Table 2.
Withdrawals and adverse events in trials of pimecrolimus and tacrolimus for treating atopic dermatitis
|
Test for homogeneity
|
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|---|---|---|---|---|---|
| Adverse effect | Crude rate | No of studies | Pooled relative risk (95% CI) | P value | I2 (%) |
| Pimecrolimus 1% v vehicle: | |||||
| Withdrawal (any reason) | 273/1211 v 259/622 | 7 | 0.49 (0.38 to 0.64)* | 0.042 | 54.1 |
| Withdrawal (side effects) | 9/408 v 15/275 | 4 | 0.46 (0.20 to 1.06) | 0.887 | 0 |
| Bacterial skin infections | 98/899 v 84/443 | 4 | 0.67 (0.28 to 1.60) | 0.042 | 63.5 |
| Viral skin infections | 76/776 v 23/380 | 3 | 1.53 (0.78 to 2.99) | 0.191 | 39.6 |
| Skin burning | 204/1166 v 131/579 | 6 | 0.87 (0.70 to 1.09) | 0.257 | 24.6 |
| Pimecrolimus 1% v potent corticosteroid (betamethasone valerate 0.1%):
|
|
|
|
|
|
| Withdrawa (any reason) | 19/43 v 7/45 | 1 | 2.17 (0.60 to 7.69) | — | — |
| Withdrawal (side effects) | 1/43 v 3/45 | 1 | 2.78 (0.30 to 25.0) | — | — |
| Skin burning | 1/43 v 2/45 | 1 | 5.26 (1.92 to 14.3)* | — | — |
| Pimecrolimus 1% v triamcinolone acetonide 0.1% (trunk and limbs) and hydrocortisone acetate 1% (face and neck):
|
|
|
|||
| Skin infections (any) | 69/328 v 80/330 | 1 | 0.87 (0.65 to 1.15) | — | — |
| Bacterial skin infections | 39/328 v 43/330 | 1 | 0.91 (0.61 to 1.37) | — | — |
| Fungal skin infections | 1/328 v 4/330 | 1 | 0.25 (0.03 to 2.24) | — | — |
| Viral skin infections | 16/328 v 26/330 | 1 | 0.62 (0.34 to 1.13) | — | — |
| Skin burning | 85/328 v 36/330 | 1 | 2.38 (1.66 to 3.40)* | — | — |
| Tacrolimus 0.1% v vehicle: | |||||
| Withdrawa (any reason) | 81/430 v 238/426 | 5 | 0.35 (0.27 to 0.46)* | 0.22 | 30.6 |
| Withdrawal (side effects) | 19/430 v 42/426 | 5 | 0.47 (0.28 to 0.80)* | 0.714 | 0 |
| Skin infections | 27/327 v 18/330 | 3 | 1.48 (0.83 to 2.65) | 0.53 | 0 |
| Skin burning | 187/430 v 92/426 | 5 | 2.08 (1.35 to 3.18)* | 0.010 | 69.9 |
| Tacrolimus 0.03% v vehicle: | |||||
| Withdrawa (any reason) | 93/425 v 238/426 | 5 | 0.40 (0.33 to 0.48)* | 0.81 | 0 |
| Withdrawal (side effects) | 20/425 v 42/426 | 5 | 0.50 (0.30 to 0.84)* | 0.800 | 0 |
| Skin infections | 27/327 v 32/330 | 3 | 0.85 (0.52 to 1.39) | 0.72 | 0 |
| Skin burning | 173/425 v 92/426 | 5 | 1.89 (1.43 to 2.50)* | 0.202 | 32.9 |
| Tacrolimus 0.1% v mild corticosteroid (hydrocortisone acetate 1%):
|
|
|
|
|
|
| Withdrawa (any reason) | 13/186 v 20/185 | 1 | 0.65 (0.33 to 1.27) | — | — |
| Withdrawal (side effects) | 3/186 v 4/185 | 1 | 0.75 (0.17 to 3.33) | — | — |
| Skin infections | 4/186 v 4/185 | 1 | 0.99 (0.25 to 3.85) | — | — |
| Skin burning | 38/186 v 13/185 | 1 | 2.94 (1.61 to 5.26)* | — | — |
| Tacrolimus 0.1% v potent corticosteroid (betamethasone valerate 0.1%, hydrocortisone butyrate 0.1%):
|
|
|
|
||
| Withdrawa (any reason) | 33/283 v 25/275 | 2 | 1.32 (0.80 to 2.13) | 0.822 | 0 |
| Withdrawal (side effects) | 8/191 v 3/186 | 1 | 2.56 (0.70 to 10.0) | — | — |
| Skin infections | 6/92 v 5/89 | 1 | 1.16 (0.37 to 3.70) | — | — |
| Skin burning | 138/283 v 27/275 | 2 | 4.76 (3.33 to 7.14)* | 0.362 | 4.9 |
| Tacrolimus 0.1% v hydrocortisone butyrate 0.1% (trunk and extremities) and hydrocortisone acetate 1% (face):
|
|
|
|||
| Withdrawa (any reason) | 124/488 v 204/487 | 1 | 0.61 (0.51 to 0.73)* | — | — |
| Withdrawal (side effects) | 10/488 v 16/487 | 1 | 0.63 (0.29 to 1.37) | — | — |
| Skin infections | 18/488 v 21/487 | 1 | 0.86 (0.46 to 1.59) | — | — |
| Skin burning | 259/488 v 67/487 | 1 | 3.85 (3.03 to 5.00)* | — | — |
| Tacrolimus 0.03% v mild corticosteroid (hydrocortisone acetate 1%):
|
|
|
|
|
|
| Withdrawa (any reason) | 42/399 v 61/392 | 2 | 0.71 (0.35 to 1.43) | 0.022 | 56.8 |
| Withdrawal (side effects) | 11/399 v 10/392 | 2 | 1.09 (0.46 to 2.56) | 0.529 | 0 |
| Skin infections | 12/399 v 10/392 | 2 | 1.18 (0.51 to 2.70) | 0.157 | 36 |
| Skin burning | 85/399 v 43/392 | 2 | 1.96 (1.25 to 3.13)* | 0.203 | 35.0 |
| Tacrolimus 0.03% v potent corticosteroid (hydrocortisone butyrate 0.1%):
|
|
|
|
|
|
| Withdrawa (any reason) | 22/193 v 17/186 | 1 | 1.03 (0.58 to 1.82) | — | — |
| Withdrawal (side effects) | 7/193 v 3/186 | 1 | 0.74 (0.17 to 3.23) | — | — |
| Skin burning | 87/193 v 24/186 | 1 | 3.45 (2.33 to 5.26)* | — | — |
| Tacrolimus 0.1% v tacrolimus 0.03%: | |||||
| Withdrawa (any reason) | 96/807 v 136/807 | 7 | 0.75 (0.49 to 1.14) | 0.024 | 58.9 |
| Withdrawal (side effects) | 30/807 v 30/807 | 7 | 0.99 (0.59 to 1.64) | 0.556 | 0 |
| Skin infections | 22/513 v 38/517 | 4 | 0.60 (0.35 to 1.02) | 0.367 | 5.2 |
| Skin burning | 338/807 v 295/807 | 7 | 1.14 (0.95 to 1.35) | 0.075 | 47.6 |
| Tacrolimus 0.1% v oral cyclosporin 3mg/kg: | |||||
| Skin burning | 4/15 v 0/15 | 1 | 9.00 (0.53 to 153.79) | — | — |
*
P<0.05.