Tension-type headache and effective pain relief: results of the prospective multicenter RAPID clinical trial

Pharmacological treatment of tension-type headache (TTH) attacks involves the selection of the most effective and safe analgesic. However, the choice of medication is limited by the insufficient number of evidence-based studies for this type of headache (HA). Objective: to evaluate the efficacy, safety, and tolerability of fast-release lornoxicam (Xefocam rapid) compared to standard lornoxicam (Xefocam), naproxen, and ibuprofen in relieving headache episodes in patients with frequent episodic TTH in routine clinical practice. Material and methods. The multicenter, observational (non-interventional), prospective RAPID study was conducted in 10 clinical centers across the Russian Federation and included 400 adult patients (74.5% women, 25.5% men) aged 18 to 76 years (mean age: 39.83±12.58 years) with frequent episodic TTH who were prescribed one of the following NSAIDs in routine practice: Xefocam, Xefocam rapid, ibuprofen, or naproxen. The following outcomes were assessed: the number of completely relieved TTH episodes, changes from baseline in the mean number of headache days, mean number of TTH episodes per month, mean duration of TTH episodes, and mean pain intensity on a numerical rating scale, time from drug intake to partial and complete relief of a TTH episode, mean number of days with intake of the drugs in question, number of patients using NSAIDs ≥15 days per month, number of patients taking additional medications for TTH relief, patient satisfaction with the prescribed treatment, number of patients who discontinued treatment, and the frequency of adverse events during therapy. Results. The study demonstrated overall high efficacy of Xefocam and Xefocam rapid in relieving TTH attacks. At the same time, the data obtained allow the identification of some priority effects of investigated drugs. Thus, Xefocam and Xefocam rapid showed the highest efficacy in achieving complete headache relief within 2 hours after intake. Moreover, Xefocam rapid was the most effective across all groups in achieving complete headache relief within the first 30 minutes. The greatest reduction in the numerical rating scale (NRS) score was also observed in the Xefocam rapid and Xefocam groups. In addition, Xefocam and Xefocam use demonstrated the lowest need for additional medications for pain relief among all groups, which may be related to the rapid onset of analgesic action and high safety profile of these drugs. Patients in the Xefocam rapid group more frequently rated their satisfaction with the therapy as excellent. Conclusion. Xefocam rapid showed a high safety profile and excellent tolerability, with the lowest incidence of adverse events among all study groups.