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Statins linked to reduced risk for recurrent CV events in men, women
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Statins appear to be associated with reduced risk for recurrent CV events in both men and women, but they do not appear to reduce all-cause mortality or stroke in women, according to results of a meta-analysis published in the Archives of Internal Medicine.
The meta-analysis included 11 randomized, double blind, placebo-controlled trials that evaluated statins for secondary prevention of CV events. Data on more than 43,000 participants were studied.
Sex-specific differences
Overall, statin therapy was associated with a reduced risk for CV events in all outcomes for men (RR=0.82; 95% CI, 0.78-0.85) and women (RR=0.81; 95% CI, 0.74-0.89).
“Statin therapy reduced the recurrence rate of any type of CV event, all-cause mortality, coronary death, any MI, cardiac intervention and any stroke type,” Jose Gutierrez, MD, MPH, of Columbia University Medical Center, and colleagues wrote.
However, the researchers found no association with statins and reduction for all-cause mortality in women vs. men (RR=0.92; 95% CI, 0.76-1.13 vs. RR=0.79; 95% CI, 0.72-0.87). There was also no association with stroke in women vs. men (RR=0.92; 95% CI, 0.76-1.1 vs. RR=0.81; 95% CI, 0.72-0.92).
Based on these findings, the researchers concluded that the meta-analysis “supports the use of statins in women for the secondary prevention of CV events.”
Comparing women and men
Gutierrez and colleagues said their results underscore differences in the benefit obtained from statins in women as compared with men.
“These differences are likely secondary to the small proportion of women included in the trials and a worse CV health status in these same women,” they wrote in the study.
Women represented just one-fifth of the 43,193 participants examined in the meta-analysis, according to the researchers.
In an invited commentary, Fiona Taylor, PhD, HonMFPH, and Shah Ebrahim, DM, FRCP, of the London School of Hygiene and Tropical Medicine, said “focusing on a lack of statistical significance in the findings for women is misleading.
“The real issue is not significance, but whether the effect size in women is materially different from the effect size in men. Overinterpretation of imprecisely estimated effects is a serious problem in meta-analyses and in primary studies,” Taylor and Ebrahim wrote. “In [this] study … the effect on stroke and all-cause mortality in women is consistent with the effect in men. If a statistical test is warranted, the appropriate P value is for the sex interaction for the outcome by sex. We suggest that statins work just as well in women as in men.”
Lack of data on women
In an editor’s note published in Archives of Internal Medicine, Chief Editor Rita F. Redberg, MD, MSc, wrote: “The issue of balancing risks and benefits for our patients is at the crux of most health care decisions. Although there is growing interest in personalized medicine, we still lack high-quality data on the largest group of patients in practice — women.”
Rita F. Redberg
Redberg, who is a member of the Cardiology Today Editorial Board, questioned whether the benefits of statins are less in women or risks are greater than for men or whether there are not enough women in clinical trials to demonstrate benefit.
“Unless we increase inclusion of women in clinical trials and report sex-specific data, there will never be sufficient data to achieve optimal care of all of our patients,” Redberg wrote.
For more information:
Gutierrez J. Arch Intern Med. 2012;172:909-919.
Taylor F. Arch Intern Med. 2012;172:919-920.
Disclosure: Drs. Ebrahim, Gutierrez and colleagues, and Taylor report no relevant financial disclosures.
Perspective
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Roger S. Blumenthal, MD
Women are about as likely to present with a stroke as the first manifestation of atherosclerotic vascular disease as they are with an MI. It will be very interesting to see if the new ATP 4 risk calculator is based updated data from other NHLBI studies other than Framingham. NHLBI has data from many other cohorts with more ethnic diversity. Most clinicians and patients would like to more accurately know their risk of any major CVD event and not just their risk of a fatal or nonfatal MI.
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