Therapeutic potential of glycosaminoglycan-peptide complex injectable form use in knee osteoarthritis treatment according to PRIMULA (Use of Rumalon with initially small success in the treatment of osteoarthritis) study results: supplemented data

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Abstract

Slow-release anti-inflammatory agents (SRIA) are widely used in osteoarthritis (OA) treatment. One of common medications of this group is a glycosaminoglycan-peptide complex - GPC (Rumalon®) that is designed for parenteral course use. GPC has a complex therapeutic effect; it suppresses pain and inflammation, and slows down OA progression. Study objective - to determine therapeutic effect and frequency of adverse events (AE) of GPC use in patients with knee OA in whom other SRIA showed low efficiency. Materials and methods. GPC Rumalon® was used in 115 patients (92.3% female, aged 63.6±8.6 years, body mass index 29.8±5.4 kg/m2), who suffered fr om significant joint pain (≥40 mm on 100 mm visual analogue scale - VAS) and needed regular use of nonsteroidal anti-inflammatory drugs (NSAD). All patients received oral SRIA in the last 6 months. At the time of treatment onset pain severity according to VAS was 59.9±15.3, WOMAC pain index -236.5±94.7, WOMAC stiffness - 101.8±43.8, WOMAC function - 806.7±349.4, WOMAC total - 1144.9±459.1. GPC was used according to manufacturer’s recommendations: 25 intramuscular injections were performed on alternate days in each patient. Effectiveness criteria included pain severity (VAS) and WOMAC index dynamics, NSAD use reduction, and patents’ personal assessment of the treatment results (on the scale 1-5 wh ere 1 - no improvement or deterioration and 5 - excellent results). The measures were estimated 8 and 12 weeks after the start of the study. Results. In 8 and 12 weeks pain severity (VAS) decreased by 29.0±17.6% and 34.6±16.2%, WOMAC pain index decreased by 29.6±15.8% and 37.2±21.7%, WOMAC stiffness - by 27.7±14.8% and 30.4±16.7%, WOMAC function - by 27.4±13.9% and 30.0±17.1%, WOMAC total - by 26.9±12.8% and 32.4±17.4%, respectively. The measures dynamics was statistically significant compared with the baseline (p<0.001). After 8 and 12 weeks of treatment 79.6% and 75.6% of patients estimated treatment results as good and excellent. After 12 weeks of treatment 31.7% of patients discontinued NSAD use, 32.4% lowered the dose or changed to NSAD use on demand. AE were reported in 1.8% of patients. AE development did not require GPC treatment course interruption, AE were corrected without further consequences after the end of treatment. Conclusion. GPC Rumalon® use allows to reduce pain and inflammation severity and functional impairment, as well as NSAD demand in OA patients including patients with severe disease progression and low effectiveness of pre-study therapy.

About the authors

A. E Karateev

V.A.Nasonova Research Institute of Rheumatology

Email: aekarat@yandex.ru
д-р мед. наук, зав. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

L. I Alekseeva

V.A.Nasonova Research Institute of Rheumatology

Email: dr.alekseeva@gmail.com
д-р мед. наук, зав. лаб. остеоартроза с отд. метаболических заболеваний костей и суставов с центром профилактики остеопороза 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

A. M Lila

V.A.Nasonova Research Institute of Rheumatology

д-р мед. наук, проф., дир. 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

S. A Makarov

V.A.Nasonova Research Institute of Rheumatology

канд. мед. наук, зав. отд-нием травматологии и ортопедии, врач травматолог-ортопед 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

N. V Chichasova

I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation

д-р мед. наук, проф. каф. ревматологии 119991, Russian Federation, Moscow, ul. Trubetskaia, d. 8, str. 2

E. V Zonova

Novosibirsk State Medical University of the Ministry of Health of the Russian Federation

Email: elena_zonova@list.ru
д-р мед. наук, проф. каф. терапии, гематологии и трансфузиологии ФПК и ППВ , гл. специалист-ревматолог СФО. 630091, Russian Federation, Novosibirsk, ul. Krasnyi pr-t, d. 52

E. I Shmidt

N.I.Pirogov City Сlinical Hospital №1 of the Department of Health of Moscow

119049, Russian Federation, Moscow, Leninskii pr-t, d. 10, korp. 5

E. A Taskina

V.A.Nasonova Research Institute of Rheumatology

Email: braell@mail.ru
канд. мед. наук, науч. сотр. лаб. остеоартроза с отд. метаболических заболеваний костей и суставов с центром профилактики остеопороза 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

N. G Kashevarova

V.A.Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
канд. мед. наук, науч. сотр. лаб. остеоартроза с отд. метаболических заболеваний костей и суставов с центром профилактики остеопороза 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

E. P Sharapova

V.A.Nasonova Research Institute of Rheumatology

Email: 2116i@mail.ru
канд. мед. наук, науч. сотр. лаб. остеоартроза с отд. метаболических заболеваний костей и суставов с центром профилактики остеопороза 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

S. G Anikin

V.A.Nasonova Research Institute of Rheumatology

канд. мед. наук, ст. науч. сотр. лаб. остеоартроза, отд. метаболических заболеваний костей и суставов с центром профилактики остеопороза 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

E. A Strebkova

V.A.Nasonova Research Institute of Rheumatology

Email: ekaterinazlepko@gmail.com
канд. мед. наук, науч. сотр. лаб. остеоартроза с отд. метаболических заболеваний костей и суставов с центром профилактики остеопороза 115522, Russian Federation, Moscow, Kashirskoe sh., d. 34a

V. V Azarovskaya

N.I.Pirogov City Сlinical Hospital №1 of the Department of Health of Moscow

Email: aekarat@yandex.ru
ревматолог 119049, Russian Federation, Moscow, Leninskii pr-t, d. 10, korp. 5

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