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Table 11 Percentage of patients in integrated double-blind studies reporting treatment-emergent changes to blood pressure and pulse

From: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

  

Galcanezumab

Placebo

n/N (%)

120 mg

n/N (%)

240 mg

n/N (%)

Systolic blood pressurea

 Low

7/1399 (0.5)

3/698 (0.4)

8/706 (1.1)

 High

40/1332 (3.0)

22/672 (3.3)

24/674 (3.6)

 PCS high

1/1409 (0.1)

1/704 (0.1)

0/708 (0.0)

 Sustained

7/1297 (0.5)

2/658 (0.3)

1/657 (0.2)

Diastolic blood pressureb

 Low

6/1404 (0.4)

2/704 (0.3)

8/709 (1.1)

 High

83/1292 (6.4)

51/653 (7.8)

46/652 (7.1)

 PCS high

8/1402 (0.6)

4/703 (0.6)

5/704 (0.7)

 Sustained

15/1260 (1.2)

9/639 (1.4)

6/637 (0.9)

Pulsec

 Low

5/1403 (0.4)

1/700 (0.1)

2/707 (0.3)

 High

32/1398 (2.3)

13/702 (1.9)

15/705 (2.1)

 Sustained

1/1361 (0.1)

0/688 (0.0)

1/687 (0.2)

  1. Abbreviations: bpm Beats per minute, N Number of patients in the analysis population, n Number of patients within each specific category, PCS Possibly clinically significant
  2. aFor systolic blood pressure: treatment-emergent low ≤90 mmHg with ≥20 mmHg decrease; treatment-emergent high ≥140 mmHg with ≥20 mmHg increase; PCS high ≥180 mmHg with ≥20 mmHg increase; sustained elevation ≥140 mmHg with ≥20 mmHg increase for 2 consecutive office visits
  3. bFor diastolic blood pressure: treatment-emergent low ≤50 mmHg with ≥10 mmHg decrease; treatment-emergent high ≥90 mmHg with ≥10 mmHg increase; PCS high ≥105 mmHg with ≥15 mmHg increase; sustained elevation ≥90 mmHg with ≥10 mmHg increase for 2 consecutive office visits
  4. cFor pulse: treatment-emergent low < 50 bpm with ≥15 bpm decrease; treatment-emergent high > 100 bpm with ≥15 bpm increase; sustained elevation > 100 bpm with ≥15 bpm increase for 2 consecutive office visits