OP51 – 3033: Prednisolone or Tetracosactide Depot for Infantile Spasms – A Meta-Analysis from UKISS and ICISS

Objective To examine the relative efficacy of prednisolone and tetracosactide depot in the treatment of infantile spasms using data from trials where treatment had been randomly allocated. Prednisone trials (against ACTH) were not included since prednisone is an inactive compound that infants poorly convert to the active compound, Prednisolone. Methods A meta-analysis of results from both UKISS and ICISS clinical trials. Both trials compared hormonal treatment alone (either Prednisolone or Tetracosactide Depot) to another treatment regime but had randomly allocated the hormonal treatment in all (UKISS) or some (ICISS) infants. Both trials used the same dosages: Prednisolone 10 mg qds increasing to 20 mg tds after 7 days if spasms continued or Tetracosactide depot 0.5 mg on alternate days increasing to 0.75 mg after 7 days if spasms continued. Cessation of spasms was defined as in UKISS: no visible spasms on Days 13 and 14. This outcome was also available for infants in ICISS where a more stringent definition was used. Results 124 infants (53 in UKISS and 71 in ICISS) were randomly allocated either Prednisolone (64) or Tetracosactide depot (60). Results for all infants are available. Cessation of spasms was achieved in 43 (67%) of those allocated Prednisolone and in 45 (75%) of those allocated Tetracosactide depot. There is no significant difference between these outcomes (Treatment difference 7.8%, 95% CI: –8.7% to +24.3%; Chi-square 0.92 and p=0.34). Conclusion When these two treatments are used as initial single treatments and where cessation of spasms is the outcome measure, there is no evidence that one treatment is better than the other. To examine the relative efficacy of prednisolone and tetracosactide depot in the treatment of infantile spasms using data from trials where treatment had been randomly allocated. Prednisone trials (against ACTH) were not included since prednisone is an inactive compound that infants poorly convert to the active compound, Prednisolone. A meta-analysis of results from both UKISS and ICISS clinical trials. Both trials compared hormonal treatment alone (either Prednisolone or Tetracosactide Depot) to another treatment regime but had randomly allocated the hormonal treatment in all (UKISS) or some (ICISS) infants. Both trials used the same dosages: Prednisolone 10 mg qds increasing to 20 mg tds after 7 days if spasms continued or Tetracosactide depot 0.5 mg on alternate days increasing to 0.75 mg after 7 days if spasms continued. Cessation of spasms was defined as in UKISS: no visible spasms on Days 13 and 14. This outcome was also available for infants in ICISS where a more stringent definition was used. 124 infants (53 in UKISS and 71 in ICISS) were randomly allocated either Prednisolone (64) or Tetracosactide depot (60). Results for all infants are available. Cessation of spasms was achieved in 43 (67%) of those allocated Prednisolone and in 45 (75%) of those allocated Tetracosactide depot. There is no significant difference between these outcomes (Treatment difference 7.8%, 95% CI: –8.7% to +24.3%; Chi-square 0.92 and p=0.34). When these two treatments are used as initial single treatments and where cessation of spasms is the outcome measure, there is no evidence that one treatment is better than the other.