News in brief from the world of cardiology
BHF to spend half a billion pounds on research
A new research strategy has been launched by the British Heart Foundation (BHF), aiming to fund over half a billion pounds of new cardiovascular research over the next five years.
The BHF’s new strategy includes a commitment to continue funding the best researchers working across all areas of cardiovascular disease research. This includes a pledge by the BHF to help women stay in research after a review highlighted the underrepresentation of women in senior cardiovascular research roles. Also, for the first time, the BHF will fund healthcare professionals, such as nurses, by establishing a dedicated grant scheme. This research is aimed at improving the quality of care for people with cardiovascular disease.
Valsartan/sacubitril receives EC authorisation
The European Commission (EC) has granted marketing authorisation to valsartan/sacubitril (Entresto™, Novartis) for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).
The decision, which follows previous approvals in the USA and Switzerland, is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown valsartan/sacubitril significantly reduced the risk of cardiovascular death versus enalapril.
At the end of the study patients who were given valsartan/sacubitril were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril. Analysis of safety data showed that the combination drug had a similar tolerability profile to enalapril.
Novartis is hoping valsartan/sacubitril will be available in the UK before the end of 2015. Patients who are currently receiving the drug under the Early Access to Medicines Scheme will be able to continue to do so until the Health Technology Assessment completes its appraisal of the medicine, anticipated in 2016.
Alirocumab available for hypercholesterolaemia
Alirocumab (Praluent®, Sanofi) is now available for certain adult patients with hypercholesterolaemia in the UK, following its authorisation by the European Commission (EC).
The drug is authorised for use in patients who are unable to reach their low-density lipoprotein (LDL) cholesterol treatment goals, despite modifying their diet and taking a maximum tolerated dose of a statin and/or other lipid-lowering therapies. These patients include those with: high levels of LDL cholesterol; heterozygous familial hypercholesterolaemia (HeFH); and patients who are statin intolerant, or contraindicated.
The UK Chief Investigator of three clinical studies involving alirocumab, Dr Adie Viljoen (Lister Hospital, Hertfordshire), said: “Alirocumab will provide high-risk patients with HeFH and those with high cardiovascular risk who have not responded adequately to optimal lipid-lowering intervention including lifestyle modification and treatment with high intensity statins, a new option to reduce their cholesterol levels with the aim of reducing their risk of heart attack and stroke”.
New NICE quality standard targets MI and stroke risk
The latest quality standard published by the National Institute for Health and Care Excellence (NICE) aims to prevent thousands of people from becoming ill and dying prematurely from myocardial infarction (MI), strokes and peripheral arterial disease. The quality standard covers identifying and assessing cardiovascular risk in adults, and, where it’s necessary, using statins to reduce levels of harmful cholesterol in order to prevent cardiovascular disease (CVD).
The quality standard includes nine statements aimed at healthcare professionals caring for people in danger of developing CVD, or who already have CVD. These include:
- Adults under 85 who have been identified with an estimated increased risk of CVD are offered a full formal risk assessment using the QRISK2 tool
- Adults with a 10-year risk of CVD exceeding 10%: receive advice on lifestyle changes before any offer of drug intervention; and are assessed for secondary causes of hyperlipidaemia before any offer of statin therapy
- Adults with a 10-year risk of CVD exceeding 10% for whom lifestyle changes are ineffective or inappropriate have a discussion on the risks and benefits of starting statin therapy.
Professor Gillian Leng (Deputy Chief Executive and Director of Health and Social Care at NICE) said: “Like the NICE clinical guideline on which this quality standard is based, we’re not saying that everyone who is assessed as having a 10% or greater risk of developing CVD within 10 years should be given a statin. Before that happens there are many things that people can do to reduce their risk, and the standard is clear that making changes to lifestyle is the first consideration”.
New UK guidelines on resuscitation
A new set of guidelines has been released by the Resuscitation Council (UK). This year’s guidance contains no significant changes to core interventions or processes, instead emphasising the importance of implementation and quality assurance to try and improve patient outcomes.
Out of hospital, there should be increased public involvement in the recognition of cardiac arrest, in calling the emergency services, in starting cardiopulmonary resuscitation (CPR), and in locating and using an automated external defibrillator (AED) as quickly as possible, say the guidelines. Healthcare professionals are encouraged to help with this by offering and supporting training initiatives wherever appropriate, particularly to schoolchildren.
The new guidelines also: identify key areas for improvement regarding survival after an in-hospital cardiac arrest, examine new evidence showing the value of waveform capnography in clinical assessment, and outline the importance of decisions surrounding end-of-life care and whether or not to attempt CPR.
New tropinin I test may rule out MI faster
A recent large study conducted by researchers at the University of Edinburgh shows a new high-sensitive troponin-I (hsTnI) test may help rule out myocardial infarction (MI) faster to help earlier discharge in two thirds of patients presenting with chest pain at A&E (Accident and Emergency).
Currently troponin blood testing is done at A&E admission, and then again within 12 hours, to evaluate whether or not patients are having MIs.
The prospective observational cohort study of over 6,000 patients published in the Lancet (doi: 10.1016/SO140-6736(15)00449-3), using Abbott’s Architect stat high sensitive troponin-I (hsTnl) suggests that by using a newly identified and precise single troponin testing level (<5 ng/L), doctors have the potential to double the number of patients who are discharged directly from A&E, which could reduce waiting times, and avoid repeat testing and hospital admission.
In an editorial comment on the British Heart Foundation funded study, Dr Louise Cullen from the Department of Emergency Medicine, Royal Brisbane and Women’s Hospital, New Zealand and colleagues, describe the study as “a huge advance in the assessment of patients with possible acute coronary syndrome in emergency departments”.
Clopidogrel does not reduce mortality or increase cancer
A report from the US Food and Drug Administration (FDA) has determined that long-term use of the antiplatelet drug clopidogrel does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the DAPT (Dual Antiplatelet Therapy) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.
The FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (six months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.
The FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis.
The recommendation is that patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of thrombus and heart attacks. They suggest that patients talk to their health care professional if they have any questions or concerns about clopidogrel. Health care professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment, the FDA recommends.
News from the EASD
Pesticides linked to risk of diabetes
Exposure to pesticides is associated with an increased risk of developing diabetes with different types of pesticides showing varying levels of risk, according to a study presented at this year’s annual meeting the European Association for the Study of Diabetes (EASD), Stockholm, Sweden.
Researchers from the University of Ioannina, Greece, and Imperial College London, analysed 21 studies on the association between pesticides and diabetes, covering 66,714 individuals (5,066 cases/ 61,648 controls). In almost all of the studies analysed, pesticide exposure was determined by blood or urine biomarker analysis.
The study found that exposure to any type of pesticide was associated with increased risk of any type of diabetes by 61%. In the 12 studies analysing only type 2 diabetes, the increased risk was 64% for those exposed to pesticides. For individual pesticides, increased risk was identified in association with exposure to chlordane, oxylchlordane, trans-nonachlor, DDT, DDE dieldrin, heptachlor and HCB.
Women with diabetes have higher risk of heart attack than men
Women with diabetes are more at risk than men of suffering from myocardial infarction and other complications as they age, according to new research presented at the meeting.
The study, carried out in the Regional Health Agency, Florence, Italy, was retrospective along a period of eight years (2005−2012) on a cohort of patients with diabetes living in Tuscany, Italy. It compared between genders the effect of age on diabetes-related excess risk of hospitalisation for acute myocardial infarction (AMI), ischaemic stroke (IS), and congestive heart failure (CHF).
The authors conclude: “In this cohort of Tuscan population, the excess risk of cardiovascular events linked with diabetes is significantly different between genders. With respect to AMI, [women with diabetes] are more disadvantaged, compared to [men with diabetes], with a gender driven ‘risk window’ for women which mostly opens around menopausal age (45 years onwards). Regarding IS and CHF, it opens later, in the postmenopausal age (55 years and over), and to a lesser extent. All this should focus attention on a timely, gender oriented, prevention of cardiovascular events in people with diabetes.”
…and are around 40% more likely to suffer ACS
Women with diabetes are around 40% more likely to suffer acute coronary syndromes (ACS) than men with diabetes, according to a meta-analysis of 19 studies containing almost 11 million patients, presented at the meeting.
The authors from Nanjing, China, examined case-control and cohort studies published between 1966 and 2014, with data for 10,856,279 individuals and at least 106,703 fatal and non-fatal ACS events. In patients with diabetes, women had a 38% increased risk of ACS.
The authors say: “Women with diabetes have a roughly 40% greater excess risk of ACS, compared with men with diabetes…We should avoid sexual prejudice in cardiovascular disease, take all necessary steps to diagnose it early, and control risk factors comprehensively to guarantee the most suitable treatments and best possible outcomes in female patients.”
