Efficacy and Cardiovascular Safety of Amtolmetin Guacil (Niselat) in Treatment of Patients with Ankylosing Spondylitis: KORONA Interim Results
Materials and Methods. In the study there were recruited 48 patients (26 males, 54.16%) with verified AS and low back pain (score ≥ 4, according to the visual analogue scale). Average age of patients was 38.2 ± 7.2 years. Patients were divided into two groups depending on anamnestically present/absent arterial hypertension: 28 and 20 persons, respectively. Therapy of patients from both groups included amtolmetin guacil at dose of 1800 mg/day for 14 days, then - at lower dose of 600 mg/day for 16 days (de-escalation therapy). Therapeutic efficacy was assessed by quantifying number of patients, which by week 2 had decreased intensity of low back pain by score ≥ 2 (according to the visual analogue scale), cardiovascular safety - by incidence of developing angina pectoris, lethal/non-lethal myocardial infarction or sudden cardiac death, acute cerebrovascular accident, and lethal/non-lethal cerebral infarction. Primary endpoint was considered as a time point when arterial blood pressure elevated by ≥ 20 mm Hg compared to baseline values was registered three times. Results. It was found that on week 2 41 patients were shown to have ameliorated low back pain. This effect was sustained by week 4. Cardiovascular events were not observed excepting increased/destabilized arterial hypertension observed by week 2 in 6 (12.5%) patients (two persons from group 1 and four persons from group 2). Conclusions. Use of amtolmetin guacil at dose of 1800 mg/day substantially contributes to ameliorating back pain in patients with AS. Subsequent administration of the drug at dose o f600 mg/day allows to preserve clinical result obtained after using it at higher dose. No 30-day cardiovascular events were documented after therapy excepting arterial hypertension. Some patients with increased risk of cardiovascular diseases (overweight, family history of arterial hypertension and ischemic heart disease, smoking) receiving high doses of amtolmetin guacil were found to result in increase/ destabilized arterial blood pressure by the end of the 2 <sup>nd</sup> week, which required administration/correction of anti-hypertensive therapy, but not withdrawing NSAID.