NHLBI statement on oral contracep...( A Women's Health Initiative (WHI) revie...),Health

A Women's Health Initiative (WHI) review of a recent abstract on the effects of oral contraceptive use on cardiovascular disease has found flaws in both the design and interpretation of the WHI data used in the study. The October presentation of the abstract at the annual scientific meeting of the American Society of Reproductive Medicine and subsequent media coverage may have created the impression that OC use is linked to lower risk of cardiovascular disease (CVD). However, the WHI review of the abstract shows no evidence that OC use is linked to lower risk of CVD.

The abstract used information provided by WHI participants at baseline when they first joined the study. Such analyses are limited and considered exploratory and they should not be used to reassure women about OC use. There is a large and reputable body of higher scientific evidence linking current OC use to future increases in risk of stroke and heart attack, especially in older women and in smokers. The abstract bears no relationship to the findings from the WHI clinical trials of hormones, which showed that postmenopausal hormone use clearly does not reduce, and in fact may increase the risk for CVD.

The presentation of the abstract was not made on behalf of the Women's Health Initiative (WHI) and it had not been reviewed by WHI or by the National Heart, Lung, and Blood Institute (NHLBI) prior to presentation in Philadelphia. The data in the abstract have now been reviewed by senior statisticians at the WHI Clinical Coordinating Center. They repeated the analysis for OC and CVD in the WHI baseline data. They controlled for age and other factors and could not find a relationship between OC use and cardiovascular disease. The statisticians also doubt the validity of a separate cancer abstract which used WHI baseline data to examine OC cancer risks. They conclude that the cancer analyses have the same potential for finding misleading results as occurred with the CVD an
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Contact: NHLBI Communications Office
nhlbi_news@nhlbi.nih.gov
301-496-4236
NIH/National Heart, Lung, and Blood Institute
15-Dec-2004

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