Table 16:
Baseline Patient Characteristics of Studies Included in the Clinical Literature Review, Migraine
| Author, year (study) | Migraine subtype, % episodic | Mean age, (SD), y | Male, % | Reported race or ethnicity, % | Mean no. of headache days per mo (SD) | Mean no. of migraine days per mo, (SD) | Preventive medication use, % | Acute medication use, mean (SD) or % | ||
|---|---|---|---|---|---|---|---|---|---|---|
| nVNS | Control | nVNS | Control | |||||||
| Silberstein et al, 201656 (EVENT) | 0 | 39 | 10.2 | Caucasian: 86.4 Black: 5.1 Other: 8.5 |
nVNS 20.8 (5.0) Control 22.3 (4.9) |
NR | Not permitted in previous 30 d | Not permitted in previous 30 d | Overall: 89.8% | Overall: 89.8% |
| Tassorelli et al, 201855 (PRESTO) | 100 |
nVNS 38.8 (11.0) Control 39.6 (11.8) |
23.5 | Caucasian: 100 |
nVNS 6.3 (2.3) Control 6.2 (2.1) |
No. of attacks nVNS 5.4 (1.5) Control 5.4 (1.5) |
35a | 28.5a | Mean use per mo: 5.6 d | Mean use per mo: 5.3 d |
| Chaudhry et al, 201959 | 63.3 | 46.96 (range 27-66) | 3.3 | NR | 16.1c | No. of attacks: 12.4b | Overall sample: 30.8b,c | Overall sample: 88.5%b | ||
| Diener et al, 201957 (PREMIUM) | 100 |
nVNS 43.5 (11.1) Control 41.4 (12.3) |
15.7 | Caucasian: 94.6 |
nVNS 8.9 (2.6) Control 9.1 (2.6) |
nVNS 7.9 (2.2) Control 8.1 (2.0) |
Not permitted in previous 30 d | Not permitted in previous 30 d | Mean use per mo: 6.8 (2.7) d | Mean use per mo: 7.0 (2.8) d |
| Najib et al, 202258 (PREMIUM II) | 59.3 |
nVNS 40.3 (13.9) Control 44.6 (10.7) |
17.7 | White or Caucasian: 90.3 |
nVNS 13.4 (4.0) Control 12.8 (3.7) |
nVNS 9.2 (4.6) Control 9.9 (3.5) |
33.9d | 31.6d | Mean use per mo: 8.2 (3.5) d | Mean use per mo: 8.8 (4.0) d |
Abbreviations: NR, not reported; nVNS, noninvasive vagus nerve stimulation; SD, standard deviation.
Excluded those with botulinum toxin injections in last 6 mo or head or neck nerve blocks in last 2 mo. Most used were vitamin B2, topiramate, magnesium, and propranolol.
Calculated from data provided in study.
Most used were beta-blockers, valproic acid, selective serotonin reuptake inhibitors, selective serotonin noradrenaline reuptake inhibitors, and topiramate.
Excluded people with 2 or more migraine prevention treatments, injections of onabotulinum toxin A, or calcitonin gene-related peptide-targeting monoclonal antibody drugs within the last 6 mo. Most used were topiramate, propranolol, zonisamide, gabapentin, and over-the-counter supplements.