Efficacy and safety of Alflutop in the treatment of patients with osteoarthritis of the knee joints: multicenter open-label randomized clinical trial

Background. Osteoarthritis is the most common form of joint damage among diseases of the musculoskeletal system. As the most common cause of pain and disability, osteoarthritis is a highly comorbid disease. The main objectives of osteoarthritis therapy include pain relief, joint function improvement, and ultimately - improvement of the patients’ quality of life. To reduce pain in traditional clinical practice, prescriptions of physicians are traditionally limited to analgesics and non-steroidal anti-inflammatory drugs, which often cause side effects, especially in elderly patients and patients with comorbidity. This situation creates a problem of drug interactions and limits the use of other drugs. That is why there is an increase in interest in drugs called symptomatic slow-acting. One of the representatives of parenteral drugs used in rheumatology for over 20 years is Alflutop (bioactive concentrate from small sea fish). Objective. In order to explore options for increasing patient adherence to OA therapy, a multicenter, open, randomized clinical study of the efficacy and safety of Alflutop in an alternating regimen (2 ml/m every other day for 20 days) compared to the standard regimen (1 ml/m daily for 20 days) in patients with osteoarthritis of the knee joints. Methods. The study involved 130 patients, 65 patients in each group. The duration of the study was 3 months. The effectiveness of therapy was assessed according to generally accepted criteria. Results. The results of a multicenter clinical study have shown that both of the therapy regimens used have comparable therapeutic potential, having a positive effect on the clinical manifestations of osteoarthritis. Conclusion. The obtained results of the study confirm the high efficacy and safety of the drug Alflutop both in the standard and in the alternating regimen of use. In both study groups, a rapid comparable analgesic effect was demonstrated. During treatment, significant improvement in knee joint function and quality of life was noted, which, possibly, will contribute to an increase in patient adherence to therapy.

osteoarthritis, comorbidity, symptomatic delayed-action drugs, Alflutop