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

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: 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.

[Long-term effects of structum administration (according to data from multicenter trial)]. / Otdalennye rezul'taty primeneniia struktuma (po materialam mnogotsentrovogo issledovaniia).

AIM: To evaluate duration of a clinical response to the drug structum in patients with osteoarthrosis (OA) of the knee and hip joints as well as structum effects on OA course and that of concomitant diseases. MATERIAL AND METHODS: The duration of a clinical response to structum after the end of the treatment and its effect on OA and concominant diseases course were studied for 12 months in 9 centers participating in the study of the drug efficacy and tolerance in patients with gon- and coxarthrosis in an open multicenter randomized controlled 6-month trial. Out of 555 patients with OA of the knee and hip joints enrolled in the first study, the examination covered 373 patients: 159 patients of the test group treated for 6 months with structum and 214 controls. By basic clinical parameters the groups were similar. Clinical examination was made after structum treatment and 12 months later and included assessment of the number of exacerbations, hospitalizations, outpatient consultations, days of temporary disability for OA, pain in the joints while walking and at rest by the visual scale, Leken's functional index, x-ray pictures of the joints, administration of nonsteroidal anti-inflammatory drugs (NSAID), exacerbations of concomitant diseases (gastrointestinal diseases, arterial hypertension, ischemic heart disease). RESULTS: An overall functional Leken's index in patients with gon- and coxarthrosis given structum 12 months after the treatment did not reach the initial values as well as pain and daily need in NSAID. Structum effect in patients with knee joint OA persisted for 4.6 months, in hip joint OA--4.1 months; in patients with stage I-II the effect lasted longer than in stage III (5.2 and 4.6 months vs 4.17 and 3.24 months, respectively. Even short-term therapy with structum reduced the number of further exacerbations, hospitalizations and visits to their doctor. 12 months after structum therapy the effect persisted in 40% patients. Frequency of exacerbations of the concomitant diseases was less than in patients on continuous NSAID. CONCLUSION: Structum is a highly effective drug against OA as it acts long, reduces frequency of exacerbations, hospitalizations, visits to the doctor, duration of disability, NSAID requirement and improves the course of some concomitant diseases.

[Results of the multicenter clinical trial of structum preparation in Russia]. / Itogi mnogotsentrovogo klinicheskogo issledovaniia preparata struktuma v Rossii.

AIM: To study clinical effectiveness and tolerance of structum in patients with osteoarthrosis (OA) of the knee joints (KJ) and hip joints (HJ) in a multicenter open randomised trial. MATERIAL AND METHODS: A 6-month trial of effectiveness and tolerance of structum has been performed in 9 medical centers and included outpatients (males and females) with KJ OA or HJ OA satisfying the OA diagnostic criteria of the American Rheumatology College, having x-ray stage I-III according to Kellgren-Lawrence with manifest pain, a total functional Leken index from 4 to 11, regular intake of non-steroid antiinflammatory drugs (NAID) for 30 days in the last 3 months. Consent was obtained from each patient. 192 patients received structum, 363 matched patients served control. Structum was given per os for 3 weeks in a dose of 1.5 g/day then in a dose 1.0 g/day up to 6 months. The patients continued on NAID. The patients' examination was performed in the beginning of the study, at its months 3 and 6. RESULTS: Leken index in HJ and KJ OA significantly fell after 3 months of structum treatment. Up to month 6 it fell still further (p < 0.05). After 6 months of treatment pain syndrome relieved both at rest and movement, pain at rest disappeared fully in 57% of NJ OA patients and 46% of HJ OA patients, for movement pain it was 17 and 13%, respectively. During the treatment NAID intake was less required in both groups (p < 0.05) while 55% of patients in both groups could discontinue NAID after 6 months of the treatment. Tolerance of the drug was rather good, side effects were mild. CONCLUSION: Structum (chondroitin sulphate) is an effective drug for treatment of KJ and HJ OA: it relieves pain, preserves and improves articular function, allows to reduce or discontinue NAID, is well tolerated.