Can atorvastatin improve the response to sildenafil in men with erectile dysfunction not initially responsive to sildenafil? Hypothesis and pilot trial results.
BACKGROUND
Erectile dysfunction (ED) may be one manifestation of a generalized vascular disorder characterized by endothelial dysfunction. Statin drugs may improve endothelial function, even before altering the lipid profile.


OBJECTIVE
We sought to determine whether the addition of a statin with sildenafil would improve ED in men who initially responded poorly to sildenafil.


METHODS
Men with moderate-to-severe ED despite an adequate sildenafil trial were enrolled in this randomized, double-blind, placebo-controlled pilot study. ED was defined using a validated self-administered questionnaire as a score of <or=16 on the International Index of Erectile Function (erectile function domain score range of 6-30). Improvement in ED score with sildenafil was reassessed at 6 and 12 weeks of treatment with atorvastatin (80 mg daily) or matching placebo.


RESULTS
Twelve men (mean age 58 +/- 13 years) with a mean domain score of 8.2 +/- 6.9 and a mean duration of ED of 3.7 years were enrolled in the study. Treatment with atorvastatin decreased mean low-density lipoprotein cholesterol by 43% and resulted in an improvement with sildenafil in domain score of 7.8 (P = 0.036); an effect was apparent by 6 weeks. The increase in domain score in placebo patients was not statistically significant.


CONCLUSIONS
Treatment with atorvastatin improved sexual function and the response to oral sildenafil in men who did not initially respond to treatment with sildenafil. The results of this pilot study support the hypothesis that vascular endothelial dysfunction contributes to ED in sildenafil nonresponders and deserves further testing in a large clinical trial.
Herrmann
Howard C
HC
Hospital of the University of Pennsylvania, Philadelphia, 19104, USA. howard.herrmann@uphs.upenn.edu
Levine
Laurence A
LA
Macaluso
Joseph
J
Walsh
Michelle
M
Bradbury
Danielle
D
Schwartz
Stanley
S
Mohler
Emile R
ER
Kimmel
Stephen E
SE
D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D000069059:Atorvastatin; D008078:Cholesterol, LDL / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects*; D010865:Pilot Projects; D010879:Piperazines / Q000008:administration & dosage*; D011687:Purines; D011758:Pyrroles / Q000008:administration & dosage*; D000068677:Sildenafil Citrate; D013450:Sulfones; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D010879:Piperazines; D011687:Purines; D011758:Pyrroles; D013450:Sulfones; D000069059:Atorvastatin; D000068677:Sildenafil Citrate