Effectiveness

Six double-blind RCTs compared terbinafine with placebo.33,145,156-159 Each study reported terbinafine, 250 mg/day, to be significantly more effective than placebo in treating onychomycosis.

Ten double-blind RCTs compared continuous terbinafine with other drugs.35,149,160-167 Mycological cure rates ranged from 67% to 95% and the corresponding clinical response rates from 66% to 97% with a follow up of no more than 72 weeks.

Four open RCTs reported the efficacy of continuous terbinafine for 3 or 4 months.168-171

Table 33.1 Treatment of dermatophyte fingernail onychomycosis

Year

Authors

Treatment

évaluable patients

Regimen

Treatment duration

Follow up (post-treatment)

Efficacy measure (%) MC CR CC

2001

Itraconazole package Insert (US)155

Continuous Itraconazole

Double-blind, randomised, placebo-controlled

37

200 mg/day

2 months

(61)

(47)

2001

Terbinafine package Insert (US)156

Continuous terbinafine

Double-blind, randomised, placebo-controlled

Not stated

250 mg/day

6 wks

24 wks

(79)

(59)

1997

Itraconazole

Double-blind, randomised, multicentre, placebo-controlled

37

400 mg/day 1 wk/month

2 months

Up to19 wks

16/22 (73)

17/22 (77)

15/22 (68)

1998

Drake eia/.137

Fluconazole

Double-blind, randomised, parallel, multicentre, placebo-controlled

78

150 mg/wk

Up to 9 months

6 months

70/78 (90)*

69/78 (88)

61/78 (78)*

1995

Haneke141

Grlseofulvln

Double-blind, randomised, comparative (continuous terbinafine)

92

500 mg/day

12 wks, followed by 12 wks placebo

6 months

45/72 (63)

(39)

Mycologlcal cure (MC) Is defined as negative microscopy and culture unless Indicated otherwise; clinical response (CR) Is defined as cured or markedly Improved unless Indicated otherwise; Complete cure (CC) Is defined as mycologlcal and clinical cure or Improvement unless Indicated otherwise; *not defined *CC defined as clinical cure and negative mycologlcal culture; defined as MC and continuous growth of unaffected nail; ACR variable definitions; 11, MC defined as negative microscopy

Mycologlcal cure (MC) Is defined as negative microscopy and culture unless Indicated otherwise; clinical response (CR) Is defined as cured or markedly Improved unless Indicated otherwise; Complete cure (CC) Is defined as mycologlcal and clinical cure or Improvement unless Indicated otherwise; *not defined *CC defined as clinical cure and negative mycologlcal culture; defined as MC and continuous growth of unaffected nail; ACR variable definitions; 11, MC defined as negative microscopy

Table 33.2 Treatment of dermatophyte toenail onychomycosis using griseofulvin therapy

Year

Authors

Study type

No. of evaluable patients

Regimen

Treatment duration

Follow up (post-treatment)

Efficacy measure (%) MC CR CC

1997

Baran eia/.144

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

58

1 g/day

Up to 12 months

(69)

(44)

1995

Faergemann eia/.143

Double-blind, randomised, parallel, comparative (continuous terblnafine)

41

500 mg/day

13 months

(2)«

1995

Hofmann eia/.140

Double-blind, randomised, comparative (continuous terblnafine)

88

1000 mg/day

48 wks

24 wks

42/68 (62)

49/88 (56) ***

1993

Körting efal.142

Open, randomised, comparative (continuous Itraconazole)

36 36

660 mg/day 990 mg/day

Up to 18 months

2/36 (6) 2/36 (6)

See Table 33.1 for abbreviations.

Year

Authors

évaluable patients

Regimen

Treatment duration

Follow up (from baseline)

Efficacy measure (%) MC

CR

CC

2002

Heikkila et a/.160

Double-blind, double dummy, randomised multicentre, comparative (pulse Itraconazole)

23 18

250 mg/day

12 wks 16 wks

72 wks

Negative microscopy: 21/23 (91) Negative culture: 20/23 (87)

Negative microscopy: 18/18 (100) Negative culture: 7/18 (94)

9/18 (50)*

2002

Sigurgeirsson eia/.1£i1

Double-blind, double dummy, randomised comparative (pulse Itraconazole)

74

250 mg/day

12 or 16 wks

Up to 5 years

34/74 (46)

26/74 (35)

2001

TER Package Insert (US)156

Double-blind, randomised, placebo-controlled

Not Stated

250 mg/day

12 wks

48 wks

(70)

(38)

2000

Havu efa/.162

Double-blind; double-placebo, randomised multicentre, comparative (fluconazole)

46

250 mg/day

12 wks

60 wks

41/46 (89)

39/46 (85)A

1999

Evans et ai.3'-'

Double-blind, double dummy, randomised parallel, multicentre, comparative (pulse Itraconazole)

99

250 mg/day

12 wks 16 wks

72 wks

81/107 (76) 80/99 (81)

67/102 (66)* 67/95 (71)*

49/107 (46) 54/98 (55)

1999

Degreef eia/.165

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

144

250 mg/day

12 wks

48 months

(67)

(87)

1999

Blllstein et ai. 157

Double-blind, randomised parallel, multicentre, placebo-controlled

29 27

250 mg/day

12 wks 16 wks

72 wks

18/21 (86) 13/16 (81)

*

*

Year

Authors

évaluable patients

Regimen

Treatment duration

Follow up (from baseline)

Efficacy measure (%) MC

CR

CC

1998

De Backer et al.1"

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

186

250 mg/day

12 wks

48 wks

119/163 (73)

(76)*

(38)

1997

Drake et al. 33

Double-blind, randomised multicentre, placebo-controlled

142

250 mg/day

12 wks

48 wks

(70)

58/71 (82)

1997

Svejgaard et al,153

Double-blind, randomised multicentre, placebo-controlled

48

250 mg/day

3 months

9 or 12 months

19/48 (40)

'

18/48 (38)

1997

Honeyman eia/.164

Double-blind, double dummy, randomised parallel, multicentre, comparative (continuous Itraconazole)

64

250 mg/day

4 months

48 wks

61/64 (95)11

62/64 (97)

61/64 (95)

1997

Tausch etal.13-'

Double-blind, randomised multicentre, duration finding

56

250 mg/day

12 wks

48 wks

46/56 (82)

33/56 (59)A

33/56 (59)

1995

Brautigam eia/.1£,£i

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

86

250 mg/day

12 wks

52 wks

70/86 (81)

69/86 (80)*

1995

Faergemann et a/.14'3

Double-blind, randomised parallel, comparative (grlseofulvln)

43

250 mg/day

4 months

36/43 (84)*

18/43 (42)«

1995

Watson étal.™

Double-blind, randomised, placebo-controlled

56

250 mg/day

12 wks

24 wks

33/56 (59)

1994

De Backer efa/.167

Double-blind, randomised parallel, comparative (continuous terblnafine)

49 51

250 mg/day 500 mg/day

4 months

48 wks

41/49 (84) 46/51 (90)

44/49 (90) 45/51 (88)

*

Table 33.3 (Continued)

Year

Authors

évaluable patients

Regimen

Treatment duration

Follow up (from baseline)

Efficacy measure (%) MC

CR

CC

1992

van der Schroeff143

Double-blind, randomised, duration-finding

30 34 34

250 mg/day

6 wks 12 wks 24 wks

48 wks

12/29 (41) 24/34 (71) 28/34 (82)

24/34

27/34

(79)

1992

Goodfleld etat"-'

Double-blind, randomised parallel, multicentre, placebo-controlled

45

250 mg/day

12 wks

48 wks

37/45 (82)

2002

Area et al.™

Open, randomised comparative (pulse Itraconazole, fluconazole)

16

250 mg/day

3 months

6 months

12/16 (75)

10/16 (63)

1996

Alpsoy et a/.170

Open, randomised comparative (pulse terblnaflne)

24

250 mg/day

3 months

12 months

19/24 (79)

1999

Kejda171

Open, randomised parallel, comparative (pulse Itraconazole)

25

250 mg/day

3 months

12 months

(76)

17/25 (68)

1996

Tostl et a/.1®

Open, randomised, comparative (pulse Itraconazole, pulse terblnaflne)

19

250 mg/day

4 months

10 months

16/17 (94)

13/17 (76)

See Table 33.1 for abbreviations

See Table 33.1 for abbreviations

Mycological cure ranged between 75% and 94%. In one study, clinical response was reported to be 68%.171 Complete cure ranged from 63% to 79%.

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