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. 2018 Oct 1;14:2519–2530. doi: 10.2147/NDT.S176676

Table 2.

Efficacy outcomes

Outcome Comparison n SMD 95% CI P-value I2 (%)
PANSS total score BRE 4 mg vs placebo 939 −0.30 −0.43, −0.17 <0.00001 0
BRE 2 mg vs placebo 943 −0.30 −0.46, −0.13 0.0003 36
BRE 4 mg vs BRE 2 mg 940 0.00 −0.19, 0.19 0.98 53a
PANSS positive score BRE 4 mg vs placebo 939 −0.18 −0.42, 0.07 0.16 72b
BRE 2 mg vs placebo 943 −0.17 −0.32, −0.02 0.03 30
BRE 4 mg vs BRE 2 mg 940 −0.01 −0.23, 0.20 0.91 63c
PANSS negative score BRE 4 mg vs placebo 939 −0.30 −0.43, −0.17 <0.00001 0
BRE 2 mg vs placebo 943 −0.32 −0.51, −0.13 0.001 53d
BRE 4 mg vs BRE 2 mg 940 0.01 −0.12, 0.14 0.90 0
CGI-S BRE 4 mg vs placebo 942 −0.25 −0.42, −0.08 0.004 43
BRE 2 mg vs placebo 947 −0.22 −0.35, −0.10 0.0006 0
BRE 4 mg vs BRE 2 mg 941 −0.02 −0.22, 0.18 0.83 58
CGI-I BRE 4 mg vs placebo 942 −0.28 −0.49, −0.07 0.008 61
BRE 2 mg vs placebo 947 −0.29 −0.42, −0.16 <0.0001 0
BRE 4 mg vs BRE 2 mg 941 0.01 −0.20, 0.21 0.96 60

Outcome Comparison n RR 95% CI P-value I2 (%)

Response rate BRE 4 mg vs placebo 939 0.82 0.70, 0.96 0.02e 67f
BRE 2 mg vs placebo 943 0.86 0.76, 0.98 0.03g 52h
BRE 4 mg vs BRE 2 mg 940 0.95 0.83, 1.10 0.50 49
Discontinuation rate due to inefficacy BRE 4 mg vs placebo 961 0.72 0.39, 1.32 0.29 42
BRE 2 mg vs placebo 967 1.00 0.68, 1.47 0.99 0
BRE 4 mg vs BRE 2 mg 960 0.72 0.44, 1.15 0.17 13

Notes:

a

After excluding Kane study data, considerable heterogeneity disappeared (I2 =0%). 4 mg was similar to 2 mg (SMD =−0.09, 95% CI =−0.07, 0.26, P=0.26).

b

After excluding Ishigooka study data, considerable heterogeneity disappeared (I2 =0%). 4 mg was superior to placebo (SMD =−0.30, 95% CI =−0.44, −0.15, P<0.0001).

c

After excluding Ishigooka study data, considerable heterogeneity disappeared (I2 =4%). 4 mg was similar to 2 mg (SMD =−0.11, 95% CI =−0.26, 0.04, P=0.16).

d

After excluding Kane 2015 study data, considerable heterogeneity disappeared (I2 =0%), 2 mg was superior to placebo (SMD =−0.41, 95% CI =−0.57, −0.25, P<0.00001).

e

NNT =8.

f

After excluding Ishigooka study data, considerable heterogeneity disappeared (I2 =0%). 4 mg was superior to placebo (RR =0.76, 95% CI =0.67, 0.85, P<0.00001, NNT =6).

g

NNT =10.

h

After excluding Correll et al study data, considerable heterogeneity disappeared (I2 =0%). 2 mg was not superior to placebo (RR =0.92, 95% CI =0.83, 1.02, P=0.11).

Abbreviations: 95% CI, 95% confidence interval; BRE, brexpiprazole; CGI-I, Clinical Global Impression–Improvement; CGI-S, Clinical Global Impression–Severity; NNT, number needed to treat; PANSS, Positive and Negative Syndrome Scale; RR, risk ratio; SMD, standardized mean difference.