Physicians joke that the cholesterol-lowering medications statins 'should be in the water" because of their effectiveness at treating cardiovascular disease (CVD).
While this is clearly an exaggeration, skeptics say "there is evidence that statins provide little benefit for healthy patients" and "can trigger dangerous side effects."
As a prescriber of statins, I decided to review the medical literature on the use of statins in healthy patients.
CVD is the leading cause of death in America. Many lifestyle factors (smoking, diet, exercise) impact the risk of developing CVD, and should be addressed prior to starting medication. The evidence shows that patients with CVD who take statins have fewer heart attacks. Is there evidence that treating healthy people, who do not have CVD (or a risk like diabetes) with a statin is beneficial?
1) The West of Scotland Coronary Prevention Study (Shepherd NEJM 1995) evaluated the effect of Pravastatin on the rate of heart attacks and cardiac death in 6,595 men with high cholesterol and no CVD. Total cholesterol fell 20 percent, and there was a 32 percent reduction in cardiovascular deaths and a 22 percent reduction in all deaths. The study did not include women.
2) Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol level (Downs JAMA 1998) was a trial of lovastatinÂ in 6,605 patients without CVD. Women were included in this study that showed only 2 percent reduction in death, but a significant reduction in heart attacks.
3) Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein (Ridker NEJM 2008) studied 17,802 healthy men and women with normal cholesterol and a high CRP (C Reactive Protein level). The trial was stopped early because cardiovascular events were lower in patients treated with rosuvastatin.
4) A review of 11 statin trials with 65,229 patients without CVD (Ray Arch Intern Med. 2010) showed a small reduction in total death.
In February, the FDA added warnings on statins that they may raise levels of blood sugar and could cause memory loss. Many patients have asked if they should stop their statin because of this warning.
Steven Nissen, chief of cardiology at Cleveland Clinic, stated: "The fact that the blood sugar went up a little bit did not diminish the effectiveness of the statins in reducing heart risk for patients."
The FDA said there is no proof that statins cause memory loss, but people need to be aware of the possibility. The FDA also announced patients taking statins no longer need periodic monitoring of liver enzymes.
More than 20 million Americans are taking statins. The absolute benefits of statins are smaller in healthy people than in those with known CVD. and while there is a significant reduction in heart attacks, the overall reduction in death with statins in healthy people is quite small. The answer to the question "Should statins be in the water?" is clearly no. However, patients should discuss the risks and benefits of statins with their doctor.
Dr. Benjamin Voss, is board-certified in internal medicine. He is on staff at Missouri Baptist Medical Center and a member of BJC Medical Group. He earned a medical degree from Creighton University School of Medicine. He completed a combined internship/residency in internal medicine at Washington University School of Medicine