Trial of Intravenous Immune Globulin in Dermatomyositis.

BACKGROUND: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated. METHODS: We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS ≥40) and major improvement (TIS ≥60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index. RESULTS: A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events. CONCLUSIONS: In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.).

THE CHRONIC KIDNEY DISEASE RISK ANALYSIS IN PATIENTS WITH ARTERIAL HYPERTENSION AND COEXISTENT HYPERURICEMIA.

OBJECTIVE: The aim: Is the analysis of chronic kidney disease risk in patients with arterial hypertension and coexistent hyperuricemia. PATIENTS AND METHODS: Materials and methods:We observed 40 patients with arterial hypertension and coexistent hyperuricemia (I group), 35 - with arterial hypertension (II group) and 30 practically healthy people (control). The duration of hypertension was 4,3 ± 2,31 years and 4,0 ± 2,11 years (p = 0,9247) for I and II group respectively, of hyperuricemia - 4,1 ± 0,35 years for I group. Categories of albuminuria (А1, А2, А3) and glomerular filtration rate (G1, G2, G3A, G3B, G4, G5) were determined in all observed patients. Clinical, anthropometric, biochemical, immunoassay, statistical (SPSS 21, Graph Pad) methods were used. RESULTS: Results:The categories of albuminuria and glomerular filtration rate in patients from the I group demonstrated that A1G1 was confirmed in 3 persons, A1G2 - 5, A2G1 - 7, A2G2 - 20, A1G3A - 1, A1G3B - 1, A2G3A - 2, A2G3B - 1. Among patients from the II group category A1G1 was defined in 7, A1G2 - 2, A2G1 - 16, A2G2 - 10 persons. The percent of low chronic kidney disease risk was on 5,7 % higher in hypertensive persons comparable with comorbid persons. High and very high risk was confirmed in 10 % persons from I group and nobody from the ІІ group. CONCLUSION: Conclusions:Chronic kidney disease risk is increased in patients with arterial hypertension and coexistent hyperuricemia. This indicates an association between elevated uric acid levels and chronic kidney disease progression.

Indicators of left ventricle hypertrophy in patients with arterial hypertension combined with obesity and their interconnection with polymorphism of lys198asn genе of endothelin-1.

OBJECTIVE: The aim of the study was to find dependence of left ventricular hypertrophy indexes to polymorphism of Les198Asn gene endothelin-1 and BMI. PATIENTS AND METHODS: Materials and methods: We took research in 160 patients with arterial hypertension, using ECG and polymerase chain reaction (PCR). Groups were divided additionally according to BMI (body mass index). RESULTS: Results: It was found, that patients with obesity had their Left ventricular mass and hypertrophy left ventricular indexes higher, than in patients with normal and increased body weight. Carriers of Asn198Asn and Lys198Asn genotypes Left ventricular mass and hypertrophy left ventricular indexes are higher than in carriers of Lys198Lys genotype. CONCLUSION: Conclusions: It was determined that in patients-carriers of Asn198Asn genotype, Left ventricular mass (LVMI) and hypertrophy left ventricular indexes (LVMMI) were higher compared to patients-carriers of Lys198Lys and Lys198Asn type, both in men and women. The dependence of LVMI and LVMMI are shown to be higher in patients with obesity than in people with normal and increased body mass.

Arterial hypertension associated with hyperuricemia: features of heart damage.

OBJECTIVE: The aim is the analysis of hyperuricemia influence on the heart features in patients with arterial hypertension. PATIENTS AND METHODS: Materials and methods: We include 75 patients with arterial hypertension which were divided in two groups according to the level of uric acid in the blood, 30 practically healthy people. Patients from the I group (n = 40) had arterial hypertension and coexistent hyperuricemia; ІІ (n = 35) - arterial hypertension. Left ventricular mass index was determined for left ventricular hypertrophy confirmation. We used clinical, anthropometric, biochemical, instrumental, statistical method. Serum uric acid level was observed by the reaction with uricase. Left ventricular mass index was calculated as left ventricular mass to body surface area ratio. The results were analyzed statistically by SPSS 21 and Graphpad. RESULTS: Results: Left ventricular mass index was significantly higher (р = 0,0498) in patients from the І group (109,7 ± 3,21) g/m2 comparable with the ІІ (97,6 ± 5,35) g/m2 and increased in proportion to the biggest level of uric acid (r = 0,31; p = 0,04) in patients with arterial hypertension and hyperuricemia. CONCLUSION: Conclusions: Concentric and excentric left ventricular hypertrophy, increased left ventricular mass index proportionally to uric acid levels (r = 0,31; p = 0,04) is the confirmation of important role of hyperuricemia in the left ventricular hypertrophy development in patients with arterial hypertension.