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

Table 6 High blood pressure by age group

			Systolic Blood Pressure High^a		Diastolic Blood Pressure High^b
Dose Group	Age Group (years)	N	n/TPY	EAIR (95% CI)	n/TPY	EAIR (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)

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
^aHigh systolic blood pressure is defined as any postbaseline measurement ≥140 mmHg and a ≥20 mmHg increase from baseline
^bHigh diastolic blood pressure is defined as any postbaseline measurement ≥90 mmHg and a ≥10 mmHg increase from baseline

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