We conducted a trial to establish whether, in men with untreated erectile dysfunction (ED) and untreated cardiovascular risk factors, lowering LDL cholesterol with simvastatin 40 mg improves ED as measured by the abridged International Index of Erectile Function (IIEF-5).
Secondary outcomes:
i) improves sexual health related quality of life (QOL); whether
ii) improvement in erectile function correlates with a reduction in LDL cholesterol and/or improved endothelial function; and whether
iii) treatment of ED with simvastatin is cost effective.
173 men were randomised to receive either 40 mg simvastatin or a placebo for six months.
Baseline characteristics: The average age of the patients was 56.1 years, with BMI 27.7, testosterone 15.1 nmol/L, and 10 year CVD risk of 8.2%. The average IIEF score 13.5.
113 patients completed all the study measures, and a further 18 patients (N=131) completed the QoL measures despite withdrawing from the study. .
Data is available for 117 patients.
Main study outcomes : The improvement in IIEF due to Statin treatment is not statistically different to Placebo (1.28 versus 0.07, z=1.1, p=0.27). All patients with Severe ED at baseline show a larger change than patients with Mild/Moderate ED (1.8 and 0.08, z=8.5, p<0.001). There was a statistically larger improvement in MED QoL for men on Statin compared to Placebo (5% vs 2%, z=2.09, p=.04). There is an increase in reported Satisfaction over time (z=2.17, p=.03). Both 10 year CVD risk and LDLwas reduced. (CV risk, z=-3.67, p<.001; LDL, z=-5.46, p<0.001). Testosterone is unaffected by treatment (z=-.94), and Baseline Testosterone is not related to any of the study outcomes ( z=1.63, p=.1). The cost and QALY regression results indicate that simvastatin may potentially reduce costs in this group.
There was no consistent change in the endothelial function.
Original languageEnglish
Publication statusUnpublished - 2012
EventBritish Society for Sexual Medicine, 15th Annual Scientific Meeting 2012 - London, United Kingdom
Duration: 27 Jan 201227 Jan 2012


ConferenceBritish Society for Sexual Medicine, 15th Annual Scientific Meeting 2012
Country/TerritoryUnited Kingdom


  • erectile dysfunction, statins, randomised controlled trial


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