The International Society for Sexual Medicine's Process of Care for the Assessment and Management of Testosterone Deficiency in Adult Men.

INTRODUCTION: In 2014, the International Society for Sexual Medicine (ISSM) convened a panel of experts to develop an evidence-based process of care for the diagnosis and management of testosterone deficiency (TD) in adult men. The panel considered the definition, epidemiology, etiology, physiologic effects, diagnosis, assessment and treatment of TD. It also considered the treatment of TD in special populations and commented on contemporary controversies about testosterone replacement therapy, cardiovascular risk and prostate cancer. AIM: The aim was to develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of diagnosis and management of TD for clinicians without expertise in endocrinology, such as physicians in family medicine and general urology practice. METHOD: A comprehensive literature review was performed, followed by a structured, 3-day panel meeting and 6-month panel consultation process using electronic communication. The final guideline was compiled from reports by individual panel members on areas reflecting their special expertise, and then agreed by all through an iterative process. RESULTS: This article contains the report of the ISSM TD Process of Care Committee. It offers a definition of TD and recommendations for assessment and treatment in different populations. Finally, best practice treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with TD. CONCLUSION: Development of a process of care is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to new insights into the pathophysiology of TD, as well as new, efficacious and safe treatments. We recommend that this process of care be reevaluated and updated by the ISSM in 4 years.

A feasibility study comparing pharmacist and physician recommendations for sildenafil treatment.

INTRODUCTION: In Europe, pharmacists may be an important first point of contact for men with erectile dysfunction (ED) asking for advice and treatment. AIM: To determine if European community pharmacists could appropriately recommend suitability for supply of sildenafil 50 mg for the treatment of ED. METHODS: For this cross-sectional, observational study, the current Summary of Product Characteristics was adapted to create a study drug information sheet for use in a pharmacy setting in which, for certain patients, supply is not suitable and referral to a physician is recommended. After training and with use of a guidance questionnaire, pharmacists assessed the suitability of supply of sildenafil 50 mg for men presenting to their pharmacy. Men with self-reported ED who were not currently using a phosphodiesterase type 5 inhibitor were recruited. Within 7 days of the pharmacist-patient interaction, a physician with experience in the management of ED telephoned the subject to assess suitability. If there was discordance between the pharmacist and physician recommendations, the case was independently reassessed by a physician specialist in sexual medicine. MAIN OUTCOME MEASURES: The primary end point was the concordance rate (with 95% confidence intervals) between pharmacist and physician recommendations. Rates were weighted by country sample sizes. RESULTS: Concordance (95% confidence interval) was 0.70 (0.66-0.74) between pharmacist and physician recommendation, indicating agreement in 70% of cases, and was 0.90 (0.86-0.94) between pharmacist and physician specialist in sexual medicine. Furthermore, if the cases in which the pharmacist did not put subjects at risk (i.e., gave an acceptable recommendation) are assessed, the success rate is 83.5% (79.6-87.4%) and 92.8% (90.1-95.5%), respectively. CONCLUSION: Pharmacists were accurate in providing suitable treatment recommendation, generally not recommending sildenafil for men without ED and recommending physician assessment when there was any question about cardiovascular health, other comorbidity, or co-medication.

Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes.

OBJECTIVE: Rapid-acting insulin analogs in basal-bolus regimens can reduce nocturnal hypoglycemia, so it is conceivable that twice-daily biphasic insulin analogs might reduce hypoglycemia in patients with insulin-treated type 2 diabetes. We used a continuous glucose monitoring system (CGMS) and self-reported episodes to investigate differences in the frequency of low glucose values in patients with type 2 diabetes, using either biphasic insulin aspart 30 (BIAsp 30) or biphasic human insulin 30 (BHI 30). RESEARCH DESIGN AND METHODS: This was a double-blind, two-period, crossover trial involving 160 subjects. After 8 weeks' run-in, subjects were randomized to the first of two 16-week treatment periods. RESULTS: No differences in overall incidence of low interstitial glucose (IG) were found. Twenty-four-hour plots of CGMS showed low IG was more frequent at night than during the day and was unrecognized by patients. At night, subjects spent significantly less time (percentage of total CGMS recorded) with IG <3.5 and <2.5 mmol/l during BIAsp 30 than during BHI 30 treatment, respectively (<3.5 mmol/l: 6.36 vs. 7.93% [mean], 0.67 vs. 2.43% [median], P = 0.018; <2.5 mmol/l: 2.35 vs. 2.86% [mean], 0 vs. 0% [median], P = 0.0467). No treatment difference in A1C was observed. CONCLUSIONS: Overall rates of low glucose over 24 h were not different but were twice as frequent at night than during the day in individuals with type 2 diabetes. Compared with BHI 30, BIAsp 30 was associated with similar low IG readings over 24 h but with fewer nocturnal episodes and less self-reported nocturnal hypoglycemia.

Long-term effects of testim(r) 1% testosterone gel in hypogonadal men.

A new transdermal preparation, Testim(R) 1% testosterone gel, has recently become available for normalization of serum testosterone in hypogonadal men. In short-term studies, it has been shown to reverse the clinical signs and symptoms of low testosterone and to be well tolerated with less applicationsite irritation than with testosterone patches. In 2 long-term studies with Testim, the predose early morning serum testosterone (T), dihydrotestosterone (DHT), and free testosterone (FT) levels were assessed. Serum T, DHT, and FT were all maintained in the normal range for up to 12 months. In these studies, involving a total of 371 hypogonadal men, evaluation by means of dual-energy x-ray absorptiometry revealed a significant increase from baseline in bone mineral density. A significant improvement was also observed in body composition (increased lean body mass, decreased fat mass, and decreased percentage fat). In addition, significant improvements in mood and sexual function were maintained for up to 12 months of treatment. The parameters measured included sexual performance, sexual motivation, sexual desire, and occurrence of spontaneous erections. These data from the 2 long-term studies support the results of the 90-day studies with Testim showing that the gel significantly improves the signs and symptoms associated with low testosterone compared with placebo. The data also support the conclusion that these improvements are maintained for up to 1 year of additional treatment.

Long-term effects of testim(r) 1% testosterone gel in hypogonadal men.

A new transdermal preparation, Testim(R) 1% testosterone gel, has recently become available for normalization of serum testosterone in hypogonadal men. In short-term studies, it has been shown to reverse the clinical signs and symptoms of low testosterone and to be well tolerated with less application-site irritation than with testosterone patches. In 2 long-term studies with Testim, the predose early morning serum testosterone (T), dihydrotestosterone (DHT), and free testosterone (FT) levels were assessed. Serum T, DHT, and FT were all maintained in the normal range for up to 12 months. In these studies, involving a total of 371 hypogonadal men, evaluation by means of dual-energy x-ray absorptiometry revealed a significant increase from baseline in bone mineral density. A significant improvement was also observed in body composition (increased lean body mass, decreased fat mass, and decreased percent fat). In addition, significant improvements in mood and sexual function were maintained for up to 12 months of treatment. The parameters measured included sexual performance, sexual motivation, sexual desire, and occurrence of spontaneous erections. These data from the 2 long-term studies support the results of the 90-day studies with Testim showing that the gel significantly improves the signs and symptoms associated with low testosterone compared with placebo. The data also support the conclusion that these improvements are maintained for up to 1 year of additional treatment.