$8.1 million grant extends UB’s participation in Women’s Health Initiative

UB has received funding to extend its role in the Women’s Health Initiative (WHI), the groundbreaking nationwide study that has yielded major discoveries on chronic diseases that affect postmenopausal women.

The initiative is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. With this extension through 2027, the WHI will have been continuously funded for 35 years.

The new UB contract includes $8.1 million in funding to follow the health outcomes in these women and produce scholarly scientific output. The new extension study began in October.

Launched as a pilot in 1991 by Louis W. Sullivan, then-secretary of the U.S. Department of Health and Human Services, and then-NIH Director Bernadine Healy, the WHI initially consisted of a set of three large, randomized clinical trials and an observational study that enrolled women from across the nation from 1993 to 1998. In total, with all study arms combined, WHI included more than 161,000 generally healthy, postmenopausal women aged 50 to 79.

The initial WHI study consisted of three clinical trials and was funded from 1993 to 2005. A series of extension studies every five years since then has allowed researchers to continue following the participants and regularly record health outcomes in these women as they age.

UB is one of the original 16 “vanguard clinical centers” selected to participate in the initiative, and also now serves as the WHI Northeast Regional Center, managing data collection and scientific coordination among nine WHI-affiliated institutions in the mid-Atlantic and Northeast regions.

According to Jean Wactawski-Wende, dean of the School of Public Health and Health Professions and the WHI Northeast Regional Center’s principal investigator, WHI’s main goal at its inception was to explain the origins and prevention of major causes of diseases and death in postmenopausal women who were between the ages 50 and 79 when they enrolled in the study.

The trials were designed to determine whether menopausal hormone therapy, calcium plus vitamin D and a low-fat diet could prevent chronic diseases in older women. The study initially focused on health outcomes like cardiovascular disease, cancer and osteoporotic fractures.

Over time, WHI expanded to focus on many other health outcomes, including dementia, stroke, diabetes, heart failure and frailty. WHI is also looking at resilience in the women who are now 75 to over 100 years of age.

“WHI is clearly the largest and longest study of postmenopausal women. We have learned so much from these women, and with this continuation of the WHI to 2027, we can learn much more,” Wactawski-Wende says.

Today, WHI aims to increase knowledge about factors such as sleep, physical activity and others that may be associated with a good quality of life and prevention of poor health outcomes.

“We have an ongoing study of COVID-19 in over 45,000 of the WHI women,” Wactawski-Wende adds. “In Buffalo, we are also looking at the impacts of caregiving in our participants. In addition, we have an ongoing study of periodontal disease, the oral microbiome and health outcomes.”

Approximately 70,000 women are currently participating in the study 25 years later.

“A notable aspect of this study is that about 70,000 women who participated are still alive and continuing to provide input,” she says. “For instance, in 2012-13 WHI conducted Long Life Study home visits with about 7,800 women to get more data, measurements and blood samples to continue studies. We will repeat that in-person visit in 2022 as part of this extension. The scientific output has been remarkable.”

Wactawski-Wende explains the most significant outcome of the study has been results related to hormone therapy trials, in which investigators found that taking estrogen plus progestin actually increased the risk for coronary heart disease, stroke, breast cancer and blood clots, and that taking estrogen alone increased the risk for stroke and blood clots.

They also found that taking hormone therapy increased the risk of dementia in women over 65. This led to many post-menopausal women discontinuing their use of hormone therapy because of the identified risks, she notes.

Wactawski-Wende is also SUNY Distinguished Professor in the Department of Epidemiology and Environmental Health, and the Department of Obstetrics and Gynecology at the Jacobs School of Medicine and Biomedical Sciences at UB.

Her co-investigators on the WHI are Michael LaMonte, Amy Millen, Heather Ochs-Balcom and Hailey Banack, all faculty members in the Department of Epidemiology and Environmental Health at UB. She also has a subcontract with faculty at Harvard and consultants from across the United States and Europe participating. WHI has been a valuable resource for training students and early-stage career investigators, Wactawski-Wende adds.