Metabolic changes induced by peroral oestrogen and transdermal oestradiol gel therapy

Objective To investigate changes in plasma lipid and lipoprotein levels induced by peroral oestrogen replacement and transdermal oestradiol gel therapy.
Design The effects of peroral oestradiol valerate tablets (2 mg) and placebo gel were compared with 1g transdermal oestradiol gel (1mg oestradiol) and placebo tablets in a randomised, double-blind, double-dummy study for 6 months.
Setting Department of Internal Medicine, University of Oulu and Oulu Deaconess Institute, Oulu, Finland.
Population Seventy-nine hysterectomised, postmenopausal women, 39 women in the peroral oestrogen group and 40 in the gel group.
Main outcome measures Cholesterol and triglycerides in total plasma and in various lipoprotein fractions, and sex hormones.
Results In the peroral oestrogen group total and LDL cholesterol were decreased and HDL cholesterol and triglycerides were increased. In the oestradiol gel group plasma total, LDL and VLDL cholesterol and the ratio of LDL/HDL cholesterol were significantly decreased, but no change in HDL cholesterol and triglycerides was observed. Overall the decrease in LDL levels was correlated with the increase in oestrogen levels.
Conclusions Both peroral and transdermal replacement therapy had beneficial effects on plasma lipids by lowering total and LDL cholesterol and LDL/HDL cholesterol ratio. These changes seem to be associated with changes in oestrogen levels.     

Treatment of hirsutism with ethinyl estradiol-desogestrel contraceptive pills has beneficial effects on the lipid profile and improves insulin sensitivity

OBJECTIVE: To evaluate the effects on the lipid pattern and insulin sensitivity of hirsute women of an oral contraceptive pill containing 30 microg of ethinyl estradiol and 150 microg of desogestrel. DESIGN: Prospective clinical study. SETTING: Tertiary care institutional hospital. PATIENT(S): 16 hirsute women. INTERVENTION(S): Women were evaluated at baseline and after receiving six cycles of oral contraceptive therapy. MAIN OUTCOME MEASURE(S): Body mass index (BMI); hirsutism score (nine body areas); serum levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, apolipoprotein B, lipoprotein(a), and serum adrenal and ovarian androgens; and fasting glucose and insulin concentrations. RESULT(S): The mean serum total, HDL, and LDL cholesterol levels increased after six cycles of oral contraceptive therapy. Levels of HDL cholesterol were < 50 mg/dL in 7 of the 16 patients at baseline; these levels normalized in 4 patients after treatment. Serum total and LDL cholesterol remained within the normal range in all patients before and after therapy. No significant changes were observed in serum triglyceride, apolipoprotein B and lipoprotein(a) concentrations. Fasting insulin levels and insulin resistance as analyzed by homeostasis model assessment were reduced significantly after therapy. No changes in BMI were observed. Administration of oral contraceptive pills signifiCantly reduced the hirsutism score and hyperandrogenemia. CONCLUSION(S): Oral contraceptive pills containing low-dose ethinyl estradiol and desogestrel are effective in controlling hyperandrogenism and hirsutism and ameliorate the abnormal metabolic profile of women with hirsutism.     

Lipid effects of hormone replacement therapy with sequential transdermal 17-beta-estradiol and oral dydrogesterone

OBJECTIVE: To assess the effects on lipid and lipoprotein levels of a combination therapy of matrix patch and oral sequential dydrogesterone. METHODS: The lipid effects of transdermal estradiol (E2) (80 microg/day continuously) and oral dydrogesterone (10 mg from days 15-28 of each cycle) were assessed in a multicenter, prospective, open, baseline-controlled study. Subjects were 42 healthy, postmenopausal women who had not had hysterectomies. Fasting blood samples were taken at baseline, day 14 of cycle 3 (estrogen alone), and day 25 of cycle 6 (estrogen and progestogen). The main outcome measures were changes from baseline in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides after six cycles. RESULTS: Thirty-six subjects completed six cycles and in the 28 with complete data, HDL cholesterol increased by 10.6% from 65.25 to 72.2 mg/dL (95% confidence interval [CI] 2.32, 11.58, P = .005) and LDL cholesterol fell by 5.1% from 130.9 to 124.3 mg/dL (95% CI 13.9, 1.16, P = .07). There was a nonsignificant decrease in LDL cholesterol from 130.9 at baseline to 124.3 mg/dL at 6 months and in triglycerides from 110.6 to 107.1 mg/dL. CONCLUSION: Sequential treatment with transdermal E2 and oral dydrogesterone increased HDL cholesterol, without the accompanying increase in triglycerides that occurs with oral estrogen replacement therapy.     

A randomised comparison of the effects of oral versus transdermal 17beta-oestradiol, each combined with sequential oral norethisterone acetate, on serum lipoprotein levels.

OBJECTIVE: To investigate the effects of oral versus transdermal 17beta-oestradiol, given in both cases with sequential addition of oral norethisterone acetate, on serum lipid and lipoprotein levels in postmenopausal women. DESIGN: Open, randomised, parallel groups study. SETTING: University Clinical Research Group. POPULATION: Sixty-four postmenopausal women with climacteric complaints who were otherwise healthy were screened. Of these, 58 fulfilled the entry criteria. METHODS: Fifty-eight postmenopausal women were randomised to receive either oral 17beta-oestradiol/oestriol (Trisequens) or transdermal 17beta-oestradiol (Estrapak) together with cyclical addition of norethisterone acetate for 48 weeks. MAIN OUTCOME MEASURES: Serum levels of total cholesterol, triglycerides, high density lipoproteins (HDL), low density lipoproteins (LDL), very low density lipoproteins (VLDL), apolipoproteins, and lipoprotein(a) at baseline, and after 46 weeks (oestrogen-alone phase), and 48 weeks (oestrogen-progestogen phase) of treatment. RESULTS: Oral oestradiol therapy did not affect serum total cholesterol levels during the oestrogen-alone phase, but during the combined phase there was a 5% fall (P < 0.05) due to a 7% decrease in LDL cholesterol levels (P < 0.01). Oral therapy also increased serum triglyceride levels by 9.4% during the oestrogen-alone phase (P < 0.05). During the combined phase of transdermal therapy, there was a 19% fall in serum triglyceride levels (P < 0.05) and a 6% fall in HDL levels (P < 0.05). Oral oestradiol reduced lipoprotein(a) levels by 31% during the oestrogen-alone phase and by 37% with norethisterone acetate addition (P < 0.05). Transdermal therapy had no significant effect on lipoprotein(a). CONCLUSIONS: Other than a minor fall in HDL3 in women receiving transdermal 17beta-oestradiol, coadministration of oral progestogen in general improved, rather than worsened, this serum lipoprotein profile.     

口服和经皮雌激素替代疗法对手术绝经妇女围绝经症状、血脂和凝血功能的影响

目的:研究口服和经皮雌激素替代疗法(ERT)对手术绝经妇女围绝经症状、血脂和凝血功能的影响。方法:手术绝经妇女随机分为口服组和皮贴组,分别使用雌二醇(E2)口服片(1 mg/d)和雌二醇皮贴片(1.5 mg/周)3个月。用药前、后分别检测血中E2和卵泡刺激素(FSH)水平,评估围绝经症状和生存质量,测定血脂和凝血功能。结果:口服组和皮贴组用药后血清E2水平明显升高,FSH水平明显降低,围绝经症状和生存质量均得到明显改善,组间无统计学差异。口服组用药后三酰甘油(TG)、高密度脂蛋白(HDL)较治疗前显著上升,低密度脂蛋白(LDL)较治疗前显著降低;皮贴组用药后HDL较治疗前有升高趋势,但差异无统计学意义(P>0.05),LDL较治疗前显著降低(P<0.05)。口服组用药后活化部分凝血活酶时间(APTT)较治疗前显著降低,其余各凝血指标与治疗前比较均无统计学差异;皮贴组用药后各凝血指标均较治疗前无显著变化。结论:口服和经皮ERT均能改善手术绝经妇女的围绝经症状,但两者在血脂和凝血方面作用不同。     

Tibolone versus four estrogen replacement therapy protocols and plasma lipid levels in postmenopausal women.

OBJECTIVES: To compare tibolone therapy with four different estrogen replacement therapy protocols, with regard to the effects on plasma lipid profiles. METHODS: The plasma lipid levels of 178 postmenopausal women in five different therapy groups were compared with each other as well as their baseline levels with 6-month intervals during 2-year follow-up. Student's t-test, paired t-test and Pearson correlation analysis were utilized for statistical analysis. RESULTS: HDL cholesterol levels increased significantly from baseline in groups using oral estrogen (P<0.05) but a slight non-significant decrease was seen in tibolone therapy (P>0.05). LDL cholesterol levels significantly decreased at the end of the second year in oral estrogen and tibolone users (P<0.05). Triglyceride levels increased non-significantly with estrogen therapy (P>0.05), whilst decreased significantly in the tibolone group (P<0.05). CONCLUSION: Tibolone may be a good alternative to estrogen replacement therapy in postmenopausal women, as it has beneficial effects on LDL cholesterol and triglyceride levels, which play important role in atherosclerosis.     

Effects of sequential combined transdermal and oral hormone replacement therapies on serum lipid and lipoproteins in postmenopausal women

The aim of this study was to compare the effects of sequential combined transdermal and oral postmenopausal hormone replacement therapies on serum lipid-lipoprotein profiles risk markers for cardiovascular disease. A prospective randomize study was designed: Ninety-six healthy nonhysterectomised postmenopausal women were randomized to receive either transdermal continuous 17β-estradiol, 0.05 mg/d (Estraderm TTS, Novartis, Basel, Switzerland), with transdermal sequential norethisterone acetate, 0.25 mg/d (Estragest TTS, Novartis, Basel, Switzerland), or oral continuous conjugated equine estrogens, 0.625 mg/d (Premarin 0.625 mg, Wyeth, Philadelphia, U.S.A.), with oral sequential medroxyprogesterone acetate, 10 mg/d (Farlutal 5 mg, Deva, Istanbul, Turkey). 84 women completed the trial, 42 in oral and 42 in the transdermal group. The serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoproteins AI and apolipoproteins B at 6 months after starting treatment were compared with baseline values for both therapies. Both oral and transdermal therapies significantly reduced serum levels of total cholesterol (208– 190 mg/dL and 216–199 mg/dL, respectively, p=0.0001) and LDL-cholesterol (128–112 mg/dL and 140– 127 mg/dL, respectively, p=0.001). The serum levels of triglycerides did not show any significant change with oral therapy, whereas this lipid fell (128–101 mg/dL, p=0.0001) significantly with transdermal therapy. We found significant decrease in HDL-cholesterol with transdermal therapy while there was no significant change with oral therapy. Apolipoproteins AI, the major protein component of HDL₂ subfraction, was increased by oral therapy and lowered by transdermal therapy. As a conclusion, we have found that serum total cholesterol and LDL-cholesterol were lowered by both therapies, with no significant differences between treatments, whereas there were significant differences between treatments according to effects on serum triglycerides and apolipoproteins AI. Received: 15 May 2001 / Accepted: 20 July 2001     

Effect of cyclic estrone sulfate treatment on lipid profiles of postmenopausal women with elevated cholesterol levels

The effects of two doses of cyclic unopposed estrone sulfate therapy on the lipid profiles of 153 healthy postmenopausal women with baseline total cholesterol levels above 219 mg/dL were compared in a multicenter, double-blind, placebo-controlled study. Patients were assigned randomly to one of three treatment groups: estrone sulfate 0.625 mg (N = 59) or 1.25 mg (N = 43), or placebo (N = 51). The median baseline total cholesterol levels of the three treatment groups were 262, 269, and 262 mg/dL, respectively. Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and the HDL/LDL ratio were assessed after 6, 9, and 12 months of treatment. There was a significant monotonic dose-response relationship of estrone sulfate in raising HDL levels, lowering LDL levels, and raising the HDL/LDL ratio at all intervals measured. These results indicate that estrone sulfate is effective in creating a beneficial change in the lipid profile of postmenopausal women with elevated baseline total cholesterol.     

Beneficial effects of low doses of ethinyl-estradiol on the lipid profile in postmenopausal women

The purpose of this study was to investigate the beneficial effects of low doses of ethinyl-estradiol on the lipid profile in postmenopausal women. One hundred and five patients (mean age [+/-S D] 42.9 +/- 5.0 years) who underwent a hysterectomy and bilateral salpingo-oophorectomy were included in the study. For the present study serum levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, apolipoprotein B (apoB), and lipoprotein(a) [Lp(a)] were investigated. When all patients were considered together (Table 1), EE2 therapy significantly increased serum levels of total cholesterol, HDL cholesterol and LDL cholesterol. The ratio of HDL to LDL cholesterol, Lp(a) and triglyceride concentrations did not change significantly from the baseline value. Although our study was not randomized or controlled with a placebo, the beneficial metabolic effects of ethinyl-estradiol on lipid patterns should be considered in patients needing hormonal replacement therapy in postmenopause.     

Effects of postmenopausal hormone replacement therapy on lipid, lipoprotein, and apolipoprotein (a) concentrations: analysis of studies published from 1974-2000

OBJECTIVE: To establish reference estimates of the effects of different hormone replacement therapy (HRT) regimens on lipid and lipoprotein levels. DESIGN: Review and pooled analysis of prospective studies published up until the year 2000. SETTING: Clinical trials centers, hospitals, menopause clinics. PATIENT(S): Healthy postmenopausal women. INTERVENTION(S): Estrogen alone, estrogen plus progestogen, tibolone, or raloxifene in the treatment of menopausal symptoms. MAIN OUTCOME MEASURE(S): Serum high- and low-density lipoprotein (HDL and LDL) cholesterol, total cholesterol, triglycerides, and lipoprotein (a). RESULT(S): Two-hundred forty-eight studies provided information on the effects of 42 different HRT regimens. All estrogen alone regimens raised HDL cholesterol and lowered LDL and total cholesterol. Oral estrogens raised triglycerides. Transdermal estradiol 17-beta lowered triglycerides. Progestogens had little effect on estrogen-induced reductions in LDL and total cholesterol. Estrogen-induced increases in HDL and triglycerides were opposed according to type of progestogen, in the order from least to greatest effect: dydrogesterone and medrogestone, progesterone, cyproterone acetate, medroxyprogesterone acetate, transdermal norethindrone acetate, norgestrel, and oral norethindrone acetate. Tibolone decreased HDL cholesterol and triglyceride levels. Raloxifene reduced LDL cholesterol levels. In 41 studies of 20 different formulations, HRT generally lowered lipoprotein (a). CONCLUSION(S): Route of estrogen administration and type of progestogen determined differential effects of HRT on lipid and lipoprotein levels. Future work will focus on the interpretation of the clinical significance of these changes.     

Treatment of hirsutism with myo-inositol: a prospective clinical study

The aim of this study was to evaluate the effects of myo-inositol treatment in hirsute women; changes in lipid pattern and insulin sensitivity were also considered. Forty-six hirsute women were enrolled at the first Institute of Obstetrics and Gynecology and evaluated at baseline and after receiving myo-inositol therapy for 6 months. Body mass index (BMI), hirsutism, serum concentrations of total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, apolipoprotein B, lipoprotein(a), serum adrenal and ovarian androgens, fasting glucose and insulin concentrations were evaluated. No changes in BMI were observed. The hirsutism decreased after therapy (P < 0.001). Total androgens, FSH and LH concentrations decreased while oestradiol concentrations increased. There was a slight non-significant decrease in total cholesterol concentrations, an increase in HDL cholesterol concentrations and a decrease in LDL cholesterol concentrations. No significant changes were observed in serum triglyceride, apolipoprotein B and lipoprotein(a) concentrations. Insulin resistance (P < 0.01), analysed by homeostasis model assessment, was reduced significantly after therapy. Administration of oral myo-inositol significantly reduced hirsutism and hyperandrogenism and ameliorated the abnormal metabolic profile of women with hirsutism.     

Effects of oral contraceptives on lipoprotein lipids: a prospective study

One hundred sixty-nine healthy women, aged 17 to 29 years, nonsmokers or light smokers (fewer than ten cigarettes per day), were assigned randomly to take one of five oral contraceptives: 1) 100 micrograms mestranol plus 0.5 mg ethynodiol diacetate (100 M + 0.5 ED); 2) 100 micrograms mestranol plus 1.0 mg ethynodiol diacetate (100 M + 1.0 ED); 3) 50 micrograms ethinyl estradiol plus 1.0 mg ethynodiol diacetate (50 EE + 1.0 ED); 4) 30 micrograms ethinyl estradiol plus 2.0 mg ethynodiol diacetate (30 EE + 2.0 ED); or 5) 30 micrograms ethinyl estradiol plus 0.15 mg levonorgestrel (30 EE + 0.15 NG). One hundred forty-seven women completed the study. When assessed for within-group differences, all preparation caused a statistically significant increase in total triglyceride (from 17.0 to 46.4 mg/dL), total cholesterol (from 6.3 to 24.4 mg/dL), and low-density lipoprotein (LDL) cholesterol (from 7.0 to 10.3 mg/dL). Effects on high-density lipoprotein (HDL) cholesterol varied widely. The product 100 M + 0.5 ED markedly increased (9.9 mg/dL) HDL cholesterol. Neither 100 M + 1.0 ED nor 50 EE + 1.0 ED altered HDL cholesterol levels, whereas both preparations containing 30 micrograms estrogen showed decreases: the preparation containing 2.0 mg ethynodiol diacetate lowered HDL cholesterol by 3.6 mg/dL and that containing 0.15 mg levonorgestrel lowered it by 6.9 mg/dL. Specific between-group comparisons revealed no statistically significant differences between differing amounts of estrogen (50 EE + 1.0 ED versus 100 M + 1.0 ED).(ABSTRACT TRUNCATED AT 250 WORDS)     

Parameters of lipid metabolism in postmenopausal women on oral or transdermal hormone replacement with or without progesterone

OBJECTIVE: Aim of the study was to show different influences of transdermal and oral hormone replacement therapies (conjugated and micronized estrogens) with or without varying dosages of C21-progestogens on serum lipids and lipoproteins. MATERIAL AND METHODS: We report on serum triglycerides, cholesterol, HDL-, LDL-cholesterol, apolipoprotein A 1 and B levels of 80 postmenopausal women, who received hormone replacement therapies for more than one year. RESULTS: All patients showed increasing (non-significant) serum HDL/LDL-cholesterol-ratios. Transdermal estrogen monotherapy also influenced the lipid parameters in a positive way. Apolipoprotein B, cholesterol and LDL-Cholesterol decreased, apolipoprotein A 1 increased. Transdermal replacement therapy combined with C21-progestagens and all oral therapies resulted in HDL-cholesterol increases. Positive changes in lipid parameters were most remarkably in women receiving oral therapies. The addition of 42 mg medrogestone/cycle caused a more significant decrease of cholesterol serum levels than higher dosages of medrogestone did. During subsequent treatment cycles, serum triglycerides showed increasing levels within the reference limits in women receiving conjugated estrogens and medrogeston. CONCLUSIONS: Transdermal and oral hormone replacement therapies with and without C21-progestogens are ideal for hormone replacement therapy in postmenopausal women with normal or minor pathological lipid parameters. The lowest possible medrogestone dose necessary for endometrium protection should be used.     

Clinical study comparing the effects of sequential hormone replacement therapy with oestradiol/dydrogesterone and conjugated equine oestrogen/norgestrel on lipids and symptoms

A clinical study comparing the effects of sequential hormone replacement therapy with oestradiol/dydrogesterone and conjugated equine oestrogen/norgestrel on lipids and symptoms. Objective: The objective of the study was to compare the effects of sequential 17β-oestradiol/dydrogesterone and conjugated equine oestrogens (CEE)/norgestrel on lipid parameters, climacteric symptoms, bleeding patterns and tolerability. Study design: This double-blind study was conducted in 193 peri- and post-menopausal women randomised to receive six, 28-day cycles of oral sequential oestradiol 1 mg/dydrogesterone 10 mg or CEE 0.625 mg/norgestrel 0.15 mg. The change from baseline in serum lipids and hot flushes was analysed using a two-way analysis of variance. Results: After 24 weeks there was a statistically significant increase in high-density lipoprotein (HDL) cholesterol in the oestradiol/dydrogesterone group and a significant reduction in the CEE/norgestrel group. The difference between the groups was significant (P=0.001). The number of hot flushes was reduced by 86% in both groups; this improvement was supported by the Greene Climacteric Symptom Scale score, the patients’ opinion and quality of life assessments. The percentage of women experiencing cyclic bleeding was greater with CEE/norgestrel, as was the mean duration and severity of bleeding. Both treatments were well tolerated. Conclusion: Oestradiol/dydrogesterone and CEE/norgestrel were equally effective in treating climacteric symptoms, but oestradiol/dydrogesterone showed some advantages in terms of lipid profile and incidence of bleeding. Condensation : Sequential oestradiol/dydrogesterone and conjugated equine oestrogen/norgestrel are equally effective in treating climacteric symptoms, but oestradiol/dydrogesterone shows advantages in terms of lipid profile and bleeding.     

Evaluation of the effect of tibolone and transdermal estradiol on triglyceride level in hypertriglyceridemic and normotriglyceridemic postmenopausal women

The objective of the present study was to quantify the magnitude of the association between the change in triglycerides and high-density lipoprotein (HDL) cholesterol levels with the use of tibolone and transdermal estrogen in postmenopausal women with hypertriglyceridemia and normotriglyceridemia. This prospective randomized study enrolled 140 postmenopausal women who had all been hysterectomized for almost a year or more. All subjects completed the 3-month follow-up. The 140 patients were divided into two groups: 70 were given transdermal 17β-estradiol 0.05 mg/day, and 70 were given tibolone 2.5 mg/day. We compared the effects of tibolone and transdermal 17β-estradiol on lipids and climacteric symptoms of the patients. To evaluate the effects of tibolone and transdermal estrogens on triglycerides and HDL cholesterol in postmenopausal women with normotriglyceridemia and hypertriglyceridemia, the women were assigned to five groups according to triglyceride levels (0-100, 101-200, 201-300, 301-400 and ? 401 mg/dl). We compared changes in the triglyceride and HDL cholesterol levels of each group after treatment. All 140 postmenopausal women completed the trial. No significant differences were found in baseline characteristics of the patients. The tibolone group showed a 22.6% decrease whereas the transdermal estrogen group had a 10.9% decrease in the mean triglyceride levels after 3 months of treatment. The mean decrease of triglyceride level with transdermal estradiol was approximately 11% in normotriglyceridemic and hypertriglyceridemic postmenopausal women. The mean decrease of triglyceride level was 17% in the normotriglyceridemic group and 22-30% in the hypertriglyceridemic groups with tibolone. While the mean HDL cholesterol level increased in the transdermal estrogen group (3.6%), it decreased in the tibolone group (9.3%). We found that tibolone decreased triglyceride levels much more than did transdermal estradiol. However, HDL cholesterol was decreased by tibolone and increased by transdermal estradiol. Tibolone had a more marked decreasing effect in postmenopausal women who had higher initial triglyceride levels. It is suggested that the beneficial effect of tibolone on the cardiovascular system might be greater in women with a high level of triglycerides.     

性激素替代治疗对手术绝经患者血管内皮功能的影响

目的 :探讨性激素替代治疗对手术绝经患者血管内皮细胞的保护作用。方法 :5 1例手术绝经患者分为性激素替代治疗组和对照组 ,治疗组给予雌激素加孕激素联合口服 9月。两组在实验前后测定血浆总胆固醇 (Tch)、甘油三酯(TG)、高密度脂蛋白 (HDL)、低密度脂蛋白 (L DL) ,一氧化氮 (NO) ,血管性假血友病因子 (v WF) ,FSH、E2 。超声多普勒进行肱动脉充血试验。结果 :治疗组用药后 ,与对照组相比 ,Tch、L DL、v WF、FSH明显降低 ,HDL、E2 、NO明显升高 ,肱动脉内径舒张百分比明显增加。结论 :性激素替代治疗可以改善手术绝经患者血管内皮细胞功能     

Effect of oestrogen and progesterone on fasting serum cholesterol and triglyceride levels in post-menopausal women

A study of 240 post-menopausal women receiving Dixarit (clonidine hydrochloride), Premarin (conjugated equine oestrogens), Harmogen (piperazine oestrone sulphate) and Progynova (oestradiol valerate) in two different dosages alone and in combination with progestational agents such as norethisterone acetate, dydrogesterone, and norgestrel for climacteric symptoms showed that there was no adverse effect on serum lipid levels. There was no significant change in the serum cholesterol and triglyceride levels during treatment with oestrogen replacement therapy.     

LycoRed as an alternative to hormone replacement therapy in lowering serum lipids and oxidative stress markers: a randomized controlled clinical trial

AIM: Menopause is a pro-atherogenic state with a sharp rise in the incidence of coronary artery disease. This pilot study was designed as an equivalence randomized clinical trial to explore the potential of LycoRed (containing 2000 microg lycopene) as an alternative to hormone replacement therapy (HRT) for the prevention of coronary artery disease in postmenopausal women. METHODS: Forty-one healthy postmenopausal women were randomly allocated to receive either continuous combined HRT (n = 21) or LycoRed (n = 20) for six months. Serum lipid profile, marker of lipid peroxidation (malondialdehyde), and the level of endogenous antioxidant (glutathione) were measured at the baseline, and 3 and 6 months after the intervention in both groups. RESULTS: At 6 months, HRT resulted in a significant decrease in total cholesterol (TC) level by 23.5%, low-density lipoproteins (LDL) by 19.6%, and an increase in high-density lipoproteins (HDL) by 38.9%. The LycoRed group showed similar changes in TC (-24.2%), LDL (-14.9%) and HDL (+26.1%). Triglyceride levels showed a smaller though significant increase at 6 months, but not at 3 months, in both groups. There was no significant change in the very LDL (VLDL) level in either group. Malondialdehyde levels decreased significantly by 16.3% and 13.3%, whereas glutathione levels increased significantly by 5.9% and 12.5% in HRT and LycoRed groups, respectively. CONCLUSION: Both HRT and LycoRed had a favorable effect on serum lipids and oxidative stress markers which were comparable. LycoRed can be used as an alternative to HRT to reduce the risk of atherosclerosis in postmenopausal women.     

Effect of hormone replacement therapy, tibolone and raloxifene on serum lipids, apolipoprotein A1, apolipoprotein B and lipoprotein(a) in Greek postmenopausal women.

The aim of this study was to assess the effect of estrogen, two regimens of continuous combined hormone replacement therapy (HRT), tibolone and raloxffene on serum lipid, apolipoprotein A1 and B and lipoprotein(a) levels in Greek postmenopausal women. A total of 350 postmenopausal women were studied in a prospective open design. Women were assigned to one of the following regimens depending on the presence of risk factors for osteoporosis, dimacteric symptoms and an intact uterus: conjugated equine estrogen 0.625 mg (CEE, n = 34), continuous combined CEE 0.625 mg plus medroxyprogesterone acetate (MPA) 5 mg, (n = 80), continuous combined 17beta-estradiol 2 mg plus norethisterone acetate (NETA) 1 mg (n = 58), tibolone 2.5 mg (n = 83) and raloxifene HCl 60 mg (n = 50). Forty-five postmenopausal women with no indications for HRT served as controls. Total cholesterol (TC), low-density lipoprotein (LDL) cholestrol and high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) and lipoprotein(a) (Lp(a)) levels were assessed in each subject at baseline, and at 6 and 12 months of therapy. All therapy regimens lowered TC levels compared to baseline (4.2-8.0% decrease). This effect was more prominent in the subgoup of women with high baseline TC levels (9.1-20.4% decrease). LDL cholesterol decreased significantly in CEE, CEE/MPA and raloxifene groups (-11.2%, -11.9% and -11.0%, respectively). Hypercholesterolemic women exhibited a steeper decrease in LDL cholesterol (10.6-27.8% in all therapy groups). TG levels increased significantly in the CEE and CEE/MPA groups (23.7% and 21.8%, respectively), while estradiol/NETA had no effect on TG levels. Tibolone decreased TG levels markedly, by 20.6%, while raloxifene had no TG-lowering effect. HDL cholesterol and ApoA1 were increased by CEE and CEE/MPA (HDL cholesterol, 7.4% and 11.8%, respectively; ApoA1, 17.8% and 7.9%, respectively) and decreased by tibolone (HDL cholesterol, -13.6%; and ApoA1, -9.9%). All therapy regimens except raloxifene lowered Lp(a) levels, with tibolone having the more pronounced effect (-13.2 to -29.0%). In conclusion, each therapy regimen had a diferent effect on lipid-lipoprotein levels, exerting favorable and unfavorable modifications. Hypercholesterolemic women seemed to benefit more from the cholesterol-lowering effect of estrogen replacement therapy/HRT. The choice for a particular regimen should be based on individual needs, indications and lipid-lipoprotein profile.     

Effects of estrogen therapy on microalbuminuria in healthy post-menopausal women

Objective. To evaluate the impact of estrogen therapy on microalbuminuria levels in healthy post-menopausal women.

Methods. Sixty post-menopausal women were evaluated in a prospective, randomised, double-blind, placebo-controlled study. The patients were randomly allocated to one of two groups to take one pill orally per day containing either 1 mg of 17β-estradiol (E₂ group) or placebo (placebo group). Prior to initiating treatment and at the end of the sixth treatment month, microalbumin was measured in a 12-h urine sample, and lipid profile (total cholesterol, HDL, LDL and triglycerides) and fasting glucose were evaluated. Comparative intra- and inter-group analyses between the initial and final laboratory parameters were performed using the t-test for paired samples and for independent samples, respectively.

Results. Microalbuminuria levels remained within normal limits throughout the study and no statistically significant differences were found in the intra- or inter-group analyses. With respect to lipid profile, alterations characteristically encountered during use of estrogen replacement therapy were found. No statistically significant variation in glucose levels occurred during the study period.

Conclusion. Estrogen replacement therapy had no significant effect on microalbuminuria levels in healthy post-menopausal patients.