UB receives 5-year extension of Women’s Health Initiative

UB has received a five-year extension of its involvement with the Women’s Health Initiative (WHI), a federally funded, groundbreaking study that has yielded major discoveries on chronic diseases that affect postmenopausal women.

UB was awarded $6.2 million for its WHI Extension Study through the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The grant runs through October 2020.

Launched in 1991 by Louis W. Sullivan, then-secretary of the U.S. Department of Health and Human Services, the WHI initially consisted of a set of clinical trials and an observational study, which combined included more than 161,000 generally healthy postmenopausal women aged 50 to 79.

“As a society, we are aging. What we learn from these women will help the next generation of women and society in understanding these issues,” says Jean Wactawski-Wende, UB’s lead WHI investigator and dean of the School of Public Health and Health Professions. “The research that comes from a study of this breadth — the large number of participants and the length of follow-up — is remarkable,” she adds.

The study’s initial aim was to address heart disease, cancer, stroke, osteoporosis and dementia — the most common causes of death, disability and impaired quality of life in postmenopausal women, according to the NHLBI. Now, however, the participants are between 67 and 100, allowing researchers to examine the group’s quality of life as it ages, as well as frailty and predictors of healthy aging.

In addition to following health outcomes as the group ages, there are several add-on studies being conducted, including two new clinical trials begun this year: one on physical activity and health, and another on cocoa extract and multivitamins and their impact on health. UB is conducting an ancillary study examining the oral microbiome and its relation to oral and systemic health. “The science keeps expanding,” Wactawski-Wende says.

UB is one of the original 16 “vanguard clinical centers” selected to participate in the initiative, and also 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.

The main WHI study was funded from 1991 to 2005 — a series of extension studies every five years since 2005 has allowed researchers to continue following the participants — and involved regularly recording health outcomes in the participants. “The women are terrific in this aspect. We still get over 90 percent response rate from them,” says Wactawski-Wende, adding that their participation has helped researchers better understand health issues that impact postmenopausal women.

“We have learned so much from their participation in WHI. With this extension study and the new ancillary studies, we expect even more to come,” she says. “The research coming from WHI has informed women and their clinicians worldwide.”

The 12-year initial study changed the way physicians counseled patients, particularly on the use of hormone therapy. The study revealed the risks of long-term hormone therapy outweighed the benefits, and many physicians decided to stop recommending their patients use hormone therapy to help prevent heart disease and osteoporosis, as well as treatment of such symptoms of menopause as hot flashes and night sweats.

Wactawski-Wende’s co-investigators on the WHI Extension Study are Michael J. LaMonte, research associate professor; Amy Millen, associate chair and associate professor; and Heather Ochs-Balcom, assistant professor, all from the Department of Epidemiology and Environmental Health in the School of Public Health and Health Professions.