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

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

Moderators of treatment effect of non-steroidal anti-inflammatory drugs for patients with (sub) acute low back pain: Protocol for a systematic review with individual participant data meta-analysis

“…Hancock et al [18] found that female patients and patients having high levels of physical activity-related fear avoidance may respond better to NSAIDs as compared to males and those with low levels of physical activity related fear avoidance. In 2018, an observational study on patients with osteoarthritis and non-specific LBP [19] reported that the effect of NSAIDs was smaller in patients aged 65 years and older, with body mass index >30 kg/m2, experiencing severe pain, pain at rest, pain at night, and the presence of spinal stiffness. Given the potential variation in the effectiveness of NSAIDs in patients with LBP, we hypothesize the presence of distinct 'subgroups' among those with acute and sub-acute LBP, exhibiting differential responses to NSAIDs.…”

“…Our objectives are: (1) to assess the overall treatment effect of NSAID for improving pain, disability, and health-related quality of life in adults with acute and subacute LBP; (2) to identify the potential moderation of baseline patients’ characteristics on treatment effects. Based on the precious studies [ 18 , 19 ], we hypothesize that the following subgroups: patients who are female; having high levels of physical activity-related fear avoidance; aged under 65 years; body mass index ≤ 30 kg/m2; experiencing slighter pain; without pain at rest; without pain at night; without spinal stiffness, may demonstrate a more favorable response to NSAIDs. Our primary outcomes of interest are pain intensity, disability, and health-related quality of life, secondary outcomes are adverse events.…”

Assessment of the safety, tolerability and effectiveness of first Russian generic aceclofenac in patients with undifferentiated peripheral inflammatory arthritis

“…По результатам российского многоцентрового исследования НОТА также показано, что НПВП как класс являются средством выбора для лечения боли при неспецифической боли в спине и остеоартрите, а ацеклофенак, в частности, эффективен и безопасен при данной патологии [35].…”

Peculiarities of Pharmacological Activity of Tetrahydropyridone and Hexahydroquinoline Derivatives in Experiment

“…Currently, the pharmaceutical industry offers a practitioner more than 70 NSAIDs of various chemical structures (Lesnaya 2018). However, the main stumbling block in the treatment of patients with pain syndrome is their very low safety profile (Fanella et al 2017;Karateev et al 2018;Lesnaya 2018).…”

“…However, unfortunately, along with high pharmacotherapeutic efficacy for the main indications, it is the use of NSAIDs that a whole spectrum of complications is associated with (ulcerogenicity, hepatotoxicity, hematotoxicity, neurotoxicity, cardiotoxicity, etc.) (Nozadze et al 2016;Parada et al 2016;Karateev et al 2018).…”