Comparative Trial of Oral and Subcutaneous Sumatriptan in Acute Treatment of Migraine: a Multicenter Trial

Abstract

Background : The efficacy of sumatriptan(SMN) in acute management of migrane has

been well established. In Korea, however, a clinical study comparing the utility of

oral(PO) and subcutaneous(SQ) regimen had not been conducted yet. This study was

directed to compare the two regimens of SMN in terms of the efficacy as well as the

adverse events in a singed-out Korean patient group.

Methods : The 91 migrane patients were recruited and randomly assigned to either

PO or SQ regimen as the initial treatment of acute migrane attack. Then, they were

forwarded to the other regimen as an open cross-over trial. The treatment responses

and adverse events were assessed and rated by the subjects.

Results : Eighty one patient successfully tried at least one regimen of SMN. Overall,

the proportion of excellent treatment response was 90.7% (PO) and 94.1% (SQ), with the occurrence of adverse events being 67.4% (PO) and 76.5%(SQ) respectively. In 18

patients who were able to complete cross-over procedure, the efficacy was 94.4% both

in PO and SQ regimen, with the occurrence of adverse events 72.2% in both of two

regimen. Although the SQ regimen tends to induce faster treatment response regardless

of the cross-over completion, it bears no statistical significance.

Conclusions : We conclude that the PO and SQ regimens of SMN show very comparable clinical utility in achieving therapeutic responses as well as in producing

adverse events. The treatment efficacy was excellent but hight occurrence of side

effects in this study, mostly in moderate to severe degree, suggests that optimal dose

adjustment strategy needs to be elaborated in Korea.