]
PHST- 2001/04/06 10:01 [medline]
PHST- 2001/02/24 11:00 [entrez]
AID - S0190-9622(01)80760-X [pii]
AID - 10.1067/mjd.2001.110874 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2001 Mar;44(3):479-84. doi: 10.1067/mjd.2001.110874.