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(1) Women smokers four times more likely to have an abdominal aortic aneurysm (2) Background information on sudden cardiac death in young athletes (3) Aspirin does not prevent heart attacks in patients with diabetes (4) Unnecessary regulation harming clinical research in the UK, say experts
(1) Women smokers four times more likely to have an abdominal aortic aneurysm (Abdominal aortic aneurysm in the women's health initiative: cohort study) http://www.bmj.com/cgi/content/abstract/337/oct14_2/a1724 (Editorial: Abdominal aortic aneurysm events in postmenopausal women) http://www.bmj.com/cgi/content/extract/337/oct14_2/a1894
Women who smoke are four times more likely to have an abdominal aortic aneurysm repair or rupture as women who have quit smoking, and are eight times more likely than women who have never smoked, finds a study published on bmj.com today.
Abdominal aortic aneurysms (a ballooning of the artery wall) are more common in men, but are more deadly in women - aneurysms rupture at smaller diameters in women, the rate of intervention is lower, and the number of deaths after intervention may be higher. Aortic aneurysms cause around 15 000 deaths a year in the US, and 40% of these deaths are in women.
To date, most studies of abdominal aortic aneurysm have focused on men and have included too few women to generate reliable information on the risk factors in women. A better understanding of the factors associated with aortic aneurysm may improve diagnosis and outcomes for women.
Professor Frank Lederle and colleagues assessed the potential risk factors for the rupture and repair of abdominal aortic aneurysms in 161,808 postmenopausal women at 40 clinical centres in the US, and followed for an average of 7.8 years, who were part of the Women’s Health Initiative. It is one of the first studies to look at the effect of hormone replacement therapy (HRT) on the development of abdominal aortic aneurysms in women.
There were 184 reported abdominal aneurysm events (repairs or ruptures) during the study and these were strongly linked to age and smoking. The authors report that women who had ever smoked, currently smoked and the amount smoked, all contributed to the likelihood of having an abdominal aortic aneurysm.
Interestingly, the researchers found that HRT provided protection from abdominal aortic aneurysm events despite previous smaller studies reporting that oestrogen therapy alone may increase the risk. They also found that women with diabetes were at reduced risk of aneurysm events - a similar association has also been previously reported in men. Increasing height, hypertension, high cholesterol, and coronary and peripheral artery disease were also associated with an increased risk of aneurysm events.
The authors conclude by calling for further research to clarify the effect of HRT on aortic aneurysm.
In an accompanying editorial, Professor Janet Powell from Imperial College London and Professor Paul Norman from the University of Western Australia, say that these findings emphasise the need for educating women about quitting smoking to remain a public health priority.
They warn that if the incidence of abdominal aortic aneurysm in women continues to rise, then a population screening programme for women who have smoked or continue to smoke may need to be implemented.
Contacts: Frank Lederle, VA Medical Center, Minneapolis, USA Email: frank.lederle@va.gov Janet Powell, Vascular Surgery Research Group, Imperial College, London, UK Email: j.powell@imperial.ac.uk
(2) Background information on sudden cardiac death in young athletes (Preparticipation screening for cardiovascular abnormalities in young competitive athletes)http://www.bmj.com/cgi/content/short/337/sep29_1/a1596 (Cardiovascular evaluation, including resting and exercise electrocardiography, before participation in competitive sports: cross sectional study)http://www.bmj.com/cgi/content/full/337/jul03_2/a346
The sudden death of Wakefield Wildcats rugby player Adam Watene at the age of only 31, after a training session, has highlighted the rare but shocking occurence of sports-related deaths.
We don't know the cause of Adam's death, but press reports say his father died recently of a heart attack, and heart problems are one of the commonest causes of sudden death during sport. For evidence based information on this topic, see these recent BMJ articles on cardiovascular screening before competitive sports - a clinical review and a cross sectional study.
(3) Aspirin does not prevent heart attacks in patients with diabetes (The prevention of progression of arterial disease and diabetes (POPADAD): a factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease) http://www.bmj.com/cgi/content/abstract/337/oct16_2/a1840 (Editorial: Aspirin for prevention of cardiovascular events) http://www.bmj.com/cgi/content/extract/337/oct16_2/a1806
Taking regular aspirin and antioxidant supplements does not prevent heart attacks even in high risk groups with diabetes and asymptomatic arterial disease, and aspirin should only be given to patients with established heart disease, stroke or limb arterial disease, according to a study published today on bmj.com.
In light of these findings, and the evidence from six other well controlled trials, the prescribing practice of doctors and international guidelines should be reviewed so that aspirin is only prescribed to patients with established heart and stroke disease, argues the author of an accompanying editorial.
Patients with diabetes are two to five times more likely to suffer from heart disease than the general population and heart disease is a major cause of death in patients with type 1 and 2 diabetes. Although there is considerable evidence showing no protective benefit of aspirin in high risk patients without heart disease, guidelines are inconsistent and aspirin is commonly prescribed for the primary prevention of heart disease in patients with diabetes and with peripheral arterial disease.
But aspirin is one of the top 10 causes of adverse drug events reported to the Commission on Human Medicines. It causes gastrointestinal bleeding and the risk of bleeding increases with age and prolonged use.
Professor Jill Belch and colleagues from Scotland investigated whether aspirin and antioxidants given together or separately can reduce heart attacks and death in patients with diabetes and arterial disease. 1276 patients with diabetes and evidence of artery disease over 40 years of age were randomised to receive either aspirin or placebo, an antioxidant or placebo, aspirin and antioxidant or double placebo, and followed over eight years.
Overall, the researchers found no benefit from either aspirin or antioxidant treatment in the prevention of heart attacks or death. Patients in the aspirin groups had 116 primary events compared with 117 in the placebo group. No significant difference in events was seen between the antioxidant group and the placebo group.
The authors conclude by voicing their concern at the widespread prescribing of aspirin despite the lack of evidence to support its use in the primary prevention of heart attacks and death in people with diabetes and in view of its possible side effects.
These findings show that unlike statins and drugs for reducing hypertension, which have a benefit in all risk groups including those with and without heart disease, only patients with a history of clinical or symptomatic heart disease or stroke disease benefit from taking aspirin, writes Professor William Hiatt in an accompanying editorial.
Contacts: Jill Belch, Institute of Cardiovascular Research, University of Dundee, Dundee, Scotland Email: j.j.f.belch@dundee.ac.uk William R Hiatt, University of Colorado Denver School of Medicine, USA Email: Will.Hiatt@UCHSC.edu
(4) Unnecessary regulation harming clinical research in the UK, say experts (Personal View: Regulation—the real threat to clinical research) http://www.bmj.com/cgi/content/extract/337/oct16_2/a1732
Increasing bureaucracy is the biggest single threat to clinical research in the UK and urgent action needs to be taken, argue experts on bmj.com today.
European legislation introduced in 2001 was intended to simplify and harmonise the regulation of trials across the European Union. But it has led to long delays in approval, is "poorly coordinated, lacks inconsistency at all levels, and at times is completely illogical", write Professors Morris Brown and Paul Stewart.
Because of the increasingly complicated and time-consuming approval process, the UK has fallen from being one of the most attractive places for the pharmaceutical industry to undertake clinical trials to one of the least attractive, warn the authors.
Main concerns of the authors include the lengthy application process - paperwork can take up to 40 hours to complete, the inconsistencies and delays in the review process, and the lack of clarity about what requires ethical approval.
According to the authors, another key problem is the ineffectiveness of the Medicines and Healthcare Products Regulatory Agency (MHRA) approval process - the application is difficult to complete, cannot be submitted online and is sometimes lost by the MHRA.
The MHRA was set up to investigate new medicinal products, but its extended responsibility to approve all clinical trials in the UK has been counterproductive, say the authors.
"The process adds long delay for no perceived benefit… No improvement in patient safety has been demonstrated as a consequence of the extra tier of bureaucracy for such studies", say the authors, "On the contrary, the MHRA failed to prevent the TeGenero disaster at Northwick Park - or acknowledge its failure".
So what needs to be done?
The recently formed National Institute of Health Research (NIHR) has already begun a "bureaucracy busting" mission, say the authors, but they outline a number of recommendations to reduce research bureaucracy.
For example, they suggest a single and simple web based submission form for all research studies, rather than a different form for every funding and governance organisation. In addition, they suggest a national and consistent ethical review process to replace the current "postcode lottery", and an automatic grading of applications which would make patient safety "self evident".
They conclude by calling for the MHRA to concentrate on its primary responsibility, and ensure that medicines work and are safe.
Contacts: Morris Brown, Clinical Pharmacology Unit, University of Cambridge & Addenbrookes Hospital, Cambridge, UK Email: m.j.brown@cai.cam.ac.uk Paul Stewart, Division of Medical Sciences, University of Birmingham, Birmingham, UK Email: p.m.stewart@bham.ac.uk
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