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document
Can simvastatin improve erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction ? Results of the Erectile Dysfunction and Statins Trial [ ISRCTN66772971 ] . OBJECTIVE To evaluate the effectiveness and cost-effectiveness of simvastatin on erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction ( ED ) . PATIENTS AND METHODS ED is common in men aged ≥40 years and impacts upon their overall health-related quality of life and that of their partners . Men aged ≥40 years who were not receiving lipid lowering or anti-hypertensive medication and not at high cardiovascular risk were recruited from 10 general practices in the East of England . In total , 173 eligible men with untreated ED were randomized to double-blind treatment with 40 mg of simvastatin or placebo once daily for 6 months . Data were collected at three points over 30 weeks . The main outcome was erectile function ( International Index of Erectile Function-5 score ) . Secondary outcomes included male ED-specific quality of life ( MED-QoL ) , quality-adjusted life years ( QALYs ) using the generic Euroqol measure ( EQ-5D ) , endothelial function , cardiovascular risk , cholesterol and health service costs . RESULTS There was no significant difference in erectile function between the simvastatin and placebo groups ( mean change , 1.28 vs 0.07 , z = 1.1 , p = 0.27 ) , although a significant improvement in MED-QoL was observed ( 5 % vs 2 % , z = 2.09 , p = 0.04 ) . Both 10-year cardiovascular risk and low-density lipoprotein were reduced ( cardiovascular risk , z = -3.67 , p < 0.001 ; low-density lipoprotein , z = -5.46 , p < 0.001 ) , with no consistent change in endothelial function . The frequency of sexual encounters is correlated with improved erectile function . The joint distribution of costs and QALY benefits indicates that the probability of simvastatin being cost-effective for willingness-to-pay thresholds of £20,000 and £30,000 is 86 % and 83 % , respectively . CONCLUSIONS Identifying men with ED provides an opportunity to modify future cardiovascular risk and to improve MED-QoL by treating them with 40 mg of simvastatin . The joint analysis of costs and QALY benefits suggests that there is high probability that simvastatin is a cost-effective strategy in men with ED . The findings could influence urological and primary care practice by including questions on ED during routine consultations and relevant clinical protocols . This provides an opportunity to impart lifestyle advice .
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Intervention_Pharmacological
simvastatin
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Outcome_Physical
erectile function ( International Index of Erectile Function-5
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Outcome_Physical
male ED-specific quality of life ( MED-QoL )
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Outcome_Other
quality-adjusted life years ( QALYs ) using the generic Euroqol measure ( EQ-5D )
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Outcome_Physical
endothelial function
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Outcome_Physical
cardiovascular risk
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Outcome_Physical
cholesterol
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Outcome_Other
health service
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Outcome_Physical
erectile function
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Outcome_Physical
10-year cardiovascular risk
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Outcome_Physical
low-density lipoprotein
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Outcome_Physical
endothelial function
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Outcome_Physical
frequency of sexual encounters
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Outcome_Other
joint distribution of costs
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Outcome_Other
QALY benefits
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Outcome_Other
cost-effective
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Participant_Sex
Men
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Participant_Age
≥40 years
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Participant_Condition
anti-hypertensive
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Participant_Sample-size
173
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Participant_Sex
men
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Participant_Condition
untreated ED