Objectives To describe and explore differences in formal regulations around sick leave and work disability (WD) for patients with rheumatoid arthritis (RA), as well as perceptions by rheumatologists and patients on the system’s performance, across European countries. Methods We conducted three cross-sectional surveys in 50 European countries: one on work (re-)integration and social security (SS) system arrangements in case of sick leave and long-term WD due to RA (one rheumatologist per country), and two among approximately 15 rheumatologists and 15 patients per country on perceptions regarding SS arrangements on work participation. Differences in regulations and perceptions were compared across categories defined by gross domestic product (GDP), type of social welfare regime, European Union (EU) membership and country RA WD rates. Results Forty-four (88%) countries provided data on regulations, 33 (75%) on perceptions of rheumatologists (n=539) and 34 (77%) on perceptions of patients (n=719). While large variation was observed across all regulations across countries, no relationship was found between most of regulations or income compensation and GDP, type of SS system or rates of WD. Regarding perceptions, rheumatologists in high GDP and EU-member countries felt less confident in their role in the decision process towards WD (β=−0.5 (95% CI −0.9 to −0.2) and β=−0.5 (95% CI −1.0 to −0.1), respectively). The Scandinavian and Bismarckian system scored best on patients’ and rheumatologists’ perceptions of regulations and system performance. Conclusions There is large heterogeneity in rules and regulations of SS systems across Europe in relation to WD of patients with RA, and it cannot be explained by existing welfare regimes, EU membership or country’s wealth.
Abstract Aims Raised blood pressure (BP) is the biggest contributor to mortality and disease burden worldwide and fewer than half of those with hypertension are aware of it. May Measurement Month (MMM) is a global campaign set up in 2017, to raise awareness of high BP and as a pragmatic solution to a lack of formal screening worldwide. The 2018 campaign was expanded, aiming to include more participants and countries. Methods and results Eighty-nine countries participated in MMM 2018. Volunteers (≥18 years) were recruited through opportunistic sampling at a variety of screening sites. Each participant had three BP measurements and completed a questionnaire on demographic, lifestyle, and environmental factors. Hypertension was defined as a systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, or taking antihypertensive medication. In total, 74.9% of screenees provided three BP readings. Multiple imputation using chained equations was used to impute missing readings. 1 504 963 individuals (mean age 45.3 years; 52.4% female) were screened. After multiple imputation, 502 079 (33.4%) individuals had hypertension, of whom 59.5% were aware of their diagnosis and 55.3% were taking antihypertensive medication. Of those on medication, 60.0% were controlled and of all hypertensives, 33.2% were controlled. We detected 224 285 individuals with untreated hypertension and 111 214 individuals with inadequately treated (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) hypertension. Conclusion May Measurement Month expanded significantly compared with 2017, including more participants in more countries. The campaign identified over 335 000 adults with untreated or inadequately treated hypertension. In the absence of systematic screening programmes, MMM was effective at raising awareness at least among these individuals at risk.
Title of Days of AMNuBiH 2018” and “SWEP 2018” is “Ethical Dilemmas in Science Editing and Publishing”. Why? If one wants to create a scientific work, must have on his mind that creating a scientific work requires creativity and openness, honesty, trust, and obeying the ethical principles for writing a scientific paper. While working on a an biomedical research involving human subjects medical workers should have on mind that it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
Introduction: The effect of statins on risk of heart failure (HF) hospitalization and lethal outcome remains dubious. Aim: To investigate whether statin therapy improves clinical outcomes in patients hospitalized for ischemic heart failure (HF), to compare the efficacy of lipophilic and hydrophilic statins and to investigate which statin subtype provides better survival and other outcome benefits. Material and Methods: Total amount of 155 patients in the study were admitted to the Clinic for Cardiology, Rheumatology and Vascular diseases in Clinical Center University of Sarajevo in the period from January 2014- December 2017. Inclusion criteria was HF caused by ischemic coronary artery disease upon admission. For each patient the following data were obtained: gender, age, comorbidities and medications on discharge. New York Heart Association (NYHA) class for heart failure was determined by physician evaluation and left ventricle ejection fraction (LVEF) was determined by echocardiography. The patients were followed for a period of two years. Outcome points were: rehospitalization, in-hospital death, mortality after 6 months, 1 year and 2 years. All-cause mortality included cardiovascular events or worsening heart failure. Results: Overall, 58.9% of HF patients received statin therapy, with 33.9% patients receiving atorvastatin and 25.0% rosuvastatin therapy. The most frequent rehospitalization was in patients without statin therapy (66.7%), followed by patients on rosuvastatin (64.1%), and atorvastatin (13.2%), with statistically significant difference p = 0.001 between the groups. Mortality after 6 months, 1 year and 2 years was the most frequent in patients without statin therapy with a statistically significant difference (p = 0.001). Progression of HF accounted for 31.7% of mortality in patients without statin therapy, 12.8% in patients on rosuvastatin therapy and 3.8% in patients on atorvastatin therapy (p = 0.004). Conclusion: Lipophilic statin therapy is associated with substantially better long-term outcomes in patients with HF.
Objective: To investigate the efficiency and safety of the fixed combination of perindopril/amlodipin in a treatment if grade I and grade II arterial hypertension and arterial stiffness values after only two weeks of treatment. Design and method: The open clinical prospective controlled study was designed. The study was designed for two weeks and two group were formed. The first group was comprised of arterial hypertension grade I patients and group 2 of arterial hypertension grade 2. The cardiovascular risk profile was notified for all patients. The peripheral and central blood pressure, pulse wave velocity, stroke volume, augmentation index, pulse pressure, heart rate, the reflection index were analyzed before and two weeks after treatment. For the grade I arterial hypertension the fixed combination of perindopril/amlodipin was used in a dose of 5 mg/5 mg, and for grade 2 arterial hypertension dosage was 10 mg/10 mg. Therapy was given as a single tablet advised to be taken in the evening. The average grade I hypertension values were 158/92mmHg, and for grade II the average value was 162/102mmHg. The average vascular age for grade I arterial hypertension was 4,5 years, and for grade II arterial hypertension the average vascular age was 8,5years. Results: Results obtained from this short study showed significant lowering of blood pressure and the improvement of arterial stiffness values and in the vascular age was detected as well in both group. The average values of arterial hypertension felt within normal range after treatment in a both groups after two weeks of therapy. Patient compliance and satisfaction was notified. There were no side effects. Conclusions: The fixed combination of perindopril/amlodipin in a dose of 5 mg/5 mg for grade I arterial hypertension and 10 mg/10 mg for grade II arterial hypertension was proven to be effective in all patients. No adverse events were observed. The compliance of patients was excellent and evening dose is more preferable than morning regime. The arterial stiffness values are not constant and permanent. They are rather flexible and arterial hypertension values major dependent. The lower arterial hypertension, the lower arterial stiffness and vasc ular age.
Objective: The aim of this study was to evaluate corelation of serum level of NGAL to severity of hypertension and diastolic disfunction in patients with ST- segment elevation myocardial infarction treated with fibrinolytic therapy. Design and method: We included 54 consecutive ST-segment elevation myocardial infarction patients treated with fibrinolytic therapy (alteplase). The median follow-up time was 6 days (interquartile range, 5 to 7 days). Blood samples were drawn immediately after admission prior to fibrinolytic administration. The endpoints were mean systolic and diastolic pressure (continuously monitored) and mean E/A ratio as a measure of diastolic function. Results: Patients with high NGAL (above 134,05 &mgr;g/l; 75th percentile) had significantly higher mean systolic and mean diastolic blood pressure compared to patients with low NGAL (under 134,05 &mgr;g/l; 75th percentile), p = 0,001 and p = 0,003; respectively. Patients with high NGAL (above 134,05 &mgr;g/l; 75th percentile) had significantly lower E/A ratio compared to patients with low NGAL (under 134,05 &mgr;g/l; 75th percentile), p = 0,004. Conclusions: High NGAL significantly corelates with severity of hypertension and diastolic dysfunction in patients with acute STEMI.
Background: Rheumatoid arthritis (RA) is a debilitating chronic disease with an unmet need for additional therapeutic approaches. Activating neuro-immune reflex pathways by stimulation of the vagus nerve (VNS) could represent a novel means of treating RA [1] and other immune-mediated inflammatory diseases. Last year we reported a 12-week proof-of-concept study using a VNS device, approved for drug-resistant epilepsy, showing reduction in the DAS28-CRP clinical disease activity score, with concomitant reductions in TNF and IL-6 levels [2]. Objectives: To understand the long term safety and efficacy of this novel treatment approach, we followed the patients in a 24 months long-term extension study and report on the safety and clinical efficacy data. Methods: VNS devices were implanted into 17 RA patients, mostly with insufficient response to multiple conventional and biologic disease-modifying antirheumatic drugs (DMARDs), on stable background of methotrexate (≤25 mg weekly) therapy. The devices electrically stimulated the vagus nerve, 1–4 min/day, over a 12 week open label period. On completion, subjects were offered to enroll into a follow-up study, where the study physicians were given flexibility to alter VNS dosing parameters and/or to add a biologic DMARD to the treatment regimen. DAS28-CRP and Health Assessment Questionnaire-Disability Index (HAQ-DI) were collected over 2 years. Results: All subjects electively continued on VNS treatment through 24 months of the long term follow-up study. Biologic DMARDs were started in 1 and restarted in 8 of 17 subjects; of these, 4 were non-responders to VNS, and 5 had stable improvement but had not yet achieved disease remission on VNS alone (table 1). At the start of the follow-up study, the mean DAS28–28 and HAQ-DI were significantly reduced compared to the pre-implant baseline (mean difference±SE in DAS28-CRP=-1.60±0.37, p<0.0001; mean difference±SE in HAQ-DI = -0.44±0.21, p<0.037), and the depth of effect was retained through 24 months. At 24 months, there was no significant difference in DAS28-CRP between the subjects using VNS monotherapy or those using a combination of VNS and biologic DMARDs (VNS monotherapy= 3.76±1.77 vs. VNS and biologic DMARD= 3.21±1.44, p<0.54). No difference in the adverse events profile between the two groups was seen.Table 1 Two Year Efficacy of VNS Treatment. Mean DAS28-CRP at primary study baseline (month -3-5) and at visits over 2 years of long term follow up (months 0-24). Conclusions: The data presented here demonstrate that VNS in subjects with RA is associated with a substantial reduction in disease activity that is sustained for 24 months without untoward safety signals. In addition, the data suggest that biological DMARDs can be initiated safely in combination with VNS treatment, though this requires further study in larger cohorts. These results support further development of VNS devices as an alternative therapeutic approach for RA treatment, which potentially can safely be combined with biologic DMARDs. References [1]Van Maanen M, et al. The cholinergic anti-inflammatory pathway: towards innovative treatment of rheumatoid arthritis. Nat Rev Rheumatol2009;5:229–32. [2]Koopman FA, et al. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci USA2016;113(29):8284–9. Disclosure of Interest: F. Koopman: None declared, A. Musters: None declared, M. Backer: None declared, D. Gerlag Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, which has an interest in SetPoint, S. Miljko: None declared, S. Grazio: None declared, S. Sokolovic: None declared, Y. Levine Shareholder of: SetPoint Medical, Employee of: SetPoint Medical, D. Chernoff Shareholder of: SetPoint Medical, Adamas Pharmaceuticals, OLLY Nutrition, NAIA Pharma, Aquinox Pharma, Consultant for: Adamas Pharmaceuticals, OLLY Nutrition, NAIA Pharma, Aquinox Pharma, Crescendo BioScience, Employee of: SetPoint Medical, N. de Vries Grant/research support from: Abbvie, Janssen Biologics BV, Ergomed Clinical Research, GlaxoSmithKline, Pfizer, Boehringer Ingelheim, Roche, Consultant for: MSD, Pfizer, P.-P. Tak Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, which has an interest in SetPoint
Objective: The aim of this study was to evaluate corelation of serum level of NGAL to severity of hypertension and diastolic disfunction in patients with ST- segment elevation myocardial infarction treated with fibrinolytic therapy. Design and method: We included 54 consecutive ST-segment elevation myocardial infarction patients treated with fibrinolytic therapy (alteplase). The median follow-up time was 6 days (interquartile range, 5 to 7 days). Blood samples were drawn immediately after admission prior to fibrinolytic administration. The endpoints were mean systolic and diastolic pressure (continuously monitored) and mean E/A ratio as a measure of diastolic function. Results: Patients with high NGAL (above 134,05 &mgr;g/l; 75th percentile) had significantly higher mean systolic and mean diastolic blood pressure compared to patients with low NGAL (under 134,05 &mgr;g/l; 75th percentile), p = 0,001 and p = 0,003; respectively. Patients with high NGAL (above 134,05 &mgr;g/l; 75th percentile) had significantly lower E/A ratio compared to patients with low NGAL (under 134,05 &mgr;g/l; 75th percentile), p = 0,004. Conclusions: High NGAL significantly corelates with severity of hypertension and diastolic dysfunction in patients with acute STEMI.
SB5 is a biosimilar agent for adalimumab (ADA). The aim of this study was to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 in comparison with reference ADA in patients with rheumatoid arthritis (RA).
IntroductionData on management of atrial fibrillation (AF) in the Balkan Region are scarce. To capture the patterns in AF management in contemporary clinical practice in the Balkan countries a prospective survey was conducted between December 2014 and February 2015, and we report results pertinent to the use of non-vitamin K antagonist oral anticoagulants (NOACs).MethodsA 14-week prospective, multicenter survey of consecutive AF patients seen by cardiologists or internal medicine specialists was conducted in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Montenegro, Romania, and Serbia (a total of about 50 million inhabitants).ResultsOf 2712 enrolled patients, 2663 (98.2%) had complete data relevant to oral anticoagulant (OAC) use (mean age 69.1 ± 10.9 years, female 44.6%). Overall, OAC was used in 1960 patients (73.6%) of whom 338 (17.2%) received NOACs. Malignancy [odds ratio (OR), 95% confidence interval (CI) 2.06, 1.20–3.56], rhythm control (OR 1.64, 1.25–2.16), and treatment by cardiologists were independent predictors of NOAC use (OR 2.32, 1.51–3.54) [all p < 0.01)], whilst heart failure and valvular disease were negatively associated with NOAC use (both p < 0.01). Individual stroke and bleeding risk were not significantly associated with NOAC use on multivariate analysis.ConclusionsNOACs are increasingly used in AF patients in the Balkan Region, but NOAC use is predominantly guided by factors other than evidence-based decision-making (e.g., drug availability on the market or reimbursement policy). Efforts are needed to establish an evidence-based approach to OAC selection and to facilitate the optimal use of OAC, thus improving the outcomes in AF patients in this large region.
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