MULTICENTER PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF THE COMBINED USE OF GLYCOSAMINOGLYCAN-PEPTIDE COMPLEX AND DIACEREIN IN PATIENTS WITH KNEE OSTEOARTHRITIS


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Abstract

Existing osteoarthritis (OA) treatments are focused primarily on symptoms. However, around 30-40% of patients are not completely satisfied with their treatment, which leads to further active research in the field. Objectives: to evaluate the efficacy, tolerability and safety of complex therapy with Rumalon and Diaflex in patients with knee OA compared with Rumalon monotherapy. Materials and methods. A total of 78 patients (71 females and 7 males, mean age 59,7±7,3 years, mean BMI - 33±5,49 kg/m2, OA duration 5-10 years) with a verified diagnosis of knee OA (stages varying II-III Kellgren-Lawrence) and VAS pain >40 mm were enrolled in the study to receive therapy for 8 months with 2 months of follow up and aftereffect evaluation. The patients were randomized to two groups. Group 1 (combined therapy, n=45) had treatment either with Rumalon (glycosaminoglycan-peptide complex) and Diaflex (diacerein) according to the standard regimen. Group 2 (monotherapy, n=33) had treatment with Rumalon according to the standard regimen as well. Treatment efficacy was evaluated via VAS knee pain while walking, WOMAC (pain, stiffness, functional limitations), EQ-5D health status, daily need for NSAIDs, treatment efficacy when evaluated by the doctor and by the patient, OMERACT-OARSI response to therapy. Patients also performed several lab tests and knee ultrasound. Results. This study results show a significant effect of both combined and monotherapy in terms of OA knee pain reduction: WOMAC pain initially in the combined treatment group was 198 (160-280) mm, post-therapy it was 110 (34-204) mm; monotherapy group was 209 (157-241) mm initially and 112 (68-178) mm after treatment, respectively. Conclusion. This Russian multicentre randomized trial has shown the beneficial effect for both combined (Rumalon and Diaflex) and monotherapy (Rumalon) regimens in patients with knee OA: there was a decrease in pain intensity, an increase in quality of life, good safety profile and an aftereffect. The advantages of combined therapy included the speed of onset of analgesic effect, better effects towards knee synovitis and a more considerable decrease in the daily need for NSAIDs.

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About the authors

Lyudmila I. ALEKSEEVA

V.A. Nasonova Research Institute of Rheumatology; Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia

Email: dr.alekseeva@gmail.com
MD, head of the Department of metabolic diseases of bones and joints, V.A. Nasonova Scientific Research Institute of Rheumatology, professor of the Department of rheumatology of Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia Moscow

Alexander M. LILA

V.A. Nasonova Research Institute of Rheumatology; Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia

MD, professor, Director of V.A. Nasonova Scientific Research Institute of Rheumatology, head of the Department of rheumatology of the Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia. Address Moscow

Evgenia P. SHARAPOVA

V.A. Nasonova Research Institute of Rheumatology

PhD, researcher of the Department of metabolic diseases of bones and joints Moscow

Elena A. TASKINA

V.A. Nasonova Research Institute of Rheumatology

Email: braell@mail.ru
PhD, senior researcher of the Department of metabolic diseases of bones and joints Moscow

Natalya G. KASHEVAROVA

V.A. Nasonova Research Institute of Rheumatology

PhD, researcher of the Department of metabolic diseases of bones and joints Moscow

Ekaterina A. STREBKOVA

V.A. Nasonova Research Institute of Rheumatology

PhD, researcher of the Department of metabolic diseases of bones and joints Moscow

Vadim I. MAZUROV

I.I. Mechnikov North-Western State Medical University of the Ministry of Healthcare of Russia

Email: maz.nwgmu@yandex.ru
MD, professor, academician of the RAS, head of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care named after E.E. Eichwald Saint Petersburg

Elena V. ZONOVA

Novosibirsk State Medical University of the Ministry of Healthcare of Russia

MD, professor of the Department of therapy, hematology and transfusiology of the Faculty of advanced training and professional retraining of physicians Novosibirsk

Elvira N. OTTEVA

Institute for Advanced Training of Health Specialists of the Ministry of Healthcare of the Khabarovsk Territory

MD, professor of the Department of therapy and preventive medicine, head of Regional Clinical Rheumatology Center Khabarovsk

Svetlana P. YAKUPOVA

Kazan State Medical University of the Ministry of Healthcare of Russia

PhD, associate professor of the Department of hospital therapy Kazan

Irina B. VINOGRADOVA

Ulyanovsk Regional Clinical Hospital

PhD, head of Rheumatology Center

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