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Professor Schulman: and we follow by Professor Moncada from Spain who will discuss some of the other aspects of testosterone and the quality of life.
Professor Moncada: My objective in this talk will be to highlight the effects resulting from progressive decline of serum testosterone levels in elderly men and on the quality of life and to emphasize the benefits of testosterone replacement therapy on reversing these effects.
I want to point out that in the definition, in the first recommendation; there is the quality of life issue here. So this condition may result in a significant detriment in the quality of life and adversely affect the function of multiple organ systems.
So in my talk, I will review the factors that could affect the quality of life, perception in patients with LOH, to overview different quality of life scales like the AMS scale, and the other scale, the A-RHDQoL, the Age-Related Hormone Decline Quality of Life scale. What would be the potential targets of testosterone substitution contributing to an improvement in quality of life and also to show some evidence-based recommendation of clinical benefits of the testosterone replacement therapy on quality of life.
I think everybody agrees that late-onset hypogonadism has a negative impact on quality of life. The impact of these symptoms, the late-onset hypogonadism symptoms on patient functioning has not been very well established yet. The quality of life assessment includes an evaluation of different organ systems in the body: physical, mental and social functioning. Probably the main health-related quality of life scale is the short form, 36SF (SF36), but it is probably too general and not addressing the quality of life issues in patients with LOH. So we have now two scales that have been designed to explore quality of life related to hormonal decline. The one I mentioned before, AMS, and A-RHDQoL.
This study of the qualifications was done following the focus group strategies and when we want to look at what the main domains that impact the quality of life with patients with late-onset hypogonadism, we have to look at all of these domains: the physical functioning, mental, sexual functioning, and also social and emotional functioning, but in the background of all of these domains, we have energy or vitality, something like that.
We have seen in the talks before my presentation how androgen deprivation or hypogonadism is the main influence on many functions in the body. For example, sexual function, we have seen how androgen deprivation may have an impact on the level of sexual interest, the frequency of sexual activity, the rigidity of erections, the difficulty or the ability of maintaining erections and having morning erections and, in general, problems with sexual function.
Here you can see how the androgen deprivation after orchiectomy or the use of LHRH analogues have an impact on all of these items in the sexual abilities. Also, in the rest of the domains of what we call the quality of life items, like physical, emotional, pain, mental health and finally vitality, in this group of patients, patients with prostate cancer that have been submitted to androgen deprivation through orchiectomy or the use of these analogues, you can find how there is a decrease in the overall health situation and probably the most important aspect of it is vitality.
Let us now review the available scales. Probably the AMS symptom scale is the most used scale to measure health-related quality of life in this type of patient, in aging males. We have versions available in most languages and it has good psychometric characteristics in terms of reliability, consistency and test and re-test stability. But in reality, it was designed for diagnosis, not for evaluating quality of life before or after treatment with testosterone. Anyway, it is probably the only scale that will have enough data to show you some information about the quality of life before and after treatment with testosterone.
There is a new scale, this one, Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire, which is specifically designed to measure quality of life of older men with age-related hormonal decline. You will see now what types of questions this questionnaire has: it has 21 domains and there is also a free comments section. It is a questionnaire that takes into account the relevance of each aspect of life or domain for the individual.
This is one of the questions in this questionnaire, this is question 9. This is the typical way of asking the questions to patients. For example in this question, ‘If my hormone levels had not declined with age, my sexual life would be’. And the answer could be ‘very much better’, ‘much better’, ‘a little better’, ‘the same’, ‘a little worse’, ‘much worse’ or ‘very much worse’, and the patient had to choose one of those answers. The second part of this question is, ‘This aspect of my life is’. “Very important’, ‘important’, ‘somewhat important’ or ‘not important at all’. There are two parts to each question, 21 questions, and there is a weight domain score that is obtained multiplying the impact rating of the question by the importance rating. For example, if the patient answers if my hormone levels have not declined with age, my sexual life would be much better, and this aspect of my life is very important so we would have minus 2 multiplied by 3 would be minus 6. There is an overall score of this questionnaire obtained, assuming all the applicable weighted domain because the patient also can choose that this question is not applicable to him. There is another score again, assuming all the applicable weighted domain scores before dividing by the number of domains applicable to the individual.
In this publication, the impact of the mean weighted impact of each item, and these are the 21 questions here, the most important were memory, energy, sexual life, physical stamina, physical capabilities, concentration and also probably family life. These are the main areas, the main parts of the quality of life chosen by the patients with these types of problems.
So these are the areas treatment with testosterone should address: vitality and energy, physical stamina and capability, sexual life, memory and concentration, and physical appearance and self-confidence. Most of these questions have been addressed already for my predecessors in their turn, so I am not going to go through any of those but in all of those areas, the treatment with testosterone has to be shown to be effective and improving the symptoms.
For example, in vitality and energy, you can see how after 6 months and 12 months of treatment with Testim®, there is an increase in lean body mass and a decrease in fat mass and this has an impact on the energy and vitality of the patient.
There is also a factor in sexual life, how in this same study published by John Dean, shows how compared to base line there is an improvement in sexual activity and continuous erections after treatment in this 12 month study.
If we want to look at the overall quality of life, this is one of the few studies published taking into account this quality of life issue as a global thing, this study was published in this journal, Health and Quality of Life Outcomes, you can see how using this AMS questionnaire how there is an improvement in the total score in the questionnaire after treatment. This is before treatment, a base line, and how this score lowers, so the quality of those patients is improved after treatment.
This improvement is related to the severity of the symptoms, so the patients with more severe symptoms, the treatment is higher and you can see here how the improvement is almost 40% after treatment. When the symptoms are moderate or mild, the improvement is less, but there is of course less room for improvement when there is no or little symptoms, but again there is an overall improvement in the measure of quality of life for patients after treatment with testosterone.
I think everyone agrees that LOH has a negative impact on the quality of life and this impact can be measured with specific instruments. Also, testosterone therapy improves the symptoms of LOH and improves the quality of life of those patients.
Thank you very much for your attention.
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