Comment

Continuous itraconazole therapy is an effective and well-tolerated treatment for onychomycosis. Historically, treatment of onychomycosis with itraconazole was with the continuous regimen; later work done by de Doncker et a/.184,190 resulted in the widespread adaptation of pulse therapy for this indication. When patients with toenail onychomycosis were treated with continuous itraconazole therapy, 21% of the overall success group had a relapse (worsening of the global

Year Reference

Study type

No. of Regimen

évaluable patients

Treatment Follow up duration period (from baseline)

Efficacy measure (%)

2001 Itraconazole package Double-blind, randomised, placebo- 110 controlled

Insert (US)155 1999 Degreef eia/.16'

1998 Haneke ef a/.133

1998 De Backer et a!.11

1997 Elewskl etal.v

1997 Havuefa/.1'

1997 Honeyman et al.w"

Double-blind, randomised, parallel, 145 multicentre, comparative (continuous terblnaflne)

Double-blind, randomised, parallel, 479 multicentre, comparative (continuous Itraconazole + pulse Itraconazole, miconazole)

Double-blind, randomised, parallel, 186 multicentre, comparative (continuous terblnaflne)

Double-blind, randomised, 109

multicentre, placebo-controlled

Double-blind, randomised, 62

multicentre, parallel, comparative (pulse Itraconazole)

Double-blind, double dummy, 70

randomised, parallel, multicentre, comparative (continuous terblnaflne)

200 mg/day 12 wks

200 mg/day 12 wks 48 wks

200 mg/day 12 wks 48 wks

200 mg/day 12 wks 48 wks

200 mg/day 3 months 12 months 41/62 (66) 43/62 (69)

200 mg/day 4 months 12 months

200 mg/day 3 months 12 months 354/479 (74) 395/479 (82)

(Continued)

Table 33.6 (Continued)

Year

Reference

Study type

No. of

Regimen

Treatment

Follow up

Efficacy measure (%)

évaluable patients

duration

period (from baseline)

MC

CR

CC

1995

Brautlgam eia/.1£,£i

Double-blind, randomised, parallel, multicentre, comparative (continuous terbinafine)

84

200 mg/day

12 wks

52 wks

53/84 (63)

63/84 (75)*

1996

Jones et al.v-2

Double-blind, randomised, placebo-controlled

35

200 mg/day

12 wks

24/35 (69)*

27/35 (77)*

18/35 (51)*

1996

Odom et al.v-3

Double-blind, randomised, placebo-controlled

38

200 mg/day

12 wks

48 wks

18/38 (47)*

26/38 (68)

14/38 (37)

1999

Shemer et al,133

Open, randomised, comparative (pulse

Minimum of 16

200 mg/day

3 months

48 wks

*

*

(68)

Itraconazole)

patients In each group

4 months

(65)

See Table 33.1 for abbreviations.

See Table 33.1 for abbreviations.

score or conversion of KOH (potassium hydroxide) or culture from negative to positive).155

0 0

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