A Comparative Trial of Oral and Subcutaneous Sumatriptan in Acute Treatment of Migraine: a multicenter trial

Han, Seol Heui; Huh, Kyoon; Joo, In Soo; Kim, Jae Il; Kim, Seung Min; Lee, Geun Ho; Moon, Joon Shik; Lee, Ae Young; Park, Hyung Kook; Shin, Hyun Gil

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 Korea 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.
CONCLUSION
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 higher occurrence of side effects in this study, although mostly in mild degree, suggests that optimal dose adjustment strategy needs to be elaborated in Korea.