Effect of combined oral estrogen/progestogen preparation (Kliogest®) on bone mineral density, plasma lipids and postmenopausal symptoms in HRT-naïve Thai women

Background. Kliogest® is commonly prescribed for the relief of acute postmenopausal symptoms and prevention of postmenopausal bone loss. However, there have been few data on its effect in Asian women. Methods. This 1-year, single-center, randomized, double-blind and placebo-controlled study evaluated the efficacy and safety of Kliogest® in hormone replacement therapy (HRT)-naïve Thai women. The subjects were 120 healthy Thai women aged between 45 and 65 years, with intact uterus, and who had been amenorrheic for at least 1 year. Results. Kliogest® increased spine (+6%, p < 0.01) and hip (+2%, p < 0.01) bone mineral density (BMD), and lowered plasma total cholesterol (TC) (-16%, p < 0.05) and low density lipoprotein cholesterol (LDL-C) (-16%, p < 0.05) concentrations. However, Kliogest® also resulted in a decrease in high density lipoprotein cholesterol (HDL-C) concentration (-18%, p < 0.05). Compared to placebo, the reduction in menopausal symptoms by Kliogest® was not statistically significant. The frequency and severity of treatment-related uterine bleeding decreased with the duration of Kliogest® treatment. Furthermore, there was a fairly strong relationship between the change in serum estrone concentration and the average monthly weighted bleeding scores over the first 6 months (Spearman's correlation r = 0.54; p < 0.001), which became weaker over the entire treatment period (Spearman's correlation r = 0.27; p < 0.01). Although there was a small to moderate relationship between baseline estrone concentration and both lumbar (r = 0.23, p < 0.02) and hip (r = 0.20, p < 0.05) BMD, there was no significant relationship between Kliogest®-induced change in estrone concentration and change in lumbar and hip BMD. Conclusions. Continuous treatment with Kliogest® for 1 year reversed the potential postmenopausal bone loss in HRT-naïve Thai postmenopausal women. However, its effect on cardiovascular risk is uncertain. Furthermore, Kliogest® is safe but appears to have no significant effect on climacteric symptoms in the patients in the present study.