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HT failed to increase, cause mortality, CV events
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Ten years after the Women’s Health Initiative found no cardiovascular benefit from hormone therapy, new data from a Danish randomized controlled trial suggest the opposite.
The findings report that women who took HT for 10 years after menopause experienced a significant risk reduction for mortality, heart failure and myocardial infarction. Besides this reduced risk, the study also suggests there is no increased risk for cancer, deep venous thromboembolism (DVT) or stroke.
Louise Lind Schierbeck, MD, of the Bispebjerg Hospital in Copenhagen, Denmark, and colleagues randomly allocated 1,006 patients from the Danish Osteoporosis Prevention Study, a prospective multicenter trial investigating the effect of HT as the primary prevention for osteoporotic fractures.
Of the 1,006 healthy women patients aged 45 to 58 years, 502 were assigned to HT and 504 were assigned to no treatment (control). The women were all recently postmenopausal (7 months) or had perimenopausal symptoms. Those who underwent hysterectomy (aged 45 to 52 years) were included if they had recorded measurements of their postmenopausal serum follicle-stimulating hormone (FSH).
Within the HT group, patients with intact uteruses were given 2 mg synthetic 17-beta-estradiol for 12 days, 2 mg 17-beta-estradiol plus 1 mg norethisterone acetate for 10 days, and 1 mg 17-beta-estradiol for 6 days (Trisekvens, Novo Nordisk). Women who underwent hysterectomy received 2 mg estradiol per day.
The patients underwent a physical examination and screenings at baseline, 6 months, and years 1, 2, 3, 5 and 10. The primary endpoints were a composite of death and admission to the hospital for heart failure and MI.
“The planned duration of the study was 20 years. However, as data published from other trials at the time of the 10-year visit indicated that use of hormone replacement therapy might result in more harm than benefit in postmenopausal women, we advised our study participants to stop treatment,” the researchers wrote.
According to data, 41 women died during the intervention period (26 controls vs. 15 treated; HR=0.57; 95% CI, 0.30-1.08).
Heart failure was diagnosed in eight patients (7 controls; 1 treated; HR=0.14; 95% CI, 0.02-1.16). MI was diagnosed in five patients (4 controls; 1 treated; HR=0.25; 95% CI, 0.03-2.21).
The rate of strokes and the rate of DVT, as well as occurrence of any cancer, did not differ or did not differ significantly, the researchers said.
“The rate of breast cancer and other cancer was not increased in the present study, but because of the potential time lag, a longer follow-up may be necessary to make more definite conclusions,” they said.
These findings suggest that HT, when started early in the menopausal woman and continued, did not increase or cause CV events, including mortality, stroke, heart failure or MI, the researchers concluded.
Disclosure: This study was funded by the Karen Elise Jensen’s Foundation, LEO Pharma, Novartis, Novo Nordisk and University of Aarhus. Eiken is on the advisory board of Novartis and Nycomed, and the speakers’ bureau for Amgen, Eli Lilly, GlaxoSmithKline and Novartis. Jensen is on the advisory board and speakers’ bureau for Amgen, Eli Lilly, Merck Sharp & Dohme, Novartis and Nycomed. All other researchers have no relevant financial disclosures.
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