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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
 Low7/1399 (0.5)3/698 (0.4)8/706 (1.1)
 High40/1332 (3.0)22/672 (3.3)24/674 (3.6)
 PCS high1/1409 (0.1)1/704 (0.1)0/708 (0.0)
 Sustained7/1297 (0.5)2/658 (0.3)1/657 (0.2)
Diastolic blood pressureb
 Low6/1404 (0.4)2/704 (0.3)8/709 (1.1)
 High83/1292 (6.4)51/653 (7.8)46/652 (7.1)
 PCS high8/1402 (0.6)4/703 (0.6)5/704 (0.7)
 Sustained15/1260 (1.2)9/639 (1.4)6/637 (0.9)
Pulsec
 Low5/1403 (0.4)1/700 (0.1)2/707 (0.3)
 High32/1398 (2.3)13/702 (1.9)15/705 (2.1)
 Sustained1/1361 (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