Abstract text (incl. figure legends and references)

Objective: Headache can negatively impact cognitive parameters such as concentration, attention, or the ability to focus. This prospective observational real-world evidence study was conducted in Germany and Japan to describe the impact of over the counter (OTC) headache treatments on headache pain intensity and to assess the association of pain intensity with functional and cognitive impact.

Methods: Panel members who used Sanofi OTC headache treatments were invited to participate. Only attacks treated with that product were assessed. The primary endpoint was change in pain intensity assessed via 11-point Numeric Rating Scale (NRS; 0=no pain to 10=worst pain imaginable) from baseline to 2 hours after treatment, using the first headache episode treated. Secondary endpoints were changes from baseline to 2 hours post-treatment in concentration, attention, ability to focus, coordination, productivity, clear thinking, and energy – all assessed via 11-point NRS (0=no impact and 10=severe impact) on all headache episodes treated.

Results: In Germany and Japan, respectively, 426 and 452 participants were enrolled; of which 293 and 326 reported a headache and among them 202 and 196 used OTC treatment only. (Mean+SD age was 42.8+12.0 and 41.9+10.2 years; 52% and 72% were female). Mean NRS pain score 2 hours post-treatment decreased from baseline by 3.4 points (CI 95% 3.1 to 3.7) in Germany and 3.0 points (2.7 to 3.3) in Japan, both p<0.0001. All secondary endpoints with functional and cognitive parameters were improved with this pain relief (p<0.0001).

Conclusion: Participants in both countries reported significant reductions in pain 2 hours post OTC treatment, which also correlated with reduction in impact of all cognitive and functional parameters evaluated. Cognitive and functional impairment due to headache impacts patients´ quality of life and should be considered in addition to pain reduction in optimizing headache treatment.