By Duane Graveline, M.D., M.P.H.
As is well known, some of the claims for drugs, including statins (Crestor™, Lescol™, Lipitor™, Pravachol™, Zocor™ and others) found in the package insert or PDR (Physicians' Desk Reference) prepared by the drug's maker do not match the findings of unconflicted outsiders. In other words, what the drug manufacturers say about their products' side effects and the reality obtained from post marketing experience may be widely divergent.
We may ask why, in a mainstream report of discontinuation of statin drugs, 50% were said to abandon their statin in one year, and 75% by the end of two years? In 1996 the Editor-in-Chief of the American Journal of Cardiology reported that 50% of "patients" prescribed a statin drug quit in 1 year, and that only 25% continued for 2 years. What other primary reason could be responsible for such high dropout rates except adverse effects?
So it is of interest that a study based on the French Pharmacovigilance System Database reported on the incidence of Erectile Dysfunction ( ED ) with statins. Erectile Dysfunction is the inability to achieve or maintain an erection sufficient for sexual intercourse. In France the reporting of statin ADRs ( Adverse Drug Reactions ) is compulsory and therefore much more likely to reflect the true state of affairs than those of the U.S.
The period examined was from 1 Jan 85 to 31 Dec 06. Of the 106,204 male subjects not exposed to statins, the incidence of ED was 0.4%, which can reasonably be taken as the baseline level of ED in a non-statin taking group. Of the 4,371 cases exposed to statins, the incidence of reported ED was 1.1%, meaning that the incidence of ED was almost three times greater for statin users.
The mean delay of onset of erectile dysfunction after starting a statin, known for 19 cases, was 62 days with a median of 29 days. In 57% of cases, recovery occurred after withdrawal of statin, implying, somewhat ominously, that recovery did not occur in 43% of cases by the time of reporting.
But the difference between statins was interesting. The figures were too low for Lescol or Pravachol for significance. However the relative risk for simvastatin (Zocor) was 1.0% (one out of every one hundred Zocor users); atorvastatin (Lipitor) was 1.4% and rosuvastatin (Crestor) was 2.8%, meaning that nearly three of every one hundred users of rosuvastatin could expect erectile dysfunction or worsening of their existing ED.
Mechanisms of action of ED with statins have not been established but are believed to be due to statin-associated cholesterol suppression, resulting in insufficient levels for normal sexual hormone - primarily testosterone - production. We are only now beginning to realize the wide-ranging importance of cholesterol in human physiology.
If you ask your physician whether your statin drug might have caused your erectile dysfunction, compare his/her answer with the findings above.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor
From: Do C, Huyghe E, Lapeyre-Mestre M et al., Statins and Erectile Dysfunction: Results of a Case/Non-Case Study using the French Pharmacovigilance System Database, Drug Safety 2009;32(7)591-7.
Updated April 2014