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1. Neuropsychiatric Aspects in Men with Klinefelter Syndrome

Author

Giagulli, Va, Campone, B, Castellana, M, Salzano, C, Fisher, Ad, de Angelis, C, Pivonello, R, Colao, A, Pasquali, D, Maggi, M, Triggiani, V, Balercia, G, Bonomi, M, Calogero, Ae, Corona, G, Giorgino, F, Fabbri, A, Ferlin, A, Ferrante, E, Francavilla, F, Jannini, E, Lanfranco, F, Pizzocaro, A, Radicioni, A, Rochira, V, Vignozzi, L, Giagulli, Vito Angelo, Capone, Beatrice, Castellana, Marco, Salzano, Ciro, Fisher, Alessandra, de Angelis, Cristina, Pivonello, Rosario, Colao, Annamaria, Pasquali, Daniela, Maggi, Mario, and Triggiani, Vincenzo

Subjects
Male, Klinefelter Syndrome, Hypergonadotropic hypogonadism, testosterone, autism, schizophrenia, attention deficit, hyperactivity disorder, depression, anxiety, Psychosis, Pediatrics, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Hypergonadotropic hypogonadism, autism, Comorbidity, Article, 03 medical and health sciences, Klinefelter Syndrome, 0302 clinical medicine, medicine, Humans, Immunology and Allergy, Attention deficit hyperactivity disorder, 030219 obstetrics & reproductive medicine, business.industry, Hypogonadism, Mental Disorders, Brain, medicine.disease, schizophrenia, Phenotype, Schizophrenia, testosterone, depression, attention deficit, hyperactivity disorder, Autism, Anxiety, Klinefelter syndrome, medicine.symptom, business, Neurocognitive, 030217 neurology & neurosurgery
Abstract

Background and objective: Klinefelter Syndrome (KS) is the most common sex chromosome aneuploidy (47, XXY) and cause of male hypergonadotropic hypogonadism. It is characterized by an extreme clinical heterogeneity in presentation, including infertility, hypogonadism, language delay, metabolic comorbidities, and neurocognitive and psychiatric disorders. Since testosterone is known to have organizational, neurotrophic and neuroprotective effects on brain, the condition of primary hypogonadism could play a role. Moreover, given that KS subjects have an additional X, genes on the extra-chromosome could also exert a significant impact. The aim of this narrative review is to analyze the available literature on the relationship between KS and neuropsychiatric disorders.Methods:To extend to the best of published literature on the topic, appropriate keywords and MeSH terms were identified and searched in Pubmed. Finally, references of original articles and reviews were examined.Results:Both morphological and functional studies focusing on the brain showed that there were important differences in brain structure of KS subjects. Different psychiatric disorders such as Schizophrenia, autism, attention deficit hyperactivity disorder, depression and anxiety were frequently reported in KS patients according to a broad spectrum of phenotypes. T supplementation (TRT) was not able to improve the psychotic disorders in KS men with or without overt hypogonadism.Conclusion:Although the risk of psychosis, depression and autism is increased in subjects with KS, no definitive evidence has been found in studies aiming at identifying the relationship between aneuploidy, T deficit and the risk of psychiatric and cognitive disorders in subjects affected by KS.

Published
2019

2. Thyroid function in Klinefelter syndrome: a multicentre study from KING group

Author

Balercia, G., Bonomi, M., Giagulli, V. A., Lanfranco, F., Rochira, V., Giambersio, A., Accardo, G., Esposito, D., Allasia, S., Cangiano, B., De Vincentis, S., Condorelli, R. A., Calogero, A., Pasquali, D., Aversa, A., Corona, G., Giorgino, F., Fabbri, A., Ferlin, A., Ferrante, E., Francavilla, F., Giagulli, V., Jannini, E., Maggi, M., Pivonello, R., Pizzocaro, Anna, Radicioni, A., Vignozzi, L., Barchi, M., Cordeschi, G., D'Andrea, S., Mambro, A. D., Foresta, C., Francavilla, S., Garolla, A., Giovannini, L., Granata, A. R. M., La Vignera, S., Motta, G., Negri, L., Pelliccione, F., Persani, L., Salzano, C., Santi, D., Selice, R., Simoni, M., Tatone, C., Tirabassi, G., Tresoldi, A. S., Vicari, E., Balercia, G., Bonomi, M., Giagulli, V. A., Lanfranco, F., Rochira, V., Giambersio, A., Accardo, G., Esposito, D., Allasia, S., Cangiano, B., De Vincentis, S., Condorelli, R. A., Calogero, A., Pasquali, D., Aversa, A., Corona, G., Giorgino, F., Fabbri, A., Ferlin, A., Ferrante, E., Francavilla, F., Giagulli, V., Jannini, E., Maggi, M., Pivonello, R., Pizzocaro, A., Radicioni, A., Vignozzi, L., Barchi, M., Cordeschi, G., D'Andrea, S., Mambro, A. D., Foresta, C., Francavilla, S., Garolla, A., Giovannini, L., Granata, A. R. M., La Vignera, S., Motta, G., Negri, L., Pelliccione, F., Persani, L., Salzano, C., Santi, D., Selice, R., Simoni, M., Tatone, C., Tirabassi, G., Tresoldi, A. S., and Vicari, E.

Subjects
Adult, Male, endocrine system, Pediatrics, medicine.medical_specialty, Hashimoto’s thyroiditi, Adolescent, endocrine system diseases, Kallmann syndrome, Thyroid hormones, Endocrinology, Diabetes and Metabolism, Thyroid Gland, Hypergonadotropic hypogonadism, Thyrotropin, 030209 endocrinology & metabolism, Hashimoto Disease, Thyroid Function Tests, Thyroiditis, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Hypogonadotropic hypogonadism, medicine, Humans, Testosterone, Klinefelter syndrome, Aged, Academic Medical Centers, business.industry, Hypogonadism, Thyroid, Hashimoto’s thyroiditis, Middle Aged, Thyroid disease, medicine.disease, Thyroid diseases, medicine.anatomical_structure, Italy, Case-Control Studies, 030220 oncology & carcinogenesis, Concomitant, Female, Thyroid function, business
Abstract

Purpose: The prevalence and the etiopathogenesis of thyroid dysfunctions in Klinefelter syndrome (KS) are still unclear. The primary aim of this study was to evaluate the pathogenetic role of hypogonadism in the thyroid disorders described in KS, with the scope to distinguish between patients with KS and hypogonadism due to other causes (Kallmann syndrome, idiopathic hypogonadotropic hypogonadism, iatrogenic hypogonadism and acquired hypogonadotropic hypogonadism after surgical removal of pituitary adenomas) called non-KS. Therefore, we evaluated thyroid function in KS and in non-KS hypogonadal patients. Methods: This is a case–control multicentre study from KING group: Endocrinology clinics in university-affiliated medical centres. One hundred and seventy four KS, and sixty-two non-KS hypogonadal men were enrolled. The primary outcome was the prevalence of thyroid diseases in KS and in non-KS. Changes in hormonal parameters were evaluated. Exclusion criterion was secondary hypothyroidism. Analyses were performed using Student’s t test. Mann–Whitney test and Chi-square test. Results: FT4 was significantly lower in KS vs non-KS. KS and non-KS presented similar TSH and testosterone levels. Hashimoto’s thyroiditis (HT) was diagnosed in 7% of KS. Five KS developed hypothyroidism. The ratio FT3/FT4 was similar in both groups. TSH index was 1.9 in KS and 2.3 in non-KS. Adjustment for differences in age, sample size and concomitant disease in multivariate models did not alter the results. Conclusions: We demonstrated in KS no etiopathogenic link to hypogonadism or change in the set point of thyrotrophic control in the altered FT4 production. The prevalence of HT in KS was similar to normal male population, showing absence of increased risk of HT associated with the XXY karyotype.

Published
2019

3. Diagnostic and therapeutic workup of erectile dysfunction: results from a delphi consensus of andrology experts

Author

Isidori, A. M., Giammusso, B., Corona, G., Verze, P., Albanesi, L., Antomarchi, F., Arcaniolo, D., Balercia, G., Barbonetti, A., Barletta, D., Barrese, F., Bellastella, G., Biggio, A., Bitelli, M., Botturi, A., Brancato, T., Branchina, A., Cai, T., Canale, D., Capone, L., Capone, M., Carluccini, A., Citarrella, R., Cocci, A., Corvese, F., Cozza, P. P., Creta, M., D'Andrea, S., Dalena, G., Damiano, R., Defeudis, G., Del Grasso, A., Delbarba, A., Delle Rose, A., Di Crosta, G., Filippo, Di, Di Lena, S., Di Martino, M., Di Millo, F., Di Palma, P., Diazzi, D., Dicuio, M., Diosi, D., Fabbri, A., Fattorini, G., Florio, M., Formiconi, A., Franco, G., Galdiero, M., Giambersio, A. M., Gianfrilli, D., Giovannone, R., Granata, A. M., Iafrate, M., Iapicca, G., Iatrino, G., Ilacqua, N., Innocenti, F., Italiano, E., Izzo, A., Izzo, P., Lamartina, M., Ledda, A. F., Lepri, L., C. F., Lo, Lombardo, F., Luca, G., Macchione, L., Maga, T., Matteo, M., Malvestiti, G. M., Marella, G., Maretti, C., Maturo, G., Mazzaferro, D., Mazzilli, R., Migliorini, F., Milardi, D., Minardi, V., Moiso, A., Mondaini, N., Moretti, M., Motta, G., Nerva, F., Pastore, A. L., Paulis, G., Piazza, N., Pili, M., Pistone, A., Pivonello, R., Pizzocaro, A., Polverini, M., Provinzano, V., Rastrelli, G., Risi, O., Rocchegiani, A., Rolle, L., Romanelli, F., Romano, G., Russo, G. I., Salemi, G., Salzano, C., Sanna, F., Sansone, A., Santi, D., Scalese, G. A., Scarano, P., Scroppo, F. I., Serrao, M. F., Sidoti, G., Silvestre, G., Simone, O., Sorrentino, M., Tallis, V., Tammaro, R., Ughi, G., Vagnoni, V., Vavallo, A., Vecchio, D., Vita, A., Zicarelli, P., and Zucchi, A.

Subjects
Consensus, erectile dysfunction, Urology, Endocrinology, Diabetes and Metabolism, media_common.quotation_subject, education, 030232 urology & nephrology, lcsh:Medicine, Dermatology, Delphi, Consensus method, Likert scale, Andrology, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, Endocrinology, Erectile Dysfunction, PDE5 Inhibitors, Treatment, Voting, medicine, PDE5 inhibitors, computer.programming_language, media_common, 030219 obstetrics & reproductive medicine, treatment, business.industry, lcsh:R, lcsh:Other systems of medicine, medicine.disease, lcsh:RZ201-999, consensus, delphi, Phosphodiesterase Type 5 Inhibitors, Clinical Practice, Psychiatry and Mental health, Erectile dysfunction, Hot topics, Reproductive Medicine, business, computer
Abstract

Introduction Erectile dysfunction is a highly prevalent condition. Existing guidelines provide recommendations for diagnosis and treatment, but they are often disregarded in clinical practice in favor of a “patient-tailored” approach. Objectives We planned a Delphi consensus method to bridge the gap between evidence-based medicine and the real-life approach in daily practice. Materials and Methods The Advisory Board prepared 15 statements on debated topics in andrology, each including 4–6 items designed as a 5-point Likert scale. After a validation phase, the questionnaire was sent by e-mail to a panel of experts for a first round of voting; members of the panel were later invited to a second round of voting, preceded by discussion of the “hot topics” identified in the first round. Results The first round of the Delphi consensus involved 101 experts; 71 (70%) also took part in the second round of voting. The Advisory Board deemed 22 items to be worthy of debate, and these underwent the second round of voting. “Real-life” results from the survey proved quite different from evidence-based recommendations. Conclusion Although guidelines suggest the best approach for a “standard” patient, real-life settings require flexibility. Diagnostic and therapeutic approaches should be tailored to the patients’ needs. Phosphodiesterase type 5 inhibitors are recognized as the first-line therapy in both settings, including the newly introduced sildenafil orodispersible film. Indications from the panel might help close the gap between recommendations from guidelines and real-life practice in relation to the diagnosis and treatment of erectile dysfunction.

Published
2019

4. Klinefelter syndrome (KS): genetics, clinical phenotype and hypogonadism

Author

Bonomi, Marco, Rochira, V., Pasquali, D., Balercia, G., Jannini, E. A., Ferlin, A., On behalf of the Klinefelter ItaliaN Group, Null, Balercia, Giancarlo, Calogero, Aldo, Corona, Giovanni, Fabbri, Andrea, Ferlin, Alberto, Francavilla, Felice, Giagulli, Vito, Lanfranco, Fabio, Maggi, Mario, Pasquali, Daniela, Pivonello, Rosario, Pizzocaro, Alessandro, Radicioni, Antonio, Rochira, Vincenzo, Accardo, Linda, Cangiano, Biagio, Condorelli, Rosita A., Cordeschi, Giuliana, D’Andrea, Settimio, Mambro, Antonella Di, Esposito, Daniela, Foresta, Carlo, Francavilla, Sandro, Galdiero, Mariano, Garolla, Andrea, Giovannini, Lara, Balercia, Antonio R. M., La Vignera, Sandro, Motta, Giovanna, Luciano, Luciano, Pelliccione, Fiore, Persani, Luca, Santi, Daniele, Selice, Riccardo, Simoni, Manuela, Tatone, Carla, Tirabassi, Giacomo, Tresoldi, Alberto Stefano, Vicari, Enzo, Bonomi, M, Rochira, V, Pasquali, Daniela, Balercia, G, Jannini, E. A, and Ferlin, A.

Subjects
Endocrinology, Diabetes and Metabolism, Azoospermia, Chromosome abnormalities, Hypergonadotropic hypogonadism, Klinefelter syndrome, KS, Male infertility, Testosterone, Humans, Hypogonadism, Klinefelter Syndrome, Phenotype, Endocrinology, 030209 endocrinology & metabolism, Disease, Biology, Settore MED/13 - Endocrinologia, 03 medical and health sciences, 0302 clinical medicine, Genetic, medicine, Diabetes and Metabolism, Clinical phenotype, Chromosome abnormalitie, Genetics, 030219 obstetrics & reproductive medicine, medicine.disease, Short Review
Abstract

Klinefelter Syndrome (KS) is characterized by an extreme heterogeneity in its clinical and genetic presentation. The relationship between clinical phenotype and genetic background has been partially disclosed; nevertheless, physicians are aware that several aspects concerning this issue are far to be fully understood. By improving our knowledge on the role of some genetic aspects as well as on the KS, patients' interindividual differences in terms of health status will result in a better management of this chromosomal disease. The aim of this review is to provide an update on both genetic and clinical phenotype and their interrelationships.

Published
2017

5. Klinefelter syndrome: cardiovascular abnormalities and metabolic disorders

Author

Calogero, Ae, Giagulli, Va, Mongioì, Lm, Triggiani, V, Radicioni, Af, Jannini, Ea, Pasquali, D, Klinefelter ItaliaN Group KING: Balercia, G, Bonomi, M, Corona, G, Fabbri, A, Ferlin, Alberto, Francavilla, F, Giagulli, V, Lanfranco, F, Maggi, M, Pivonello, R, Pizzocaro, A, Radicioni, A, Rochira, V, Vignozzi, L, Accardo, G, Cangiano, B, Condorelli, Ra, Cordeschi, G, D'Andrea, S, Di Mambro, A, Esposito, D, Foresta, Carlo, Francavilla, S, Galdiero, M, Garolla, Andrea, Giovannini, L, Granata, Ar, La Vignera, S, Motta, G, Negri, L, Pelliccione, F, Persani, L, Salzano, C, Santi, D, Selice, R, Simoni, M, Tatone, C, Tirabassi, G, Tresoldi, As, Vicari, E., Calogero, A. E, Giagulli, V. A, Mongioì, L. M, Triggiani, V, Radicioni, A. F, Jannini, E. A, and Pasquali, Daniela

Subjects
medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Cardiovascular Abnormalities, Hypergonadotropic hypogonadism, 030209 endocrinology & metabolism, Cardiovascular disease, Chromosome abnormalities, Klinefelter syndrome, Metabolism, Testosterone, Humans, Klinefelter Syndrome, Metabolic Syndrome, Risk Factors, Male infertility, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Internal medicine, medicine, Chromosome abnormalitie, 030219 obstetrics & reproductive medicine, business.industry, Type 2 Diabetes Mellitus, medicine.disease, Comorbidity, Obesity, Standardized mortality ratio, Metabolic syndrome, business
Abstract

Klinefelter syndrome (KS) is one of the most common genetic causes of male infertility. This condition is associated with much comorbidity and with a lower life expectancy. The aim of this review is to explore more in depth cardiovascular and metabolic disorders associated to KS. KS patients have an increased risk of cerebrovascular disease (standardized mortality ratio, SMR, 2.2; 95% confidence interval, CI, 1.6-3.0), but it is not clear whether the cause of the death is of thrombotic or hemorrhagic nature. Cardiovascular congenital anomalies (SMR, 7.3; 95% CI, 2.4-17.1) and the development of thrombosis or leg ulcers (SMR, 7.9; 95% CI, 2.9-17.2) are also more frequent in these subjects. Moreover, cardiovascular abnormalities may be at least partially reversed by testosterone replacement therapy (TRT). KS patients have also an increased probability of endocrine and/or metabolic disease, especially obesity, metabolic syndrome and type 2 diabetes mellitus. The effects of TRT on these abnormalities are not entirely clear. Purpose: The prevalence and the etiopathogenesis of thyroid dysfunctions in Klinefelter syndrome (KS) are still unclear. The primary aim of this study was to evaluate the pathogenetic role of hypogonadism in the thyroid disorders described in KS, with the scope to distinguish between patients with KS and hypogonadism due to other causes (Kallmann syndrome, idiopathic hypogonadotropic hypogonadism, iatrogenic hypogonadism and acquired hypogonadotropic hypogonadism after surgical removal of pituitary adenomas) called non-KS. Therefore, we evaluated thyroid function in KS and in non-KS hypogonadal patients. Methods: This is a case–control multicentre study from KING group: Endocrinology clinics in university-affiliated medical centres. One hundred and seventy four KS, and sixty-two non-KS hypogonadal men were enrolled. The primary outcome was the prevalence of thyroid diseases in KS and in non-KS. Changes in hormonal parameters were evaluated. Exclusion criterion was secondary hypothyroidism. Analyses were performed using Student’s t test. Mann–Whitney test and Chi-square test. Results: FT4 was significantly lower in KS vs non-KS. KS and non-KS presented similar TSH and testosterone levels. Hashimoto’s thyroiditis (HT) was diagnosed in 7% of KS. Five KS developed hypothyroidism. The ratio FT3/FT4 was similar in both groups. TSH index was 1.9 in KS and 2.3 in non-KS. Adjustment for differences in age, sample size and concomitant disease in multivariate models did not alter the results. Conclusions: We demonstrated in KS no etiopathogenic link to hypogonadism or change in the set point of thyrotrophic control in the altered FT4 production. The prevalence of HT in KS was similar to normal male population, showing absence of increased risk of HT associated with the XXY karyotype.

Published
2017

6. Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: prostate health outcomes in the Registry of Hypogonadism in Men

Author

Maggi, M, Debruyne, F. M. J., Behre, H. M. b, Roehrborn, C. G. c, F. C. W. e, Wu, Schröder, F. H. f, Jones, T. H. g, Porst, H. h, Hackett, G. i, Wheaton, O. A. j, Martin-Morales, A. k, Meuleman, E. l, Cunningham, G. R. m, Divan, H. A. j, Rosen, jEmail Author, R. C., the RHYME Investigators, Dohle G., N, Arver S., N, Lenzi A., N, Stroberg P., N, Maggio M., N, Cruz N., N, Balercia G., N, Yassin A., N, Reisman C., N, Bassa L., N, Pescatori E., N, Martinez, Salamanca, J. I., N, Romero, Otero, n Jockenhoevel, J., Urology, and CCA - Evaluation of Cancer Care

Subjects
Male, medicine.medical_specialty, #PCSM, #ProstateCancer, benign prostatic hyperplasia, disease registry, hypogonadism, testosterone, Hormone Replacement Therapy, Urology, 030232 urology & nephrology, Physical examination, urologic and male genital diseases, Risk Assessment, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Lower Urinary Tract Symptoms, Lower urinary tract symptoms, Prostate, Medicine, Humans, Medical history, Testosterone, Registries, medicine.diagnostic_test, business.industry, Hypogonadism, Prostatic Neoplasms, Middle Aged, Prostate-Specific Antigen, medicine.disease, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Disease Progression, International Prostate Symptom Score, business, Blood sampling
Abstract

OBJECTIVES: To evaluate the effects of testosterone-replacement therapy (TRT) on prostate health indicators in hypogonadal men, including rates of prostate cancer diagnoses, changes in prostate-specific antigen (PSA) levels and lower urinary tract symptoms (LUTS) over time.PATIENTS AND METHODS: The Registry of Hypogonadism in Men (RHYME) is a multi-national patient registry of treated and untreated, newly-diagnosed hypogonadal men (n = 999). Follow-up assessments were performed at 3-6, 12, 24, and 36 months. Baseline and follow-up data collection included medical history, physical examination, blood sampling, and patient questionnaires. Prostate biopsies underwent blinded independent adjudication for the presence and severity of prostate cancer; PSA and testosterone levels were measured via local and central laboratory assays; and LUTS severity was assessed via the International Prostate Symptom Score (IPSS). Incidence rates per 100 000 person-years were calculated. Longitudinal mixed models were used to assess effects of testosterone on PSA levels and IPSS.RESULTS: Of the 999 men with clinically diagnosed hypogonadism (HG), 750 (75%) initiated TRT, contributing 23 900 person-months of exposure. The mean testosterone levels increased from 8.3 to 15.4 nmol/L in treated men, compared to only a slight increase from 9.4 to 11.3 nmol/L in untreated men. In all, 55 biopsies were performed for suspected prostate cancer, and 12 non-cancer related biopsies were performed for other reasons. Overall, the proportion of positive biopsies was nearly identical in men on TRT (37.5%) compared to those not on TRT (37.0%) over the course of the study. There were no differences in PSA levels, total IPSS, or the IPSS obstructive sub-scale score by TRT status. Lower IPSS irritative sub-scale scores were reported in treated compared to untreated men.CONCLUSIONS: Results support prostate safety of TRT in newly diagnosed men with HG.

Published
2017

7. Relationship between BMI, PSA and Histopathological Tumor Grade in a Caucasian Population Affected by Prostate Cancer

Author

Tenaglia R.L, Balercia G, Gioia A, Manco R, and Tirabassi G

Subjects
Gynecology, Oncology, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Prostatectomy, medicine.medical_treatment, Retrospective cohort study, urologic and male genital diseases, medicine.disease, Obesity, Tumor grade, Prostate cancer, Internal medicine, Biopsy, Medicine, business, Caucasian population, Body mass index
Abstract

The aim of this work is to show the relationship between obesity and aggressivenes of Prostate Cancer. We conducted a retrospective study of 132 men affected by Prostate Cancer underwent radical prostatectomy. Gleason score was abstracted by biopsy specimens and by post-operatory specimens. We evaluated PSA level and Body Mass Index (BMI).

Published
2014

8. Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: The PAUSE study

Author

Mirone V, ARCANIOLO, Davide, Rivas D, Bull S, Aquilina JW, Verze P, PAUSE study team Berchart G, Hass M, Ludvik G, Aalto J, Hendolin N, Lukkarinen O, Multanen M, Nurmenniemi V, Piha J, Aheimer C, Alebrahim Dehkordy A, Andreessen R, Aust C, Baer P, Bath V, Baumgrass H, Beck C, Beecken WD, Behre H, Beitzinger M, Belusa A, Bermes UR, Berning T, Bieringer La Roche D, Blasko S, Boehmer S, Borchardt A, Boerner T, Brands F, Braun PM, Braun R, Breu D, Briken P, Brueske T, Bueker R, Buse A, Carius A, Christoph F, Cuno M, Dats E, Degen N, Denil J, Dietrichs K, Domnitz R, Dorn B, Dubiel J, Eckert R, Ehrenberg W, Eichler S, El Khadra S, Engl T, Esser O, Faragallah EA, Farahmandi R, Finke G, Fleig P, Fruehauf E, Gerhardt U, Girke CG, Glauche J, Gleissner J, Gnann R, Gralla O, Grandin A, Grewe W, Gronau E, Gruber S, Grunert S, Guelbeyaz M, Guelden H, Haendel D, Haefele J, Haghighat M, Hahne D, Haschemi Schirazi R, Hecker D, Herzig J, Hettmmer R, Hitschfeld K, Hofmann J, Hohmuth H, Hoelker D, Huebner A, Hudemann B, Hung Wehmann D, Huenninghaus K, Hueter K, Igde H, Jaeger T, Javadi P, John G, Ju M, Kaisser G, Kamann L, Kastein A, Kaup F, Kellner T, Kempe T, Kempter F, Kennerknecht M, Kirschner P, Koenig M, Konert J, Kowalik S, Krieger JU, Kruppa GL, Kube U, Kuehn F, Kuefer R, Kurt T, Kwela M, Laag R, Langen L, Lehmann J, Linder C, Loeber T, Lock UC, Loebenau M, Luberg Sievers G, Luebbe R, Lutz K, Maier S, Maletz C, Mertins B, Meschede E, Meschi MR, Miersch WD, Misera A, Muehlich S, Mueller HW, Mueller D, Muench HC, Nawka P, Othman K, Paiss T, Peter K, Peters T, Petras T, Petrischenko B, Pfund A, Plate H, Ploss HJ, Pohrt U, Pooyeh S, Potempa AJ, Pusinelli WD, Rausch U, Reinhardt F, Rengel U, Rietheimer W, Rinnab L, Rohrmann K, Romahn E, Romitan Baum R, Roessler T, Rudolph R, Rueffer J, Rug M, Rueth J, Ruettgers E, Santiago RB, Schaefer A, Schaefer T, Schaetzle P, Scheunpflug K, Schlicht J, Schmidt P, Schneider J, Schnitzler M, Schonfelder R, Schreier H, Schroeder A, Schulz FM, Schulze M, Schumann M, Seidler A, Seseke S, Siebel Eggeling G, Siebels M, Sinner B, Sippel F, Soballa M, Sommer F, Spielhaupter A, Steffen H, Steinacker M, Stiersdorfer A, Stoehr C, Sturm S, Surrey HW, Swoboda A, Szymula S, Telle J, Uththoff H, Vierneisel C, Vilmar W, Wagner M, Walhoefer F, Warnack W, Weiss J, Weizert P, Wicht A, Wieland J, Willgerodt J, Wilski B, Wilson E, Wipfler G, Wohn HG, Wolf J, Zoehrlaut B, Zuerner T, Angeletti G, Avolio A, Baldassarre R, Balercia G, Balloni F, Barba G, Bartoletti R, Basile Fasolo C, Bassi PF, Beatrici V, Bertozzi MA, Bocciardi AM, Bondavalli C, Bonini F, Bonsanto M, Branchi A, Briganti A, Calabrese M, Calafiore R, Calogero AE, Cantelmo P, Caraceni E, Carbone A, Cardella A, Carini M, Carmignani L, Carmignani G, Carrino M, Caviglia C, Cecchi M, Ceruti C, Chiovato L, Cicalese V, Colpi G, Corinti M, Cormio L, Cova G, Cozzupoli P, Ottavio G, Damiano R, De Ceglie G, De Grande G, De Lisa A, DE SIO, Marco, De Stefani S, Dehò F, Delsignore A, Di Filippo A, Di Lena S, Di Trapani D, Diambrini M, Drei GN, Fabbri A, Fasolis G, Ferone D, Ferrari G, Foresta C, Francavilla S, Gadda F, Galantini A, Galì A, Gentile V, Giammusso B, Giannubilo W, Granata A, Grasso M, Iafrate M, Ilacqua N, Isidori A, Italiano E, Jallous HA, Jannini E, La Pera G, Laganà F, Lauretti S, Leonardi R, Liguori G, Loiero G, Lombardi G, Lombardo F, Lusenti C, Maffucci A, Maggi M, Maio G, Mammana G, Manieri C, Marzotto Caotorta M, Mastroeni F, Mazzilli F, Mazzone L, Minervini M, Mirone VG, Montorsi F, Morelli G, Morrone G, Nicita G, Nicola M, Palmiotto F, Paradiso M, Paulis G, Pavone C, Pescatori ES, Petterle V, Piazza N, Pittaluga P, Piubello G, Polito M, Ponchietti R, Porena M, Rago R, Risi O, Roggia A, Salzano L, Sanseverino R, SASSO, Ferdinando Carlo, Savoca G, Scarano P, Schips L, Serao A, Sforza A, Sidari V, Silvani M, Sinisi A, Sorrentino F, Spera E, Strada G, Tenaglia R, Terrone C, Titta M, Tracia A, Turchi P, Ughi G, Vecchio D, Veneziano IA, Vicini P, Vita A, Vitti P, Volpi R, Zago T, Zenico T, Zito AR, Apolinario M, Carvalho AP, Corte Real J, Matos Cabeca J, Mendes Leal A, Monteiro Pereira N, Palma dos Reis J, Patricio A, Prisco R, Rocha Mendes J, Santos A, Vieira R, Abad Gairín C, Abascal García JM, Adot Zurbano JM, Álvarez de la Red PL, Al Wattar W, Antón Saiz C, Aranda Doncel N, Arrosagaray PM, Arteaga Serrano F, Barberán Soriano J, Bataller Perello V, Beltrán Persiva J, Benejam Gual J, Blanco Díez A, Blasco Casares FJ, Blasco Villalonga M, Blázquez Izquierdo J, Boladeras Sabater J, Borrás JJ, Bouchi Bakrim AR, Bucar Terrades S, Burgués Gasión JP, Busto Castañón L, Caballero JM, Cabello Santamaría F, Cabreja López E, Carrasco Aznar JC, Casasola Chamorro J, Castellanos González L, Cimadevila García A, Closas Capdevila M, Concepción Masip T, Conde C, Conde Santos G, Cortada i. Robert J, Cos Calvet JM, Crespi Martínez F, Cruz N, De la Rosa Khermann M, Delgado Martín JA, Devesa Mújica M, Doganis Peppas C, Domínguez Freire F, Donderis Guastavino C, Duarte Vázquez JJ, El Khoury Yacob R, Escobal Tamayo V, Farré Martí JM, Fernández Fernández A, Fernández Lozano A, Fernández Viñas JA, Fiter Gómez L, Fleitas Asencio E, Frago Valls SM, Galiana Álvarez A, García Bayo I, García Contreras J, García Cruz E, García de Jalón Martín A, García Giralda L, García Marco MA, García Navas R, García Reboll L, Garrido Insúa S, Giner Santamaría C, Gómez Berjón F, Gómez Gil E, Gómez Lanza E, Gómez Pérez L, Gómez Rodríguez A, González Sala JL, González Sala MJ, Gonzalvo Ybarra A, Guerrero Martínez V, Gutiérrez González MA, Gutierrez Mínguez E, Hidalgo Arroyo J, Hmeidan M, Idígora i. Planas X, Jara Rascón J, Jiménez Verdejo J, Lledó García E, Lliteras Arañi M, López Almansa M, López Palacios MÁ, López Tello J, Lorenzo Gómez MF, Luque Gálvez P, Luque López AJ, Mallafré Sala JM, Martí Cebrián JM, Martín Clos J, Martín Huescar A, Martín Morales A, Martín Rodríguez A, Martínez Rodríguez R, Martínez Salamanca JI, Mascarós Balaguer E, Mejide Manresa R, Molero Rodríguez F, Molina Carranza A, Moncada Iribarren I, Montagud Moncho JB, Montesino Semper M, Mosteiro Ponce JA, Mouaffak Tatari N, Navarro Gil JM, Novás Castro S, Ortiz del Corral ML, Ortiz Gamiz A, Osca García JM, Padilla León M, Palomino García A, Pascual Mateo C, Peinado Ibarra F, Pérez Mestre M, Portillo Martín JA, Poyato Galán JM, Prats de Puig J, Prieto Castro R, Puigvert Martínez A, Quintana de la Rosa JL, Ramada Benlloch FJ, Reyes Martínez F, Rigabert M, Ríos Espuny AF, Robles Iniesta A, Rodrigo Aliaga M, Rodríguez Alba JL, Rodríguez Bethencourt F, Rodríguez Jiménez FJ, Rodríguez Leal DA, Rodríguez Rubio F, Rodríguez Tolrá J, Rodríguez Vallejo JM, Romero Otero J, Roselló Barbará M, Rubio Briones J, Ruíz Moriana O, Sampol Company J, San Martín Blanco C, Sánchez Encinas M, Sánchez Sánchez F, Sancho Serrano C, Santandreu Puifros J, Santisteban González M, Santos Ascarza Tabares JL, Sanz Lahoz I, Sapiña Ortola F, Sarquella Geli J, Segarra Tomás J, Soler Fernández J, Tato Rodríguez J, Tesedo Cubedo J, Traid Sender V, Valbuena Álvarez R, Valverde Rubio JM, Varela Salgado M, Vargas Rugeles M, Vilches Cocovi E, Virto Bajo FJ, Andius P, Anker Hansen O, Arver S, Bosson P, Brattberg A, Grenabo L, Hanning J, Hassler L, Paradis AÅ, Wang E., Mirone, Vincenzo, Arcaniolo, Davide, David, Riva, Scott, Bull, Joseph W., Aquilina, Verze, Paolo, Mirone, V, Arcaniolo, D, Rivas, D, Bull, S, Aquilina, JW, Verze, P, Pavone, C, Aquilina, Jw, PAUSE study team Berchart, G, Hass, M, Ludvik, G, Aalto, J, Hendolin, N, Lukkarinen, O, Multanen, M, Nurmenniemi, V, Piha, J, Aheimer, C, Alebrahim Dehkordy, A, Andreessen, R, Aust, C, Baer, P, Bath, V, Baumgrass, H, Beck, C, Beecken, Wd, Behre, H, Beitzinger, M, Belusa, A, Bermes, Ur, Berning, T, Bieringer La Roche, D, Blasko, S, Boehmer, S, Borchardt, A, Boerner, T, Brands, F, Braun, Pm, Braun, R, Breu, D, Briken, P, Brueske, T, Bueker, R, Buse, A, Carius, A, Christoph, F, Cuno, M, Dats, E, Degen, N, Denil, J, Dietrichs, K, Domnitz, R, Dorn, B, Dubiel, J, Eckert, R, Ehrenberg, W, Eichler, S, El Khadra, S, Engl, T, Esser, O, Faragallah, Ea, Farahmandi, R, Finke, G, Fleig, P, Fruehauf, E, Gerhardt, U, Girke, Cg, Glauche, J, Gleissner, J, Gnann, R, Gralla, O, Grandin, A, Grewe, W, Gronau, E, Gruber, S, Grunert, S, Guelbeyaz, M, Guelden, H, Haendel, D, Haefele, J, Haghighat, M, Hahne, D, Haschemi Schirazi, R, Hecker, D, Herzig, J, Hettmmer, R, Hitschfeld, K, Hofmann, J, Hohmuth, H, Hoelker, D, Huebner, A, Hudemann, B, Hung Wehmann, D, Huenninghaus, K, Hueter, K, Igde, H, Jaeger, T, Javadi, P, John, G, Ju, M, Kaisser, G, Kamann, L, Kastein, A, Kaup, F, Kellner, T, Kempe, T, Kempter, F, Kennerknecht, M, Kirschner, P, Koenig, M, Konert, J, Kowalik, S, Krieger, Ju, Kruppa, Gl, Kube, U, Kuehn, F, Kuefer, R, Kurt, T, Kwela, M, Laag, R, Langen, L, Lehmann, J, Linder, C, Loeber, T, Lock, Uc, Loebenau, M, Luberg Sievers, G, Luebbe, R, Lutz, K, Maier, S, Maletz, C, Mertins, B, Meschede, E, Meschi, Mr, Miersch, Wd, Misera, A, Muehlich, S, Mueller, Hw, Mueller, D, Muench, Hc, Nawka, P, Othman, K, Paiss, T, Peter, K, Peters, T, Petras, T, Petrischenko, B, Pfund, A, Plate, H, Ploss, Hj, Pohrt, U, Pooyeh, S, Potempa, Aj, Pusinelli, Wd, Rausch, U, Reinhardt, F, Rengel, U, Rietheimer, W, Rinnab, L, Rohrmann, K, Romahn, E, Romitan Baum, R, Roessler, T, Rudolph, R, Rueffer, J, Rug, M, Rueth, J, Ruettgers, E, Santiago, Rb, Schaefer, A, Schaefer, T, Schaetzle, P, Scheunpflug, K, Schlicht, J, Schmidt, P, Schneider, J, Schnitzler, M, Schonfelder, R, Schreier, H, Schroeder, A, Schulz, Fm, Schulze, M, Schumann, M, Seidler, A, Seseke, S, Siebel Eggeling, G, Siebels, M, Sinner, B, Sippel, F, Soballa, M, Sommer, F, Spielhaupter, A, Steffen, H, Steinacker, M, Stiersdorfer, A, Stoehr, C, Sturm, S, Surrey, Hw, Swoboda, A, Szymula, S, Telle, J, Uththoff, H, Vierneisel, C, Vilmar, W, Wagner, M, Walhoefer, F, Warnack, W, Weiss, J, Weizert, P, Wicht, A, Wieland, J, Willgerodt, J, Wilski, B, Wilson, E, Wipfler, G, Wohn, Hg, Wolf, J, Zoehrlaut, B, Zuerner, T, Angeletti, G, Avolio, A, Baldassarre, R, Balercia, G, Balloni, F, Barba, G, Bartoletti, R, Basile Fasolo, C, Bassi, Pf, Beatrici, V, Bertozzi, Ma, Bocciardi, Am, Bondavalli, C, Bonini, F, Bonsanto, M, Branchi, A, Briganti, A, Calabrese, M, Calafiore, R, Calogero, Ae, Cantelmo, P, Caraceni, E, Carbone, A, Cardella, A, Carini, M, Carmignani, L, Carmignani, G, Carrino, M, Caviglia, C, Cecchi, M, Ceruti, C, Chiovato, L, Cicalese, V, Colpi, G, Corinti, M, Cormio, L, Cova, G, Cozzupoli, P, Ottavio, G, Damiano, R, De Ceglie, G, De Grande, G, De Lisa, A, DE SIO, Marco, De Stefani, S, Dehò, F, Delsignore, A, Di Filippo, A, Di Lena, S, Di Trapani, D, Diambrini, M, Drei, Gn, Fabbri, A, Fasolis, G, Ferone, D, Ferrari, G, Foresta, C, Francavilla, S, Gadda, F, Galantini, A, Galì, A, Gentile, V, Giammusso, B, Giannubilo, W, Granata, A, Grasso, M, Iafrate, M, Ilacqua, N, Isidori, A, Italiano, E, Jallous, Ha, Jannini, E, La Pera, G, Laganà, F, Lauretti, S, Leonardi, R, Liguori, G, Loiero, G, Lombardi, G, Lombardo, F, Lusenti, C, Maffucci, A, Maggi, M, Maio, G, Mammana, G, Manieri, C, Marzotto Caotorta, M, Mastroeni, F, Mazzilli, F, Mazzone, L, Minervini, M, Mirone, Vg, Montorsi, F, Morelli, G, Morrone, G, Nicita, G, Nicola, M, Palmiotto, F, Paradiso, M, Paulis, G, Pescatori, E, Petterle, V, Piazza, N, Pittaluga, P, Piubello, G, Polito, M, Ponchietti, R, Porena, M, Rago, R, Risi, O, Roggia, A, Salzano, L, Sanseverino, R, Sasso, Ferdinando Carlo, Savoca, G, Scarano, P, Schips, L, Serao, A, Sforza, A, Sidari, V, Silvani, M, Sinisi, A, Sorrentino, F, Spera, E, Strada, G, Tenaglia, R, Terrone, C, Titta, M, Tracia, A, Turchi, P, Ughi, G, Vecchio, D, Veneziano, Ia, Vicini, P, Vita, A, Vitti, P, Volpi, R, Zago, T, Zenico, T, Zito, Ar, Apolinario, M, Carvalho, Ap, Corte Real, J, Matos Cabeca, J, Mendes Leal, A, Monteiro Pereira, N, Palma dos Reis, J, Patricio, A, Prisco, R, Rocha Mendes, J, Santos, A, Vieira, R, Abad Gairín, C, Abascal García, Jm, Adot Zurbano, Jm, Álvarez de la Red, Pl, Al Wattar, W, Antón Saiz, C, Aranda Doncel, N, Arrosagaray, Pm, Arteaga Serrano, F, Barberán Soriano, J, Bataller Perello, V, Beltrán Persiva, J, Benejam Gual, J, Blanco Díez, A, Blasco Casares, Fj, Blasco Villalonga, M, Blázquez Izquierdo, J, Boladeras Sabater, J, Borrás, Jj, Bouchi Bakrim, Ar, Bucar Terrades, S, Burgués Gasión, Jp, Busto Castañón, L, Caballero, Jm, Cabello Santamaría, F, Cabreja López, E, Carrasco Aznar, Jc, Casasola Chamorro, J, Castellanos González, L, Cimadevila García, A, Closas Capdevila, M, Concepción Masip, T, Conde, C, Conde Santos, G, Cortada i., Robert J, Cos Calvet, Jm, Crespi Martínez, F, Cruz, N, De la Rosa Khermann, M, Delgado Martín, Ja, Devesa Mújica, M, Doganis Peppas, C, Domínguez Freire, F, Donderis Guastavino, C, Duarte Vázquez, Jj, El Khoury Yacob, R, Escobal Tamayo, V, Farré Martí, Jm, Fernández Fernández, A, Fernández Lozano, A, Fernández Viñas, Ja, Fiter Gómez, L, Fleitas Asencio, E, Frago Valls, Sm, Galiana Álvarez, A, García Bayo, I, García Contreras, J, García Cruz, E, García de Jalón Martín, A, García Giralda, L, García Marco, Ma, García Navas, R, García Reboll, L, Garrido Insúa, S, Giner Santamaría, C, Gómez Berjón, F, Gómez Gil, E, Gómez Lanza, E, Gómez Pérez, L, Gómez Rodríguez, A, González Sala, Jl, González Sala, Mj, Gonzalvo Ybarra, A, Guerrero Martínez, V, Gutiérrez González, Ma, Gutierrez Mínguez, E, Hidalgo Arroyo, J, Hmeidan, M, Idígora i., Planas X, Jara Rascón, J, Jiménez Verdejo, J, Lledó García, E, Lliteras Arañi, M, López Almansa, M, López Palacios, Má, López Tello, J, Lorenzo Gómez, Mf, Luque Gálvez, P, Luque López, Aj, Mallafré Sala, Jm, Martí Cebrián, Jm, Martín Clos, J, Martín Huescar, A, Martín Morales, A, Martín Rodríguez, A, Martínez Rodríguez, R, Martínez Salamanca, Ji, Mascarós Balaguer, E, Mejide Manresa, R, Molero Rodríguez, F, Molina Carranza, A, Moncada Iribarren, I, Montagud Moncho, Jb, Montesino Semper, M, Mosteiro Ponce, Ja, Mouaffak Tatari, N, Navarro Gil, Jm, Novás Castro, S, Ortiz del Corral, Ml, Ortiz Gamiz, A, Osca García, Jm, Padilla León, M, Palomino García, A, Pascual Mateo, C, Peinado Ibarra, F, Pérez Mestre, M, Portillo Martín, Ja, Poyato Galán, Jm, Prats de Puig, J, Prieto Castro, R, Puigvert Martínez, A, Quintana de la Rosa, Jl, Ramada Benlloch, Fj, Reyes Martínez, F, Rigabert, M, Ríos Espuny, Af, Robles Iniesta, A, Rodrigo Aliaga, M, Rodríguez Alba, Jl, Rodríguez Bethencourt, F, Rodríguez Jiménez, Fj, Rodríguez Leal, Da, Rodríguez Rubio, F, Rodríguez Tolrá, J, Rodríguez Vallejo, Jm, Romero Otero, J, Roselló Barbará, M, Rubio Briones, J, Ruíz Moriana, O, Sampol Company, J, San Martín Blanco, C, Sánchez Encinas, M, Sánchez Sánchez, F, Sancho Serrano, C, Santandreu Puifros, J, Santisteban González, M, Santos Ascarza Tabares, Jl, Sanz Lahoz, I, Sapiña Ortola, F, Sarquella Geli, J, Segarra Tomás, J, Soler Fernández, J, Tato Rodríguez, J, Tesedo Cubedo, J, Traid Sender, V, Valbuena Álvarez, R, Valverde Rubio, Jm, Varela Salgado, M, Vargas Rugeles, M, Vilches Cocovi, E, Virto Bajo, Fj, Andius, P, Anker Hansen, O, Arver, S, Bosson, P, Brattberg, A, Grenabo, L, Hanning, J, Hassler, L, Paradis, Aå, and Wang, E.

Subjects
Adult, Complementary Therapies, Male, medicine.medical_specialty, Benzylamines, Adolescent, Nausea, Urology, Naphthalenes, Dapoxetine Safety Cardiovascular events Syncope, Syncope, Cardiovascular events, Young Adult, Internal medicine, Premature ejaculation, medicine, 80 and over, Dapoxetine, Safety, Aged, Aged, 80 and over, Humans, Middle Aged, Premature Ejaculation, Prospective Studies, Serotonin Uptake Inhibitors, Adverse effect, Prospective cohort study, Sertraline, business.industry, Settore MED/24 - UROLOGIA, Incidence (epidemiology), syncope, Anesthesia, Observational study, medicine.symptom, business, Selective Serotonin Reuptake Inhibitors, medicine.drug, Cardiovascular events, Dapoxetine, Safety, Syncope
Abstract

Background Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor and the first drug approved for the on-demand treatment of premature ejaculation (PE). Its safety was established in a thorough clinical development program. Objective To characterize the safety profile of dapoxetine in PE treatment and to report the incidence, severity, and type of adverse events. Design, setting, and participants We conducted a 12-wk, open-label, observational study with a 4-wk, postobservational contact. A total of 10 028 patients were enrolled, with 6712 patients (67.6%) treated with dapoxetine 30–60mg (group A)and 3316 (32.4%) treated with alternative care/nondapoxetine (group B). Interventions Treatment with dapoxetine or alternative care/nondapoxetine. Outcome measurements and statistical analysis Treatment-emergent adverse events (TEAEs) and concomitant therapy use during the 12-wk observational and the postobservational period were reported. Results and limitations The mean age for all patients was 40.5 yr. In group A, 93.0% of the patients were initially prescribed dapoxetine 30mg. Treatment options for group B patients included clomipramine, paroxetine, fluoxetine, sertraline, topical drugs, condoms, and behavioral counseling. Both treatment regimens were well tolerated. TEAEs were reported by 12.0% and 8.9% of group A and group B, respectively, with the highest incidence observed in patients aged >65 yr for group A (21.4%) and 30–39 yr (9.8%) for group B. The most commonly reported TEAEs were nausea, headache, and vertigo, with a higher incidence in group A (3.1%, 2.6%, and 1.0%, respectively) than in group B (oral drugs: 2.3%, 1.3%, and 0.9%, respectively). There were no cases of syncope in group A and one case in group B. A major limitation is that this was a nonrandomized, open-label, short-term study lacking efficacy data. Conclusions The results of this postmarketing observational study demonstrated that dapoxetine for treatment of PE has a good safety profile and low prevalence of TEAEs. Syncope and major cardiovascular adverse events were not reported. The high level of adherence by healthcare providers to the contraindications, special warnings, and precautions for dapoxetine minimizes the risk for its use in routine clinical practice. The current risk minimization measures for its identified and potential risks are effective.

Published
2014

9. The SIAMS-ED Trial: A National, Independent, Multicentre Study on Cardiometabolic and Hormonal Impairment of Men with Erectile Dysfunction Treated with Vardenafil

Author

Isidori, Andrea, Giovanni, Corona, Antonio, Aversa, Gianfrilli, Daniele, Jannini, Emmanuele A., Carlo, Foresta, Mario, Maggi, Lenzi, Andrea, Andò, S, Angelletti, G, Matteo, B, Balercia, G, Giuseppe, B, Calogero, A, Canale, D, Caprio, M, Caretta, N, Erennio, C, Colpi, G, Fabbri, A, Fornengo, R, Francavilla, S, Francomano, D, Gavioli, S, Angelo, G, Giannetta, E, Goglia, U, Nicola, I, La Vignera, S, Lemma, A, Mancini, M, Manieri, C, Mansani, R, Tommaso, M, Minuto, F, Alessandro, O, Paggi, F, Rosario, P, Fiore, P, Anna, P, Perrini, S, Riccardo, P, Pozza, C, Sbardella, E, Stefano, S, and Sinisi, A.

Subjects
Gerontology, medicine.medical_specialty, Article Subject, Coronary-heart-disease, Endocrinology, Diabetes and Metabolism, Population, quality-of-life, metabolic syndrome, arterial stiffness, sexual dysfunction, general-population, diabetic-patients, blood-pressure, pulse pressure, cardiovascular-disease, SIAMS-ED, lcsh:Diseases of the endocrine glands. Clinical endocrinology, Cardiometabolic and hormonal impairment, Settore MED/13 - Endocrinologia, Endocrinology, Sexual medicine, Internal medicine, medicine, Erectile dysfunction, education, Adverse effect, education.field_of_study, lcsh:RC648-665, Endocrine and Autonomic Systems, business.industry, medicine.disease, erectile dysfunction, PDE5 inhibitors, Pulse pressure, medicine.anatomical_structure, Vardenafil, Clinical Study, Vascular resistance, Metabolic syndrome, business, medicine.drug
Abstract

Increased cardiovascular risk has been associated with reduced response to proerectile drugs. The Italian Society of Andrology and Sexual Medicine (SIAMS) promoted an independent, multicenter study performed in 604 men (55 ± 12 yrs) suffering from erectile dysfunction (ED) to assess multiple health outcomes and response to 6-month vardenafil challenge in a real-life setting. Overall, 30.8% men had metabolic syndrome. Cardiovascular risk stratification revealed a greater number of ED subjects with moderate risk of a major adverse cardiovascular event than the general population (P<0.01). Age-adjusted pulse pressure was positively correlated with ED severity and negatively with androgens and waist circumference (P<0.01). A decline in total testosterone was observed with increasing arterial pulse pressure (P<0.05), which was not accompanied by compensatory LH rise. Follow-up on 185 men treated with vardenafil in an nonrandomized, open, single-arm trial documented a significant rise in IIEF-5 (delta = 6.1 ± 4.8) that was maintained in men with high cardiovascular risk. Mild adverse events occurred in

Published
2014

10. Risk behaviours and alcohol in adolescence are negatively associated with testicular volume: results from the Amico-Andrologo survey

Author

Patrizio Pasqualetti, Andrea Garolla, Giancarlo Balercia, Daniele Santi, A. R. M. Granata, Alberto Ferlin, Rosario Pivonello, Andrea Lenzi, A.M. Sinisi, Daniele Gianfrilli, Andrea M. Isidori, Fabio Lanfranco, Andrea Sansone, Mario Maggi, Carlo Foresta, Gianfrilli, D, Ferlin, A, Isidori, A M, Garolla, A, Maggi, M, Pivonello, R, Santi, D, Sansone, A, Balercia, G, Granata, A R M, Sinisi, A, Lanfranco, F, Pasqualetti, P, Foresta, C, Lenzi, A, Gianfrilli, D., Ferlin, A., Isidori, A. M., Garolla, A., Maggi, M., Pivonello, R., Santi, D., Sansone, A., Balercia, G., Granata, A. R. M., Sinisi, A., Lanfranco, F., Pasqualetti, P., Foresta, C., and Lenzi, A.

Subjects
Male, Adolescent, Alcohol Drinking, Substance-Related Disorders, Urology, Endocrinology, Diabetes and Metabolism, Sexual Behavior, health risk behaviour, Overweight, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Endocrinology, Settore MED/13, Risk-Taking, prevention, Recall bias, Sexual medicine, health risk behaviours, Surveys and Questionnaires, Premature ejaculation, Testis, medicine, Humans, Sexual Maturation, adolescence, alcohol, andrological health, testicular development, Reproductive health, 030219 obstetrics & reproductive medicine, business.industry, Smoking, adolescence, alcohol, andrological health, health risk behaviours, prevention, testicular development, Reproductive Health, Reproductive Medicine, Genital Diseases, Cohort, medicine.symptom, Underweight, Genital Diseases, Male, business, Demography, Adolescent health
Abstract

Background Risk factors established during adolescence affect health outcomes in adulthood, although little is known about how adolescent health risk behaviours (HRBs) affect testicular development and reproductive health. Objectives To assess prevalence of HRBs among last year high school students; to describe the most prevalent andrological disorders in this cohort; to explore HRBs associated with andrological disorders and investigate factors possibly associated with impaired testicular development in puberty. Materials and methods The Amico-Andrologo Survey is a permanent nationwide surveillance programme conducted by the Italian Society of Andrology and Sexual Medicine and supported by the Ministry of Health. A nationally representative survey of final-year male high school students was conducted using a validated structured interview (n = 10124) and medical examination (n = 3816). Results Smoking (32.6%), drinking (80.6%) and use of illegal drugs (46.5%) are common in adolescence. 16.6% of subjects were overweight, 3.1% were underweight and 2.3% were obese. Among sexually active students (60.3%), unprotected sex was very common (48.3%). Only 11.6% had been treated for andrological disorders, despite an abnormal clinical examination in 34.6%. Bilateral testicular hypotrophy (14.0%), varicocoele (27.1%) and phimosis (7.1%) were the most prevalent disorders; 5.1% complained of premature ejaculation and 4.7% had an STI. Underweight and heavy alcohol or drug use were associated with testicular hypotrophy. HRBs emerged as significant predictors of testicular hypotrophy, explaining up to 9.6% of its variance. Limitations include risk of selection bias for voluntary physical examination and recall bias for the self-compiled questionnaire. Discussion There is an emerging global adverse trend of HRBs in male high school students. A significant proportion of adolescent males with unsuspected andrological disorders engage in behaviours that could impair testicular development. Conclusion Greater attention to the prevention of andrological health in adolescence is needed.

Published
2019

11. Epidemiology, diagnosis, and treatment of male hypogonadotropic hypogonadism

Author

Andrea Lenzi, Mariano Galdiero, Francesco Lombardo, Antonio F. Radicioni, Riccardo Selice, Antonio Bellastella, Mario Maggi, Carlo Foresta, Gianni Forti, Annamaria Colao, Andrea Fabbri, Csilla Krausz, Loredana Gandini, Antonio Agostino Sinisi, Giancarlo Balercia, Gaetano Lombardi, Lenzi, A., Balercia, G., Bellastella, Antonio, Colao, Annamaria, Fabbri, A., Foresta, C., Galdiero, Mariano, Gandini, L., Krausz, C., Lombardi, Gaetano, Lombardo, F., Maggi, M., Radicioni, A., Selice, R., Sinisi, ANTONIO AGOSTINO, Forti, G., Lenzi, A, Balercia, G, Bellastella, A, Colao, A, Fabbri, A, Foresta, C, Galdiero, M, Gandini, L, Krausz, C, Lombardi, G, Lombardo, F, Maggi, M, Radicioni, A, Selice, R, and Sinisi, Antonio Agostino

Subjects
Adult, Male, medicine.medical_specialty, Hormone Replacement Therapy, medicine.drug_class, Endocrinology, Diabetes and Metabolism, functional hypogonadotropic hypogonadism, male hypogonadotropic hypogonadism, Context (language use), Physical exercise, Chorionic Gonadotropin, male infertility, Male infertility, Settore MED/13, Endocrinology, Hypogonadotropic hypogonadism, Internal medicine, medicine, Humans, Endocrine system, Child, functional hypogoradotropic hypogonadism, Testosterone, business.industry, Hypogonadism, Puberty, hypogonadotropic hypogonadism, Follicle Stimulating Hormone, fsh, testosterone, medicine.disease, Gonadotropin secretion, Gonadotropin, business
Abstract

Hypogonadotropic hypogonadism (HH), or secondary hypogonadism, is a clinical condition due to an impairment of the pituitary function, characterized by low testosterone plasma levels associated with normal or low FSH and LH plasma levels. An impairment of gonadotropin secretion and, therefore, a reduced efficiency of spermatogenesis was reported to be frequently associated to conditions different from the classical causes of secondary hypogonadism. These conditions (metabolic, endocrine and eating disorders, physical exercise etc.) have been associated with a non-classical form of HH that could be called "functional" HH (FHH). FHH differs from the classical one by the evidence that gonadotropin levels are in the low-normal range, but are inadequate for the testosterone levels, that often are also in the low-normal range. This commentary aims at reviewing knowledge on the forms of male HH in order to indicate and discuss clinical context, diagnostic and therapeutic approach in the less known non-classical form, i.e. FHH.

Published
2009

12. Vitamin D and Male Sexual Function: A Transversal and Longitudinal Study

Author

Giovanni Corona, Giovanna Muscogiuri, Giacomo Tirabassi, Maurizio Sudano, Gianmaria Salvio, Melissa Cutini, Giancarlo Balercia, Tirabassi, G., Sudano, M., Salvio, G., Cutini, M., Muscogiuri, G., Corona, G., and Balercia, G.

Subjects
Longitudinal study, D SUPPLEMENTATION, Article Subject, Endocrinology, Diabetes and Metabolism, Physiology, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Logistic regression, lcsh:Diseases of the endocrine glands. Clinical endocrinology, 03 medical and health sciences, D DEFICIENCY, 0302 clinical medicine, Endocrinology, D-RECEPTOR, ERECTILE DYSFUNCTION, TESTOSTERONE, Vitamin D and neurology, Medicine, lcsh:RC648-665, DYSREGULATION, Free testosterone, Endocrine and Autonomic Systems, business.industry, Testosterone (patch), Erectile function, PREVALENCE, HYPOGONADISM, business, Sexual function, Male sexual function, Research Article
Abstract

Background. The effects of vitamin D on sexual function are very unclear. Therefore, we aimed at evaluating the possible association between vitamin D and sexual function and at assessing the influence of vitamin D administration on sexual function. Methods. We retrospectively studied 114 men by evaluating clinical, biochemical, and sexual parameters. A subsample (n=41) was also studied longitudinally before and after vitamin D replacement therapy. Results. In the whole sample, after performing logistic regression models, higher levels of 25(OH) vitamin D were significantly associated with high values of total testosterone and of all the International Index of Erectile Function (IIEF) questionnaire parameters. On the other hand, higher levels of total testosterone were positively and significantly associated with high levels of erectile function and IIEF total score. After vitamin D replacement therapy, total and free testosterone increased and erectile function improved, whereas other sexual parameters did not change significantly. At logistic regression analysis, higher levels of vitamin D increase (Δ-) were significantly associated with high values of Δ-erectile function after adjustment for Δ-testosterone. Conclusions. Vitamin D is important for the wellness of male sexual function, and vitamin D administration improves sexual function.

Published
2018
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13. GLP-1: benefits beyond pancreas

Author

G, Muscogiuri, A, Cignarelli, F, Giorgino, F, Prodam, F, Prodram, D, Santi, G, Tirabassi, G, Balercia, R, Modica, A, Faggiano, A, Colao, Muscogiuri, Giovanna, Cignarelli, A, Giorgino, F, Prodram, F, Santi, D, Tirabassi, G, Balercia, G, Modica, R, Faggiano, Antongiulio, and Colao, Annamaria

Subjects
cardiovascular risk, endocrine system, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Central nervous system, Type 2 diabetes, Biology, Bone remodeling, body weight, Endocrinology, Glucagon-Like Peptide 1, Risk Factors, Internal medicine, Diabetes mellitus, Bone cell, medicine, Animals, Humans, Obesity, Receptor, Pancreas, Kidney, nervous system, digestive, oral, and skin physiology, medicine.disease, medicine.anatomical_structure, GLP1, pancreas, Diabetes Mellitus, Type 2, Cardiovascular Diseases, hormones, hormone substitutes, and hormone antagonists
Abstract

Introduction: Glucagon-like peptide 1 (GLP-1) is an intestinal hormone secreted after the ingestion of various nutrients. The main role of GLP-1 is to stimulate insulin secretion in a glucose-dependent manner. However, the expression of GLP-1 receptor was found to be expressed in a variety of tissues beyond pancreas such as lung, stomach, intestine, kidney, heart and brain. Beyond pancreas, a beneficial effect of GLP-1 on body weight reduction has been shown, suggesting its role for the treatment of obesity. In addition, GLP-1 has been demonstrated to reduce cardiovascular risk factors and to have a direct cardioprotective effect, fostering heart recovery after ischemic injury. Further, data from both experimental animal models and human studies have shown beneficial effect of GLP-1 on bone metabolism, either directly or indirectly on bone cells. Materials and methods: We review here the recent findings of the extra-pancreatic effects of GLP-1 focusing on both basic and clinical studies, thus opening future perspectives to the use of GLP-1 analogs for the treatment of disease beyond type 2 diabetes. Conclusion: Finally, the GLP-1 has been demonstrated to have a beneficial effect on both vascular, degenerative diseases of central nervous system and psoriasis.

Published
2014

14. Vitamin D and thyroid disease: To D or not to D?

Author

Giacomo Tirabassi, Y Shoenfeld, Giovanna Muscogiuri, Andromachi Vryonidou, Giancarlo Balercia, Annamaria Colao, F Orio, Giorgia Bizzaro, Stavroula A Paschou, Muscogiuri, Giovanna, Tirabassi, G., Bizzaro, G., Orio, Francesco, Paschou, S. A., Vryonidou, A., Balercia, G., Shoenfeld, Y., and Colao, Annamaria

Subjects
medicine.medical_specialty, endocrine system, endocrine system diseases, Thyroid Disease, Medicine (miscellaneous), Type 2 diabetes, Disease, Hashimoto Disease, Thyroiditis, Vitamin, Internal medicine, medicine, Vitamin D and neurology, Nutrition and Dietetic, Humans, Thyroid Neoplasms, Vitamin D, Thyroid cancer, Thyroid Neoplasm, Dietary Supplement, Nutrition and Dietetics, business.industry, Thyroid disease, Medicine (all), Thyroid, Vitamins, medicine.disease, Vitamin D Deficiency, Polycystic ovary, Thyroid Diseases, Graves Disease, Endocrinology, medicine.anatomical_structure, Dietary Supplements, business, Human
Abstract

The main role of vitamin D is to maintain calcium and phosphorus homeostasis, thus preserving bone health. Recent evidence has demonstrated that vitamin D may also have a role in a variety of nonskeletal disorders such as endocrine diseases and in particular type 1 diabetes, type 2 diabetes, adrenal diseases and polycystic ovary syndrome. Low levels of vitamin D have also been associated with thyroid disease, such as Hashimoto's thyroiditis. Similarly, patients with new-onset Graves' disease were found to have decreased 25-hydroxyvitamin D concentrations. Impaired vitamin D signaling has been reported to encourage thyroid tumorigenesis. This review will focus on the role of vitamin D in thyroid diseases, both autoimmune diseases and thyroid cancer, and will summarize the results of vitamin D supplementation studies performed in patients with thyroid disorders. Although observational studies support a beneficial role of vitamin D in the management of thyroid disease, randomized controlled trials are required to provide insight into the efficacy and safety of vitamin D as a therapeutic tool for this dysfunction.

Published
2015

15. Erratum to: GLP-1: Benefits beyond pancreas

Author

Roberta Modica, Giovanna Muscogiuri, Antongiulio Faggiano, A. Colao, Flavia Prodam, Angelo Cignarelli, Giacomo Tirabassi, Daniele Santi, Francesco Giorgino, Giancarlo Balercia, Muscogiuri, G., Cignarelli, A., Giorgino, F., Prodam, F., Santi, D., Tirabassi, G., Balercia, G., Modica, R., Faggiano, A., and Colao, A.

Subjects
medicine.medical_specialty, Endocrinology, medicine.anatomical_structure, business.industry, Endocrinology, Diabetes and Metabolism, Internal medicine, medicine, Pancreas, business
Published
2015

16. Consensus statement on diagnosis and clinical management of Klinefelter syndrome

Author

Linda Vignozzi, Giancarlo Balercia, Carlo Foresta, Alberto Ferlin, Antonio F. Radicioni, Andrea Lenzi, Mario Maggi, Daniela Pasquali, Radicioni, Af, Ferlin, A, Balercia, G, Pasquali, Daniela, Vignozzi, L, Maggi, M, Foresta, C, and Lenzi, A.

Subjects
Infertility, Adult, Male, medicine.medical_specialty, Pathology, Adolescent, Statement (logic), Endocrinology, Diabetes and Metabolism, MEDLINE, Endocrinology, Cognition, Klinefelter Syndrome, Sexual medicine, Epidemiology, medicine, Diabetes Mellitus, hypogonadism, Humans, aneuploidy, Child, Gonadal Steroid Hormones, Metabolic Syndrome, rare diseases, testosterone, infertility, klinefelter syndrome, epidemiology, business.industry, Puberty, Infant, Newborn, medicine.disease, Infant newborn, Family medicine, Osteoporosis, Klinefelter syndrome, business
Abstract

Nearly 70 years after its description, Klinefelter syndrome (KS) remains a largely undiagnosed condition. As its clinical presentation may be subtle, many of those affected may be unaware or diagnosed only during evaluation for hypogonadism and/or infertility. In February 2010 an interdisciplinary panel of specialists met in Abano Terme (Padua, Italy) in a workshop on "Klinefelter Syndrome: diagnosis and clinical management". The main aim of this meeting was to discuss several aspects related to the epidemiology, pathogenesis, and evaluation of KS and to develop a consensus defining its early diagnosis and treatment. In the present consensus we have highlighted the features that may prompt the physicians to look after patients with KS both for the syndrome and correlated diseases. We have provided evidences that, during the different phases of life, there might be some advantages in establishing the diagnosis and starting proper follow-up and treatment. The workshop was carried out under the auspices of the Italian Society of andrology and Sexual Medicine (SIAMS).

Published
2011

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