Postmenopausal
women using vaginal estrogen are not at increased risk of cardiovascular
disease and cancer reports the result of study published August 14, 2017 in
Menopause.
This is
another important study conducted using data from Women's Health Initiative(WHI) observational study which tracked the medical history and health habits
of 93,676 women nationwide for 8-12 years. The current study recruited 45,663
women between 50-79 years of age, across 40 US clinical centers. These women
did not use systematic estrogen and underwent a median follow-up of 7.2 years.
Results of this
prospective observational cohort study showed that in women with intact uterus
and using vaginal estrogen, the risk of cardiovascular event, pulmonary
embolism, stroke, invasive breast cancer, endometrial and colorectal cancer
does not exceed the risk faced by non-hormone users.
Women using
vaginal estrogen had 32% lower risk of global index event (GIE), defined as time
to first occurrence of coronary heart disease (CHD), invasive breast cancer,
stroke, pulmonary embolism, hip fracture, colorectal cancer, endometrial cancer,
or death from any cause as compared to non-users (GIE adjusted hazard ratio
0.68, 95% confidence interval 0.55-0.86).
Based on the
results of this trial, US FDA is considering a proposal to revise the warning
labels on low dose estrogen packaging to incorporate the safety profile of
vaginal estrogen.
Current
labels were approved before any evidence was put forth about safety of vaginal
estrogen and it may discourage patients from using topical estrogen which are safe
and highly effective in treatment of genitourinary symptoms of menopause.
Different
formulations like topical creams, an intravaginal insert, and an intravaginal
ring have the same safety and efficacy.
JoAnn
Pinkerton, MD, executive director, North American
Menopause Society (NAMS), said in a position statement released by North American Menopause Society on August 17, “These findings
should reassure women and their healthcare providers that low-dose vaginal
estrogen, which keeps blood levels within the normal postmenopausal range, is
effective and safe for postmenopausal women who need relief from only vaginal
symptoms,” says Dr. JoAnn Pinkerton, NAMS executive director. “The boxed
warnings about the risk of heart disease, stroke, blood clots, and cancer do not
apply to these low-dose vaginal therapies. Instead, women who experience
bleeding or those with breast cancer should include their healthcare providers
and oncologists in deciding about this option.”
