Comparative analysis of efficacy and safety of different medicines containing celecoxib in patients with knee osteoarthritis

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Abstract

Information concerning the therapeutic equivalence of generics to original drugs obtained in the course of clinical trials, including post-registration ones, is of great practical value for physicians.

Aim of the study: to evaluate the efficacy and safety of Simcoxib® medicine comparatively to the original celecoxib in patients with osteoarthritis (OA) of the knee joint.

Material and methods. The study included 59 patients with knee OA, randomized into two comparable groups: patients of the first group (n=30) received Simcoxib® as therapy, examined persons from the second group (n=29) received the original celecoxib. The course of treatment for each medicine was 14 days on daily dose of 400 mg, with a further change to on-demand regimen. The observation was carried out at four time points for 28 days.

Results. Patients of both groups had a significant positive dynamics in the form of a decrease in the pain VAS score (p <0,001) and the WOMAC index (p <0,001). At the same time, the efficacy of studied medicines was similar (p ≥0,05 at each of the visits). During the study, patients in both groups had comparable values of average arterial pressure and eGFR, which did not exceed the normal values in the population. During the entire observation period, the number of adverse events did not differ between groups of patients receiving each of the medicines.

Conclusion. Celecoxib is a selective COX-2 inhibitor with proven high efficacy in the treatment of pain of various origins. At the same time, this medicine has a good safety profile in relation to the gastrointestinal tract and cardiovascular system. In the treatment of knee OA, Simcoxib® is significantly effective in reducing VAS pain and WOMAC index and in these indexes is comparable with original celecoxib. The frequency of adverse events while Simcoxib® intake does not exceed the same when original celecoxib use.

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About the authors

Evgeny A. Trofimov

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

Author for correspondence.
Email: evgeniy.trofimov@szgmu.ru
ORCID iD: 0000-0003-3236-4485
SPIN-code: 4358-1663

MD, deputy director of the Research Institute of Rheumatology and professor of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care named after E.E. Eichwald

Russian Federation, Saint Petersburg

Vadim I. Mazurov

I.I. Mechnikov North-Western State Medical University of the Ministry of Healthcare of Russia; Clinical Rheumatological Hospital No. 25

Email: maz.nwgmu@yandex.ru
ORCID iD: 0000-0002-0797-2051

MD, professor, academician of RAS, Chief scientific consultant, director of the Research Institute of Rheumatology and head of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care named after E.E. Eichwald, head of the Center for autoimmune diseases, Honored Worker of Science of the Russian Federation

Russian Federation, Saint Petersburg; Saint Petersburg

Roman A. Bashkinov

I.I. Mechnikov North-Western State Medical University of the Ministry of Healthcare of Russia; Clinical Rheumatological Hospital No. 25

Email: bashkinov-roman@mail.ru
ORCID iD: 0000-0001-9344-1304
SPIN-code: 5169-5066

postgraduate student of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care named after E.E. Eichwald, rhemautologist

Russian Federation, Saint Petersburg; Saint Petersburg

Anna S. Trofimova

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

Email: anna.trofimova@szgmu.ru
ORCID iD: 0000-0001-5926-7912
SPIN-code: 6827-3934

PhD in Medical Sciences, assistant at the Department of therapy, rheumatology, examination of temporary disability and quality of medical care named after E.E. Eichwald

Russian Federation, Saint Petersburg

Inna Z. Gaydukova

I.I. Mechnikov North-Western State Medical University of the Ministry of Healthcare of Russia; Clinical Rheumatological Hospital No. 25

Email: ubp1976@list.ru
ORCID iD: 0000-0003-3500-7256

MD, professor, deputy director of the Research Institute of Rheumatology and professor of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care named after E.E. Eichwald, rhemautologist

Russian Federation, Saint Petersburg; Saint Petersburg

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