Table 7 safety outcome results identified in studies included for review
Study | Design | Treatment | Treatment regimen | Sample size (males) | Age [mean (SD)] years | Safety assessment (week) | % of patients experienced to adverse events | % of patients experienced to adverse events due to treatment intervention | Reported adverse events likely to be related to treatment intervention |
|---|---|---|---|---|---|---|---|---|---|
Pollak [44] | Case series | Terbinafine | 250 mg oral terbinafine once daily for 12 weeks†| 77 (N/R) | N/R | 6, 12,18, 24, 30, 36, 48, 72 | 61% (47/77) | 10.4% (8/77) | Gastrointestinal |
Albreski [45] | RCT | Itraconazole Palliative | 200 mg of oral itraconazole taken twice a day for the first week of three consecutive months Toenail trimming, cleaning and soaking†| 27 (26) 25 (25) | 70.52 (7.99) 72.32 (4.42) | 32 32 | 15% (4/27) 0% | 4% (1/27) 0% | Elevated liver function test N/A |
Brenner [43] | Case series | Ciclopirox 8% | Ciclopirox 8% nail lacquer applied daily to nail and 5 mm surrounding skin for 48 weeks. Nails care every 8 weeks. | 49(36) | 63.8 (12.0) | 48 | 44.9% (22/49) | 29% (14/49) | Toenail disorders and infection |
Farkas [46] | Case series | Terbinafine | 250 mg oral terbinafine once daily for 12 weeks. | 89 (47) | 55.7 (11.7) | 36 | 13.5% (12/89) | 7.9% (7/89) | Gastrointestinal disturbance, headache, change in taste sensation and |
Gupta [42] | RCT | Itraconazole Terbinafine | 200 mg of oral itraconazole taken twice a day for the first week of three consecutive months 250 mg oral terbinafine once daily for 12 weeks. | 35 (16) 35 (18) | 57.77 (2.3) 63.65 (1.9) | 48 48 | Not reported Not reported | 8.6% (3/35) 0% | Gastrointestinal N/A |