[Compliance with hormone replacement therapy in menopausal women: results of a two-year prospective French study comparing transdermal treatment with fixed oral combination therapy]

Abstract

Objectives: To evaluate rates of continuation with hormone replacement therapy (HRT) at 2 years in 2 cohorts of female patients, one of which was treated with a set combination of oral oestradiol valerate and medroxyprogesterone acetate and the other with percutaneous 17 beta-oestradiol gel combined with an oral progestogen selected by the prescribing doctor.

Patients and methods: A prospective, randomised, open study, including 885 patients followed for 2 years whose 477 were in the oral HRT cohort and 408 were in the dermal cohort. Randomisation was done by group with prescription of the selected HRT for the cohort. The 2 treatment groups were compared using chi(2) tests and Fisher's exact test for qualitative variables, Student's t test or Wilcoxon's test for qualitative variables and Kaplan-Meier survival curves for continuation of HRT, with comparisons using the log-rank test. The prognostic value of baseline parameters on subsequent continuation of HRT was studied using the Cox model (Wald test, odds ratio). RESULTS; Among the 885 treated patients, 711 received the HRT assigned to their cohort (382 in the oral HRT cohort, 329 in the dermal HRT cohort). After 2 years, 77.9% of the patients in the oral HRT cohort and 73.4% of the patients in the dermal HRT cohort were continuing to take their prescribed HRT (P = 0. 076): 37.9% of patients in the oral HRT cohort and 20.2% of patients in the dermal HRT cohort (P < 0.001) continued taking their treatment without any modification.

Conclusion: Although there was no significant difference in the level of compliance in the 2 groups, it is nonetheless worth noting that the HRT compliance with a sequential fixed estroprogestogen combination was, in this trial, at least equal to that with the free combination of a transdermal estrogen and a progestogen whose nature, dosage and sequence duration are selected by the prescriber. On the other hand, treatment modifications occurred more frequently in the cutaneous HRT group, which is logical as free combination affords to adapt the treatment to each patient.