The designers of heart disease trials should ensure that they recruit enough women to reveal reliably whether they are responding to the drugs in a different way from men, according to research published on line today (Tuesday, 2 August) in Europes leading cardiology journal, the European Heart Journal.
Women are under represented in most clinical studies, so the data and the results are less well documented for them, according to Dr Verena Stangl, senior author of the paper, who is from the Charité Hospital, Humboldt-University Berlin, Germany.
Dr Stangl, who is Professor of Cardiology (Molecular Atherosclerosis) at the hospitals Department of Cardiology, Angiology and Pneumology, said that although the percentage of women in studies of coronary heart disease had risen since the mid 1980s to reflect the prevalence of CHD in women, they were still under represented in trials involving coronary artery disease, arterial hypertension and heart failure.
"Because too few women participate in heart disease trials we are not sure whether they really benefit from some therapeutic strategies that have shown clinical benefit in trials conducted predominantly in men. So, we prescribe drugs to women adapted from evidence-based data obtained from studies conducted mainly in men and we do not really know whether we help or harm the female patients. Take one example: as we have no prospective data for digitalis in female patients, its unclear whether it is really linked to increased mortality among women or whether this increase is an effect only of an overdose, and therefore whether they would benefit from lower doses adapted to their weight."
Dr Stangl said women have historically been under-represented in trials. The main reason was probably because cardiovascular diseases have erroneously been perceived as male diseases. As most cardiovascular diseases tend to occur later in women, co-existing health problems and age limitations on trials have worked against their inclusion. Late diagnosis due to different and more ambiguous symptoms was another reason and, for women of child-bearing age, the risks of damaging a foetus if a woman became pregnant, led to exclusion.
Dr Stangls call for increasing the numbers of women in heart trials is backed in an editorial also published in EHJ on line today by specialists from the University of Pavia in Italy.
Senior author Dr Silvia Priori, Associate Professor of Cardiology at the University of Pavia, said that research published this year showed that of 300 new drug applications to the US Food and Drug Administration (FDA) between 1995 and 2000 only 163 included an analysis according to gender. Yet 11 of the drugs involved showed a difference in the way a womans body dealt with the drugs compared with a mans (the pharmacokinetics).
"These differences underlie the importance of studying women as well as men in major cardiovascular trials. Most of the progress in this direction has occurred in the USA as a direct consequence of the commitment of funding agencies that have provided economic support only when a balanced gender presence was assured in the design of a trial," said Dr Priori.
She urged scientific societies to play a major role in ensuring trials investigate gender- specific response to therapy. The Europe Society of Cardiology (ESC), which publishes the European Heart Journal, recently developed the Women at Heart programme to organise initiatives targeted at promoting research and education in cardiovascular disease in women.
The ESC Congress in Stockholm (3-7 September) will focus specially on women and cardiovascular diseases, said Dr Priori, and the ESC is to perform gender-based analyses of data in the Euro Heart Survey – the programme that monitors clinical practice in Europe. She added that, in future, the ESC will work to promote a larger representation of women in clinical trials to provide missing data on gender differences in response to drug therapy.
 Female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. European Heart Journal. doi: 101093/eurheartj/ehi397.
 Gender-specific prescription for cardiovascular diseases? European Heart Journal. doi: 10.1093/eurheartj/ehi428.
Margaret Willson | alfa
Laser activated gold pyramids could deliver drugs, DNA into cells without harm
24.03.2017 | Harvard John A. Paulson School of Engineering and Applied Sciences
What does congenital Zika syndrome look like?
24.03.2017 | University of California - San Diego
Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.
The results will be published on March 22 in the journal „Astronomy & Astrophysics“.
Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...
Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.
Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...
In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...
Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to simulate these confined natural conditions in artificial vesicles for the first time. As reported in the academic journal Small, the results are offering better insight into the development of nanoreactors and artificial organelles.
Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to...
20.03.2017 | Event News
14.03.2017 | Event News
07.03.2017 | Event News
24.03.2017 | Materials Sciences
24.03.2017 | Physics and Astronomy
24.03.2017 | Physics and Astronomy