Clinical efficacy and safety of the Rakstan-Sanovel in patients with acute low back pain (results of a multicenter postmarketing observational study)

• Published in: РМЖ: Медицинское обозрение Vol. 6; no. 10; pp. 541 - 550
• Main Authors: Danilov, A.B., Merkulova, D.M., Zhivolupov, S.A., Devlikamova, F.I., Doronin, B.M., Shirokov, V.A., Balyazina, E.V., Komarov, A.N.
• Format: Journal Article
• Language: English; Russian
• Published: 2022
• ISSN: 2587-6821; 2686-9918
• DOI: 10.32364/2587-6821-2022-6-10-541-550

Aim: to analyze the efficacy (time of onset, severity and duration of pain relief) and safety of a nonsteroidal anti-inflammatory drug (NSAID), Rakstan-sanovel (flurbiprofen; further Rakstan), in the complex treatment of patients with acute LBP. Patients and Methods: the study involved 210 patients with acute LBP, randomly divided into 2 similar groups of 105 subjects. In the control group (CG), a standard treatment regimen was used for two consecutive weeks. Drug therapy included any NSAID (except Rakstan), muscle relaxants, B vitamins in the doses recommended in the patient information leaflet. Non-drug therapy included physical exercise or physiotherapy (patients could receive one of these treatments or a combination of them) as determined by the doctor. In the main group (MG), Rakstan was used to relieve pain in combination with other necessary concomitant therapy (muscle relaxants, B vitamins, physical exercise and physiotherapy). The tendency of clinical condition was analyzed according to the following scales: VAS, Roland-Morris Disability Questionnaire, CGI (to assess the overall clinical impression of the doctor and the patient), EQ-5D-5L. The total duration of drug intake follow- up was 10 days, as well as 2 subsequent weeks. Results: the majority of patients were female (the quantitative proportion of male and female was 1:1,4); the average age was 43.5 [29; 57] years with a disease duration of 14.4±6.3 days. Lumbar spondylosis was the predominant trigger of pain in 105 (50%) patients, sacroiliac joint injury — in 39 (18.6%), degenerative-dystrophic changes of the intervertebral disc — in 66 (31.4%). The majority (68%) of patients in both groups had a moderate pain level with a score of 45–74 points according to the VAS. By the end of the therapy course, the average difference between groups according to VAS was 19 points. By the end of the therapy course, 90% of patients with MG had reached a zero level of pain according to VAS, while in CG — only 50%. Besides, 2 weeks after the end of treatment, no pain recurrence was registered in the MG, and there was an improvement equaled 69% (41.6 points) in the assessment of the functional state according to the Roland-Morris Disability Questionnaire in the MG, while in the CG it reached only 24% (14.3 points). Assessment of the general clinical impression of the doctor according to the CGI questionnaire in the MG showed that 86 out of 105 patients rated their condition as "completely normal", while in the CG only 1 patient gave such an assessment. Adverse events (nausea, stomach pain, dizziness, diarrhea) were noted in 4 patients of the CG. Conclusions: the use of Rakstan allows to accelerate the recovery of patients with acute LBP without the development of additional adverse events, which may have a significant benefit in rational therapy, as well as in the prevention of chronification and relapses in patients of this category. KEYWORDS: acute lower back pain, non-steroidal anti-inflammatory drugs, flurbiprofen, Rakstan, recurrence. FOR CITATION: Danilov A.B., Merkulova D.M., Zhivolupov S.A. et al. Clinical efficacy and safety of the Rakstan-Sanovel in patients with acute low back pain (results of a multicenter postmarketing observational study). Russian Medical Inquiry. 2022;6(10):541–550 (in Russ.). DOI: 10.32364/2587-6821-2022-6-10-541-550.