Cady Roger K, Munjal Sagar, Cady Ryan J, Manley Heather R, Brand-Schieber Elimor
Clinvest/A Division of Banyan Inc., 3805 S Kansas Expy, Springfield, MO, 65807, USA.
Dr. Reddy's Laboratories Ltd., 107 College Road East, Princeton, NJ, 08540, USA.
J Headache Pain. 2017 Dec;18(1):17. doi: 10.1186/s10194-016-0717-7. Epub 2017 Feb 7.
A 6-mg dose of SC sumatriptan is the most efficacious and fast-acting acute treatment for migraine, but a 3-mg dose of SC sumatriptan may improve tolerability while maintaining efficacy.
This randomized, double-blind, crossover study compared the efficacy and tolerability of 3 mg subcutaneous (SC) sumatriptan (DFN-11) with 6 mg SC sumatriptan in 20 adults with rapidly-escalating migraine attacks. Eligible subjects were randomized (1:1) to treat 1 attack with DFN-11 and matching placebo autoinjector consecutively or 2 DFN-11 autoinjectors consecutively and a second attack similarly but with the alternative dose (3 mg or 6 mg).
The proportions of subjects who were pain-free at 60 min postdose, the primary endpoint, were similar following treatment with 3 mg SC sumatriptan and 6 mg SC sumatriptan (50% vs 52.6%, P = .87). The proportions of subjects experiencing pain relief (P ≥ .48); reductions in migraine pain intensity (P ≥ .78); and relief from nausea, photophobia, or phonophobia (P ≥ .88) with 3 mg SC sumatriptan and 6 mg SC sumatriptan were similar, as were the mean scores for satisfaction with treatment (M = 2.6 vs M = 2.4, P = .81) and the mean number of rescue medications used (M = .11 vs M = .26, P = .32). The most common adverse events with the 3- and 6-mg doses were triptan sensations - paresthesia, neck pain, flushing, and involuntary muscle contractions of the neck - and the incidence of adverse events with both doses was similar (32 events total: 3 mg, n = 14 [44%]; 6 mg, n = 18 [56%], P = .60). Triptan sensations affected 4 subjects with the 6-mg dose only, 1 subject with the 3-mg dose only, and 7 subjects with both sumatriptan doses. Chest pain affected 2 subjects (10%) treated with the 6-mg dose and no subjects (0%) treated with the 3-mg dose of DFN-11. There were no serious adverse events.
The 3-mg SC dose of sumatriptan in DFN-11 provided relief of migraine pain and associated symptoms comparable to a 6-mg SC dose of sumatriptan. Tolerability was similar with both study medications; DFN-11 treatment was associated with fewer triptan sensations than the 6-mg dose. DFN-11, with its 3-mg dose of sumatriptan, may be a clinically useful alternative to higher-dose autoinjectors.
6毫克皮下注射舒马曲坦是偏头痛最有效且起效迅速的急性治疗药物，但3毫克皮下注射舒马曲坦可能在维持疗效的同时提高耐受性。
本随机、双盲、交叉研究比较了3毫克皮下注射舒马曲坦（DFN - 11）与6毫克皮下注射舒马曲坦对20名偏头痛发作迅速加重的成年人的疗效和耐受性。符合条件的受试者被随机（1:1）分为两组，一组先用DFN - 11和匹配的安慰剂自动注射器连续治疗1次发作，另一组先用2支DFN - 11自动注射器连续治疗1次发作，第二次发作则使用替代剂量（3毫克或6毫克）进行类似治疗。
以给药后60分钟无痛作为主要终点，3毫克皮下注射舒马曲坦和6毫克皮下注射舒马曲坦治疗后无痛的受试者比例相似（50%对52.6%，P = 0.87）。3毫克皮下注射舒马曲坦和6毫克皮下注射舒马曲坦在疼痛缓解（P≥0.48）、偏头痛疼痛强度降低（P≥0.78）以及恶心、畏光或畏声缓解（P≥0.88）方面的受试者比例相似，治疗满意度平均得分（M = 2.6对M = 2.4，P = 0.81）和使用急救药物的平均次数（M = 0.11对M = 0.26，P = 0.32）也相似。3毫克和6毫克剂量最常见的不良事件是曲坦类药物相关感觉——感觉异常、颈部疼痛、潮红以及颈部肌肉不自主收缩，两种剂量的不良事件发生率相似（共32例事件：3毫克组，n = 14 [44%]；6毫克组，n = 18 [56%]，P = 0.60）。曲坦类药物相关感觉仅影响6毫克剂量组的4名受试者、3毫克剂量组的1名受试者以及两种舒马曲坦剂量组的7名受试者。胸痛影响了2名接受6毫克剂量治疗的受试者（10%），而接受3毫克DFN - 11剂量治疗的受试者中无人出现胸痛（0%）。未发生严重不良事件。
DFN - 11中3毫克皮下注射舒马曲坦缓解偏头痛疼痛及相关症状的效果与6毫克皮下注射舒马曲坦相当。两种研究药物的耐受性相似；DFN - 11治疗相比6毫克剂量，曲坦类药物相关感觉更少。含3毫克舒马曲坦剂量的DFN - 11可能是高剂量自动注射器在临床上有用的替代药物。
