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Table 6 High blood pressure by age group

From: Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials

 Systolic Blood Pressure HighaDiastolic Blood Pressure Highb
Dose GroupAge Group (years)Nn/TPYEAIR (95% CI)n/TPYEAIR (95% CI)
Double-blind treatment phase
Phase 3_Pooled Placebo< 42
42 to < 50
50 to < 60
60 to ≤65
656
354
305
95
10/244.4
11/134.2
16/109.9
5/33.3
4.1 (2.0, 7.5)
8.2 (4.1, 14.7)
14.6 (8.3, 23.7)
15.0 (4.9, 35.0)
31/240.6
33/131.4
28/109.0
7/32.2
12.9 (8.8, 18.3)
25.1 (17.3, 35.3)
25.7 (17.1, 37.1)
21.7 (8.7, 44.8)
Phase 3_Pooled GMB< 42
42 to < 50
50 to < 60
60 to ≤65
728
321
295
70
16/269.5
8/121.6
20/109.1
4/25.6
5.9 (3.4, 9.6)
6.6 (2.8, 13.0)
18.3 (11.2, 28.3)
15.6 (4.3, 40.0)
43/265.4
31/117.4
25/108.5
9/25.3
16.2 (11.7, 21.8)
26.4 (17.9, 37.5)
23.0 (14.9, 34.0)
35.6 (16.3, 67.6)
Treatment-by-age group interaction p-value 0.802 0.734
All GMB exposure
All GMB Exposure< 42
42 to < 50
50 to < 60
60 to ≤65
1268
598
530
152
32/703.9
28/350.1
42/299.7
13/87.3
4.6 (3.1, 6.4)
8.0 (5.3, 11.6)
14.0 (10.1, 18.9)
14.9 (7.9, 25.5)
92/685.0
77/332.1
58/293.9
17/85.0
13.4 (10.8, 16.5)
23.2 (18.3, 29.0)
19.7 (15.0, 25.5)
20.0 (11.7, 32.0)
  1. Abbreviations: All GMB Exposure Patients treated with any GMB dose in any duration, CI Confidence interval, EAIR Exposure-adjusted incidence rate, GMB Galcanezumab, Phase 3_Pooled All patients from the 3 placebo-controlled phase 3 trials, TPY Total patient years at risk
  2. aHigh systolic blood pressure is defined as any postbaseline measurement ≥140 mmHg and a ≥20 mmHg increase from baseline
  3. bHigh diastolic blood pressure is defined as any postbaseline measurement ≥90 mmHg and a ≥10 mmHg increase from baseline
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