THS: confirmed increase in cardiovascular risk and thrombosis during a long initiation after menopause

The results of the Anglo-Saxon WISDOM trial , which was discontinued after the U.S. trial Women's Health Initiative (WHI ) confirm that hormone replacement therapy (HRT ) increases the risk of cardiovascular and thromboembolic when initiated several years after menopause.
Originally planned to assess 10 years of HRT , the trial was stopped prematurely after 11.9 months median follow-up , three months after the cessation of the WHI study. The results support the recommendation not to use HRT long-term goal of cardiovascular prevention in particular .

The WHI was the first randomized study against placebo to evaluate the effects of long-term HRT , was also stopped early after the discovery of an excess risk of cardiovascular and breast cancer.

The population was included , however, older than that usually initiates HRT , and products used very specific Anglo-Saxon market. Studies have since shown that the risks were not the same with HRT use in France .

However , the recommendations are now using HRT only for the treatment of symptoms associated with menopause , for the shortest time possible and at the lowest possible doses.

WISDOM was initially include patients younger age ( 45-60 years ) than the WHI to reflect normal use of HRT , but eventually the age slipped to 50-64 and 50-69 for it there is a good probability of finding relevant events during the test , providing 10 years of treatment and 10 additional years of follow-up , the authors noted .

The results relate to 5692 women in the UK , Australia or New Zealand, included in the study when they were postmenopausal for at least 12 months or had undergone a hysterectomy . They were randomized to estrogen alone (for hysterectomy patients ) , combined HRT and placebo.

The products used were the same as in WHI ( conjugated equine estrogens and medroxyprogesterone acetate) .

The average age of patients was 62.8 years and they were postmenopausal average from 15 to 18 .

After less than a year of monitoring, compared with placebo, combined HRT was associated with an increase in the number of major cardiovascular events ( seven against zero) and venous thromboembolism ( three against 22 , a risk multiplied by 7,36 ) .

There was no significant difference in the risk of breast cancer or other cancers , cerebrovascular event , fracture and overall mortality. There was also no difference between estrogen alone and combined HRT .

"These results are consistent with those of the WHI and secondary prevention studies . Research is needed to assess the risks and long-term benefits of initiation of HRT around the menopause, when the effects are likely to be different " the authors conclude.

Analysis derived from the WHI among younger participants already suggest that there is no excess cardiovascular risk with HRT initiated around menopause .