Headache treatment with the fixed dose combination ibuprofen plus caffeine (400/100 mg)

In total, 1124 analyzable questionnaires were collected. IbuCaff was taken by 895 participants (304 without, and 538 with concomitant shoulder/neck pain) to treat headache, 229 provided no data or used the product for other types of pain (these data were not analyzed further). Mean age of headache sufferers was ≈42 years, the majority were female (≈70%). Mean pain intensity was higher in those suffering from concomitant shoulder/neck pain (6.3 points on a 10-point pain scale), compared to those without (5.8 points). 

In both groups, pain reduction at 2 h after intake was similar (to about 1.5 points) (Fig. 1A). Pain reduction by 50% at 2 h was reached in 90% of patients, and 57% (64%) became pain-free within 2 h. Onset of pain relief within 15 min was reported by 38%, and within 30 min by 79% (Fig. 1B). The rating “very fast” or “fast” onset of action was given by 70% of participants. Efficacy and tolerability were rated as “very good” or “good” by 93% and 97%, respectively (Fig 1C and 1D). Early onset of pain relief was positively correlated with percent pain reduction at 2 h, assessment of efficacy, and interestingly also with assessment of tolerability. 

In addition to the treatment effects participants perceived, they were asked which analgesic they have taken for the last similar pain period, and how IbuCaff compared to it (in terms of onset of analgesic effect, perceived efficacy and tolerability) Ibuprofen and ibuprofen lysinate were taken by about 34 and 24%, other fixed-dose combinations by about 13%, paracetamol by 12%, and aspirin by 8%; data from [2]; Fig. 2). Only low percentages rated IbuCaff as worse compared to the last other pain treatment. Efficacy was ranked better by 35% (in comparison to ibuprofen lysinate) to 65.5% (in comparison to paracetamol) (Fig. 2A). Between 37.5% (ibuprofen lysinate) and 66.1% (paracetamol) found IbuCaff to act faster (Fig. 2B), and tolerability was ranked higher by 12.8% (ibuprofen lysinate) to 44.9% (naproxen) (Fig. 2C).

Taken together this real-world evidence study in patients treating their headache with the fixed-dose combination ibuprofen plus caffeine (400/100 mg) showed that patients reported fast onset of action and robust pain reduction at 2 h. High percentages assessed efficacy and tolerability as “very good” or “good”. Many patients found IbuCaff to act faster, more effective, and at least as tolerable compared to their last headache treatment. 

^{Acknowledgements: The author thanks Paula Fontanilla, PhD, for critically reviewing the manuscript for scientific content.}

^{Conflict of interest: T. Weiser is a Sanofi employee.}

^{Disclosure: Publication funded by Sanofi.}