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Health risks after cessation of postmenopausal hormone therapy

The Women’s Health Initiative (WHI) investigators have produced another article [1], which probably marks the opening of another set of publications, in which the consequences of a further 2.4-year follow-up (after cessation of the study medication) on the estrogen + progestogen (E + P) cohort are reported. They concluded that, by the end of the post-intervention period, the global index, a newly formed and unvalidated tool used in the WHI trial, was still higher in women randomly assigned to receive E + P compared with placebo.

“After such long and painful debates over the results of the WHI study and the perception that age is a very important determinant of the benefit–risk evaluation, it is really a pity that once again the current information on the extended follow-up period is presented in an unsatisfactory way”, says Professor Amos Pines, the President of the International Menopause Society. It seems that the following mistakes were repeated:

1. There is no mention of the results by age groups and yet, for the age group 50–59 years, the data recorded for the active phase of the WHI E + P arm showed no significant increase in risk of coronary events, strokes and breast cancer in the early postmenopause period. Also, there is no breakdown of the data by years of follow-up. It would be extremely important to know whether the results for the first year post cessation of therapy are similar to those for year 2 and year 3 of follow-up.
2. The breast cancer results for first-time users of E + P were not presented, whereas breast cancer risk during the active phase of the WHI was similar to that of the placebo group in women with no prior use of E + P.
3. There is little relevance in the presentation of the combined results for the active phase and the follow-up phase, since it has no real scientific importance. Combining the two periods and grouping the outcomes (all cancers, all cardiovascular events) ‘helped’ the authors to show significance in some of the variables. However, the overall differences in the annualized rates between the E + P arm and the placebo arm were in the order of 1.5 cardiovascular events per 1000 women/year and 1.2 cancers per 1000 women/year. Again, no data were shown for the younger age group.

“It seems that the WHI investigators have forgotten the turmoil and anxiety they caused in 2002 when they published the preliminary results of the E + P cohort”, concluded Professor Pines. By releasing the new data without performing all the necessary, important sub-analyses, women could face another unjustified turmoil related to hormone therapy.

Reference

1. Heiss G, Wallace R, Anderson GL, et al. JAMA 2008;299:1036

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