Comment

Itraconazole pulse therapy is effective and safe in onychomycosis. The pulse regimen used to

Table 33.5 Treatment of dermatophyte toenail onychomycosis using itraconazole pulse therapy

Year

Reference

Study type

No. of

Regimen

Treatment Follow up

Efficacy measure (%

evaluable

duration period (from

patients

baseline)

MC

CRA

CC

2002

Helkklla et al.160

Double-blind, double dummy,

18

400 mg/day

12 wks 72 wks

Negative

*

6/18

randomised, multicentre,

1 wk/month

microscopy: 11/18

(33)*

comparative (continuous

(61)

terblnafine)

Negative culture:

12/18 (67)

17

16 wks

Negative

*

3/17

microscopy: 11/17

(18)*

(65)

Negative culture:

13/17 (76)

2002

Slgurgeirrsson

Double-blind, double dummy,

77

400 mg/day

12 or 16 wks Up to 5 years

10/77 (13)

*

11/77

et a/.161

randomised, comparative

1 wk/month

(14)

(continuous terblnafine)

2000

Gupta etal. 130

Double-blind, randomised,

78

400 mg/day

3 months 48 wks

48/78 (62)

51/78

*

placebo-controlled

1 wk/month

(65)

1999

Evans eia/.35

Double-blind, double dummy,

107

400 mg/day

12 wks 72 wks

41/107 (38)

29/102

25/107

randomised, parallel, multicentre,

1 wk/month

(28)A

(23)

comparative (continuous

109

16 wks

53/108 (49)

35/104

28/108

terblnafine)

(34)*

(26)

1997

Havu etal."'

Double-blind, randomised, parallel,

59

400 mg/day

3 months 12 months

41/59 (69)

48/59

*

multicentre, comparative

1 wk/month

(81)

(continuous Itraconazole)

2002

Area et al. 163

Open, randomised, comparative

18

400 mg/day

3 months 6 months

11/18 (61)

*

11/18

(continuous terblnafine,

1 wk/month

(61)

fluconazole)

Table 33.5 (Continued)

Year

Reference

évaluable patients

Regimen

Treatment duration

Follow up period (from baseline)

Efficacy measure (%) MC

CR

CC

1999

Shemer etat. 133

Open, randomised, comparative (continuous Itraconazole)

Minimum of 16 patients ¬°In each group

4 months

48 wks

*

*

(50) (65)

1999

Kedja171

Open, randomised, parallel, comparative (continuous terblnaflne)

26

400 mg/day 1 wk/month

3 months

12 months

(75)

20/26 (77)

1996

Tostl et a/.16'3

Open, randomised, comparative (continuous 1/pulse terblnaflne)

21

400 mg/day 1 wk/month

4 months

10 months

15/20 (75)

8/21 (38)

1996

De Doncker eia/.134

Open, randomised, comparative (pulse Itraconazole)

25 25

4 months

Up to 1 yr

16/25 (64) 18/25 (72)

22/25 (88) 21/25 (84)

*

See Table 33.1 for abbreviations.

See Table 33.1 for abbreviations.

treat toenail onychomycosis decreases the itraconazole required by one-half compared with the continuous regimen with this triazole. This may result in monetary saving, increased compliance and may reduce the frequency of adverse events.180 185 188-190 In fact, the pulse regimen is the preferred mode of drug delivery when using itraconazole. No significant difference was found between three- and four-pulse regimens of itraconazole for the primary efficacy parameters in the treatment of toenail onychomycosis.184 In one report, after the use of three pulses for the treatment of toenail onychomycosis, the relapse rate at follow up 12 months after the start of therapy was 10-4%.190 Two pulses of itraconazole should be effective and safe in fingernail onychomycosis.

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