Cleves Catalina, Tepper Stewart J
Department of Pediatric Neurology, Center for Headache and Pain, Neurological Institute, Cleveland Clinic Foundation, 778 Long Ridge Rd, Stamford, CT 06902, USA.
Expert Rev Neurother. 2008 Sep;8(9):1289-97. doi: 10.1586/14737175.8.9.1289.
Sumatriptan 85 mg with naproxen sodium 500 mg, a combination tablet for the acute treatment of migraine, is approved in the USA. It is likely that triptan/NSAID combination benefits are a class effect, although the majority of data are on sumatriptan and naproxen sodium. The combination tablet demonstrated superior effectiveness over its individual components or placebo in two Phase III regulatory trials on six coprimary end points. The pharmacokinetic shifts in the combination tablet result in an earlier T(max) for sumatriptan, a later T(max) for naproxen sodium and a reduction of the C(max) by 36% for naproxen sodium compared with the components alone. In addition, the 85 mg dose of sumatriptan in the combination tablet has an area under the curve similar to 100 mg of sumatriptan alone. The clinical advantage of the sumatriptan and naproxen sodium combination is likely to be prolonged benefit per attack, that is, a sustained pain-free response.
舒马曲坦85毫克与萘普生钠500毫克的复方片剂,用于偏头痛急性治疗,已在美国获批。尽管大多数数据是关于舒马曲坦和萘普生钠的,但曲坦类/非甾体抗炎药联合使用的益处可能具有类效应。在两项针对六个共同主要终点的III期监管试验中,该复方片剂显示出优于其单一成分或安慰剂的有效性。与单独成分相比,复方片剂的药代动力学变化导致舒马曲坦的达峰时间(T(max))提前,萘普生钠的达峰时间延迟,且萘普生钠的峰浓度(C(max))降低36%。此外,复方片剂中85毫克剂量的舒马曲坦的曲线下面积与单独使用100毫克舒马曲坦相似。舒马曲坦和萘普生钠联合使用的临床优势可能是每次发作的益处延长,即持续的无痛反应。