Little Evidence that Statins Help Women Prevent Heart Disease

There is little evidence that the cholesterol-lowering drugs known as statins help prevent heart disease or death from heart disease in the majority of women. There is a narrow group of women under age 65 with already existing serious heart disease that may benefit from statins, but otherwise the evidence is not there. Researchers have to really tweak the data to show benefit even in that group.

Perhaps the drugs don’t help because there is no evidence, except in extreme cases, that lowering LDL cholesterol in older women prevents heart disease or reduces the risk of death, and disturbing evidence that it may be harmful.

Here are a few points to ponder if you’re a woman who has been prescribed a cholesterol-lowering drug:

A study by a legal group that examined all of the high quality studies on using statins to prevent heart disease in women with risk factors and/or moderate symptoms concluded, “Our findings indicate that each year, reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist.”

A comment in the medical journal Lancet by two Harvard Medical School heart experts stated, “…Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age…”

A huge Austrian study found that in women over the age of 50, low cholesterol was associated with higher death rates from cancer, liver disease, depression and mental illness.

The famous Framingham Study concluded that, “…the risk of death from causes other than coronary heart disease [e.g. cancer] increases significantly with lower total cholesterol levels for men and women after they reach the age of 50.”

Even Lipitor’s own clinical studies did not find a statistically significant benefit for women.

You would never know this from drug industry advertising, but cancer, not heart disease, is the leading cause of death in women until after age 75. According to the U.S. Centers for Disease Control:

• From age 65 to 74, heart disease causes 30% of deaths in women and cancer causes 36%.
• From age 75 to 84, heart disease causes 28% of deaths in women and cancer causes 23%.
• It is only at age 85 and up that heart disease really bypasses cancer as the leading cause of death in women.

The bottom-line take-home message is that unless you’re under the age of 65 and have serious existing heart disease, statins are unlikely to reduce your risk of death from heart disease and may increase the risk of death from other causes. Statin drugs are very hard on the liver, and may increase the risk of other problems by interfering with liver function, especially if you are taking a lot of other drugs.

Related Article: Women and Heart Disease by John R. Lee, M.D.

References

Abramson J, Wright J, “Are lipid-lowering guidelines evidence-based?” The Lancet 2007; 369 (January 20):168-169.

Albert CM, Chae CU, Grodstein F et al, “Prospective study of sudden cardiac death among
women in the United States,” Circulation 2003; 107:2096-2101.

Baigent C and collaborators, “Efficacy and safety of cholesterol lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomized control trials,” Lancet. 2005; 366:1267-1278.

Eisenberg T, Wells MT, “Statins and Adverse Cardiovascular Events in Moderate-Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims,” Journal of Empirical Legal Studies, 2008; 5 (3): 507.

Rosenberg H, Allard D, “Evidence for Caution: Women and Statin Use,” Women and Health Protection, Health Canada, June 2007. http://www.whp-apsf.ca/pdf/statinsEvidenceCaution.pdf

Tikhonoff V et al, “Low-density lipoprotein cholesterol and mortality in older people,” Journal of the American Geriatrics Society 2005; 53:2159-2164.

Ulmer H, Kelleher C, Diem G et al, “Why Eve is not Adam: Prospective follow-up in 149,650 women and men of cholesterol and other risk factors related to cardiovascular and all-cause mortality,” Journal of Women’s Health 2004; 13(1):41-53.

Walsh JME, Pignone M, “Drug treatment of hyperlipidemia in women,” JAMA. 2004; 291:2243-2252.