MICHAEL ZITZMANN: We often find a discrepancy between local laboratory reports about testosterone levels and guideline levels, because these local laboratories have other thresholds for testosterone. It is unclear how these are created. Sometimes they are provided by the manufacturers of the assay kits.
Sometimes these thresholds are created by the laboratories themselves, by very small cohorts. But definitely, these are not reflecting the reality, because the guidelines always refer to patient numbers above 10,000, values that have been measured by mass spectrometry, and been associated with complaints by validated questionnaires. So, it is always useful to choose that. That is very close with its normal range to the normal reference guidelines that we have, and it is doubtful to trust a lab that provides you with normal values, especially if they have age-related ranges, which is absolutely not in agreement with current data.
There are different guidelines on testosterone therapy, especially regarding thresholds for T-levels in an associated patient with symptoms of course. Then we start treatment. It is difficult to really assess the eligibility of a patient to be treated just by one threshold, because every symptom seems to have a different threshold, and this is, of course, an individual item, because everybody has a different genetic setting for receptibility to testosterone. This is why we usually follow the guidelines, but not very strictly. If someone has clear complaints and we can see that testosterone levels are in the low/normal range, we would try a treatment.
Now different types of hypogonadism that can be treated, for example the classical forms where you have an organic disease, for example the testes do not function very well or the pituitary, which is the regulatory organ in the brain that is in common, so to say, of all glands in the body, that may not function well. These are called classical forms of hypogonadism. And then, we have also other forms of hypogonadism which are called functional. They do not refer to organ damage, but to a kind of inflammatory status that is present in a certain patient. For example, when he is obese or has diabetes Type II—and usually we always, and there are many studies that provide us with data according to this—usually we see good treatment effects in both types of patients, in those with the classical forms and also those who have functional hypogonadism. Especially those who have functional hypogonadism tend to be obese, and of course testosterone is able to reduce obesity in coalition with life style changes. And then we see more pronounced effects in those people who have functional hypogonadism.
We treat patients with hypogonadism, which can be classical forms or those with functional forms, and they all benefit. So, we see a tremendous effect on weight loss, especially over time, but also the other functions that are dependent on testosterone, for example—sexuality or mood. So, basically there’s no big difference between classical and functional hypogonadism when patients are being treated.
To initiative therapy, we have different testosterone preparations. We have long-acting intramuscularly injected testosterone forms, and we have transdermal gels, which are applied to the skin. And it basically really depends on the patient and his choice of what he likes. If he likes to put on a gel daily, he can have a gel. If he wants to rely on the doctor and have a monthly visit, he can have injectable forms of testosterone. So, both act very fine and we have a good tolerability, and we leave it up to the patient.
Adherence is definitely something that is very important in any kind of medication, and also in testosterone substitution. But as these patients who are being treated by testosterone therapy experience the wellbeing that comes over time, they tend to be very compliant. And I have the impression that those who receive the injections for which they need a doctor are especially compliant. And thus, we have patients who have been under treatment for more than 20 years now.
The new guidelines on testosterone therapy and hypogonadism always, or many of them, mention that obesity and Type II diabetes are risk factors for hypogonadism, and those patients should be screened for low testosterone levels and other symptoms. So, physicians who encounter patients for various reasons of obesity or Type II diabetes—it could be a urologist or a general practitioner—should be aware that this patient has hypogonadism and could benefit of testosterone therapy. So, he should screen them.