An open label multicenter observational study of the efficacy , tolerability and safety of Amtolmetin Guacil – a non-steroidal anti-inflammatory drug , in patients with knee osteoarthritis and dyspepsia

1 Federal State Funded Research Institution of Rheumatology, named after V.A. Nasonova", Moscow, Russia; 2Regional State Funded Clinical Hospital "Regional Clinical Hospital No. 1 named after Professor S.I. Sergeev" and KGBOUPO "Institute for Advanced Training of Health Professionals" of the Khabarovsk Ministry of Health, Khabarovsk, Russia; 3 Federal State Funded Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Health of Russia, Vladivostok, Russia; 4 Federal State Funded Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of Russia, Kazan, Russia; 5Federal State Funded Healthcare Institution "Voronezh Regional Clinical Hospital No. 1", Voronezh, Russia; 6 Federal State Funded Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Health of Russia, Yaroslavl, Russia; 7 Federal State Funded Educational Institution of Higher Education "Nizhny Novgorod State Medical Academy" of the Ministry of Health of Russia, Nizhny Novgorod, Russia; 8 SPb Federal State Funded Healthcare Institution "City Clinic No. 100 Nevsky District", St. Petersburg, Russia; 9 "Regional Medical Diagnostic Center" LLC, Novosibirsk, Russia; 10 Federal State Funded Educational Institution of Higher Education "The First Moscow State Medical University named after I.M. Sechenov", Ministry of Health of Russia, Department of Rheumatology, Institute of Professional Education, Moscow, Russia 1 34A Kashirskoye shosse, Moscow, 15522; 2 9 Krasnodarskaya Street, Khabarovsk, 680009; 32 Ostryakov Avenue, Vladivostok, 690002 ; 4 49 Butlerova Street, Kazan, 420012; 5151 Moscow Avenue, Voronezh, 394066; 6 5 Revolyutsionnaya Street, Goal — to study the efficiency and tolerability of Amtolmetin Guacil (AMG; Niselat, Dr. Reddy's Laboratories Ltd., India) in patients with knee osteoarthritis (OA) and signs of dyspepsia, compared with previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs). Material and methods. The open observational study included 220 patients, ages 30–65 years, with OA of the knee-joint and intense pain, on the back of the therapy with NSAIDs and with symptoms of dyspepsia in the absence of contraindications to AMG. In general, following concomitant diseases occurred in 68 % of patients, among them hypertension (42 %), varicose veins of the lower extremities (6.4 %) and diabetes (6 %). The therapy efficiency was assessed using the three scales of the WOMAC index (Western Ontario and McMaster Universities Osteoarthritis Index), pain intensity and overall health rating from the visual analog scale. Researchers used the SODA index (The Severity of Dyspepsia Assessment) to quantify dyspepsia. Results and discussion. AMG has a pronounced analgesic effect, confirmed by pain reduction (by 40 % or more), which occurred in 72.5 % of patients. The high intensity of the AMG analgesic effect was reliably confirmed statistically (p <0.001) by a significant decrease in the WOMAC index (pain and stiffness), and an increase in functional activity. The study established a significant decrease in the pain and other signs of dyspepsia, as well as the positive dynamics of the indicators "general assessment of the severity of dyspepsia" (p <0.001) and "satisfaction with therapy". The overall assessment of therapy with AMG was decidedly positive: "Excellent" – in 33 % of patients, "good" – in 56 % and "satisfactory" – in 11 % of patients. Serious adverse reactions (AR) have not been reported. The severity of AR in 8 % of cases was average, and in 82 % of cases – mild. The AR were reported by 7.7 % of patients. Conclusion. The obtained results confirm the good prospects of using AMG for treatment of knee-joint OA.