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Press releases Monday 17 August to Friday 21 August 2009

Please remember to credit the BMJ as source when publicising an article and to tell your readers that they can read its full text on the journal's website (http://www.bmj.com).

(1) Diabetes drug linked to increased risk of heart failure
(2) Smokeless tobacco increases risk of heart attack and stroke
(3) Mums-to-be warned over use of fetal heart rate monitors

(1) Diabetes drug linked to increased risk of heart failure
(Research: Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study)
http://www.bmj.com/cgi/content/full/339/aug18_2/b2942
(Editorial: Rosiglitazone or pioglitazone in type 2 diabetes?)
http://www.bmj.com/cgi/content/full/339/aug18_2/b3076

Rosiglitazone, a drug used to treat type 2 diabetes, is associated with an increased risk of heart failure and death among older patients compared to a similar drug (pioglitazone), concludes a study published on bmj.com today.

As such, the researchers say it is difficult to advocate continued use of rosiglitazone for most patients.

Rosiglitazone and pioglitazone belong to a class of drugs called thiazolidinediones and are widely used for the treatment of type 2 diabetes. They help to control blood sugar levels, but both drugs can also cause side effects including weight gain, fluid retention and heart failure.

It is unclear whether there are clinically important differences in the cardiac safety of these two drugs, so researchers in Canada compared the risk of heart attack, heart failure and death in patients treated with rosiglitazone and pioglitazone.

Using prescription records, they identified nearly 40,000 patients aged 66 years and older who started treatment with either rosiglitazone or pioglitazone between April 2002 and March 2008.

Data on hospital admission for either a heart attack or heart failure during the six-year study period were recorded and deaths were identified from a national database.

Detailed analysis showed that patients treated with pioglitazone had a significantly lower risk of heart failure and death compared to patients treated with rosiglitazone, but there was no significant difference in the risk of heart attack.

The researchers estimate that, for every 93 patients treated with rosiglitazone rather than pioglitazone, one additional cardiovascular event or death would be predicted to occur annually.

"Our findings suggest clinically important differences in the cardiovascular safety profiles of rosiglitazone and pioglitazone in clinical practice", say the authors. "Given the accumulating evidence of harm with rosiglitazone treatment and the lack of a distinct clinical advantage for the drug over pioglitazone, it is reasonable to question whether ongoing use of rosiglitazone is justified," they conclude.

This study reinforces the message that thiazolidinediones should be avoided in heart failure patients, but the claim that pioglitazone is safer than rosiglitazone is not fully supported by the data, say two experts from the Universities of Bath and Surrey in an accompanying editorial.

Although it may be tempting to move away from prescribing thiazolidinedione altogether, they write, long term follow-up data for newer products are not yet available.

Given that randomised trials are unlikely ever to provide the full picture, they suggest that enhancements to healthcare databases coupled with well designed studies like this one are essential for determining the full risk-benefit profile of medicines. People who have concerns regarding their diabetes treatment are urged to consult their GP and not to discontinue taking their medication.

Contacts:
David Juurlink, Division Head, Clinical Pharmacology and Toxicology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Email: david.juurlink@ices.on.ca

Corinne de Vries, Professor of Pharmacoepidemiology, Department of Pharmacy and Pharmacology, University of Bath, UK
Email: c.de-vries@bath.ac.uk

(2) Smokeless tobacco increases risk of heart attack and stroke
(Research: Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis)
http://www.bmj.com/cgi/content/full/339/aug18_2/b3060

People who use smokeless tobacco products like snus have a slightly higher risk of having a fatal heart attack or stroke, according to research published on bmj.com today.

In the past few decades there has been an increase in the number of people in Europe and North America using smokeless tobacco, particularly among people younger than 40. Given that these products are being promoted as 'safer' alternatives to smoking cigarettes, the number of individuals using them is set to increase, says the study.

The research team, led by Dr Paolo Boffetta at International Agency for Research on Cancer in France, analysed the results of 11 studies carried out in Sweden and North America on the use of smokeless tobacco products and the risk of developing or dying from a heart attack or stroke.

Differences in study design and quality were taken into account to minimise bias.

They found a small increased risk of death from a heart attack or stroke among users of smokeless tobacco products compared with non-users. Smokeless tobacco caused 0.5% of all heart attacks in the United States and 5.6% in Sweden. The products were also the cause of 1.7% of stroke deaths in the United States and 5.4% in Sweden.

The authors conclude that, although the magnitude of the excess risk, particularly for fatal myocardial infarction, was small, the consistency of the results among studies and their robustness with respect to study design and quality added to their credibility.

If the association is real, the authors believe that its public health and clinical implications might be substantial and they call for more research in this area.

Contacts:
Kurt Straif, Epidemiologist, International Agency for Research on Cancer, Lyon, France
Email: straif@iarc.fr

(3) Mums-to-be warned over use of fetal heart rate monitors
(Filler: Caution with home fetal Doppler devices)
http://www.bmj.com/cgi/content/full/339/aug18_2/b3220

Mums-to-be are being advised not to use personal monitors (Doppler devices) to listen to their baby's heartbeat at home over fears that they may lead to delays in seeking help for reduced fetal movements.

In this week's BMJ, Dr Thomas Aust and colleagues from the Department of Obstetrics and Gynaecology at Arrowe Park Hospital, Wirral describe the case of a 27 year old woman who presented to their labour ward 32 weeks into her first pregnancy with reduced fetal movements.

She had first noted a reduction in her baby's activity two days earlier but had used her own Doppler device to listen to the heartbeat and reassured herself that everything was normal.

Further monitoring by the antenatal care team was not reassuring and the baby was delivered by caesarean section later that evening. The baby remained on the special care baby unit for eight weeks and is making steady progress.

A hand-held Doppler device assesses the presence of fetal heart pulsations only at that moment, and it is used by midwives and obstetricians to check for viability or for intermittent monitoring during labour, explain the authors. In untrained hands it is more likely that blood flow through the placenta or the mother's main blood vessels will be heard.

Following this case, they searched the internet and found that a fetal Doppler device could be hired for £10 a month or bought for £25-50 (www.ebay.co.uk). Although the companies offering sales state that the device is not intended to replace recommended antenatal care, they also make claims such as "you will be able to locate and hear the heartbeat with excellent clarity" (www.hi-baby.co.uk).

It is difficult to say whether self monitoring altered the outcome in this case, say the authors. But they now have posters in their antenatal areas recommending that patients do not use these devices.

Contact:
Mr Akin Famoriyo, Consultant, Department of Obstetrics and Gynaecology, Wirral University Teaching Hospital NHS Foundation Trust, Arrowe Park Hospital, Wirral, UK
Email: akin.famoriyo@whnt.nhs.uk

FOR ACCREDITED JOURNALISTS

For more information please contact:

Emma Dickinson
Tel: +44 (0)20 7383 6529
Email: edickinson@bmj.com

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BMA House, Tavistock Square, London WC1H 9JP

and from:

the EurekAlert website, run by the American Association for the Advancement of Science (http://www.eurekalert.org)
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