Tag Archives: clinical trials

What’s new in transplantation Are kidney donors worse off? The meeting was opened by Dr Anna Price (Queen Elizabeth University Hospital, Birmingham) who addressed the long-term cardiovascular effects of unilateral nephrectomy in living kidney donors.1 Previous studies have shown a significant prevalence of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD),2,3 but the effects of reduced renal function in living kidney donors has been unexplored until now. A recent study by Price et al. demonstrated that living kidney donors had a reduction in estimated glomerular filtration rate (eGFR) from 95 to 67 ml/min

Introduction To date, five pharmacological approaches have been demonstrated to significantly reduce the risk of mortality and prevent hospitalisation for worsening heart failure (HF) in patients with HF with reduced ejection fraction (HFrEF): the combination of a neprilysin inhibitor and an angiotensin-receptor blocker (i.e. sacubitril/valsartan), a beta blocker, a mineralocorticoid-receptor antagonist (MRA) and a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Hereafter, these five agents, which can be prescribed as four pills, will be referred to as the ‘four foundational therapies for HFrEF’.1-11 The combination of these four ther

Introduction Coronary heart disease (CHD) remains the major cause of death throughout European and other developed countries. While death rates have been consistently falling, rates in the UK remain relatively high compared to some Western European countries. The commonest clinical presentation of CHD is angina pectoris. Angina incidence rates generally increase with age and are highest in the 65−74 years age group in both men and women. The prevalence of angina is estimated to be 5% in men and 4% in women in the UK, giving a total of nearly 2.1 million (>1.2 million <75 years of age) with the condition.1 It is therefore a common dise

Quality standards and legislation To ensure the overall quality of clinical trials of medicinal products the pharmaceutical industry spearheaded, in January 1997, the use of a set of quality standards known as Good Clinical Practice (GCP).2 In 2001, the European Union (EU) used this approach as the basis for a new draft Directive on Clinical Trials, which would extend the coverage of GCP to include all clinical trials of investigational medicinal products in humans, irrespective of their funding and support.3 For the first time there would be a legal framework for the conduct of clinical trials across Europe and in the UK in accordance with