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The effect of simvastatin in penile erection: a randomized, double-blind, placebo-controlled clinical trial (Simvastatin treatment for erectile dysfunction—STED TRIAL)

International Journal of Impotence Research volume 23, pages 242–248 (2011)Cite this article

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Abstract

The aim of the study is to evaluate the effect of simvastatin in erectile dysfunction (ED) secondary to endothelial dysfunction. This study is a double-blind, randomized, placebo-controlled, clinical trial in patients with ED and endothelial dysfunction. Patients were randomized to receive 20 mg simvastatin (n=21) or placebo (n=20) daily for 6 months and subsequently 10 mg of vardenafil on demand for 4 weeks. Serum cholesterol, hormone profile, ultrasensitive C-reactive protein, the International Index of Erectile Dysfunction (IIEF) and the ED Index of Treatment Satisfaction were evaluated. There was a significant reduction in serum cholesterol in the treatment group. The hormonal profile remained unaltered. There was no difference in the IIEF between the groups at follow-up, although, at the beginning, 26% of the patients of both groups presented with mild ED and 74% with moderate-to-severe ED; at the end of the 7th month, all patients from the simvastatin group progressed to mild ED, compared with only 83% in the placebo group. There was no statistically significant difference in penile erection after intake of simvastatin or placebo. This study does not support the use of simvastatin as erectogenic medication. Further studies are necessary to verify if simvastatin has any beneficial effect on ED.

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References

  1. Kaya C, Uslu Z, Karaman I . Is endothelial function impaired in erectile dysfunction patients? Int J Impot Res 2006; 18: 55–60.

    Article  CAS  Google Scholar 

  2. Thompson IM, Tangen CM, Goodman PJ, Probstfield JL, Moinpour CM, Coltman CA . Erectile dysfunction and subsequent cardiovascular disease. JAMA 2005; 294: 2996–3002.

    Article  CAS  Google Scholar 

  3. Müller A, Mulhall JP . Cardiovascular disease, metabolic syndrome and erectile dysfunction. Curr Opin Urol 2006; 16: 435–443.

    Article  Google Scholar 

  4. Departamento de Aterosclerose da Sociedade Brasileira de Cardiologia. IV Diretriz Brasileira Sobre Dislipidemias e Prevenção da Aterosclerose do Departamento de Aterosclerose da Sociedade Brasileira de Cardiologia. Arq Bras Cardiol 2007; 88 (Suplemento I): 2–19.

    Google Scholar 

  5. Giugliano F, Esposito K, Di Palo C, Ciotola M, Giugliano G, Marfella R et al. Erectile dysfunction associates with endothelial dysfunction and raised proinflammatory cytokine levels in obese men. J Endocrinol Invest 2004; 27: 665–669.

    Article  CAS  Google Scholar 

  6. Billups KL, Kaiser DR, Kelly AS, Wetterling RA, Tsai MY, Hanson N et al. Relation of C-reactive protein and other cardiovascular risk factors to penile vascular disease in men with erectile dysfunction. Int J Impot Res 2003; 15: 231–236. Erratum in: Int J Impot Res 2003;15:388.

    Article  CAS  Google Scholar 

  7. McFarlane SI, Muniyappa R, Francisco R, Sowers JR . Pleiotropic effects of statins: lipid reduction and beyond. J Clin Endocrinol Metab 2002; 87: 1451–1458.

    Article  CAS  Google Scholar 

  8. Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344: 1383–1389.

    Google Scholar 

  9. Rizvi K, Hampson JP, Harvey JN . Do lipid-lowering drugs cause erectile dysfunction? A systematic review. Farm Prac 2002; 19: 95–98.

    Article  Google Scholar 

  10. Solomon H, Samarasinghe YP, Feher MD, Man J, Rivas-Toro H, Lumb PJ et al. Erectile dysfunction and statin treatment in high cardiovascular risk patients. Int J Clin Pract 2006; 60: 141–145.

    Article  CAS  Google Scholar 

  11. Carvajal A, Macias D, Sáinz M, Ortega S, Martín Arias LH, Velasco A et al. HMG CoA reductase inhibitors and impotence: two case series from the Spanish and French drug monitoring systems. Drug Saf 2006; 29: 143–149.

    Article  CAS  Google Scholar 

  12. Do C, Huyghe E, Lapeyre-Mestre M, Montastruc JL, Bagheri H . Statins and erectile dysfunction: results of a case/non-case study using the French Pharmacovigilance System Database. Drug Saf 2009; 32: 591–597.

    Article  CAS  Google Scholar 

  13. Pedersen TR, Faergeman O . Simvastatin seems unlikely to cause impotence. BMJ 1999; 318: 192.

    Article  CAS  Google Scholar 

  14. Miner M, Billups KL . Erectile dysfunction and dyslipidemia: relevance and role of phosphodiesterase type-5 inhibitors and statins. J Sex Med 2008; 5: 1066–1078.

    Article  CAS  Google Scholar 

  15. Dobs AS, Miller S, Neri G, Weiss S, Tate AC, Shapiro DR et al. Effects of simvastatin and pravastatin on gonadal function in male hypercholesterolemic patients. Metabolism 2000; 49: 115–121.

    Article  CAS  Google Scholar 

  16. Saltzman EA, Guay AT, Jacobson J . Improvement in erectile function in men with organic erectile dysfunction by correction of elevated cholesterol levels: a clinical observation. J Urol 2004; 172: 255–258.

    Article  Google Scholar 

  17. Nangle MR, Cotter MA, Cameron NE . Effects of rosuvastatin on nitric oxide-dependent function in aorta and corpus cavernosum of diabetic mice. Relationship to cholesterol biosynthesis pathway inhibition and lipid lowering. Diabetes 2003; 52: 2396–2402.

    Article  CAS  Google Scholar 

  18. Castro MM, Rizzi E, Rascado RR . Atorvastatin enhances sildenafil-induced vasodilation through nitric oxide-mediated mechanisms. Eur J Pharmacol 2004; 13: 189–194.

    Article  Google Scholar 

  19. Herrmann HC, Levine LA, Macaluso Jr J, Walsh M, Bradbury D, Schwartz S et al. Can atorvastatin improve the response to sildenafil in men with erectile dysfunction not initially responsive to sildenafil? Hypothesis and pilot trial results. J Sex Med 2006; 3: 303–308.

    Article  CAS  Google Scholar 

  20. Miner M, Gilderman L, Bailen J, Cook D, Dawson K, Stanislaus M et al. Vardenafil in men with stable therapy and dyslipidemia. J Sex Med 2008; 5: 1455–1467.

    Article  CAS  Google Scholar 

  21. Bank AJ, Kelly AS, Kaiser DR, Crawford WW, Waxman B, Schow DA et al. The effects of quinapril and atorvastatin on the responsiveness to sildenafil in men with erectile dysfunction. Vasc Med 2006; 11: 251–257.

    Article  Google Scholar 

  22. Gokkaya SC, Ozden C, Levent O, Hakan Koyuncu H, Guzel O, Memis A . Effect of correcting serum cholesterol levels on erectile function in patients with vasculogenic erectile dysfunction. Scand J Urol Nephrol 2008; 42: 437–440.

    Article  CAS  Google Scholar 

  23. Hong SK, Han BK, Jeong SJ, Byun SS, Lee SE . Effect of statin therapy on early return of potency after nerve sparing radical retropubic prostatectomy. J Urol 2007; 178: 613–616.

    Article  Google Scholar 

  24. Morelli A, Chavalmane AK, Filippi S, Fibbi B, Silvestrini E, Sarchielli E et al. Atorvastatin ameliorates sildenafil-induced penile erections in experimental diabetes by inhibiting diabetes-induced RhoA/Rho-kinase signaling hyperactivation. J Sex Med 2009; 6: 91–106.

    Article  CAS  Google Scholar 

  25. Rhoden EL, Mastalir ET, Teloken PE, Blaya R, Teloken C . Effects of statins on nitric oxide metabolites in the corpora cavernosa of rats fed a hyperlipidic diet. In: American Urological Association Annual Meeting 2007, Anahein. J Urol 2007, volume 177 (Abstracts).

  26. Dadkhah F, Safarinejad MR, Asgari MA, Hosseini SY, Lashay A, Amini E . Atorvastatin improves the response to sildenafil in hypercholesterolemic men with erectile dysfunction not initially responsive to sildenafil. Int J Impot Res 2010; 22: 51–60.

    Article  CAS  Google Scholar 

  27. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto Jr AM, Kastelein JJ et al. Reduction in C-reative protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet 2009; 373: 1175–1182.

    Article  CAS  Google Scholar 

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Authors and Affiliations

  1. Urology Division from Santa Casa de Porto Alegre, Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia Rio Grande do Sul, Porto Alegre, Brazil

    E T Mastalir

  2. Urology Division from PUCRS, Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, Brazil

    G F Carvalhal

  3. Cardiology Division from Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, Brazil

    V L Portal

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  1. E T Mastalir
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Correspondence to E T Mastalir.

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Mastalir, E., Carvalhal, G. & Portal, V. The effect of simvastatin in penile erection: a randomized, double-blind, placebo-controlled clinical trial (Simvastatin treatment for erectile dysfunction—STED TRIAL). Int J Impot Res 23, 242–248 (2011). https://doi.org/10.1038/ijir.2011.33

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