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Introduction Structural and functional changes of the vascular wall in women occur already at the very early stages of reproductive aging. An emergence of applanation tonometry made it possible to evaluate arterial stiffness and central hemodynamic parameters non-invasively, which considerably expanded the information that had been provided previously by invasive methods used for studying these parameters during cardiac catheterization. Whereas a few studies have assessed central aortic pressure (CAP) parameters and reflected pulse wave in women at different phases of their reproductive aging, none investigated the daily profile of CAP and reflected pulse wave parameters in women undergoing different stages of the menopause. Background: assessment of the daily variability in CAP and daily profile of amplification and augmentation of pulse blood pressure (PBP) in women at different menopause phases. Methods The study involved 384 climacteric women. The first group included 168 women undergoing perimenopause, the second group comprised of 216 women in their early postmenopausal stage. A 24-h blood pressure (BP) monitoring in the brachial artery and aorta (BPLab® Vasotens® system, Petr Telegin LLC, Russia) was performed via the measurements of the following indicators: systolic blood pressure (SBP), pulse blood pressure (PBP), central aortic systolic pressure (CASP), central aortic pulse pressure (CAPP), aortic augmentation index (AIxao), and pulse pressure amplification (PPA). Results When investigating PPA values in the brachial artery and aorta, we detected smaller amplification and higher aortic augmentation index at night than in daytime, which reflected a disproportionately higher CAP level during night hours. This pattern was more pronounced in postmenopausal women. We calculated the logistic regression equation (adjusted R 2  = 0.49, log-likelihood = − 50.3, chi-square (19) = 97.6, p  < 0.001), in which dependent variable was represented by the menopausal status, whereas body mass index with all indicators of a 24-h BP monitoring represented independent variables. In this model, two indicators (body mass index and AIxao) were, independently of each other, associated significantly with the menopause phases. Differences among women at various climacteric phases in terms of remaining indicators of a 24-h BP monitoring, apparently, matched the differences in their body mass index values. Conclusion Rising CAP, in combination with declining PPA and augmenting reflected pulse wave amplitude, may be associated with an increased risk of cardiovascular complications.

Guselkumab, a human monoclonal antibody that binds to the p19 subunit of interleukin 23, has been approved for the treatment of moderate-to-severe psoriasis. Psoriatic arthritis is a common comorbidity of psoriasis with an umet need for novel treatments. We assessed the efficacy and safety of guselkumab in patients with active psoriatic arthritis. We did a randomised, double-blind, placebo-controlled, phase 2a trial at 34 rheumatology and dermatology practices in Canada, Germany, Poland, Romania, Russia, Spain, and the USA. Eligible participants were aged 18 years or older with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with three or more of 66 tender joints and three or more of 68 swollen joints, who had an inadequate response or intolerance to standard treatments. We randomly assigned patients (2:1) via a central interactive web-response system using computer-generated permuted blocks with a block size of six, stratified by previous anti-tumour necrosis factor-α use, to receive subcutaneous guselkumab 100 mg or placebo at week 0, week 4, and every 8 weeks thereafter for 24 weeks. Patients, investigators, and site staff were masked to treatment assignment until final database lock at week 56. At week 16, patients with less than 5% improvement in swollen and tender joint counts were eligible for early escape to ustekinumab. At week 24, the remaining placebo-treated patients crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 and guselkumab-treated patients received a placebo injection at week 24, followed by guselkumab injections at weeks 28, 36, and 44. The primary endpoint was the proportion of patients with at least 20% improvement at week 24 in signs and symptoms of psoriatic arthritis according to American College of Rheumatology criteria (ACR20) in the modified intention-to-treat population (ie, all randomly assigned patients who received at least one dose of study treatment). Safety analyses included patients according to the study drug received. This study is registered with ClinicalTrials.gov, number NCT02319759. Between March 27, 2015, and Jan 17, 2017, we randomly assigned 149 patients to treatment: 100 to guselkumab and 49 to placebo. 17 (35%) of 49 patients in the placebo group and ten (10%) of 100 patients in the guselkumab group were eligible for early escape to ustekinumab at week 16. 29 (59%) of 49 patients in the placebo group crossed over and received guselkumab at week 24. Three (6%) of 49 patients in the placebo group, one (3%) of 29 patients who crossed over from placebo to guselkumab, and six (6%) of 100 patients in the guselkumab group discontinued study treatment before week 44. 58 (58%) of 100 patients in the guselkumab group and nine (18%) of 49 patients in the placebo group achieved an ACR20 response at week 24 (percentage difference 39·7% [95% CI 25·3–54·1]; p<0·0001). Between week 0 and week 24, 36 (36%) of 100 guselkumab-treated patients and 16 (33%) of 49 placebo-treated patients had at least one adverse event. The most frequent adverse event was infection in both groups (16 [16%] of 100 patients in the guselkumab group vs ten [20%] of 49 patients in the placebo group). The prevalence of adverse events between week 0 and week 56 in guselkumab-treated patients (51 [40%] of 129) indicated no disproportional increase with longer guselkumab exposure. No deaths occurred. Guselkumab, a novel anti-interleukin 23p19 antibody, significantly improved signs and symptoms of active psoriatic arthritis and was well tolerated during 44 weeks of treatment. The results of this study support further development of guselkumab as a novel and comprehensive treatment in psoriatic arthritis. Janssen Research & Development.

The purpose of this study was to investigate autonomous regulation of the cardiac activity by means of the heart rate variability (HRV) assessment and possible influence of conventional cardiovascular risk factors and disease activity parameters on it in patients with psoriatic arthritis (PsA). In total, 38 patients with the reliable diagnosis of PsA without clinically manifest cardiovascular pathology, known rhythm or conduction disturbances, diabetes mellitus, and hypercholesterolemia were included. In the control group, 25 age- and sex-matched healthy persons comparable with PsA patients in cardiovascular risk profile were included. For the HRV analysis, we used 5-min-long ECG records obtained at rest. Time and frequency domain parameters of HRV were calculated. Patients with PsA had decreased HRV in comparison to healthy controls as reflected by decrease of the standard deviation of normal R-R intervals (65.1 ± 66.8 vs. 83.2 ± 43.3 ms, respectively, p  = 0.011), of the percentage of normal R-R intervals that differ by more than 50 ms (12.9 ± 15.4 vs. 20.6 ± 17.1 %, respectively, p  = 0.035), and of the total power (2,069.4 ± 1,537.8 vs. 2,942.5 ± 1,734.2 ms 2 , respectively, p  = 0.006). A significant correlation of HRV parameters with disease duration and parameters of disease activity in PsA was found. Patients with PsA had impaired autonomous regulation of the cardiac activity, which is likely to be related to the presence of systemic inflammation and which could contribute to the increase of cardiovascular risk in this disease.

The LEUKOSPECT study aimed to describe health service utilization and to estimate the direct medical costs (DMCs) of chronic lymphocytic leukemia (CLL) in 2013 in the adult population of three post-Soviet countries - Russia, Ukraine, and Kazakhstan. As oncologic medical care is provided by federal state-owned, specialized medical institutions, the cost estimation in this study primarily informs from a state budget perspective. Patients' contributions to medical costs were not included in the cost evaluation. This was a multinational, multicenter, retrospective study conducted in eight specialized centers (four in Russia, three in Ukraine, and one in Kazakhstan). The investigators captured data from the medical documents of all adult patients with an established CLL diagnosis before December 31, 2013, and who made at least one visit to their respective center between January 1 and December 31, 2013. A total of 319 adult CLL patients were enrolled (124 in Kazakhstan, 106 in Russia, and 89 in Ukraine). In 2013, the DMCs of CLL management (without CLL therapy) were €215.40 in Kazakhstan, €1,342.20 in Russia, and €13,260.70 in Ukraine. Hospitalizations formed the largest proportion of total cost: 18.1%, 23.1%, and 40.4%, respectively. The mean cost of CLL medical treatment was €13,580.60 (Russia), €399.40 (Kazakhstan), and €7,453.00 (Ukraine). CLL treatment standards varied across the selected countries; higher usage of biologic therapy was noted in Russia. Future research is needed to assess DMCs which include CLL treatment, which is another essential factor contributing to CLL DMCs.