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The Mortar & Pestle
MD Custom Rx's monthly e-newsletter
October 2015   
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Thank you for entrusting in the compounding services at MD Custom Rx to help meet the unique medication needs of your patients.  We are excited to share with you our monthly newsletter and look forward to continuing to be your medication problem solvers.  Please don't ever hesitate to let us know how we can be of further assistance to you and your practice.
 
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John, Dan and Monica
Long-term Androgen Replacement Therapy: Effects on Aging Males with Late-Onset Hypogonadism

  While the efficacy of androgen replacement therapy (ART) has been widely investigated in Western countries, it remains controversial whether ART can improve health and prolong active lifestyles. A multicenter randomized controlled trial in Japan (EARTH Study) evaluated the efficacy of ART on late-onset hypogonadism (LOH) and prospectively assessed long-term effects on the physical and mental statuses of aging men. The primary endpoint was health-related quality of life assessed by questionnaires. Secondary endpoints included glycemic control, lipid parameters, blood pressure, waist circumference, body composition, muscular strength, International Prostate Symptom Scores (IPSS), International Index of Erectile Function-5 (IIEF-5) scores, and serum prostate-specific antigen levels. Of the 1637 eligible volunteers, 334 patients > 40 years with LOH were randomly assigned to either the ART (n = 169) or control groups (n = 165). Fifty-two weeks after the initial treatment, ART was associated with significant decreases in waist circumstance and serum triglyceride (TG); with significant increases in whole-body and leg muscle mass volumes, serum hemoglobin, IPSS voiding subscore, and a positive effect on erectile function. There was no significant difference between the groups in terms of severe adverse events.

   Another study investigated the potential benefits of testosterone administration to elderly men (>65 years) with LOH in comparison with younger men and assessed the safety of testosterone administration in elderly men. A total of 561 hypogonadal men from two registry studies were divided into age groups of ≤65 years (group Y, n=450; range, 32-65 years) and >65 years (group O, n=111; range, 66-84 years). Following an initial 6-week interval, all men were treated with testosterone for up to 6 years.
   
   Over the 6 years, there was a progressive decrease of body weight and waist circumference. Beneficial effects on lipids and other metabolic factors and on psychological and sexual functioning progressed over the first 24 to 42 months and were sustained. Rather than a deterioration, there was an improvement of urinary parameters. Prostate volume and prostate-specific antigen increased moderately. Hematocrit levels increased but remained within safe margins.

   This study concluded: "The benefits of restoring serum testosterone in men with LOH were not significantly different between men older than 65 years of age and younger men. There were no indications that side effects were more severe in elderly men. The effects on prostate and urinary function and hematocrit were within safe margins. Age itself need not be a contraindication to testosterone treatment of elderly men with LOH."

Androgen Replacement and Atherosclerotic Risk

     Idiopathic hypogonadotropic hypogonadism is a rare disorder. A study of forty-three male patients (range: 24-39 years) who were newly diagnosed with idiopathic hypogonadotropic hypogonadism and twenty controls (age and weight-matched) evaluated the effect of androgen replacement therapy on atherosclerotic risk markers in young-to-middle-aged men with this disorder. The patients were assessed at a pretreatment visit and 3 and 6 months after the treatment. Inflammatory markers and lipid parameters were evaluated.

   The carotid intima-media thickness and per cent flow-mediated diameter were significantly improved in the patient group 6 months after androgen replacement therapy began, indicating significantly reduced atherosclerotic risk markers in these patients.

Clin Endocrinol (Oxf). 2015 Mar;82(3):422-8.
Testosterone Therapy and Cardiovascular Mortality

    Testosterone therapy is recommended for men with symptomatic androgen deficiency and unequivocally low testosterone levels. Although the prevalence of hypogonadism seems relatively constant, studies of prescribing patterns in both the United States and the United Kingdom show a dramatic increase in testosterone prescription in recent years, possibly due to increased marketing and inappropriate therapy. Concurrent with this, there has been growing concern regarding the potential adverse effects of testosterone therapy, particularly its cardiovascular risks. Based on the current evidence, Tanna et al. of the Division of Cardiology, New York University School of Medicine, concluded that testosterone therapy can be safely considered in men with appropriately diagnosed clinical androgen deficiency and increased cardiovascular risk after a thorough discussion of potential risks and with guideline-recommended safety monitoring.

Men with Borderline Testosterone Levels Have Higher Rates of Depression

   Men with borderline testosterone levels have higher rates of depression and depressive symptoms than the general population. The results of new research were presented Saturday, March 7, at ENDO 2015, the annual meeting of the Endocrine Society in San Diego.

   "Over half of men referred for borderline testosterone levels have depression. This study found that men seeking management for borderline testosterone have a very high rate of depression, depressive symptoms, obesity and physical inactivity," said principal study author Michael S. Irwig, MD, FACE, associate professor of medicine and director of the Center for Andrology in the Division of Endocrinology at George Washington University in Washington, DC. "Clinicians need to be aware of the clinical characteristics of this sample population and manage their comorbidities such as depression and obesity."

  Dr. Irwig and his colleagues studied 200 adult men between 20 and 77 years of age whose testosterone levels were borderline (200 - 350 nanograms/deciliter). The researchers collected the men's demographic information, medical histories, medication use, and signs and symptoms of hypogonadism. They re-measured the men's total testosterone and assessed depression from their medical history and depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9). Using a score of 10 or higher on the PHQ-9, 56% of the study participants had significant depressive symptoms, known diagnosis of depression and/or use of an antidepressant. They also had a high prevalence of overweight (39%), obesity (40%) and physical inactivity; other than walking, 51% of the men did not engage in regular exercise. The most common symptoms reported were erectile dysfunction (78%), low libido (69%) and low energy (52%).

   The research concluded that appropriate referrals should be made for formal evaluation and proper treatment of depressed men with borderline testosterone levels.

Testosterone Therapy in Men with Crohn's Disease May Improve the Clinical Course

   Crohn's disease is an inflammatory chronic bowel disease characterized by an imbalanced production of pro-inflammatory mediators (tumor necrosis factor-α) and an increased recruitment of leukocytes to the site of inflammation. Low serum testosterone is associated with an increase in inflammatory factors, while testosterone administration reduces them. There is evidence for an immunomodulatory effect of testosterone on differentiation of regulatory T cells.

   A cumulative prospective study tested for testosterone deficiency in men diagnosed with and appropriately treated for Crohn's disease. In total, 92 men with low testosterone levels received testosterone therapy for up to 7 years. Fourteen men opted not to receive testosterone and served as a comparison group.

   In men receiving testosterone, the Crohn's Disease Activity Index declined from 239.36±36.96 to 71.67±3.26 at 84 months. C-reactive protein levels decreased from 12.89±8.64 to 1.78±1.37 mg/L at 84 months. Leukocyte count decreased from 11.93±2.85 to 6.21±1.01×109/L. No changes were observed in the comparison group. There were no significant side effects of testosterone.

   The study concluded that normalizing serum testosterone in hypogonadal men with Crohn's disease had a positive effect on the clinical course.

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