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Biomedical subjects

Abraham Morgentaler

Publications and source records attributed to Abraham Morgentaler.

15 recordsLinked to original sources

Efficacy and safety of tadalafil across ethnic groups and various risk factors in men with erectile dysfunction: Use of a novel noninferiority study design.

AIM: This U.S. multicenter open-label study used a noninferiority trial design to assess the efficacy of tadalafil 20 mg to treat erectile dysfunction (ED) in the black American and Hispanic groups compared with a reference group of Caucasians. A secondary objective was to demonstrate the efficacy and safety of tadalafil 20 mg in various populations of men with ED. METHODS: A total of 1,911 patients with ED were enrolled into eight predefined groups: (1-3) Caucasian (Reference group), Black American, or Hispanic patients, < or =65 years of age with no diabetes mellitus or depression; (4) patients with depression, < or =65 years of age, no diabetes; (5) patients with diabetes, < or =65 years of age, no depression; (6) patients >65 years of age, no diabetes or depression; (7) patients who met enrollment criteria but were not included in any other group; and (8) patients with ED due to traumatic spinal cord injury. The study had a 4-week run-in period, followed by a 12-week treatment period with tadalafil taken as needed, up to one dose/day, prior to sexual activity. Change from baseline to endpoint in the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) was used to determine noninferiority of groups 2 and 3 from group 1. Secondary efficacy measures included other IIEF domains and Sexual Encounter Profile (SEP). RESULTS: Noninferiority analyses based on the EF domain score showed that tadalafil was as efficacious in the Hispanic and Black American groups as in the Reference group. Patients in each of the eight groups had a significant change from baseline (P < 0.001) in the IIEF EF domain score and positive responses to SEP Questions 1-5. The most common treatment-emergent adverse events reported by patients in all eight groups were headache, nasal congestion, dyspepsia, flushing, and back pain. CONCLUSION: Tadalafil 20 mg was as efficacious in the Hispanic and black American groups as in the Caucasian/Reference group. Tadalafil was efficacious and well tolerated in each of the groups studied in this trial.

Adult↗

Testosterone replacement therapy and prostate risks: where's the beef?

It has been part of the conventional medical wisdom for six decades that higher testosterone in some way increases the risk of prostate cancer. This belief is derived largely from the well-documented regression of prostate cancer in the face of surgical or pharmacological castration. However, there is an absence of scientific data supporting the concept that higher testosterone levels are associated with an increased risk of prostate cancer. Specifically, no increased risk of prostate cancer was noted in 1) clinical trials of testosterone supplementation, 2) longitudinal population-based studies, or 3) in a high-risk population of hypogonadal men receiving testosterone treatment. Moreover, hypogonadal men have a substantial rate of biopsy-detectable prostate cancer, suggesting that low testosterone has no protective effect against development of prostate cancer. These results argue against an increased risk of prostate cancer with testosterone replacement therapy.

Hormone Replacement Therapy↗

Hypogonadism in the man with erectile dysfunction: what to look for and when to treat.

Hypogonadism (low serum testosterone) is commonly associated with erectile dysfunction (ED). However, many urologists may lack appreciation of the relative merits of treating hypogonadism compared with oral phosphodiesterase inhibitors for sexual dysfunction. Testosterone-replacement therapy (TRT) may be the best treatment for men with ED when the presentation includes diminished libido or other sexual symptoms or when non-sexual symptoms such as depressed mood, decreased sense of vitality, and increased fatigue also exist. The health benefits of TRT also include improvements in body composition, bone density, cognition, and sense of well-being. Thus, there may be good reasons to use TRT as first-line therapy for the man with ED. Concerns regarding prostatic and cardiovascular risks of TRT have not been supported by the literature. Nevertheless, men receiving TRT must be monitored at regular intervals with digital rectal examination and blood testing for prostate-specific antigen. Hematocrit or hemoglobin also should be obtained regularly due to the risk of erythrocytosis. Awareness of the benefits of TRT in the man with ED may improve clinical outcomes.

Androgens↗

Quality of life following simultaneous placement of penile prosthesis with radical prostatectomy.

PURPOSE: The present study examined erectile functioning, frequency of sexual contact, psychological functioning, partner/marital satisfaction and overall quality of life (QOL) after immediate sexual rehabilitation for prostate cancer via simultaneous placement of a penile prosthesis at radical retropubic prostatectomy (RP). MATERIALS AND METHODS: Questionnaire packets were sent to and received from 51 men who had undergone simultaneous implantation of a penile prosthesis at the time of RP (PP+) and from a comparison group of 47 men who undergone RP alone (PP-) matched by age and year of surgery. Questionnaires included the Erectile Dysfunction Inventory of Treatment Satisfaction, the Depression Anxiety Stress Scales, the Dyadic Adjustment Scale and a prostate specific European Organization for the Research and Treatment of Cancer (EORTC) QOL questionnaire. Further comparisons were performed for a PP- subgroup consisting of 15 patients who had undergone nerve sparing RP. RESULTS: Higher Erectile Dysfunction Inventory of Treatment Satisfaction, EORTC Sexual Functioning, EORTC Total scores and more frequent sexual contact were reported by the PP+ group compared with the PP- group. The PP+ group also had better outcomes that approached but did not reach statistical significance compared with the nerve sparing subgroup with regard to Depression Anxiety Stress Scales and EORTC Emotional Functioning scores. CONCLUSIONS: Men who chose simultaneous placement of a penile prosthesis with RP reported greater overall QOL, erectile function and more frequent sexual contact than a comparison group of men who underwent RP alone. Placement of penile prosthesis at the time of RP may be a desirable option for men with prostate cancer in whom a nerve sparing procedure may not be ideal. These results underscore the importance of sexual function for men undergoing prostate cancer treatment.

Aged↗

The value of pituitary magnetic resonance imaging in men with hypogonadism.

PURPOSE: We assessed the usefulness of magnetic resonance imaging (MRI) of the brain in the evaluation of hypogonadal men with a variety of endocrine patterns. MATERIALS AND METHODS: A total of 51 men with low levels of total testosterone (TT) or free testosterone (FT) underwent MRI. Erectile dysfunction and/or decreased libido were present in 43 (84.3%) of cases and infertility in 8 (15.7%). Serum prolactin (PRL) was obtained in all cases. Low levels of TT and FT were defined as less than 300 and 1.5 ng/dl, respectively. Markedly low levels of TT were defined as less than 200 ng/dl. RESULTS: In 38 of 51 (74.5%) men the MRI was normal. A small pituitary gland (the partially empty sella syndrome) was noted in 9 (17.6%) cases and microadenoma was noted in 4 (7.8%). Prolactin levels were greater than twice the upper limit of normal in 3 of 4 (75%) cases of adenoma, and low FT was noted in all 4 cases. An additional case of adenoma was identified in a man with markedly decreased TT and normal PRL. All men with adenoma presented with the combination of erectile dysfunction and decreased libido. Among men without adenomas the highest PRL value was always less than twice the upper limit of normal. Overall, only 1 of 17 men with markedly decreased TT (less than 200 ng/dl) demonstrated adenoma. None of the 17 men with low luteinizing hormone with low TT or FT had an adenoma or pituitary/hypothalamic mass. CONCLUSIONS: The likelihood of identifying pituitary adenoma by MRI is high if PRL levels are more than twice the upper limit of normal. Medically significant abnormalities are identified in only a small percentage of hypogonadal men with low luteinizing hormone or if TT levels are markedly decreased. The decision to obtain MRI in these latter cases should be based on individual circumstances.

Adenoma↗

Testosterone replacement therapy in hypogonadal men at high risk for prostate cancer: results of 1 year of treatment in men with prostatic intraepithelial neoplasia.

PURPOSE: One of the greatest concerns among clinicians regarding testosterone replacement therapy (TRT) is the fear of causing or promoting prostate cancer. We evaluated prostatic changes in hypogonadal men with and without high grade prostatic intraepithelial neoplasia (PIN), which is considered a prostatic precancerous lesion, after 1 year of TRT. MATERIALS AND METHODS: A total of 75 hypogonadal who completed 12 months of TRT were studied. All underwent prostate biopsy prior to initiating treatment. Of the men 55 had benign prostate biopsies (PIN-) and 20 had PIN without frank cancer (PIN+). All men with PIN underwent repeat biopsy to exclude cancer prior to the initiation of testosterone treatment. Prostate specific antigen (PSA), and total and free testosterone were determined prior to treatment and at 1 year. Repeat biopsy was performed for a change noted on digital rectal examination or for a PSA increase of 1 ng/l or greater. RESULTS: PSA was similar at baseline in men with and without PIN (1.49 +/- 1.1 and 1.53 +/- 1.6 ng/dl, p >0.05) and after 12 months of TRT (1.82 +/- 1.1 and 1.78 +/- 1.6 ng/dl, respectively, p >0.05). A slight, similar increase in mean PSA was noted in the PIN- and PIN+ groups (0.25 +/- 0.6 and 0.33 +/- 0.6 ng/dl, p >0.05). One man in the PIN+ group had cancer after biopsy was performed due to abnormal digital rectal examination. Four additional men in the PIN- group and 2 in the PIN+ group underwent re-biopsy for elevated PSA and none had cancer. No differences were noted between the PIN- and PIN+ groups with regard to total and free testosterone at baseline and at 1 year (p = 0.267). CONCLUSIONS: After 1 year of TRT men with PIN do not have a greater increase in PSA or a significantly increased risk of cancer than men without PIN. These results indicate that TRT is not contraindicated in men with a history of PIN.

Adult↗

Effects of chronic administration of dehydroepiandrosterone on serum testosterone levels and prostatic tissue in rats.

PURPOSE: We evaluated the effects of chronic administration of dehydroepiandrosterone (DHEA) on serum total testosterone and DHEA sulfate (DHEAS), prostatic weight and histological features in the rat. MATERIALS AND METHODS: Wistar rats were divided into 2 groups. The first group of 9 rats received saline solution orally once daily during 5 days of the week for 10 months and the second group of 15 received 5 mg/kg daily DHEA in suspension orally in the same pattern. RESULTS: At the end of the 10-month study period total testosterone levels were higher in the DHEA group compared with controls (2.0 +/- 0.4 vs 0.8 +/- 0.2 mg/dl, p <0.0001) and DHEAS levels were also greater in the treated group compared with placebo (222.1 +/- 41.5 vs 2.0 +/- 0.3 mg/dl, p <0.0001). Weight of the prostate, testis and body did not differ between the groups (p >0.05). No differences between the 2 groups were noted in regard to the degree of hyperplasia, atrophy, a papillary component or the stromal-to-gland ratio (p >0.05). CONCLUSIONS: Oral ingestion of DHEA on a chronic basis in the rat increases serum DHEAS and total testosterone without any evident change in prostate weight or histology.

Administration, Oral↗

Erectile dysfunction.

The past several years have witnessed a veritable revolution in our understanding and management of erectile dysfunction. Although surgical implants in the form of penile prostheses continue to be an important part of treatment of end-stage cases, the largest change has been brought about by the introduction of oral medications, such as sildenafil (Viagra). This review addresses the etiology, epidemiology, diagnosis, and treatment of erectile dysfunction in light of the remarkable advances in the field.

Adult↗

P53 and Fas are sequential mechanisms of testicular germ cell apoptosis.

Testicular germ cell apoptosis in the cryptorchid testis is induced by abdominal heat stress. p53-dependent apoptosis appears responsible for the initial phase of germ cell loss in experimental cryptorchidism based on a 3-day delay of apoptosis in p53-/- mice. However, the mechanisms underlying the subsequent p53-independent apoptosis have not been identified. Although studies have suggested that Fas plays a role in testicular germ cell apoptosis, no direct evidence has been shown. To test the hypothesis that Fas is involved in testicular germ cell apoptosis and is responsible for the p53-independent phase of apoptosis in the cryptorchid testis, p53-/-, lpr/lpr (a spontaneous mutation in the Fas gene, which causes autoimmune disease) double-mutant mice were generated and unilateral cryptorchidism was induced in these mice. It was found that testicular weight reduction and germ cell apoptosis were delayed by an additional 3 days, and the Fas production increased in the time frame of p53-independent apoptosis in the experimental cryptorchid testis of wild-type mice. These results suggest that Fas is involved in testicular germ cell apoptosis, and that Fas-dependent apoptosis is responsible for the p53-independent phase of germ cell apoptosis in the cryptorchid testis. The cascade of testicular germ cell apoptosis in response to heat stress implies the existence of sequential quality control mechanisms in spermatogenesis.

Animals↗