Testosterone and Diabetes Part 3 of 3 Sara Dempsey Doctor of Pharmacy Candidate LECOM School of Pharmacy

Treating Low Testosterone www.atlanticapothecary.com

How can we treat low testosterone Along with diet, exercise, and diabetes medications, testosterone replacement may be considered in diabetic men Testosterone replacement options Topical Gel Topical Solution Intramuscular (IM) injection Testosterone patch Buccal testosterone Dosage adjustments should be made based on serum testosterone levels Correlation between dose of testosterone and rise in levels "Low Testosterone (Low T)." . MedicineNet, 12 Sept 2012. Web. 20 Jan 2013. <http://www.medicinenet.com/low_testosterone/article.htm>. Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2012 Clinical pharmacology

Testosterone treatment options Gel Androgel® 1%-50-100 mg applied to the abdomen or to the shoulders and upper arms in the morning 1.62%-40.5-81 mg applied to shoulders and upper arms in the morning Fortesta® 10-70 mg applied to thighs every morning Testim® 5 -10 grams (contains 50-100 mg of testosterone) applied to shoulders and upper arms in the morning Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2012 Clinical pharmacology

Testosterone treatment options continued Solution Axiron ® 30-120 mg Applied to the underarms each morning https://adpharm.net/blog/2011/07/usa-axiron-underarm/ Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2012 Clinical pharmacology

Testosterone treatment options continued IM injection Testosterone enanthate or testosterone cypionate FDA approved dosing: 50-400 mg q 2-4 weeks Buccal Striant ® 30 mg q 12 h applied to gums Transdermal Androderm® Initially 4- 5 mg daily news.bbc.co.uk Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology

Results of testosterone replacement therapy Normal serum testosterone levels can be seen: Androgel (Gel) After 30 days of application serum testosterone levels have been seen to be within the normal range Average of 556 ng/dl for 1% and 792 ng/dl for 1.62% gel Axiron (Solution) After 14 days of application steady state concentrations have been seen Injection After 7 days since the first injection, testosterone levels should be within the range of 400-700 ng/dl Striant (Buccal) After 7 days of therapy , avg testosterone levels were 550 ng/dl in clinical trials Androderm (Transdermal) After 14 days of therapy testosterone levels should be between 400-930 ng/dl "Androgel-Prescribing information." . Abbott Laboratories, n.d. Web. 27 Jan 2013. <http://www.rxabbvie.com/pdf/androgel_PI.pdf>. "Prescribing Information-Axiron." . Lilly USA, n.d. Web. 26 Jan 2013. <http://pi.lilly.com/us/axiron-pi.pdf>. Bhasin et al. Guidelines for Testosterone Therapy in Androgen-Deficient Men J Clin Endocrinol Metab, June 2010, 95(6):2536–2559 "Prescribing information-Androderm." . Watson Pharma, n.d. Web. 26 Jan 2013. <http://pi.actavis.com/data_stream.asp?product_group=1200&p=pi&language=E>. "Striant-prescribing information." . Columbia laboratories, n.d. Web. 27 Jan 2013. <http://www.actientpharma.com/filebin/pdf/products/58816-10_Striant_full_PI_4pager.pdf>.

Results of testosterone replacement therapy In general, overall results of testosterone replacement therapy Insulin sensitivity- results may be seen within a few days Glycemic control- results may be seen in 3-12 months Changes in body composition- results may be seen in 12-16 weeks Saad, F. "Onset of effects of testosterone treatment and time span until maximum effects are achieved." Eur J Endocrinol.. 165.5 (2011): 675-85. Print.

Testosterone replacement therapy benefits in diabetes Study looked at benefits of testosterone replacement therapy in men 30 years of age or older with type 2 diabetes Crossover Study: Double blind, placebo controlled Treatment- 200 mg IM testosterone q 2 weeks versus placebo for 3 months Conclusion: Benefits of testosterone therapy Insulin resistance was decreased Glycemic control was improved Kapoor, D. "Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes." European Journal of Endocrinology . 154. (2006): 899-906. Print.

Other benefits of testosterone replacement Testosterone replacement therapy has the potential to: Boost energy levels Increase strength and muscle mass Improve bone mineral density Reduction of fat Bassil, N. "The benefits and risks of testosterone replacement therapy: a review." NCBI. US National Library of Medicine National Insitute of Health, 22 Jun 2009. Web. 20 Jan 2013. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2701485/>.

Risks of testosterone replacement Possible risks associated with testosterone replacement can include: Increase risk for prostate cancer BPH symptoms may worsen Hepatotoxicity or liver failure Gynecomastia Infertility Development of sleep apnea Bassil, N. "The benefits and risks of testosterone replacement therapy: a review." NCBI. US National Library of Medicine National Insitute of Health, 22 Jun 2009. Web. 20 Jan 2013. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2701485/>.

Concerns with testosterone replacement therapy Other Adverse Reactions Reactions at application site such as itching, burning, or blisters Increase in hemoglobin and hematocrit (H&H) Contraindications Men with prostate cancer Monitoring parameters Prior to therapy and then after six months LFT’s, H&H, and lipids Serum Testosterone Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology

Concerns with testosterone replacement therapy Drug interactions Testosterone may increase the concentration of Cyclosporine Testosterone may increase the effect of Vitamin K antagonists such as warfarin Testosterone concentration may decrease with usage of St. Johns wart Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology

What if testosterone replacement doesn’t work If testosterone replacement fails to increase serum testosterone levels then Stop testosterone replacement therapy Investigate other possible causes of low serum testosterone levels Bassil, N. "The benefits and risks of testosterone replacement therapy: a review." NCBI. US National Library of Medicine National Insitute of Health, 22 Jun 2009. Web. 20 Jan 2013. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2701485/>.

Summary Testosterone is an important hormone that helps maintain many body systems Testosterone levels decline with age Testosterone levels are often decreased in obese men and men with type 2 diabetes Food, drugs, and exercise can all effect testosterone levels

Summary Testosterone replacement therapy along with diet, exercise, and diabetes medications is an option for men with low testosterone and type 2 diabetes Testosterone treatment options consist of IM injection, topical, transdermal, and buccal dosage forms If testosterone levels do not increase after testosterone replacement therapy, then medication should be discontinued and further follow up is needed to determine cause of low testosterone

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