ORAL AND SUBCUTANEOUS SUMATRIPTAN IN THE ACUTE TREATMENT OF MIGRAINE - AN OPEN RANDOMIZED CROSS-OVER STUDY

In an open, randomized cross-over study in 124 patients, we compared t he efficacy, safety and patient preference of oral and subcutaneous su matriptan in the acute treatment of migraine. Patients were treated fo r 3 attacks or 3 months and then crossed over. Primary clinical effica cy was defined as a reduction in headache severity on a four-point sel f-rating scale from severe (3) or moderate (2) to mild (1) or none (0) , or mild (1) to none (0). Efficacy was evaluated 2 h after the admini stration of subcutaneous and 4 h after the administration of oral suma triptan. Subcutaneous sumatriptan was significantly more effective tha n oral sumatriptan in relieving headache (over all three attacks 78% v s 61% improvement), improving clinical disability (55% vs 41% improvem ent) and relieving nausea (69% vs 53%), vomiting (72% vs 32%) and phon o- or photophobia (67% vs 49%). Median time to recurrence was shorter after subcutaneous (12.5 h) than after oral sumatriptan (18 h); the nu mber of patients experiencing a recurrence was similar. Patients repor ted more adverse events after subcutaneous sumatriptan (1.32 per attac k) than after the oral form (0.85 per attack), but all adverse events were mild to moderate in intensity and of short duration. Patient opin ion was more often positive after subcutaneous sumatriptan. These resu lts may be useful in counselling patients to choose between the availa ble marketed formulations of sumatriptan.