Quantifying the return of headache in triptan-treated migraineurs: an observational study.

To improve understanding of secondary treatment failure in migraine patients, we evaluated 'headache return' as a novel endpoint to assess returning headaches according to their severity, expanding on current standard assessments of overall recurrence or relapse rates, in a six-month observational study of triptan-treated migraineurs. A total of 359 patients (91% female; mean age, 42.5 years) recorded data for 2168 headaches in electronic diaries. Two-thirds of headaches responded to triptan treatment (improved-to-mild or no pain two hours post-dose); 34% of headaches had a pain-free response. By 48 hours post-dose, 19% of all responding headaches returned; 24% of headaches achieving a pain-free response returned, predominantly to mild pain. More severe baseline headache, short duration since diagnosis of migraine, and female gender were associated with increased likelihood of headache return. Treatment satisfaction declined with increasing severity of headache return, demonstrating the value of assessing headache return by severity to fully evaluate its impact.