BACKGROUND: 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) versus 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.

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