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Table 3 Efficacy endpoints with C1-INH(SC) and C1-INH(IV) in the placebo-controlled COMPACT and CHANGE studies, respectively

From: Indirect comparison of intravenous vs. subcutaneous C1-inhibitor placebo-controlled trials for routine prevention of hereditary angioedema attacks

  COMPACT studya
C1-INH(SC) 60 IU/kg (N = 40)c
CHANGE studyb
C1-INH(IV) 1000 U
(N = 22)
Adjusted differenced P-value
Monthly reduction in number of attacks vs. placebo
 Least-squares mean (95% CI) 3.6 (2.9, 4.2) 2.3 (1.4, 3.3) 1.3 (0.1, 2.4) 0.034
 Adjusted median (95% CI) 3.1 (2.3, 4.4) 2.2 (1.9, 3.6) 1.2 (− 0.9, 3.3) 0.251
Attack rate reduction vs. placebo (%)
 Least-squares mean (95% CI) 84.0 (75.6, 92.4) 50.8 (30.4, 71.3) 32.8 (14.4, 51.2) <0.001
 Adjusted median (95% CI) 95.1 (86.4, 100.0) 53.1 (30.7, 88.3) 42.7 (11.6, 73.7) 0.008
  1. Adjusted data for the crossover study design variables—means adjusted for period and sequence and medians for sequence within treatment (period not included for convergence reasons); may vary slightly from previously reported unadjusted data
  2. CI confidence interval, IU international units, IV intravenous, SC subcutaneous, U units
  3. aObservation period of 14 weeks
  4. bObservation period of 12 weeks
  5. cFive of the 45 patients in COMPACT had missing attack values (3 during the placebo period and 2 during the C1-INH[SC] 60 IU/kg period) and were excluded from analyses
  6. dModel-based estimates for differences in outcomes