Background Beyond clinical trial evidence, the perceived association of statin use and impotence in general practice is not infrequent and the most common associated consequence is the discontinuation of the statin treatment. Aim of the study To carry out a randomised clinical trial on Caucasian men refusing to continue statin therapy because of perceived worsening of erectile function in order to test the tolerability of alternative lipid-lowering strategies. Methods This is a single-blind, randomised clinical trial carried out on 50 moderately hypercholesterolaemic subjects (mean age: 54±6 years old) who voluntarily interrupted statin treatment because of self-reported erectile dysfunction (ED) during statin treatment, randomised to treatment with ezetimibe 10 mg or a combined lipid-lowering nutraceutical containing red yeast rice and berberine (3 mg monacolins and 500 mg per dose, respectively), to be taken as one dose per evening for 12 weeks. The effects of both treatments on ED and subjective well-being was tested by administrating, before and after 12 weeks of treatment, the International Index of Erectile Function (IIEF-5) and the Satisfaction Profile (SAT-P), and comparing the baseline hormonal level with the final one. Results After 12 weeks of treatment, both ezetimibe- and nutraceutical-treated patients experienced a significant improvement in low-density lipoprotein cholesterolaemia and triglyceridaemia (both p<0.05) and a significant increase in IIEF-5 score (p<0.05 for both). However, patients taking the nutraceutical experienced a more significant increase than the group taking ezetimibe (1.2±0.7 vs. 0.7±0.3, p=0.04). Both ezetimibe- and nutraceutical-treated subjects experienced a significant improvement in psychological performance-related SAT-P score, but the nutraceutical-treated group’s improvement was larger than that of the ezetimibe-treated group (+8±4 vs. +6±3, p<0.05). Moreover, only the nutraceutical-treated patients experienced a significant improvement in physical and social performance related SAT-P score compared to the baseline (+7±5 and 6±3, both p<0.05). Conclusion Our data support the use of alternative lipid-lowering strategies in patients refusing to continue statin consumption because of perceived worsening of erectile function.
Subjective effects of a combined lipid-lowering nutraceutical or ezetimibe on well-being and sexual performance in patients with perceived worsening of erectile function during statin treatment: a randomised clinical trial
CICERO, ARRIGO FRANCESCO GIUSEPPE;ROSTICCI, MARTINA;CAGNATI, MARCELLA;D'ADDATO, SERGIO;BORGHI, CLAUDIO
2015
Abstract
Background Beyond clinical trial evidence, the perceived association of statin use and impotence in general practice is not infrequent and the most common associated consequence is the discontinuation of the statin treatment. Aim of the study To carry out a randomised clinical trial on Caucasian men refusing to continue statin therapy because of perceived worsening of erectile function in order to test the tolerability of alternative lipid-lowering strategies. Methods This is a single-blind, randomised clinical trial carried out on 50 moderately hypercholesterolaemic subjects (mean age: 54±6 years old) who voluntarily interrupted statin treatment because of self-reported erectile dysfunction (ED) during statin treatment, randomised to treatment with ezetimibe 10 mg or a combined lipid-lowering nutraceutical containing red yeast rice and berberine (3 mg monacolins and 500 mg per dose, respectively), to be taken as one dose per evening for 12 weeks. The effects of both treatments on ED and subjective well-being was tested by administrating, before and after 12 weeks of treatment, the International Index of Erectile Function (IIEF-5) and the Satisfaction Profile (SAT-P), and comparing the baseline hormonal level with the final one. Results After 12 weeks of treatment, both ezetimibe- and nutraceutical-treated patients experienced a significant improvement in low-density lipoprotein cholesterolaemia and triglyceridaemia (both p<0.05) and a significant increase in IIEF-5 score (p<0.05 for both). However, patients taking the nutraceutical experienced a more significant increase than the group taking ezetimibe (1.2±0.7 vs. 0.7±0.3, p=0.04). Both ezetimibe- and nutraceutical-treated subjects experienced a significant improvement in psychological performance-related SAT-P score, but the nutraceutical-treated group’s improvement was larger than that of the ezetimibe-treated group (+8±4 vs. +6±3, p<0.05). Moreover, only the nutraceutical-treated patients experienced a significant improvement in physical and social performance related SAT-P score compared to the baseline (+7±5 and 6±3, both p<0.05). Conclusion Our data support the use of alternative lipid-lowering strategies in patients refusing to continue statin consumption because of perceived worsening of erectile function.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
