SARA DEMPSEY DOCTOR OF PHARMACY CANDIDATE LECOM SCHOOL OF PHARMACY Testosterone and Diabetes Part 3 of 3

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


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


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


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


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


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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SARA DEMPSEY DOCTOR OF PHARMACY CANDIDATE LECOM SCHOOL OF PHARMACY Testosterone and Diabetes Part 3 of 3