The Women's Health Initiative (WHI) is a long-term national health study focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. Launched in 1993, the WHI enrolled 161,808 women aged 50-79 into one or more randomized Clinical Trials (CT), testing the health effects of hormone therapy (HT), dietary modification (DM), and/or
calcium and Vitamin D supplementation (CaD) or to an
Observational Study (OS). At the end of the initial study period in 2005, WHI Extension Studies (2005-2010,
2010-2020) continued follow-up of all women who consented.
This ground-breaking study changed the way health care providers prevent and treat some of the major diseases impacting postmenopausal women. Results from the WHI Hormone Trials have been estimated to have already saved $35.2 billion in direct medical costs in the US alone. To date, WHI has published over 1,400
articles and approved and funded 289 ancillary studies.
Interested scientists are encouraged to submit paper and ancillary study proposals for using WHI data. To assist in this, this website includes an
overview of WHI,
study documentation, and information on how to
submit a paper or
ancillary study proposal.
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Desai P, et al. Cancer Med. 2018 Apr 2. doi: 10.1002/cam4.1368. [Epub ahead of print]Background: Statins are the most widely prescribed class of cholesterol lowering drugs and by acting as a competitive inhibitor of the rate limiting enzyme in the mevalonate pathway (hydroxyl methyl glutaryl coenzyme A (HMG CoA) leads to lower levels of down-stream products which may have implications for cancer chemoprevention.
Methods: We used data from the WHI's observational study (OS) and clinical trial (CT) to analyze the relationship between statin use, type, potency, and lipophilicity with risk of Non Hodgkin's Lymphoma (NHL), overall and NHL subtypes. The study population included 161,563 women from which there were 712 cases of NHL diagnosed after 10.8 years of follow-up. We used multivariable adjusted HR and 95% CI to evaluate the relationship between statin use at baseline, as well as in a time dependent manner. Separate analyses were performed for individual NHL subtypes including Diffuse large B-Cell lymphoma (DLBCL), follicular lymphoma and small lymphocytic lymphoma.
Results: In our time dependent models, statin use was associated with a borderline lower risk of NHL (HR 0.81, 95% C.I. 0.66-1.00). Considering histologic subtypes, statin use was associated with a lower risk of CLBCL (HR 0.62, 95% C.I. 0.42-0.91), but not other sub-types. Interestingly, this lower risk was driven by lipid soluble statins (HR 0.62, 95% C.I. 0.40-0.96), which included atorvastatin, simvastatin, lovastatin and fluvastatin.
Conclusions: These results may have impact on primary prevention in patients at high risk of NHL or secondary prevention in patients who have a high risk for relapse (higher stage of disease and high risk biology), particularly for DLBCL.
Desai P, et al. Gynecol Oncol. 2018 Mar;148(3):540-546. doi: 10.1016/j.ygyno.2018.01.006. Epub 2018 Feb 13.Background: Endometrial and ovarian cancers commonly carry mutations in pathways affected by the inhibition of the mevalonate pathway suggesting that these cancers may be potential targets of preventive strategies utilizing statins.
Methods: We used data from the WHI's observational study (OS) and clinical trial (CT) to analyze the relationship between statin use, type, potency, and lipophilicity with risk of endometrial and ovarian cancer. The study population included 161,808 women from which there 1377 cases of endometrial cancer and 763 cases of ovarian cancer after 10.8 years of follow-up. We used multivariable adjusted HR and 95% CI to evaluate the relationship between statin use at baseline, as well as in a time dependent manner. .
Results: Using multivariable adjusted models; we found a lower risk of endometrial cancer among users of baseline statins users (HR 0.74, 95% C.I. 0.59-0.94) but not when time dependent statin use was taken into consideration (HR 0.91, 95% C.I. 0.76-1.08). Statin use was associated with a higher risk of ovarian cancer (HR 1.30, 95% CI 1.04-1.62) which was mostly driven by pravastatin use (HR 1.89, 95% CI 1.24-2.88).
Conclusions: There was a reduction in risk of endometrial cancer among statin users at baseline but not in time-dependent models. Pravastatin use was associated with an increased risk of ovarian cancer. Analyses of larger numbers of cases are needed to further evaluate these findings.
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