Supporting Active Pharmacovigilance via IT Tools in the Clinical Setting and Beyond: Regulatory and Management Aspects.

Information Technology (IT) could have a prominent role towards the "Active Pharmacovigilance" (AP) paradigm by facilitating the analysis of potential Adverse Drug Reactions (ADRs). PVClinical project aims to build an IT platform enabling the investigation of potential ADRs in the clinical environment and beyond. In this paper, we outline the respective EU regulatory framework and the related Business Processes (BPs), elaborated based on input from clinicians and PV experts as part of the project's "user requirements analysis" phase, highlighting their potential pivotal role in the design of IT tools aiming to support AP.

Start low, go slow, but look far: the case of geriatric medicine in Balkan countries.

Purpose: To present an insight of the situation of geriatric medicine in Balkan countries, as it was presented in the context of the 2nd pre-congress seminar of the 16th European Geriatric Medicine Society (EuGMS) Congress Athens 2021.

Methods: Representatives from 8 Balkan countries (Albania, Croatia, Greece, Republic of North Macedonia, Romania, Serbia, Slovenia, Turkey) answered 3 questions to reflect the state of geriatric medicine in their country: education on geriatrics; systems/methods for assessment of functional status and frailty; pre-operative risk assessment. An open discussion followed.

Association between cardiotrophin 1 levels and central blood pressure in untreated patients with essential hypertension.

Background: Cardiotrophin 1 (CT-1) is an interleukin 6-related cytokine recently implicated in cardiac hypertrophy and vascular damage in essential hypertension (EH). We aimed first to determine CT-1 levels in naive, untreated patients with grade I EH (UH) as compared with normotensive (NT) individuals and, second, to investigate a possible association of CT-1 levels with indices of arterial stiffness.

Methods: We enrolled 45 consecutive untreated patients recently diagnosed with grade I EH by means of office and ambulatory blood pressure (BP) measurements and 25 age- and sex-matched NT subjects.

Comparison of the diagnostic accuracy of ischemia-modified albumin and echocardiography in patients with acute chest pain.

Background: Several imaging tests and biomarkers have been proposed for the identification of patients with unstable angina among those presenting to the emergency department with acute chest pain. Preliminary data suggest that ischemia-modified albumin (IMA) may represent a potentially useful biomarker in these patients.

Objective: To compare IMA and echocardiography in excluding unstable angina in patients with acute chest pain.

Divergent retinal vascular abnormalities in normotensive persons and patients with never-treated, masked, white coat hypertension.

Background: Hypertensive patients with retinal arteriolar abnormalities are at increased risk for cardiovascular events. However, the extent of retinal microvascular changes in naïve, never-treated patients with hypertension of short duration has not been established. In addition to this, the lack of relevant data about other phenotypes of hypertension (masked and white-coat hypertension) determined by ambulatory blood-pressure measurement (ABPM) is notable, despite their relationship to increased cardiovascular risk mediated by underlying target-organ and vascular damage.

Leiomyosarcoma of renal vein, initially resembling pheochromocytoma.

We report the case of a 43-year-old woman who presented with mild left-sided abdominal pain. Computed tomography and MRI findings revealed a 10.7 × 8.

Surgical management of primary aldosteronism. not everything that shines is gold.

Background: Primary aldosteronism (PA) is a syndrome which includes a group of clinical entities in which aldosterone production is inappropriately high and nonsupressible by sodium loading. The most frequent causes of PA are adrenal adenoma and unilateral or bilateral primary hyperplasia.

Methods: We report a case of a 55-year-old man with a 10-year history of hypertension in whom functional hormonal studies were indicative of PA.

Carotid baroreceptor stimulation for the treatment of resistant hypertension.

Interventional activation of the carotid baroreflex has been an appealing idea for the management of resistant hypertension for several decades, yet its clinical application remained elusive and a goal for the future. It is only recently that the profound understanding of the complex anatomy and pathophysiology of the circuit, combined with the accumulation of relevant experimental and clinical data both in animals and in humans, has allowed the development of a more effective and well-promising approach. Indeed, current data support a sustained over a transient reduction of blood pressure through the resetting of baroreceptors, and technical deficits have been minimized with a subsequent recession of adverse events.

Double probe pH-monitoring findings in patients with benign lesions of the true vocal folds: comparison with typical GERD and the effect of smoking.

We conducted a pH-monitoring study to determine the prevalence of pathologic gastroesophageal reflux (GER+) and laryngopharyngeal reflux (LPR+) in patients with resected benign true vocal fold lesions (TVFLs) and positive reflux finding score (RFS). We compared our findings with those of patients with typical GER disease (GERD) symptoms and normal laryngoscopy. In the group of patients with TVFLs, we compared the pH-monitoring findings of smokers with those of non-smokers.

Benefits from treatment and control of patients with resistant hypertension.

Resistant hypertension is commonly found in everyday clinical practice. However, the risks of resistant hypertension, as well as the benefits of treatment and control of blood pressure in patients with resistant hypertension remain vaguely clarified. Data from small clinical studies and observational cohorts suggest that patients with resistant hypertension are at increased cardiovascular risk, while control of blood pressure offers substantial benefits.

Prevalence, awareness, treatment and control of hypertension in an elderly population in Greece.

Introduction: Hypertension is a major public health problem and its prevalence increases with age. Despite an aging population, only a limited number of population-based studies, and fewer Greek studies, have focused exclusively on the elderly. The objective of this study was to investigate the prevalence, awareness, treatment and control of hypertension in the rural residents of Paliouri village in Greece who were aged 65 years and older.

Platelet activation in essential hypertension: implications for antiplatelet treatment.

Essential hypertension is associated with increased risk of arterial thrombotic disease. Among other factors, enhanced platelet activity contributes significantly to this phenomenon. An increased level of circulating monocyte-platelet aggregates (MPAs) represents one of the most robust markers of platelet activation; furthermore, these aggregates are also believed to contribute to the pathophysiology of atherothrombotic disease.

Nitric oxide dysfunction in vascular endothelium and platelets: role in essential hypertension.

Both endothelial and platelet-derived nitric oxide have important vasculoprotective properties. Increasing evidence suggests a dysfunctional platelet nitric oxide synthase type 3 (NOS3) pathway in essential hypertension, whereas for endothelial-derived nitric oxide the picture is more complicated, with many studies suggesting an impairment of endothelial nitric oxide generation, whilst others have suggested that the endothelial nitric oxide pathway is preserved. Controversy also exists as to whether any observed reduction in endothelial or platelet-derived nitric oxide exerts a pathogenetic role or is simply the result of the raised blood pressure.

Decreased platelet nitric oxide contributes to increased circulating monocyte-platelet aggregates in hypertension.

Aims: The aim of this study was to determine the effect of blood pressure (BP) on platelet nitric oxide (NO) signalling and on formation of circulating monocyte-platelet aggregates (MPA), as well as the role of platelet NO in modulating MPA in hypertension.

Methods And Results: We first examined platelet NO signalling in 23 untreated hypertensive (UH) and 23 normotensive (NT) subjects. Platelets from hypertensives exhibited reduced NO synthase activation by albuterol or collagen, as well as suppressed basal and stimulated NO-attributable cyclic guanosine-3',5'-monophosphate, compared with NT.

Molecular basis of statin-associated myopathy.

Coronary artery disease (CAD) constitutes the most common cause of morbidity and mortality in developed countries. Statins effectively reduce low-density lipoprotein cholesterol, an important risk factor for CAD and related acute coronary syndromes. They are an extensively studied group of drugs with versatile properties.

Prevalence of primary hyperaldosteronism in resistant hypertension: a retrospective observational study.

Background: Results of several studies published since 1999 suggest that primary hyperaldosteronism (also known as Conn's syndrome) affects more than 10% of people with hypertension; however, such a high prevalence has also been disputed. Experts generally agree that resistant hypertension has the highest prevalence of primary hyperaldosteronism, on the basis of small studies. We aimed to assess the prevalence of primary hyperaldosteronism in a large group of patients with resistant hypertension.

The interaction of vasoactive substances during exercise modulates platelet aggregation in hypertension and coronary artery disease.

Background: Acute vigorous exercise, associated with increased release of plasma catecholamines, transiently increases the risk of primary cardiac arrest. We tested the effect of acute submaximal exercise on vasoactive substances and their combined result on platelet function.

Methods: Healthy volunteers, hypertensive patients and patients with coronary artery disease (CAD) performed a modified treadmill exercise test.

Pheochromocytoma presenting as diabetic ketoacidosis.

Pheochromocytoma is a rare form of secondary hypertension and may be potentially lethal if left untreated. The classical symptoms are paroxysmal hypertension, headaches, palpitations and sweating. They are caused by sudden catecholamine release.

In vivo comparative study of linear versus geometrically correct three-dimensional reconstruction of coronary arteries.

Although conventional linear 3-dimensional (3D) reconstruction of coronary arteries by intravascular ultrasound has been widely used for the assessment of plaque volume and progression; the volumetric error (VE) that is produced has not been adequately studied. Linear and geometrically correct 3D reconstruction was applied in 16 coronary arterial segments from 9 patients. Using geometrically correct reconstruction as reference, VE was assessed in 1-mm-long arterial slices.

Elevated heart rate and atherosclerosis: an overview of the pathogenetic mechanisms.

Several epidemiological studies have reported that an elevated heart rate is associated with coronary atherosclerosis independently of other risk factors. In this review we explore the pathophysiologic mechanisms involved in the pro-atherosclerotic effect of elevated heart rate, apart from its association with sympathetic tone. An elevated heart rate enhances the magnitude and frequency of the tensile stress imposed on the arterial wall and prolongs the exposure of coronary endothelium to the systolic low and oscillatory shear stress.

Effect of pioglitazone on heart function and N-terminal pro-brain natriuretic peptide levels of patients with type 2 diabetes.

We assessed the effect of the addition of pioglitazone on metabolic control and heart function of patients with type 2 diabetes already receiving sulfonylurea plus metformin. Forty-four patients were given 30 mg of pioglitazone for 3 months. Physical examination, laboratory tests including N-terminal pro-brain natriuretic peptide (NT-proBNP), and echocardiography, were performed at baseline and at study completion.

Hypertension associated with rhabdomyolysis.

Primary aldosteronism accompanied by hypokalemia is a cause of secondary hypertension. Diagnosis of primary aldosteronism has increased dramatically in recent years with the wider availability of aldosterone and plasma renin activity measurements. The authors present the case of a patient with resistant hypertension and severe hypokalemia that evaded diagnosis until complications from hypokalemia occurred.

Vascular endothelial growth factor and nitric oxide serum levels in arterial hypertension.

Vascular endothelial growth factor (VEGF) is a specific mitogen for endothelial cells and an inducer of the angiogenic procedure. Endothelial nitric oxide (NO) is a potent vasodilator. Because both are implicated in vascular function, it is possible that they would be significantly affected in arterial hypertension.