Aerodiol((R)) versus the transdermal route: perspectives for patient preference

Objective: to compare the efficacy, tolerability and user preference of Aer odiol((R)) intranasal and transdermal patch administration of 17 beta -estr adiol for climacteric symptoms. Methods: an open-label, multicenter, crosso ver trial in which recently postmenopausal women were randomized to receive either Aerodiol 300 mug daily (n = 176), or transdermal 17 beta -estradiol (reservoir patches delivering 50 mug/day), 2 patches per week (n = 185), f or 12 weeks, followed by 4 weeks of the alternative treatment. Efficacy was assessed primarily by the Kupperman index at the end of each treatment per iod. User satisfaction was assessed by questionnaire at weeks 12 and 16, an d at week 16 the women chose which treatment they preferred to use for a fu rther 40-week period. Results: Aerodiol and transdermal patch therapy produ ced marked and similar reductions in the Kupperman index and the incidence of hot flushes at weeks 12 and 16. The reduction in the Kupperman index at week 12 was statistically equivalent for the two treatments. The tolerabili ty of both treatments was good, with similar numbers of emergent adverse ev ents reported in both groups. The incidence of moderate or severe mastalgia , however, was significantly lower with Aerodiol (P = 0.02). Significantly more women chose to continue treatment with Aerodiol than with the transder mal patch (66 vs. 34%, P < 0.001). When all women had experienced both trea tments, reported levels of satisfaction were significantly higher with Aero diol than with transdermal therapy (P < 0.001 for all six categories assess ed). Conclusions: Aerodiol and transdermal patch treatments were of similar efficacy and tolerability. Levels of user preference and satisfaction, how ever, were higher with Aerodiol, which should contribute towards good long- term compliance with this therapy. (C) 2001 Elsevier Science Ireland Ltd. A ll rights reserved.