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A Randomised Placebo Controlled Trial of the Effects of Tibolone on Blood Pressure and Lipids in Hypertensive Women

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A Randomised Placebo Controlled Trial of the Effects of Tibolone on Blood Pressure and Lipids in Hypertensive Women Journal of Human Hypertension (2000) 14, 99–104 2000 Macmillan Publishers Ltd All rights reserved 0950-9240/00 $15.00 www.nature.com/jhh ORIGINAL ARTICLE A randomised placebo controlled trial of the effects of tibolone on blood pressure and lipids in hypertensive women G Lloyd1, E McGing1, A Cooper1, N Patel1, PJ Lumb2, AS Wierzbicki2 and G Jackson1 1Department of Cardiology and 2Chemical Pathology, Guys and St Thomas’ Hospital Trust, Lambeth Palace Road, London SE1 7EH, UK The effects of hormone replacement therapy in hyper- high-density lipoprotein (HDL)-cholesterol by tensive women are controversial. This randomised pla- 21.7 ؎ 3.8% vs 2.4 ؎ 2.6% (P Ͻ 0.01) with tibolone as cebo controlled trial assessed the effect of tibolone opposed to placebo. No significant differences were 2.5 mg on blood pressure and fasting plasma lipids in observed in total cholesterol, low-density lipoprotein 29 hypertensive postmenopausal women over 6 months (LDL)-cholesterol and lipoprotein (a). Fibrinogen levels using a 2:1 randomisation to tibolone. The primary clini- were reduced by 13.6 ؎ 6.8% on tibolone compared to cal end-point was mean office blood pressure. At 6 a 19.3 ؎ 15.4% rise (P Ͻ 0.05) on placebo. This study months systolic blood pressure declined by suggests that tibolone has no deleterious effect on vs 4.94 ؎ 3.37% whilst diastolic blood blood pressure in women with hypertension but has 2.87% ؎ 5.30 -pressure declined 5.38 ؎ 2.65% vs 0.85 ؎ 3.69% on contrasting effects on biochemical risk factors. Large tibolone and placebo respectively. These differences scale studies are required to determine the overall effect were not statistically significant. Triglycerides of tibolone on cardiovascular morbidity and mortality. decreased by 33.3 ؎ 6.1% vs 7.6 ؎ 7.9% (P Ͻ 0.01) and Journal of Human Hypertension (2000) 14, 99–104 Keywords: hormone replacement; hypertension; lipids; trial Introduction women with pre-existing hypertension on both blood pressure and biochemical cardiovascular The role of hormone replacement therapy (HRT) in risk factors. women with hypertension remains controversial. Oestrogen-based HRT remains underused in these women probably because of concerns about blood Materials and methods pressure deterioration in younger women taking the Study design oral contraceptive.1 However, the potentially ben- eficial effects of HRT in reducing coronary heart dis- The trial had a double-blind, randomised, placebo- ease (CHD) risk would suggest a role for it in the controlled format. Randomisation was 2:1 in favour management of hypertension.2,3 The loss of oes- of tibolone to increase the probability of demonstrat- trogen at the menopause appears to be associated ing a treatment effect. The study received local ethi- with an overall rise in blood pressure.4 Little infor- cal approval and written informed consent was mation is available regarding the long-term effects obtained. At two baseline visits clinical details, of HRT in hypertensive women, but short duration baseline blood pressure, quality of life parameters studies in hypertensive women have demonstrated and fasting lipid profiles were measured. Patients either a neutral or even modest hypotensive were reviewed monthly for continued blood press- effect.5–10 ure assessment. Baseline biochemical investigations Cyclical HRT preparations are unacceptable to were repeated at the final clinical visit after 6 most women suffering from coronary disease or months treatment. hypertension. Tibolone is a novel steroid com- 11 pound, which controls menopausal symptoms, Eligibility inhibits postmenopausal bone loss12 and augments forearm blood flow.13 It does not induce endometrial Eligible patients had previously diagnosed hyper- hyperplasia or, usually, postmenopausal bleeding.14 tension on or off treatment with antihypertensives. We investigated the effect of introducing tibolone in All had three separate standard mercury sphygmo- manometer blood pressure readings greater than 160/90 mm Hg over 3 months or were taking long- Correspondence: Dr Guy Lloyd, Cardiothoracic Department, 6th term antihypertensive treatment. All were 1 or more Floor, East Wing, St Thomas’ Hospital, London SE1 7EH, UK years postmenopausal on clinical grounds. Received 24 May 1999; revised and accepted 3 September 1999 Exclusion criteria included, intrinsic renal disease, Tibolone randomised controlled trial G Lloyd et al 100 insulin-dependent diabetes or a past history of an at the final visit. Data were analysed using the SPSS oestrogen dependent tumour. Women who had used statistical package (version 6.0). Parametric data are sex steroid compounds including oral contracep- displayed as mean and standard error, non-para- tion, previous HRT, progesterone, tibolone or tamox- metric data as median and range while frequency ifen within the previous 3 months were excluded. data as value and percentage. Principal analysis was performed using ANOVA for repeated measures with unpaired t-testing for individual two-way com- Blood pressure measurement parisons between subjects allocated to tibolone or Blood pressure was measured as near as possible at placebo. Non-parametric data (lipoprotein (a) and the same time of the same day of the week by one triglycerides) were compared using the appropriate of two operators using the British Hypertension non-parametric test (Mann–Whitney) with contin- Society approved methods.15 For the purposes of gency table testing of frequency data (Yates’ conti- analysis the mean of the three recumbant blood nuity correction). P Ͻ 0.05 was considered statisti- pressure measurements was calculated. If blood cally significant. pressure exceeded 210/120 mm Hg on two separate visits, the patient left the study to allow modifi- cation of medication, otherwise all concomitant Results antihypertensive medication was left unchanged for Demographics the duration of the study. Major demographic features were similar in the active and placebo arms of the study (Table 1). The Plasma lipids and lipoproteins mean age of the women was 60.1 years in the active Blood samples were drawn in the recumbant pos- group and 62.7 years in the placebo group. Both ition after a 12-h fast. Samples were centrifuged groups were more than 10 years after the menopause immediately and stored at −70°C until subsequent (11.5 years tibolone and 16.1 years placebo). There analysis. Plasma lipid profiles were detained in a were non-significant statistical differences in other single batch by standard automated methods for patient characteristics and in concomitant total cholesterol, triglycerides and HDL on a Cobas medications. Fara II analyser. Low-density lipoprotein (LDL) was calculated by the Freidewald equation if triglycer- Blood pressure ides Ͻ4.5 mmol/L. Apolipoprotein (apo) A1, A2, B, lipoprotein (a) [Lp(a)] and fibrinogen were measured Study blood pressure readings are recorded in Fig- by immunoturbidimetric methods on the same ana- ure 1 and Table 2. The entry mean blood pressure lyser. Lp(a) samples were pre-treated by centrifug- was 161 ± 5.2/91 ± 1.8 mm Hg in the tibolone group ation and lipase treatment to reduce any triglyceride and 157 ± 5.4/85 ± 2.4 mm Hg in the placebo. Base- interference with the assay. All methods used were line diastolic blood pressure was slightly but sig- validated against International Federation of nificantly higher in the active treatment arm (P Ͻ Clinical Chemistry standards and had standard 0.05) but the mean arterial pressure was not signifi- deviations of Ͻ2.5% for lipids, Ͻ4% for apolipo- cantly different (126.0 ± 3.2 vs 121.2 ± 3.6 mm Hg). proteins, Ͻ6% for Lp(a) and Ͻ3% for fibrinogen for Systolic blood pressure fell by 5.2%, diastolic press- medium range calibrators. ure by 3.6% and mean arterial pressure by 4.6%. After 6 months the blood pressures were 151 ± 5.5/87 ± 3.4 mm Hg in the active and Quality of life 148 ± 4.1/84 ± 3.2 mm Hg in the placebo arm. Quality of life was recorded at baseline and at 6 Neither absolute or percentage reductions in systolic months using the SF-36 General Health Question- and diastolic blood pressures were significantly dif- naire.16 This measures eight health concepts: physi- ferent at 6 months. Similarly the pulse pressure was cal functioning, physical and emotional role limi- unaffected by allocation to treatment arm. tations, bodily pain, general health, vitality, social functioning, mental health and reported health tran- Lipids, lipoproteins and fibrinogen sition. In each measure, a higher score indicates a better health state. Biochemical data from the trial are presented in Table 2 and Figure 2. Total cholesterol fell in both arms of the study with no difference between Statistical analysis tibolone and placebo groups. The reduction in total The study was powered to detect a change in mean cholesterol in the placebo group was however stat- blood of 15 mm Hg. A 2:1 randomisation was used istically significant (P = 0.04). LDL-cholesterol rose to increase the power to detect a treatment effect slightly by 1.2 ± 8.0% in the tibolone group com- while accepting an increased risk of a type I error. pared with a 5.3 ± 2.5% fall on placebo. High-den- In patients who dropped out of the study the blood sity lipoprotein (HDL) was significantly reduced pressure at the last visit was carried forward to suc- (21.7 ± 3.8%) falling from 1.40 ± 0.1 to cessive visits. Blood pressure data were analysed on 1.08 ± 0.1 mmol/L with tibolone compared to a an intention-to-treat basis but percentage change in 2.4 ± 2.6% rise in those on placebo. Similarly apoli- lipid
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