Department of Urology, Shahid Modarress Hospital, Shahid Beheshti University, MC, Tehran, Iran.
Int J Impot Res. 2010 Jan-Feb;22(1):51-60. doi: 10.1038/ijir.2009.48. Epub 2009 Oct 29.
Despite the initial enthusiasm, the significant number of patients in whom sildenafil is contraindicated or ineffective is a major challenge to all urologists. Our aim was to determine the safety and efficacy of adjunctive atorvastatin in restoring normal erectile function in hypercholesterolemic (low-density lipoprotein (LDL) cholesterol >120 mg per 100 ml) sildenafil nonresponders. The study comprised 131 men with ED not responding to sildenafil citrate. They were randomized either to 40 mg atorvastatin daily (n=66, group 1) or matching placebo (n=65, group 2) for 12 weeks while they were taking on-demand 100 mg sildenafil. Erectile function was subjectively assessed using the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire and response to the global efficacy question (GEQ). Serum biochemical and lipid profile (total cholesterol, triglycerides, LDL cholesterol and high-density lipoprotein cholesterol) analyses were performed at baseline and repeated at post-treatment weeks 6 and 12. Compared with the placebo group (59 patients, mean age+/-s.d. 61.9+/-6.1, mean years ED 3.9+/-1.8), the atorvastatin group (59 patients, mean age+/-s.d. 63.9+/-6.9, mean years ED 3.7+/-1.6) had significantly greater improvements in all IIEF-5 questions (P=0.01) and GEQ (P=0.001). Subgroup analyses did reveal trends in the atorvastatin group to indicate that a change in the IIEF-5 score is affected by age, severity of ED and baseline serum levels of LDL. Patients with moderate (r=0.28, P=0.01) and severe (r=0.20, P=0.01) ED had better positive response rates to adjunctive atorvastatin than patients with mild to moderate ED. None of the patients taking atorvastatin achieved a response of 5 to the IIEF-5 questions and none of the patients regained normal erectile function as defined by the IIEF-5 score >21. Subjects experienced a statistically significant but modest improvement in erectile function. Further investigation is needed to test the usefulness of long-term atorvastatin administration to restore erectile function in sildenafil nonresponders.
尽管最初的热情很高，但对于所有泌尿科医生来说，有相当数量的患者对西地那非禁忌或无效是一个主要挑战。我们的目的是确定辅助阿托伐他汀在恢复高胆固醇血症（低密度脂蛋白（LDL）胆固醇> 120mg/100ml）西地那非无反应患者正常勃起功能方面的安全性和有效性。该研究包括 131 名对枸橼酸西地那非无反应的 ED 患者。他们被随机分为每天 40mg 阿托伐他汀组（n=66，第 1 组）或匹配安慰剂组（n=65，第 2 组），同时服用按需 100mg 西地那非。勃起功能通过国际勃起功能指数（IIEF-5）问卷的 5 项版本和对全球疗效问题（GEQ）的反应进行主观评估。在基线时和治疗后第 6 周和第 12 周进行血清生化和血脂谱（总胆固醇、甘油三酯、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇）分析。与安慰剂组（59 例患者，平均年龄+/-标准差 61.9+/-6.1，ED 平均年限 3.9+/-1.8）相比，阿托伐他汀组（59 例患者，平均年龄+/-标准差 63.9+/-6.9，ED 平均年限 3.7+/-1.6）在所有 IIEF-5 问题（P=0.01）和 GEQ（P=0.001）方面均有显著改善。亚组分析确实表明，阿托伐他汀组的变化趋势表明，IIEF-5 评分的变化受年龄、ED 严重程度和基线 LDL 血清水平的影响。中重度（r=0.28，P=0.01）和重度（r=0.20，P=0.01）ED 患者对辅助阿托伐他汀的阳性反应率高于轻度至中度 ED 患者。服用阿托伐他汀的患者中，没有一人对 IIEF-5 问题的回答达到 5 分，也没有一人恢复到 IIEF-5 评分>21 定义的正常勃起功能。患者的勃起功能有统计学上显著但适度的改善。需要进一步的研究来测试长期阿托伐他汀给药在恢复西地那非无反应患者勃起功能方面的有效性。
