Efficacy and safety of Tafalgin in palliative patients with chronic pain: results of a multicenter NIKITA-P study

Objective. To evaluate the efficacy and safety of the peptide analgesic Tafalgin in palliative patients with chronic pain syndrome. Material and methods. A multicenter (19 centers) non-interventional clinical trial of NIKITA-Palliative was conducted in 188 patients, mainly with oncological (84.5%) chronic pain syndrome (CPS) and comorbid pathology. Results. The initial pain intensity (IP) was 7.18—8.11 NRS points (from 0 to 10), 15 minutes after injection there was a statistically significant decrease in pain at rest and during movement (p<0.0001); after 1 hour, IP decreased below the level of <3 points. Maximal analgesic effect was achieved after an average of 45 minutes, and the duration of anesthesia was 8.5 hours. The proportion of patients who responded to Tafalgin therapy was 94.1%, and 72.3% of patients achieved a sufficient level of anesthesia. During treatment, there was a statistically significant improvement in quality of life: a decrease in general weakness, irritability, daytime sleepiness, an improvement in nighttime sleep and appetite (p<0.0001), and an improvement in the quality of nighttime sleep. The majority of doctors (69.7%) and patients (66.6%) rated the effectiveness of Tafalgin therapy as good or excellent. Adverse reactions (AR) were reported in 14 of 188 patients (7.4%), with a total of 26 AR. The most common were blurred consciousness (2.6%), dizziness (2.1%) and dry mouth (1.6%). All AR were mild or moderate, no serious adverse reactions were recorded, and all episodes were treated without consequences. Conclusion. Tafalgin demonstrated an effective reduction in pain intensity lasting 8.5 hours against the background of a favorable safety profile in palliative patients with chronic pain syndrome despite concomitant pathology. The drug can be considered as an effective component of analgesic therapy of severe pain, including in combination with non-narcotic, narcotic and adjuvant analgesics.