Factors affecting the results of analgesic therapy. Results of the Russian multicentre study of NOTE (NSAID: Open-label Trial of Efficacy)


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Abstract

Non-steroidal anti-inflammatory drugs (NSAIDs) are most popular medications for the treatment of pain in common musculoskeletal diseases such as osteoarthritis (OA) and non-specific low back pain (LBP). However, the factors affecting the effectiveness of these drugs have not been determined fully. Aim: to identify factors affecting the effectiveness of NSAIDs in patients with OA and LBP. Materials and methods. An observational study was conducted to evaluate the effectiveness of a 2-week course of NSAIDs in OA and LBP in real clinical practice. The study group consisted of 3604 patients with OA and LBP (60.6% women and 39.4% men, mean age 55.0±13.4 years). According to the study design, aceclofenac (Airtal) and other NSAIDs used in the ratio 1:1. The main criterion of effectiveness was the frequency of complete pain relief after 2 weeks of therapy. In addition, the decrease of pain and general health were determined on a 10-point numerical rating scale (NRS). We compared the frequency of complete pain relief in patients who had and did not have the studied factors. The value of the studied factors was determined using OR (95% CI). Results and discussion. Most patients received aceclofenac (54.9%), as well as diclofenac (2.0%), ketoprofen (1.9%), lornoxicam (2.2%), meloxicam (13.7%), naproxen (2.1%), nimesulide (5.8%), celecoxib (5.9%), ethicoxib (7.1%) and other NSAIDs (4.4%); 56.2% of patients received muscle relaxants, mainly tolperisone (74.7%), vitamin B (10.4%), and proton pump inhibitors (42.8%). Complete pain relief was achieved in 54.8% of patients. The pain decrease and general health improvement were (for NRS) 63.9±13.4% and 61.7±14.8%, respectively. The efficacy of aceclofenac was slightly higher than in the whole group: complete pain relief was in 59.9% of patients. Adverse events in aceclofenac use were observed in 2.3% of patients, other NSAIDs-from 2.4 to 14.1%. The frequency of complete pain relief was higher in men: OR 1,239 (95% CI 1.08-1.418; p=0.002), who had the first episode of pain - OR 3.341 (95% CI 2.873-3.875; p=0.000), a good" response " to NSAIDs in history - OR 1.656 (95% CI 1.385-1.980; p=0.000) and received NSAIDs in combination with muscle relaxants - OR 1.218 (95% CI 1.067-1.390; p=0.004). The effect of therapy is lower in patients 65 years and older-OR 0,378 (95% CI 0.324-0.442; p=0,000), with body mass index >30 kg/m² - OR 0.619 (95% CI 0.529-0.723; p=0.000), with severe pain (≥7 points NRS) - OR 0.662 (95% CI 0.580-0.756; p=0.002), with pain at rest, - OR 0.515 (95% CI 0.450-0,589; p=0.000), pain at night - OR 0.581 (95% CI 0.501-0.672; p=0.000) and the presence of stiffness - OR 0.501 (95% CI 0.438-0,573; p=0.000). Treatment results are significantly worse in the cases of combination of LBP and joint pain, as well as pain in the trochanter major and pes anserinus area (p<0.001). Conclusion. NSAIDs are the first-line medications for the pain treatment in LBP and OA. Aceclofenac is effective and safe in this conditions. When carrying out analgesic therapy should take into account factors that affect the effectiveness of treatment: old age, overweight, insufficient effect of NSAIDs in history, severe pain, signs of "inflammatory" pain, multiple sources of pain.

About the authors

A E Karateev

V.A. Nasonova Research Institute of Rheumatology

Email: aekarat@yandex.ru
м.н., зав. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний ФГБНУ НИИР им. В.А. Насоновой; ORCID 0000-0002-1391-0711 Moscow, Russia

E Yu Pogozheva

V.A. Nasonova Research Institute of Rheumatology

к.м.н., н.с. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний ФГБНУ НИИР им. В.А. Насоновой Moscow, Russia

E A Filatova

V.A. Nasonova Research Institute of Rheumatology

врач-невролог, к.м.н., н.с. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний ФГБНУ НИИР им. В.А. Насоновой Moscow, Russia

V N Amirjanova

V.A. Nasonova Research Institute of Rheumatology

д.м.н., в.н.с. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний ФГБНУ НИИР им. В.А. Насоновой Moscow, Russia

A M Lila

V.A. Nasonova Research Institute of Rheumatology

д.м.н., проф., врио директора ФГБНУ НИИР им. В.А. Насоновой Moscow, Russia

O V Antipova

Autonomous Healthcare Institution "Irkutsk Clinical Hospital №1"

ОГУЗ «Иркутская городская клиническая больница №1» зав. ревматологическим центром Иркутской ГКБ №1 Irkutsk, Russia

A R Babaeva

Volgograd State Medical University

д.м.н., проф., зав. каф. факультетской терапии ВолгГМУ, главный внештатный специалист Южного федерального округа Volgograd, Russia

A V Volkorezova

Orel Regional Clinical Hospital

к.м.н., БУЗ Орловской области «Областная клиническая больница», главный внештатный ревматолог Орловской области Orel, Russia

A F Davydova

S.V.Ochapovskiy Regional Clinical Hospital №1, Ministry of Health of Krasnodar Region

ГБУЗ «Научно-исследовательский институт - Краевая клиническая больница №1 им. проф. С.В. Очаповского», зав. ревматологическим отд-нием, главный внештатный специалист Краснодарского края Krasnodar, Russia

V G Davtyan

Clinic of medical expertise, LLC

к.м.н., ООО «Клиника медицинских экспертиз» (Владимир) Vladimir, Russia

E V Zonova

Novosibirsk State Medical University

д.м.н., проф., ГБОУ ВО «Новосибирский гос. медицинский университет», каф. терапии факультета усовершенствования врачей, главный внештатный специалист Сибирского федерального округа Novosibirsk, Russia

O N Ivanova

Voronezh Regional Clinical Hospital №1

к.м.н., БУЗ ВО «Воронежская областная клиническая больница №1», главный внештатный ревматолог Воронежской области Voronezh, Russia

N N Kalinina

Budgetary State Institution "Regional Hospital"

м.н., ГБУЗ Тверской области «Областная клиническая больница», каф. внутренних болезней ФДПО ФГБУ ВО «Тверской государственный медицинский университет» Tver, Russia

N I Kiseleva

Murmansk Regional Clinical Hospital named after P.A. Bayandin

ГОБУЗ «Мурманская областная клиническая больница им. П.А. Баяндина» Murmansk, Russia

L A Knyazeva

Kursk State Medical University

д.м.н., ФГБОУ ВО «Курский государственный медицинский университет», проф. каф. внутренних болезней №1, зав. кабинетом терапии генно-инженерными биологическими препаратами, главный внештатный специалист Курской области Kursk, Russia

A I Kulikov

Rostov Regional Clinical Hospital №2

ГБУ РО «Областная клиническая больница № 2», главный внештатный специалист Ростовской области Rostov-on-Don, Russia

O B Nesmeyanova

Chelyabinsk Regional Clinical Hospital

к.м.н., ГЛПУЗ «Челябинская областная клиническая больница», главный внештатный специалист Челябинской области, главный внештатный ревматолог Уральского федерального округа Chelyabinsk, Russia

V I Mazurov

North-Western State Medical University named after I.I. Mechnikov

академик РАН, д.м.н., проф., ГБОУ ВПО «Северо-Западный государственный медицинский университет им. И.И. Мечникова», зав. каф. терапии и ревматологии им. Э.Э. Эйхвальда, главный ревматолог Северо-Западного федерального округа Saint-Petersburg, Russia

L V Masneva

Belgorod Regional Clinical Hospital

ОГБУЗ «Белгородская областная клиническая больница», зав. ревматологическим отд-нием, главный внештатный специалист Белгородской области Belgorod, Russia

L V Menshikova

Irkutsk State Medical Academy for Postgraduate Education

д.м.н., проф., ГОУ ДПО «ИГИУВ Росздрава» - Иркутский государственный институт усовершенствования врачей - филиал РМАНПО, зав. каф. семейной медицины, главный внештатный специалист Иркутской области Irkutsk, Russia

I V Obuhova

Arkhangelsk Regional Clinical Hospital

ГБУЗ АО «Архангельская областная клиническая больница» Arkhangelsk, Russia

E N Otteva

Professor S.I. Sergeev Regional Clinical Hospital №1

д.м.н., проф., КОГБУЗ «Краевая клиническая больница №1 им. проф. С.И. Сергеева», главный внештатный специалист Хабаровского края, главный внештатный ревматолог Дальневосточного федерального округа Khabarovsk, Russia

T S Salnikova

Tula Regional Clinical Hospital

к.м.н., ГУЗ Тульской области «Тульская областная клиническая больница», зав. ревматологическим отд-нием, главный внештатный ревматолог Тульской области Tula, Russia

I N Shchendrygin

The State Budget Health Care Institution of Stavropol Territory «Stavropol Regional Clinical Center of Specialized Types of Medical Care»

ГУЗ «Ставропольский краевой клинический центр специализированных видов медицинской помощи», зав. ревматологическим отд-нием, главный внештатный специалист Ставропольского края Stavropol, Russia

S P Yakupova

Kazan State Medical University

к.м.н., ФГБОУ ВО «Казанский государственный медицинский университет», доц. каф. госпитальной терапии, главный внештатный специалист Республики Татарстан Kazan, Russia

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