More must be done to address gender differences in cardiovascular drugs. Even in 2017, women are under-represented in randomised clinical trials.
Professor Juan Tamargo, Professor of Pharmacology, Universidad Compultense, Madrid, Spain talks about the need to educate cardiologists and physicians about sex-differences in heart disease, and how the guidelines must also reflect these differences.
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TRANSCRIPT
Why is there a need for sex-specific labelling in CVD drugs?
I think the main point is that usually when we write a guideline or a position paper in the ESC, we just mention the compounds that are recommended with different levels of evidence. And all this evidence, in general, has been obtained from randomised clinical trials where mainly men were involved.
So we are extrapolating the data from these clinical trials to both genders and we can probably accept that it can be extrapolated. But in some cases it is not the case.
The reason why we cannot extrapolate the data is that even in 2017 women are under-represented in randomised clinical trials.
This is very important. First of all, we have the idea that women are protected during their active sexual life, but after menopause we know that things change quite dramatically. When we try to compare men and women of the same range of age, we miss the point that women live longer than men.
Sometimes, we as practitioners say ‘they are protected, this is not a problem for women,’ but it is a problem for women and we need all the information related to differences in drug response to be included in clinical guidelines.
If we have the evidence it should be mentioned in the clinical guidelines and position papers. And indeed this is what we are not doing.
What are the main sex-related differences in the pharmacokinetics of CVD drugs?
I would like to say not only pharmacokinetics. The main point is that when we put on a clinical trial we give the same dose of a certain drug to men and women, and we forget something. For instance, usually women’s weight is lower, and usually we forget that women have a different renal function which is slower than in men. So if we give the same dose to men and women, the problem is that the plasma levels usually are higher in women than in men, and this can explain simple things like the higher incidence of adverse effects in women.
When we try to compare men and women, the first thing we need to look at is the dose calculated based on body weight, and secondly it is calculated according to renal function – and in most cases this does not happen.
We must remember that women are different than men, just because of weight, dose and renal function.
And I would like to also look at pharmacodynamics, because the responses are different. If I gave torsemide, a diuretic, I know that the electrolyte disturbances are more frequent in women than in men. Adverse effects are more frequent in women than in men.
This is important because of pharmacokinetics, because of the different responses, incidences of adverse effects is greater in women. Women may stop treatment, they do not continue with the treatment, or they do not follow my indications as a general practitioner. As a result they are not protected against cardiovascular diseases. This is a real problem.
There is also the feeling – and this is funny- because men, medical doctors usually consider that women need the less strict treatment, we don’t give the same advice to men as we do to women and so on.
There are a lot of things that should be included in position papers and clinical guidelines, but this is not the case. We need to offer to the general practitioner and the cardiologist all this information, because there is misinformation.
What now needs to be done?
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