New Study on the Effectiveness of Statin Use in Women

Since statins first came on the market, it has been assumed that both men and women benefit equally from these drugs. The findings from a new study published in the Archives of Medicine seriously question this assumption.

Statins are one of the most widely used classes of drugs in the U.S., both in terms of the number of prescriptions and total sales. As of 2012, seven statins (see table below) have been approved by the Food and Drug Administration (FDA) because of their ability to lower cholesterol levels in people with elevated cholesterol.

In addition, all but two of these cholesterol-lowering drugs are now also indicated to reduce cardiac-related risks associated with elevated cholesterol either in patients without coronary heart disease (known as primary prevention) or in those with coronary heart disease (known as secondary prevention) or for both.

In 2011 (the last year for which there is data), LIPITOR (atorva-statin) was the No. 1 brand-name drug in total prescriptions, and CRESTOR (rosuvastatin) was No. 6. Together, the two drugs accounted for almost 67 million prescriptions and $12 billion in sales in the U.S. that year.

Statin Drugs Available in the U.S.

* Do Not Use on WorstPills.org
** Do Not Use for Seven Years (2016)

Statin effectiveness in women

The clinical studies that led to the indications for which statins were approved included few women, yet statins are widely prescribed for both genders. Whether benefits apply equally to both genders has not been clear.

This uncertainty has now been remedied in part by a June 2012 article published in the Archives of Internal Medicine. In their meta-analysis of previously published studies on the use of statins in women, researchers included all randomized, double-blind, placebo-controlled clinical trials lasting at least 16 weeks, having at least 100 participants and reporting outcomes categorized by gender. Their data, from January 1996 to September 2010, came from the National Library of Medicine database.

To shed light on the effectiveness of statins for secondary prevention in women, the researchers reviewed only those studies with participants who had evidence of previous cardiovascular disease defined as prior myocardial infarction (heart attack), angina, any cardiac intervention, stroke or transient ischemic attack, peripheral arterial disease or more than three cardiovascular risk factors.

A total of 11 studies met the researchers’ criteria. These studies included approximately 43,000 participants, of which 21 percent were women, and evaluated pravastatin (PRAVACHOL), atorvastatin, fluvastatin (LESCOL), simvastatin (ZOCOR) and lovastatin (MEVACOR).

The meta-analysis revealed two major findings: First, the benefits of statins were significant for all outcomes in men, a result consistent with previously published results. Secondly, while there was a statistically significant risk reduction in both men and women for coronary mortality, heart attack (fatal and nonfatal) and cardiac intervention, there was “no statistically significant risk reduction for women taking statins compared with women taking placebo for the reduction of all-cause mortality [death from any cause] and any type of stroke.”

The authors mentioned several caveats in reaching their conclusions: the small sample size (only 21 percent of the population studied was women), the possibly worse cardiovascular health status of the women studied and the use of a single database. Nevertheless, the results demonstrated a possible disparity in statin benefit, which the authors would like to see remedied by an increased awareness plus public policies to address it.

An accompanying editorial by the journal’s editor, Dr. Rita Redberg, concurred that more data were needed and asserted the only way for researchers to be clear on the issue of statin effectiveness in women: “Don’t assume women are the same as men: include them in the trial.” Redberg went on to say that “[a]lthough there is a growing interest in personalized medicine, we still lack high-quality data on the largest group of patients in practice — women.”