Clinical efficacy and safety of Flamidase in the treatment of lumbar pain: results of a multicenter observational comparative study in Ukraine

Анотація

Pain in the lumbar region (lumbalgia) is one of the leading causes of temporary disability among the economically active population worldwide, including Ukraine. Nonsteroidal anti-inflammatory drugs remain the first-line treatment for vertebrogenic pain syndromes, providing analgesic and anti-inflammatory effects, but their use is limited by gastrointestinal disorders. Flamidase is a combination drug based on potassium diclofenac and paracetamol, which also contains the enzyme serratiopeptidase. This combination achieves a synergistic effect: paracetamol enhances the analgesic effect of potassium diclofenac, reducing the need to increase the dose of the nonsteroidal anti-inflammatory drug, while serratiopeptidase provides additional anti-inflammatory and anti-edema effects. The aim of the study was to evaluate the efficacy and safety of the combination drug Flamidase (potassium diclofenac, paracetamol, serratiopep­tidase) compared to sodium diclofenac in the treatment of acute lower back pain (lumbago, lumbosciatica). A comparative prospective multicenter observational study was conducted involving 157 patients from 15 regions of Ukraine. Participants were divided into 4 groups depending on the nosology and the drug used: lumbago-Diclofenac (n=29), lumbosciatica-Diclofenac (n=49), lumbago-Flamidase (n=25), lumbosciatica-Flamidase (n=54). Efficacy was assessed based on the dynamics of pain syndrome from days 1 to 7 of treatment, safety was assessed based on the activity of transaminase enzymes (ALT, AST) in blood plasma, as well as subjective manifestations of side effects (nausea, abdominal pain, etc.). Both diclofenac sodium and Flamidase are effective in reducing the intensity of low back pain, with Flamidase significantly superior to diclofenac in terms of the severity and speed of the analgesic effect (especially in the nociceptive component). The average reduction in pain intensity (ΔVAS) over 7 days of treatment was 5.76 points in the Flamidase group versus 4.12 points in the diclofenac sodium group, which is statistically significant (p<0.05). In patients with lumbago, ΔVAS was 6.12 points (Flamidase) versus 4,48 points (diclofenac). In patients with lumbosciatica, it was 5.39 points (Flamidase) versus 3.76 points (diclofenac). The median VAS on the 7th day of treatment was 0 points in the Flamidase group versus 2 points in the diclofenac group. In terms of safety, diclofenac sodium is also slightly inferior to Flamidase, reliably (but clinically insignificantly) increasing ALT and AST activity, while no statistically significant difference between the drugs in terms of their effect on the stomach was verified: gastrointestinal side effects were observed in 15% of patients on diclofenac and 11% on Flamidase. Flamidase demonstrates better efficacy and safety compared to diclofenac sodium in the treatment of acute low back pain, especially in the presence of a nociceptive component. The combined action of potassium diclofenac, paracetamol, and seratopeptidase provides a pronounced analgesic effect without creating additional gastric and hepatobiliary risks for the patient. The results obtained indicate that the combination drug Flamidase may be an effective option for pharmacotherapy of acute low back pain. Further randomized controlled trials with a longer follow-up period are needed to confirm these results.