Sumatriptan: Pharmacological Basis and Clinical Results

Carl G. H. Dahlöf

Disclosures

Curr Med Res Opin. 2001;17(1s) 

In This Article

Expanding the Utility of Sumatriptan

Research initiatives undertaken within the past 3 years have focused on (1) expanding the utility of sumatriptan to new attack types and patient groups, and on (2) identifying treatment parameters associated with optimal patient responses.

Many headache sufferers experience a range of headache types including migraine, migrainous, and episodic tension-type headaches. The results of The Spectrum Study, a randomized, double-blind, clinical trial of the efficacy of sumatriptan in a range of headache types experienced by patients with International Headache Society (IHS)-diagnosed migraine, show that sumatriptan tablets 50 mg are effective for several headache types experienced by migraineurs[46]. The incidence of headache relief 4 h post-dose was significantly greater for sumatriptan tablets 50 mg compared with placebo for migraine headaches (66% vs 48%), migrainous headaches (71% vs 39%), and tension-type headaches (78% vs 50%). A practical implication of these data would be that IHS migraine sufferers need not wait until they determine whether or not the headache episode fulfils the IHS criteria for migraine before using sumatriptan.

Another means by which the utility of sumatriptan is being expanded is its use in adolescent migraine. Tablet forms of sumatriptan and other medicines have previously been studied in adolescent migraine and have not proven consistently more effective than placebo. The lack of differentiation between sumatriptan tablets and placebo in the treatment of adolescent migraine results from a high incidence of placebo response in adolescents. The high placebo response has been attributed to characteristics of the patients and/or to the shorter migraine attack duration, on average, among adolescent patients compared with adults. Perhaps because it is a more rapidly effective dosing form than tablet migraine medicines, sumatriptan nasal spray has been demonstrated effective compared with placebo in adolescent patients with migraine[47,48]. In one study assessing the 5 mg, 10 mg and 20 mg doses in 12- to 17-year-old migraineurs, headache relief 1 hour post-dose was reported by 47-56% of sumatriptan nasal spraytreated patients compared with 41% of placebo patients[48]. Headache relief 2 h post-dose was reported by significantly more patients using sumatriptan nasal spray 5mg compared with placebo. The 20 mg dose was more effective than placebo beginning 1 hour after dosing and was more effective 2 h post-dose in conferring complete relief from pain. Sumatriptan nasal spray was well-tolerated at all three doses.

Data published in 2000 suggest that the utility of sumatriptan can also be expanded by using it early during a migraine attack to maximize headache relief[49,50]. For example, a retrospective analysis of data from three sumatriptan tablet clinical trials (S2CM09, S2BT25, S2BT26) demonstrates that treatment outcomes are improved by administering sumatriptan early in a migrainewhenpain is mild as opposed to later in the migraine when pain is more severe[49]. In the S2CM09 study, the incidence of freedom from pain 2 h post-dose was higher when pain was treated early when it was mild (51% 50 mg and 67% 100 mg) than when it was moderate or severe (31% 50 mg and 36% 100 mg). Freedom from pain 4 h post-dose likewise was higher when pain was treated early when it was mild (75% 50 mg and 90% 100 mg) than when it was moderate or severe (56% 50 mg and 61% 100 mg). Similarly, the incidence of maintenance of pain-free response from 2 to 24 h post-dose was higher when pain was treated early when it was mild (34% with 50 mg and 53% with 100 mg) than when it was moderate or severe (19% with 50 mg and 24% with 100 mg). A similar pattern of results showing a benefit of using sumatriptan tablets early in the migraine when pain is mild was observed for relief of nausea, photophobia, phonophobia and clinical disability. The benefit of treating early in the migraine when pain is mild was not observed with non-specific/non-selective medications such as ergotamine or aspirin plus metoclopramide[49]. The incidence of freedom from pain 2 h post-dose after early treatment of mild pain was significantly higher with sumatriptan tablets 100 mg (69%) compared with ergotamine plus caffeine 34% and with sumatriptan tablets 100 mg (73%) compared with aspirin plus metoclopramide (25%).

Pain-free response when treating at different baseline severity was recently followed over six attacks. Up to 168 migraine attacks treated with a triptan (sumatriptan, naratriptan and zolmitriptan) were evaluated in 28 migraineurs (86% female and 14% male, ages 22-64 years) participating in an open, randomized, cross-over, patient-preference trial. Based on the results, it was concluded that a pain-free response is obtained earlier if attacks are treated at mild rather than moderate or severe intensity. Time to meaningful relief was also longer when treating attacks with severe intensity at baseline compared to those that were moderate or mild[51].

Headache recurrence, defined as a significant improvement (>50% on a visual analogue scale) within 2 h of dosing followed by a return of pain at any time during the attacks was also followed over these six attacks. Attacks treated at mild pain intensity were least likely to have a headache recurrence[52]. Early treatment when headache is mild thus may improve the total outcome of triptan therapy. Randomized clinical trials addressing these issues are warranted.

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