Table 3.
Subgroup analyses of efficacy and safety outcomes.
Efficacy | Safety | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Mean monthly headache days, baseline to week 12 | Mean monthly migraine days, baseline to week 12 | At least one adverse event | At least one adverse event related to trial regimen | At least one serious adverse event | ||||||
MD, 95% CI | P-value | MD, 95% CI | P-value | RR, 95% CI | P-value | RR, 95% CI | P-value | RR, 95% CI | P-value | |
Dose regimens | ||||||||||
Monthly | −2.85 (−4.32, 1.38) | 0.0001 | −2.27 (−3.52, −1.01) | 0.0004 | 1.22 (1.01, 1.47) | 0.04 | 1.36 (1.12, 1.65) | 0.002 | 0.70 (0.33, 1.47) | 0.35 |
Quarterly | −2.55 (−4.02, −1.08) | 0.0007 | −2.00 (−3.17, −0.83) | 0.0008 | 1.34 (1.11, 1.62) | 0.002 | 1.30 (1.07, 1.58) | 0.007 | 0.47 (0.20, 1.09) | 0.08 |
Subgroup differences | P = 0.78 | P = 0.86 | P = 0.48 | P = 0.74 | P = 0.48 | |||||
Types of migraine | ||||||||||
CM | −1.99 (−2.55, −1.43) | 0.0001 | −2.43 (−3.70, −1.17) | 0.0002 | 1.12 (1.03, 1.21) | 0.01 | 1.37 (0.91, 2.06) | 0.13 | 0.93 (0.36, 2.37) | 0.87 |
EM | −1.90 (−2.88, −0.92 | 0.0001 | −2.36 (−3.55, −1.17) | 0.0001 | 1.08 (0.89, 1.31) | 0.44 | 1.25 (1.07, 1.47) | 0.005 | 1.58 (0.06, 41.14) | 0.78 |
Subgroup differences | P = 0.88 | P = 0.93 | P = 0.75 | P = 0.69 | P = 0.76 | |||||
Preventive medications | ||||||||||
No more than 2 used | −1.97 (−2.45, −1.48) | 0.0001 | −1.77 (−2.29, −1.25) | 0.0001 | 1.12 (1.04, 1.20) | 0.003 | 1.23 (1.11, 1.36) | 0.0001 | 0.94 (0.35, 2.53) | 0.91 |
2–4 used | −3.40 (−4.18, −2.62) | 0.0001 | −3.30 (−4.08, −2.52) | 0.0001 | 1.04 (0.90, 1.21) | 0.58 | 1.02 (0.76, 1.36) | 0.91 | 0.75 (0.21, 2.63) | 0.65 |
Subgroup differences | P = 0.002 | P = 0.001 | P = 0.42 | P = 0.22 | P = 0.78 |