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Table 4 Summary and analysis of likely cardiovascular treatment-emergent adverse events by cardiovascular risk factor categories

From: Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials

Categorical baseline CV risk factors
Preferred Term
Placebo
(N = 1262)
All LTN
(N = 3177)
Comparison between all LTN vs. placebo
n (%) [adj %] n (%) [adj %] ORa 95% CIa p valueb
0 0 (0.0) [0.0] 5 (0.2) [0.2]    0.14
 Bradycardia 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
 Hypertension 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Palpitations 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
 Sinus bradycardia 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
 Tachycardia 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
≥ 1 5 (0.4) [0.4] 25 (0.8) [0.8] 2.03 (0.77, 5.34) 0.15
 Palpitations 1 (0.1) [0.1] 11 (0.3) [0.3] 4.22 (0.56, 31.70) 0.12
 Heart rate increased 1 (0.1) [0.1] 5 (0.2) [0.2] 1.89 (0.23, 15.65) 0.54
 Tachycardia 0 (0.0) [0.0] 5 (0.2) [0.2]    0.18
 Blood pressure increased 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Electrocardiogram abnormal 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
 Hypertension 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
 Syncope 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Abdominal pain upper 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
 Bradycardia 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
 Cardiac murmur 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
≥ 2 3 (0.2) [0.2] 11 (0.3) [0.3] 1.48 (0.41, 5.38) 0.56
 Palpitations 0 (0.0) [0.0] 4 (0.1) [0.1]    0.20
 Tachycardia 0 (0.0) [0.0] 3 (0.1) [0.1]    0.28
 Heart rate increased 1 (0.1) [0.1] 2 (0.1) [0.1] 0.67   0.74
 Blood pressure increased 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Hypertension 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
 Abdominal pain upper 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
 Cardiac murmur 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
≥ 3 0 (0.0) [0.0] 3 (0.1) [0.1]    0.28
 Hypertension 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
 Palpitations 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Tachycardia 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
≥ 4 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Palpitations 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
  1. aMantel-Haenszel OR stratified by study and 95% CI (CI calculated if ≥4 events in numerator and ≥ 1 event in denominator)
  2. bp values are from Cochran-Mantel-Haenszel test of general association stratified by study
  3. ACC/AHA American College of Cardiology and American Heart Association, adj % study size adjusted percentage, CI confidence interval, CNS central nervous system, CV cardiovascular, HDL high-density lipoprotein, LTN lasmiditan, MedDRA Medical Dictionary for Drug Regulatory Activities, N number of patients in the analysis population, n number of patients within each specific category, OR odds ratio, PT Preferred Term, SMQ Standardized MedDRA Query, TEAE treatment-emergent adverse event
  4. Note: Likely CV TEAEs are from medical review out of potential CV TEAEs that are selected based on broad and narrow terms in the SMQs Cardiac arrhythmias, Cardiac failure, Cardiomyopathy, CNS vascular disorders, Embolic and thrombotic events, Hypertension, Ischemic heart disease, Pulmonary hypertension, and Torsade de pointes/QT prolongation and the PTs abdominal pain, abdominal pain upper, and abdominal pain lower
  5. The CV disease risk factors are identified based on the ACC/AHA Task Force on Practice Guidelines [45]. A present/absent criterion was applied to each variable as follows: age > 40 years for both men and women, diabetes mellitus (any), current smoker, total cholesterol ≥240 mg/dL (laboratory measure), HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women (laboratory measure), and systolic blood pressure ≥ 140 mmHg (vital signs measure) and/or self-reported high blood pressure were included as hypertension
  6. MedDRA version 21.0