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

AIM: To evaluate the effectiveness and tolerability of the drug in patients with undifferentiated peripheral inflammatory arthritis (UPIA). MATERIALS AND METHODS: We observed 60 patients (39 women and 21 men) met G. Hazlewood et al., UPIA criteria, 2011. Patients were divided into 3 groups: with monoarthritis, oligoarthritis and polyarthritis. They took aceclofenac 100 mg twice day for 3 weeks. RESULTS: We noted significant decreasing in pain level according to visual analogue scale: in patients with monoarthritis by 69.3 mm (p0.001); in oligoarthritis group by 47.5 mm (p0.001), in patients with polyarthritis by 30 mm (p0.001). The life quality by the EQ-5D-5L index was improved too in all groups from 0.616 to 0.829 (p0.001). The satisfaction with the therapy was: in monoarthritis patients (80% of patients and 93% of doctors noted good results), in oligoarthritis group (53% and 39% accordingly) and polyarthritis (74% and 64% respectively). We suppose the difference was due to the fact that mono- and oligoarthritis patients suffered from initial forms of seronegative spondylarthropathy, in which the effectiveness of NSAIDs is traditionally higher; polyarthritis patients probably had debut of rheumatoid arthritis. Adverse events of therapy were mild. We noted gastrointestinal tract symptoms (dyspepsia) and increased ALT in 10 patients and increased blood pressure in 1 patient. The symptoms did not require discontinuation of therapy. Сonclusion. Post-registration observational study of first Russian generic aceclofenac (Alental, Vertex, Russia) was conducted. In UPIA patients aceclofenac therapy was most effective in mono- and oligoarthritis patients. The first Russian generic aceclofenac (Alental, Vertex, Russia) has good efficacy, tolerability and safety and can be recommended for arthritis treatment.

[Serum nesfatin-1 as a marker of systemic inflammation in rheumatoid arthritis.]

The purpose of this study was to determine the level of nesfatin-1 (NF-1) in the blood serum of healthy volunteers and patients with rheumatoid arthritis (RA) to establish the threshold for normal values of this parameter and to reveal the relationship between the level of NF-1 and clinical manifestations of RA. We examined 170 people, of which 110 patients with RA and 60 donors who made up the comparison group. The mean level of serum nesfatin-1 in healthy subjects was 31.61 ± 3.17 ng/ml (M ± σ). The level of normal values of nesfatin-1 in healthy individuals, defined as M ± 2σ, was from 25.27 to 37.95 ng/ml. These studies showed the relationship between the concentration of NF-1 and the severity of clinical manifestations of RA. We found that a higher serum level of NF-1 was characteristic of patients with a more severe clinical course of the disease. The data obtained indicate that high level of NF-1 positively correlates with higher concentrations of C-reactive protein and ESR. This data indirectly proves the proinflammatory effect of NF-1 and confirms the hypothesis about the primary role of systemic inflammation in the pathogenesis of RA.

Cardiovascular safety of non-steroidal anti-inflammatory drugs in chronic inflammatory rheumatic diseases.

Rheumatic diseases (RD), such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, vasculitis, gout are associated with increase in cardiovascular morbidity and mortality. The main causes of increased cardiovascular risk are inflammatory heart and vascular lesions, accelerated progression of atherosclerosis and side effects of drug therapy. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used in clinical practice and are on the list of the most prescribed medications. It is known that NSAIDs have a negative effect on the cardiovascular system (CVS). However NSAIDs may decrease the intensity of inflammation, which is an independent risk risk factor for CVS pathology. Therefore in patients with RD it is theoretically possible to reduce the severity of cardiovascular side effects when using NSAIDs. The article discusses the issues of NSAID's cardiovascular safety, the molecular mechanisms underlying the negative effect of them on CVS, critically evaluated the results of main studies concerning the cardiovascular safety of NSAIDs in chronic inflammatory diseases.

[Novel hepatokine in rheumatoid arthritis laboratory diagnostics.]

Fetuin-A (α2-Heremans-Schmid glycoprotein, AHSG) is a glycoprotein mainly secreted by hepar in adults. It was shown, that AHSG is a positive as well as a negative acute-phase protein with pro- and anti-inflammatory effects. We studied serum levels of an AHSG in patients with rheumatoid arthritis (RA) and healthy controls in order to determine its role in the diagnostics of this disease. We measured serum levels of AHSG in 110 patients with RA and 30 healthy controls. To determine RA phenotype we measured rheumatoid factor and anticitrullinated protein antibodies. All patients were examined by the rheumatologist to identify clinical features of RA. Serum CRP and ESR were measured to assess inflammation. Mean level of AHSG in group with RA was 765,67±120,66 (Hereinafter M±σ), which was significantly lower than of healthy controls (812,76,2±76,2 µg/ml; p=0,0437). Insignificant difference of mean levels of AHSG was observed between men and women with RA (p=0,424). The reference ranges for AHSG measured from the healty controls were 653,55-972,19 ug/ml (M±2σ). We studied mean levels of AHSG according to the clinical and immunological manifestations of RA. AHSG levels were significantly lower within patients positive on ACCP, with moderate or high disease activity, with 2nd, 3rd and 4th x-ray stages and functional classes, with erosivity, extra-articular manifestations and complications. The moderate negative correlation was observed between AHSG level and CRP (r=-0,3146; p<0,001), ESR (r=-0,344; p<0,001) and DAS28 (r=-0,4334; p<0,001). In summary, AHSG mean levels were significantly different in patients with RA. It can be used to improve the diagnostics of RA activity, severity, extra-articular manifestations and complications.

[Irisin as a new marker for the early diagnosis of low-traumatic fractures in rheumatoid arthritis.]

The aim of this study was to study the relationship between serum irisin level and the presence of low-traumatic bone fractures in rheumatoid arthritis (RA) patients. We examined 170 people including 110 RA patients and 60 healthy individuals as comparison group. The serum irisin level was determined with solid-phase enzyme-linked immunosorbent assay using ELISA Irisin test system (BioVendor, cat. No. RAG018R). The average level of irisin in the group of healthy individuals was 20.49 ± 4.82 µg/ml (µ±σ). The level of normal values, defined as M ± 2σ, was 10.85-30.13 µg/ml. Decreased irisin level was detected in 41 of 110 patients with RA diagnosis (37% of cases). This group of patients had higher RA activity degree (DAS28), extra-articular manifestations, disease duration from 5 to 10 years, greater class of functional joint's failure, lower level of 25 (OH) -vitamin D. There was also a reliable relationship between serum irisin level and presence of low-fracture bone fractures in the anamnesis.

[The nicotinamide-phosphoribosiltransferase as a marker of systemic inflammation under osteoarthrosis.]

The purpose of study is to establish the level of visfatin (Nampt, nicotinamide-phosphoribosiltransferase) in blood serum of healthy volunteers for determination of the level of normal values of of the given parameter specific to healthy people. Besides, the given parameter also was analyzed in patients with osteoarthritis. The sampling consisted of 152 individuals. Out of them, 92 patients with primary osteoarthritis and 60 healthy individuals. The level of Nampt in blood serum of healthy people was detected by using commercial test-systems (RaiBiotech, cat. № EIA-VIS-1). The average level of Nampt in blood serum of healthy people made up to 2,43±0,17 ng/ml (M ± m). The level of normal values of Nampt in healthy people detected as М ± 2σ, made up to from 0 to 5.07 ng/ml. The study data proved the relationship between concentration of Nampt ans expression of clinical manifestations of osteoarthritis. It is demonstrated that higher level of Nampt in blood serum was typical for patients with more severe clinical course of disease. The obtained data testify that high level of Nampt correlates positively with higher concentrations of C-reactive protein and ESR that indirectly testifies in behalf of anti-inflammatory character of action of Nampt and substantiates hypothesis about primary role of systemic inflammation in pathogenesis of osteoarthritis.

[Evidence of feasibility etoricoxib therapy in osteoarthritis in elderly patients].

The article presents the results of a study of clinical efficacy in the treatment of etorikoxib pain in patients with osteoarthritis of the knee and hip joints in elderly patients. The study involved 296 patients with gonarthrosis and coxarthrosis. It is shown that etoricoxib effectively relieves pain, has an advantage over other NSAIDs speed and severity of the analgesic and anti-inflammatory effect, positive impact on laboratory signs of inflammation, demonstrated good tolerability and a low incidence of side effects, does not require discontinuation of therapy.

[The efficacy and safety of etoricoxib versus meloxicam in the treatment of patients with gonarthrosis]. / Sravnitel'naya effektivnost' i bezopasnost' etorikoksiba i meloksikama v lechenii bol'nykh gonartrozom.

AIM: To evaluate the clinical efficacy and tolerability of etoricoxib and meloxicam in patients with gonarthrosis. SUBJECTS AND METHODS: A postregistration, open-labeled, prospective, comparative randomized study was conducted. 40 patients aged 37 to 75 years with primary knee osteoarthritis were examined. Therapeutic effectiveness was evaluated determining the functional index WOMAC with the use of a visual analogue scale (VAS). The tolerability of the drugs was assessed according to the opinions of a patient and a physician. RESULTS: Both drugs caused a reduction in WOMAC and VAS scores for pain and the severity of the disease. Etoricoxib demonstrated a significantly high rate of occurrence and completeness of its analgesic effect. Meloxicam showed a less pronounced decrease in joint stiffness and an insufficient analgesic effect. The incidence of side effects was similar in both groups. CONCLUSION: Both drugs demonstrated a good tolerability and a low incidence of side effects. The efficacy of etoricoxib was significantly higher than that of meloxicam.