Tfelt-Hansen P, De Vries P, Saxena P R
Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark.
Drugs. 2000 Dec;60(6):1259-87. doi: 10.2165/00003495-200060060-00003.
Triptans are a new class of compounds developed for the treatment of migraine attacks. The first of the class, sumatriptan, and the newer triptans (zolmitriptan, naratriptan, rizatriptan, eletriptan, almotriptan and frovatriptan) display high agonist activity at mainly the serotonin 5-HT1B and 5-HT1D receptor subtypes. As expected for a class of compounds developed for affinity at a specific receptor, there are minor pharmacodynamic differences between the triptans. Sumatriptan has a low oral bioavailability (14%) and all the newer triptans have an improved oral bioavailability and for one, risatriptan, the rate of absorption is faster. The half-lives of naratriptan, eletriptan and, in particular, frovatriptan (26 to 30h) are longer than that of sumatriptan (2h). These pharmacokinetic improvements of the newer triptans so far seem to have only resulted in minor differences in their efficacy in migraine. Double-blind, randomised clinical trials (RCTs) comparing the different triptans and triptans with other medication should ideally be the basis for judging their place in migraine therapy. In only 15 of the 83 reported RCTs were 2 triptans compared, and in 11 trials triptans were compared with other drugs. Therefore, in all placebo-controlled randomised clinical trials, the relative efficacy of the triptans was also judged by calculating the therapeutic gain (i.e. percentage response for active minus percentage response for placebo). The mean therapeutic gain with subcutaneous sumatriptan 6mg (51%) was more than that for all other dosage forms of triptans (oral sumatriptan 100mg 32%; oral sumatriptan 50mg 29%: intranasal sumatriptan 20mg 30%; rectal sumatriptan 25mg 31%; oral zolmitriptan 2.5mg 32%; oral rizatriptan 10mg 37%; oral eletriptan 40mg 37%; oral almotriptan 12.5mg 26%). Compared with oral sumatriptan 100mg (32%), the mean therapeutic gain was higher with oral eletriptan 80mg (42%) but lower with oral naratriptan 2.5mg (22%) or oral frovatriptan 2.5mg (16%). The few direct comparative randomised clinical trials with oral triptans reveal the same picture. Recurrence of headache within 24 hours after an initial successful response occurs in 30 to 40% of sumatriptan-treated patients. Apart from naratriptan, which has a tendency towards less recurrence, there appears to be no consistent difference in recurrence rates between the newer triptans and sumatriptan. Rizatriptan with its shorter time to maximum concentration (tmax) tended to produce a quicker onset of headache relief than sumatriptan and zolmitriptan. The place of triptans compared with non-triptan drugs in migraine therapy remains to be established and further RCTs are required.
曲坦类药物是为治疗偏头痛发作而研发的一类新型化合物。该类药物中的首个药物舒马曲坦,以及较新的曲坦类药物(佐米曲坦、那拉曲坦、利扎曲坦、依立曲坦、阿莫曲坦和夫罗曲坦)主要在5-羟色胺5-HT1B和5-HT1D受体亚型上表现出高激动活性。正如为特定受体亲和力而研发的一类化合物所预期的那样,曲坦类药物之间存在微小的药效学差异。舒马曲坦口服生物利用度低(14%),所有较新的曲坦类药物口服生物利用度均有所提高,其中利扎曲坦的吸收速度更快。那拉曲坦、依立曲坦,尤其是夫罗曲坦(26至30小时)的半衰期长于舒马曲坦(2小时)。到目前为止,较新曲坦类药物的这些药代动力学改善似乎仅导致它们在偏头痛疗效上有微小差异。比较不同曲坦类药物以及曲坦类药物与其他药物的双盲、随机临床试验(RCT)理想情况下应作为判断它们在偏头痛治疗中地位的依据。在83项已报道的RCT中,仅15项比较了2种曲坦类药物,11项试验将曲坦类药物与其他药物进行了比较。因此,在所有安慰剂对照的随机临床试验中,曲坦类药物的相对疗效也通过计算治疗增益来判断(即活性药物的反应百分比减去安慰剂的反应百分比)。皮下注射6mg舒马曲坦的平均治疗增益(51%)高于曲坦类药物的所有其他剂型(口服100mg舒马曲坦32%;口服50mg舒马曲坦29%;鼻内使用20mg舒马曲坦30%;直肠使用25mg舒马曲坦31%;口服2.5mg佐米曲坦32%;口服10mg利扎曲坦37%;口服40mg依立曲坦37%;口服12.5mg阿莫曲坦26%)。与口服100mg舒马曲坦(32%)相比,口服80mg依立曲坦的平均治疗增益更高(42%),但口服2.5mg那拉曲坦(22%)或口服2.5mg夫罗曲坦(16%)的平均治疗增益更低。少数口服曲坦类药物的直接比较随机临床试验也显示了相同的情况。初始成功缓解后24小时内头痛复发的情况在3�%至40%接受舒马曲坦治疗的患者中出现。除那拉曲坦复发倾向较小外,较新的曲坦类药物与舒马曲坦之间的复发率似乎没有一致的差异。利扎曲坦达到最大浓度的时间(tmax)较短,其缓解头痛的起效往往比舒马曲坦和佐米曲坦更快。曲坦类药物与非曲坦类药物在偏头痛治疗中的地位仍有待确定,需要进一步的RCT。