- Email: [email protected]
NON-HORMONAL DRUGS IN MENOPAUSE
8th European Congress on Menopause (EMAS) / Maturitas 63, Supplement 1 (2009) S1–S136
severe bone loss, than that seen in other postmenopausal women. Thus, BC patients also have a 5-fold higher incidence of osteoporosis than peer women of their age. Management: About a third of symptomatic patients take various treatments to alleviate symptoms. It is commonly admitted that HRT and tibolone are not indicated for these patients since they increase BC recurrence risk. In AI users, even vaginal oestrogens are contra-indicated. Some evidence exists, concerning the efficacy of serotonin reuptake inhibitors and gabapentine, but there are concerns about their safety. There is a consensus that in AI users, bone mineral density and osteoporosis risk should be evaluated, and that osteoporosis treatment should be initiated at an early stage (when osteopenia combined with risk factors occurs, or in cases of severe osteopenia). The current attitude is to use Bisphosphonates, although other drugs are being developed. There is recent evidence that biphosphonates also decrease BC recurrence risk. Conclusions: Osteopenia should be detected and treated in AI users. There is a need for the development of safe and efficacient symptomatic treatments for these patients. Keywords: Breast cancer survivors, oestrogen deficiency, aromatase inhibitors, Bisphosphonates.
S7
with desvenlafaxine (DVS) as SNRI, the efficacy of DVS was approximately 60% to 65% reduction from baseline in the number of hot flushes vs. 50% for placebo. The most frequent adverse effect was nausea, above all when the treatment was started. Other studies are being carried out to try to minimize adverse effects at the beginning of the treatment. Within non-estrogenic herbal remedies, Black Cohosh is the most studied. This preparation contains serotonergic and dopaminergic components. Data from the literature are contradictory and there is no consensus on its efficacy. There are two types of non-hormonal treatments for genitourinary atrophy: vaginal lubricants and vaginal moisturizers. Moisturizers have a positive effect on the vaginal epithelium and are effective in the treatment for the symptoms of urogenital atrophy. Conclusion: SNRIs for hot flushes are encouraging. Adverse effects must be reduced and more data on safety are also needed. The non-estrogenic herbal treatments field is being fully developed, but more evidences are needed. Vaginal lubricants and moisturizers are effective and advisable.
Parallel Session: The Ageing Male – Late Onset Hypogonadism (LOH)
Parallel Session: New Developments for Tomorrow 22 ISSAM RECOMMENDATIONS FOR THE MANAGEMENT OF LATE ONSET HYPOGONADISM
20 SERMS AND RELATED REGIMENS
B. Lunenfeld. President International Society for the Study of the Aging Male (ISSAM), Tel Aviv, Israel
J. Pickar. Wyeth Research, Philadelphia, United States Objectives: To provide an update on SERMs and related regimens. Methods: Review of the literature and recent data from clinical trials. Results: SERMs have been clinically available for over 50 years; however, the term was first published about 15 years ago. Prior to this they were referred to as antiestrogens until both preclinical and clinical data demonstrated the presence of both estrogen agonist as well as antagonist activity. At least 16 SERMs have been studied clinically and there have now been pairings of a SERM with an estrogen as a Tissue Selective Estrogen Complex (TSEC). The ultimate effects of the SERM, including its differential estrogen agonist/antagonist activity, are the result of the distribution of ERα and ERβ and the differential binding affinity of the ligand for each receptor. This binding results in conformational changes in the receptors which will influence the interaction with coactivators and corepressors and ultimately transcription. The distribution of the coactivators and corepressors in the various cell types also will contirbute to the tissue selective actions of the SERM. The TSEC which pairs Bazedoxifene and conjugated estrogens represents a new generation of menopausal therapy. Studies suggest this pairing maintains estrogens favorable effects on menopausal symptoms and both estrogen’s and the SERM’s favorable effect on osteoporosis while preventing unopposed estrogenic stimulation of the uterus. Additionally, this TSEC achieves far superior rates of amenorrhea and less breast tenderness compared with estrogen/progestin combinations. Conclusions: Significant advances continue to be made in the understanding and use of SERMs and related regimens. Keywords: SERM, TSEC, Bazedoxifene/conjugated estrogens.
21 NON-HORMONAL DRUGS IN MENOPAUSE S. Palacios. Palacios Institute of Woman’s Health, Madrid, Spain Objective: To review the published data concerning the use of nonhormonal drugs in menopause. Design and methods: This review is based upon the published English language literature identified by searching in Medline (1969-2008) for randomized clinical trials, meta-analysis and guidelines of antidepressants, antiseizures and non-estrogenic herbal remedies in menopause. Results: There are some clinical data for the relief of vasomotor symptoms with SSRIs and SNRIs. In a recent phase III clinical development programme
The growing importance and enormous potential of the impact of a rapidly mounting population of males over the age of 50 years which will be positioned for special health needs in the first quarter of this century and probably beyond, has been realized. Among these needs Testosterone therapy (TT) for late-onset hypogonadism (LOH) or androgen deficiency is a fast developing field. The understanding of LOH among large sections of the medical profession dealing with mature men has not kept pace with the developments in the field. Confusion and misunderstandings surrounding diagnosis, treatment and monitoring of LOH still exist. The recognition, evaluation, and treatment of LOH in the male patient is often dismissed by patients and overlooked by physicians. Symptoms and signs of Hypogonadism should be identified through appropriate questioning of the patient and a directed physical examination and confirmed by laboratory investigation. Therefore, ISSAM -in fulfilling its mandate- considered that this was an opportune time to provide factual information on various clinical aspects of LOH and its diagnosis in the form a set of practical recommendations dealing exclusively with monitoring and safety of TT (www.issam.ch). Testosterone therapy in patients diagnosed with LOH can often enable the patient to maintain quality of life, function in a more normal manner and delay or decrease the risk of future problems such as the metabolic syndrome, sexual disfunction, mood disturbances, lack of concentration fatigue, osteoporosis and frailty.
23 TREATMENT OPTIONS FOR TESTOSTERONE DEFICIENCY M. Zitzmann. University Clinics Muenster Germany, Center for Reproductive Medicine and Andrology, Muenster, Germany Male hypogonadism presents with a clinical picture that is most often associated with typical symptoms, such as disturbances of mood as well as sexual functions. Furtheron, a decrease in muscle mass and strength, an accumulation of body fat and osteopenia/osteoporosis are frequently observed. There are indications that insulin sensitivity is attenuated by androgen deficiency. Especially in older men, symptoms of androgen deficiency may exhibit a differential profile due to accompanying other chronic illnesses. Restoring serum testosterone levels by replacement therapy can markedly mitigate, if not totally relieve, the clinical picture of hypogonadism. New treatment modalities have been introduced during the recent years, which include short-acting transdermal or buccal modalities as well as the long-acting depot preparation of testosterone undecanoate. This review discusses the various modern methods of initiation and surveil-
severe bone loss, than that seen in other postmenopausal women. Thus, BC patients also have a 5-fold higher incidence of osteoporosis than peer women of their age. Management: About a third of symptomatic patients take various treatments to alleviate symptoms. It is commonly admitted that HRT and tibolone are not indicated for these patients since they increase BC recurrence risk. In AI users, even vaginal oestrogens are contra-indicated. Some evidence exists, concerning the efficacy of serotonin reuptake inhibitors and gabapentine, but there are concerns about their safety. There is a consensus that in AI users, bone mineral density and osteoporosis risk should be evaluated, and that osteoporosis treatment should be initiated at an early stage (when osteopenia combined with risk factors occurs, or in cases of severe osteopenia). The current attitude is to use Bisphosphonates, although other drugs are being developed. There is recent evidence that biphosphonates also decrease BC recurrence risk. Conclusions: Osteopenia should be detected and treated in AI users. There is a need for the development of safe and efficacient symptomatic treatments for these patients. Keywords: Breast cancer survivors, oestrogen deficiency, aromatase inhibitors, Bisphosphonates.
S7
with desvenlafaxine (DVS) as SNRI, the efficacy of DVS was approximately 60% to 65% reduction from baseline in the number of hot flushes vs. 50% for placebo. The most frequent adverse effect was nausea, above all when the treatment was started. Other studies are being carried out to try to minimize adverse effects at the beginning of the treatment. Within non-estrogenic herbal remedies, Black Cohosh is the most studied. This preparation contains serotonergic and dopaminergic components. Data from the literature are contradictory and there is no consensus on its efficacy. There are two types of non-hormonal treatments for genitourinary atrophy: vaginal lubricants and vaginal moisturizers. Moisturizers have a positive effect on the vaginal epithelium and are effective in the treatment for the symptoms of urogenital atrophy. Conclusion: SNRIs for hot flushes are encouraging. Adverse effects must be reduced and more data on safety are also needed. The non-estrogenic herbal treatments field is being fully developed, but more evidences are needed. Vaginal lubricants and moisturizers are effective and advisable.
Parallel Session: The Ageing Male – Late Onset Hypogonadism (LOH)
Parallel Session: New Developments for Tomorrow 22 ISSAM RECOMMENDATIONS FOR THE MANAGEMENT OF LATE ONSET HYPOGONADISM
20 SERMS AND RELATED REGIMENS
B. Lunenfeld. President International Society for the Study of the Aging Male (ISSAM), Tel Aviv, Israel
J. Pickar. Wyeth Research, Philadelphia, United States Objectives: To provide an update on SERMs and related regimens. Methods: Review of the literature and recent data from clinical trials. Results: SERMs have been clinically available for over 50 years; however, the term was first published about 15 years ago. Prior to this they were referred to as antiestrogens until both preclinical and clinical data demonstrated the presence of both estrogen agonist as well as antagonist activity. At least 16 SERMs have been studied clinically and there have now been pairings of a SERM with an estrogen as a Tissue Selective Estrogen Complex (TSEC). The ultimate effects of the SERM, including its differential estrogen agonist/antagonist activity, are the result of the distribution of ERα and ERβ and the differential binding affinity of the ligand for each receptor. This binding results in conformational changes in the receptors which will influence the interaction with coactivators and corepressors and ultimately transcription. The distribution of the coactivators and corepressors in the various cell types also will contirbute to the tissue selective actions of the SERM. The TSEC which pairs Bazedoxifene and conjugated estrogens represents a new generation of menopausal therapy. Studies suggest this pairing maintains estrogens favorable effects on menopausal symptoms and both estrogen’s and the SERM’s favorable effect on osteoporosis while preventing unopposed estrogenic stimulation of the uterus. Additionally, this TSEC achieves far superior rates of amenorrhea and less breast tenderness compared with estrogen/progestin combinations. Conclusions: Significant advances continue to be made in the understanding and use of SERMs and related regimens. Keywords: SERM, TSEC, Bazedoxifene/conjugated estrogens.
21 NON-HORMONAL DRUGS IN MENOPAUSE S. Palacios. Palacios Institute of Woman’s Health, Madrid, Spain Objective: To review the published data concerning the use of nonhormonal drugs in menopause. Design and methods: This review is based upon the published English language literature identified by searching in Medline (1969-2008) for randomized clinical trials, meta-analysis and guidelines of antidepressants, antiseizures and non-estrogenic herbal remedies in menopause. Results: There are some clinical data for the relief of vasomotor symptoms with SSRIs and SNRIs. In a recent phase III clinical development programme
The growing importance and enormous potential of the impact of a rapidly mounting population of males over the age of 50 years which will be positioned for special health needs in the first quarter of this century and probably beyond, has been realized. Among these needs Testosterone therapy (TT) for late-onset hypogonadism (LOH) or androgen deficiency is a fast developing field. The understanding of LOH among large sections of the medical profession dealing with mature men has not kept pace with the developments in the field. Confusion and misunderstandings surrounding diagnosis, treatment and monitoring of LOH still exist. The recognition, evaluation, and treatment of LOH in the male patient is often dismissed by patients and overlooked by physicians. Symptoms and signs of Hypogonadism should be identified through appropriate questioning of the patient and a directed physical examination and confirmed by laboratory investigation. Therefore, ISSAM -in fulfilling its mandate- considered that this was an opportune time to provide factual information on various clinical aspects of LOH and its diagnosis in the form a set of practical recommendations dealing exclusively with monitoring and safety of TT (www.issam.ch). Testosterone therapy in patients diagnosed with LOH can often enable the patient to maintain quality of life, function in a more normal manner and delay or decrease the risk of future problems such as the metabolic syndrome, sexual disfunction, mood disturbances, lack of concentration fatigue, osteoporosis and frailty.
23 TREATMENT OPTIONS FOR TESTOSTERONE DEFICIENCY M. Zitzmann. University Clinics Muenster Germany, Center for Reproductive Medicine and Andrology, Muenster, Germany Male hypogonadism presents with a clinical picture that is most often associated with typical symptoms, such as disturbances of mood as well as sexual functions. Furtheron, a decrease in muscle mass and strength, an accumulation of body fat and osteopenia/osteoporosis are frequently observed. There are indications that insulin sensitivity is attenuated by androgen deficiency. Especially in older men, symptoms of androgen deficiency may exhibit a differential profile due to accompanying other chronic illnesses. Restoring serum testosterone levels by replacement therapy can markedly mitigate, if not totally relieve, the clinical picture of hypogonadism. New treatment modalities have been introduced during the recent years, which include short-acting transdermal or buccal modalities as well as the long-acting depot preparation of testosterone undecanoate. This review discusses the various modern methods of initiation and surveil-