Pulsed estrogen therapy: relieving climacteric symptoms, preventing postmenopausal bone loss.

Aerodiol with its new mode of action--pulsed estrogen therapy made possible by a unique pharmacokinetic profile and an innovative route of administration--acts on the full range of climacteric symptoms and on the long-term consequences of estrogen deprivation. Four well-designed, international studies investigating the efficacy of pulsed estrogen therapy on both the short- and long-term consequences of estrogen deprivation were conducted. Climacteric symptoms and their reduction were assessed individually and also using the Kupperman index, which is a weighted score. Aerodiol produced a significant reduction in the Kupperman index and in the occurrence of menopausal symptoms, such as hot flushes and night sweats. This reduction appeared to be significant as early as the second week of treatment. Moreover, Aerodiol remained effective even among highly symptomatic women with more than seven hot flushes per day, and also among smokers. Since it avoids hepatic first-pass metabolism, pulsed estrogen therapy also has a favorable action on the lipid profile, decreasing lipoprotein(a), apolipoprotein B, total cholesterol, and low-density lipoprotein cholesterol. Furthermore, Aerodiol is neutral with regard to clotting factors, angiotensinogen and insulin levels. The effect of pulsed estrogen therapy on bone has been assessed in both the short and the long term. Bone turnover, as measured by markers of resorption and formation, was normalized to premenopausal levels after 3 months of treatment at a dose of 300 microg/day. Aerodiol, again at the dose of 300 microg/day, is as effective as a 50-microg/day transdermal patch in increasing bone mineral density (p < 0.001 versus baseline) at the spine and hip after 56 weeks. Finally, data collected during the development of Aerodiol have shown that pulsed estrogen therapy is at least as effective as 2 mg of oral estrogen or 50 microg of transdermal estrogen in relieving climacteric symptoms and preventing postmenopausal bone loss.