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

Background. Kliogest((R)) 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((R)) in hormone replacement therapy (HRT)-naive 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((R)) 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((R)) 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((R)) was not statistically significant. The frequency and severity of treatment-related uterine bleeding decreased with the duration of Kliogest((R)) 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((R)) -induced change in estrone concentration and change in lumbar and hip BMD. Conclusions. Continuous treatment with Kliogest((R)) for 1 year reversed the potential postmenopausal bone loss in HRT-naive Thai postmenopausal women. However, its effect on cardiovascular risk is uncertain. Furthermore, Kliogest((R)) is safe but appears to have no significant effect on climacteric symptoms in the patients in the present study.