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Assessment of Adverse Events Associated
with Triptans -- Methods of Assessment
Influence the Results
Sheftell F, Feleppa M, Tepper S, et al.
Posted: January 2005  
Headache 2004;44:978-982

Background:  A recent study conducted in triptan-naïve migraine patients showed that tolerability was the second most important attribute of an acute treatment. However, the proportion of patients reporting side effects after any acute treatment may vary with regard to the method of assessment.

Objectives:   To contrast two methods of assessing adverse events (prompted and unprompted) in those with headache using triptans.

Results:   Most patients reported no side effects in the unprompted questionnaire. However, most of them reported at least one side effect in the prompted questionnaire. Most patients that reported side effects in the unprompted questionnaire said they had just one adverse event, while most reported two or more side effects in the prompted questionnaire. Both in the unprompted and in the prompted questionnaires, most side effects were rated as mild or moderate. Interestingly, 31 subjects graded their adverse events as severe in the prompted questionnaire, but had not self-reported them.

Conclusions:   (1) When assessing adverse events, the method of data collection may dramatically influence the results. (2) From those subjects who did not self-report adverse events after using a triptan, most of them will report positively if presented with a list of side effects.