SARA DEMPSEYDOCTOR OF PHARMACY CANDIDATE
LECOM SCHOOL OF PHARMACY
Testosterone and Diabetes
Part 3 of 3
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
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20 th 2012 Clinical pharmacology
https://adpharm.net/blog/2011/07/usa-axiron-underarm/
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
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology
news.bbc.co.uk
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 ageTestosterone levels are often decreased in
obese men and men with type 2 diabetesFood, 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
References
1. Bowen, R. "Gonadotropins: Luteinizing and Follicle Stimulating Hormones." . N.p., 13 May 2004. Web. 20 Jan 2013. <http://www.vivo.colostate.edu/hbooks/pathphys/endocrine/hypopit/lhfsh.html>.
2. "Mayo Clinic." Testosterone therapy: Key to male vitality?. Mayo Foundation for Medical Education and Research, 10 Apr 2012. Web. 20 Jan 2013. <http://www.mayoclinic.com/health/testosterone-therapy/MC00030>.
3. "Matsumoto, A. "Fundamental Aspects of Hypogonadism in the Aging Male." Rev Urol.. 5.(Suppl 1) (2003): S3-S10. Print. 4. "Low Testosterone (Low T)." . MedicineNet, 12 Sept 2012. Web. 20 Jan 2013. <http://www.medicinenet.com/low_testosterone/article.htm>. 5. Wang, C. "Low Testosterone AssociatedWith Obesity and theMetabolic Syndrome Contributes to Sexual Dysfunction and Cardiovascular Disease Risk
inMen With Type 2 Diabetes." Diabetes Care. 34.July (2011): 1669-75. Print. 6. Dhindsa, S. "Testosterone Concentrations in Diabetic and Nondiabetic Obese Men." Diabetes Care. 33. (2010): 1186-92. Print. 7. "Testosterone decreases after ingestion of sugar (glucose)." The Endocrine Society. N.p., 12 Jun 2009. Web. 20 Jan 2013. <http://www.endo-
society.org/media/ENDO-09/Testosteronedecreasesafteringestionofsugar.cfm>.8. Emanuele, M. "Alcohol and the Male Reproductive System." National Institute on Alcohol Abuse and Alcoholism. National Institutes of Health. Web. 20
Jan 2013. <http://pubs.niaaa.nih.gov/publications/arh25-4/282-287.htm>.9. Armanini, D. "Reduction of Serum Testosterone in Men by Licorice." N Engl J Med. 341. (1999): 1158. Print.10. Goodin , S. "Clinical and biological activity of soy protein powder supplementation in healthy male volunteers.." Cancer Epidemiol Biomarkers Prev..
16.4 (2007): 829-33. Print.11. Maskarinec, G. "Serum prostate-specific antigen but not testosterone levels decrease in a randomized soy intervention among men." European Journal
of Clinical Nutrition. 60. (2006): 1423-29. Print.12. Drug-induced male sexual dysfunction. Pharmacist's Letter/Prescriber's Letter 2006;22(9):220907.13. Oishi, S. "Effects of butylparaben on the male reproductive system in rats." Toxicol Ind Health . 17.31 (2001): n. page. Print. 14. Oishi, S. "Effects of propyl paraben on the male reproductive system." Food and Chemical Toxicilogy. 40.12 (2002): 1807-13. Print.15. Linnamo, V. "Acute hormonal responses to submaximal and maximal heavy resistance and explosive exercises in men and women.." J Strength Cond
Res.. 19.3 (2005): 566-71. Abstract. 16. Zmuda, J. "Exercise increases serum testosterone and sex hormone-binding globulin levels in older men.." Metabolism. 45.8 (1996): 935-9. Abstract.17. Melville, N. "Medscape Medical News." Low Testosterone Levels Can Improve With Weight Loss, Exercise. N.p., 26 Jun 2012. Web. 20 Jan 2013.
<http://www.medscape.com/viewarticle/766459>. 18. Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20 th 2013 Clinical pharmacology19. "Androgel-Prescribing information." . Abbott Laboratories, n.d. Web. 27 Jan 2013. <http://www.rxabbvie.com/pdf/androgel_PI.pdf>.20. "Prescribing Information-Axiron." . Lilly USA, n.d. Web. 26 Jan 2013. <http://pi.lilly.com/us/axiron-pi.pdf>.21. Bhasin et al. Guidelines for Testosterone Therapy in Androgen-Deficient Men J Clin Endocrinol Metab, June 2010, 95(6):2536–255922. "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>.23. "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>.24. 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. 25. 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. 26. 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/>.
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