5 CHAPTER 5 102 analyses. The demographic and clinical characteristics of cases and controls are shown in Table 1. There were no adverse events reported. Table 1 Demographic and clinical characteristics of the study population Participants Characteristics Migraine cases (n = 33) Healthy controls (n = 24) P value GTN responders (n = 27) GTN nonresponders (n = 6) General characteristics Age 34.3 ± 8.2 35.2 ± 9.1 0.709† 35.2 ± 8.4 30.3 ± 6.4 BMI 22.9 ± 2.6 23.2 ± 2.7 0.714† 23.3 ± 2.7 21.6 ± 1.4 Smoking (n, %) 5 (15.1%) 3 (12.5%) 1.000‡ 5 (18.5%) 0 (0%) Migraine characteristics Age of onset 16.3 ± 5.6 - 17.4 ± 4.7 11.2 ± 6.7 Migraine days (attack/month) 4.7 ± 2.7 - 5.1 ± 2.8 2.7 ± 0.8 Values are expressed as absolute values and percentage or mean ± SD., P values are calculated with † Student’s t-test, ‡ Fisher’s Exact Test. GTN, glyceryl trinitrate, BMI, body mass index. GTN response In total, n = 28 subjects with migraine (85%) and n = 18 healthy controls (75%) developed an immediate headache (VRS ≥ 1) during the GTN infusion. At 5 minutes after the start of GTN infusion, the mean VRS value was 1.6 for those with migraine (1.8 for responders and 0.7 for non-responders) and 1 for controls. In total, n = 20 subjects with migraine (61%) and n = 10 healthy controls (42%) had an immediate headache. The mean VRS value increased until the end of the GTN infusion to 2.6 (3 for responders and 1.5 for non-responders) and 1.5, for subjects with migraine and controls, respectively. At 20 minutes, 26 subjects with migraine (79%) and 13 controls (54%) experienced a headache. Overall, the immediate headache was mild to moderate in severity and generally resolved rapidly after termination of the infusion (Figure 3, Figure S1). In some subjects with migraine a ‘’headache-free’’ interval was absent (Figure S1), in those subjects the headache continued after infusion and eventually became more severe with characteristics of a migraine-like attack. The mean VRS for those who responded to GTN (responders) continued to increase, as the headache became more severe although only at a later stage met the criteria of migraine and in those who classified as non-responders the headache severity decreased. Generally, the immediate phase is considered to be 0-90 minutes post infusion. Four subjects developed migraine within this timeframe. One subject with migraine developed a headache fulfilling the migraine-like criteria within one hour after the start of GTN infusion, one at 60 minutes, and two at 75 minutes. Eventually, 27 (82%) subjects with migraine receiving GTN experienced a migraine-like attack (Figure 4) during the study day and 6 (18%) did not experience such an attack, hence they were labelled as GTN responders and GTN non-responders, respectively (Table 1). Migraine-like attack onset ranged between 45 and 345 minutes (mean 192 ± 84 minutes) (Figure 4).
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