The Effect of 5α-Reductase Inhibition With Dutasteride and Finasteride

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The Effect of 5α-Reductase Inhibition With Dutasteride and Finasteride on Bone Mineral Density, Serum Lipoproteins, Hemoglobin, Prostate Specific Antigen and Sexual Function in Healthy Young Men

John K. Amory,* Bradley D. Anawalt,† Alvin M. Matsumoto,‡ Stephanie T. Page, William J. Bremner, Christina Wang,§ Ronald S. Swerdloff,|| and Richard V. Clark¶

From the Department of Medicine (JKA, BDA, AMM, STP, WJB), Veterans Affairs-Puget Sound Health Care System (BDA, AMM), and Geriatric Research, Education and Clinical Center (AMM), University of Washington, Seattle, Washington, Department of Medicine (RSS, CW) and General Clinical Research Center (CW), Harbor-UCLA Medical Center, Los Angeles Biomedical Research Institute, Torrance, California, and Division of Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina (RVC)
¶Correspondence and requests for reprints: Clinical Pharmacology–Metabolic Discovery Medicine, GlaxoSmithKline Research and Development, Five Moore Drive–5.5742, PO Box 13398, Research Triangle Park, North Carolina 27709-3398
*Financial interest and/or other relationship with GlaxoSmithKline and Merrion Pharmaceuticals.
†Financial interest and/or other relationship with GlaxoSmithKline.
‡Financial interest and/or other relationship with GSK, Solvay, Ascend, Ardana and GTx.
§Financial interest and/or other relationship with GSK, Acrux, BMS, Indevus, Schering-Bayer and Ardana.
||Financial interest and/or other relationship with Acrux, Ardana, Ascend, Clarus, Corcept, GlaxoSmithKline, Indevus, Lilly, Organon, Pierre Fabre, Solvay Pharmaceuticals Inc and Repros.



Purpose

Dutasteride and finasteride are 5α-reductase inhibitors that dramatically decrease serum levels of dihydrotestosterone. Because androgens affect bone, lipids, hematopoiesis, prostate and sexual function, we determined the impact of 5α-reductase inhibitors on these end points.

Materials and Methods

We conducted a randomized, double-blinded, placebo controlled trial of 99 men 18 to 55 years old randomly assigned to receive 0.5 mg dutasteride (33), 5 mg finasteride (34) or placebo (32) daily for 1 year. Bone mineral density was measured at baseline, after 1 year of treatment and 6 months after drug discontinuation. In addition, markers of bone turnover, fasting serum lipoprotein concentrations, hemoglobin and prostate specific antigen were measured at baseline, after 26 and 52 weeks of treatment, and again 24 weeks after drug discontinuation. Sexual function was assessed at these points by a validated questionnaire.

Results

Significant suppression of circulating dihydrotestosterone levels with the administration of dutasteride or finasteride did not significantly affect bone mineral density or markers of bone metabolism. Similarly serum lipoproteins and hemoglobin were unaffected. Serum prostate specific antigen and self-assessed sexual function decreased slightly during treatment with both 5α-reductase inhibitors but returned to baseline during followup.

Conclusions

Profound suppression of circulating serum dihydrotestosterone induced by 5α-reductase inhibitors during 1 year does not adversely impact bone, serum lipoproteins or hemoglobin, and has a minimal, reversible effect on serum prostate specific antigen and sexual function in normal men. Circulating dihydrotestosterone does not appear to have a clinically significant role in modulating bone mass, hematopoiesis or lipid metabolism in normal men.


Πηγή: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684818/
 

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