The PRESTO study of non-invasive
vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International
Headache Society to provide Class I evidence that for patients with an episodic
migraine, nVNS significantly increases the probability of having mild
pain or being
pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in
pain intensity while reducing the need for rescue medication.
METHODS: Patients recorded
pain intensity for treated
migraine attacks on a 4-point scale. Data were examined to compare nVNS and
sham with regard to the percentage of patients who benefited by at least 1 point in
pain intensity. We also assessed the percentage of attacks that required rescue medication and
pain-free rates stratified by
pain intensity at treatment initiation.
RESULTS: A significantly higher percentage of patients who used acute nVNS treatment (n = 120) vs
sham (n = 123) reported a ≥ 1-point decrease in
pain intensity at 30 min (nVNS, 32.2%;
sham, 18.5%; P = 0.020), 60 min (nVNS, 38.8%;
sham, 24.0%; P = 0.017), and 120 min (nVNS, 46.8%;
sham, 26.2%; P = 0.002) after the first attack. Similar significant results were seen when assessing the benefit in all attacks. The proportion of patients who did not require rescue medication was significantly higher with nVNS than with
sham for the first attack (nVNS, 59.3%;
sham, 41.9%; P = 0.013) and all attacks (nVNS, 52.3%;
sham, 37.3%; P = 0.008). When initial
pain intensity was mild, the percentage of patients with no
pain after treatment was significantly higher with nVNS than with
sham at 60 min (all attacks: nVNS, 37.0%;
sham, 21.2%; P = 0.025) and 120 min (first attack: nVNS, 50.0%;
sham, 25.0%; P = 0.018; all attacks: nVNS, 46.7%;
sham, 30.1%; P = 0.037).
CONCLUSIONS: This post hoc analysis demonstrated that acute nVNS treatment quickly and consistently reduced
pain intensity while decreasing rescue medication use. These clinical benefits provide guidance in the optimal use of nVNS in everyday practice, which can potentially reduce use of acute pharmacologic medications and their associated adverse events.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02686034 .