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Free PDF Download European Review for Medical and Pharmacological Sciences 2003; 7: 117-125 Efficacy and safety of oral tibolone 1.25 or 2.5 mg/day vs. placebo in postmenopausal women D. HUDITA, C. POSEA, I. CEAUSU, M. RUSU Department of Obstetrics and Gynecology, “Dr. I. Cantacuzino” Clinical Hospital - Bucharest (Romania) Abstract. – Background: tibolone at usual Conclusions: tibolone at doses of 1.25 or 2.5 doses of 2.5 mg/day in postmenopausal women mg/day given for 24 weeks to postmenopausal has been shown to improve climacteric com- women displayed similar efficacy and safety plaints, without affecting endometrial thickness profiles, though were more effective than place- and lipid profile or blood glucose. However, the bo. Tibolone 1.25 mg induced a more gradual re- potentially similar efficacy, but better tolerabili- lief from climacteric symptoms and a more ty, of a low dose of this drug (1.25 mg) has never prompt improvement of sexual function. been established. Key Words: Methods: 162 healthy, non-obese, post- menopausal women, aged 40-65 years, with an Postmenopausal, Climacteric symptoms, Sexual life, intact uterus were enrolled in a national, single Vaginal bleeding, Lipid profile, Tibolone. centre, randomised, double blind, placebo con- trolled, parallel group trial. After 1 week of run- in, patients were treated for 24 weeks with place- bo, tibolone 1.25 mg or 2.5 mg/day. During the study laboratory tests, endometrial ultrasound scans and mammography were performed. Introduction Occurrence of menopausal signs and symp- toms, including vaginal bleeding, and quality of sexual life were also checked. Menopause is frequently characterized by Results: in the 120 patients terminating the occurrence of vasomotor symptoms (hot study without major protocol violations, cli- flushes, nausea, dizziness, headache, palpita- macteric symptoms were similarly improved by tions, night sweat, etc.), alteration of sexual tibolone 1.25 and 2.5 mg (78% and 90% reduc- function and changes in lipid profiles1,2. tion at week 24 for hot flushes, 36% and 34% Vasomotor symptoms, and in particular hot for sweating episodes and 44% and 51% for flushes, may negatively affect patient’s quali- vaginal dryness), but not by placebo. Benefits 3 occurred earlier in the group treated with ti- ty of life , while the increase in total choles- bolone 2.5 mg. Quality of sexual life was almost terol and triglycerides may be responsible for invariably improved by tibolone as compared an increased risk of coronary heart disease4. to placebo, but improvement occurred earlier in Several controlled clinical trials have shown the tibolone 1.25 mg group. Severity of vaginal that the most effective form of therapy for bleeding was not different between placebo vasomotor symptoms is estrogen replacement and active treatment groups, except at week 12 when was higher. At the end of treatment vagi- therapy or hormone replacement therapy (es- 5 nal bleeding occurred in 15% of patients treat- trogens combined with progestin) . This ed with placebo, 14% treated with tibolone 1.25 treatment also affects lipid metabolism, by in- mg and 12% treated with tibolone 2.5 mg. creasing high density lipoprotein cholesterol Endometrial thickness and breast density were (HDL) and triglycerides and by reducing to- not changed by treatment, as well as FSH, 17-β- tal and low dose lipoprotein (LDL) choles- estradiol, total cholesterol, HDL and LDL cho- terol, the increase in triglycerides being po- lesterol, triglycerides and blood glucose. Adverse events were reported by 14.7%, 26.7% tentially not beneficial for the cardiovascular 6-8 and 24.4% of patients treated with placebo, ti- system . bolone 1.25 mg and tibolone 2.5 mg/day, re- Tibolone is a synthetic pro-drug steroid spectively. that has several different metabolites with tis- 117 D. Hudita, C. Posea, I. Ceausu, M. Rusu sue-specific estrogenic, progestogenic and an- drugs; (13) glucose intolerance (blood glu- drogenic properties9,10. In post-menopausal cose > 125 mg/dl), hypercholesterolemia (to- women, tibolone at doses of 2.5 mg/day has tal cholesterol > 300 mg/dl) or hypertriglyc- been shown to improve climacteric com- eridemia (triglycerides > 300 mg/dl), hyper- plaints (in particular vasomotor symptoms tension (systolic blood pressure > 160 mm Hg and vaginal lubrication) and libido11-15, to pre- or diastolic blood pressure > 90 mm Hg). vent osteoporosis11,16-19 and to improve some Written informed consent was obtained lipid parameters, without affecting endome- from all patients prior to their inclusion into trial thickness and uterine fibroids vol- the study, which was approved by the Ethics ume11,14,20-25. In particular, its androgenic ac- Committees of the centres involved. tion may reduce triglycerides, though unfor- tunately also HDL cholesterol, both com- Study Design monly increased by estrogens11,26. The main This was a national (Romania), single cen- unwanted effect of tibolone is vaginal bleed- tre, randomised, double blind, placebo con- ing, which, however, is reported in half as trolled, parallel group trial consisting of a 1 many cases as respect to estrogens27-29. week run-in followed by a 24 week treatment Aim of the present study was to assess the period with placebo, tibolone 1.25 mg or ti- efficacy, in terms of control of symptoms and bolone 2.5 mg given orally and once daily improvement of sexual function, the safety with a 1:1:1 ratio. and the effects on lipid profile and blood glu- Medical history was collected and a phys- cose, of a low dose of tibolone (1.25 mg) vs. ical examination (including gynaecological the usually employed dose (2.5 mg) and vs. examination), laboratory tests (FSH and 17- placebo. The study hypothesis was that a low β-estradiol determination, blood glucose, dose of tibolone might have been more effec- total cholesterol, LDL and HDL cholesterol tive than placebo and as effective as a 2.5 mg and triglycerides), ultrasound scan (for as- dose, but safer. sessment of endometrial thickness) and mammography were performed at inclusion (visit 1). Laboratory tests, ultrasound scan and mammography were repeated at the Material and Methods end of the study. At the time of randomiza- tion (visit 2) and after 4, 12 and 24 weeks of Study Population treatment (visit 3, 4 and 5, respectively) oc- The study included 162 healthy, non-obese, currence of clinical signs and symptoms (hot postmenopausal women, aged between 40 flushes, sweating episodes, vaginal dryness and 65 years, with an intact uterus. and vaginal bleeding) was checked, and Menopause was defined by the evidence of at severity was quantified using a five-point least 12 months of amenorrhea with levels of scoring system (0 = none, 1 = light, 2 = mod- FSH > 30 mIU/ml and of 17-β-estradiol < 50 erate, 3 = severe, 4 = very severe). Sexual pg/ml. Patients were excluded if they had: (1) activity was assessed and quantified using previous deep thrombophlebitis or cerebral an adapted version of McCoy sex scale apoplexia; (2) mammary or gynaecological questionnaire based on a five-point scoring neoplasia; (3) uncontrolled diabetes; (4) ab- system30. Occurrence of adverse events was normal mammography; (5) abnormal values recorded at visit 3, 4 and 5. of C-reactive and S-coagulative protein; (6) endometrial thickness > 4 mm or an abnor- Data Analysis mal Papanicolaou smear; (7) abnormal bleed- Main study objective was to demon- ing of undetermined origin; (8) history of he- strate the equivalence of tibolone 1.25 mg patic or renal diseases; (9) use of estrogenic, and 2.5 mg and their superiority as com- progestinic or androgenic drugs in the 8 pared to placebo in reducing the severity weeks preceding enrolment into the study; of menopausal symptoms (hot flushes, (10) use of IUD in the preceding 3 months; sweating episodes and vaginal dryness). (11) use of medications known to affect vaso- Starting from this assumption sample size motor system in the 2 weeks prior to enrol- estimation by a two-sided test (α = 0.05, ment; (12) known hypersensitivity to study power = 80%) indicated that at least 162 pa- 118 Efficacy and safety of oral tibolone 1.25 or 2.5 mg/day vs. placebo in postmenopausal women tients (54 patients for each treatment group) events were summarised by treatment group had to be randomised in order to have 120 and by type of event. valuable subjects. Homogeneity of demographic, clinical and The primary efficacy end-point of the laboratory data at baseline was verified by study was the severity of menopausal symp- analysis of variance for continuous variables toms in the three treatment groups at base- and by a Chi-square test for categorical vari- line and after 4, 12 and 24 weeks of treat- ables. ment. Secondary end-points were among Data are shown as means ± SD. A p < 0.05 treatments comparisons of: (1) severity of was used as the level of statistical signifi- vaginal bleeding at week 0, 4, 12 and 24; (2) cance. quality of sexual life at week 0, 4, 12 and 24; (3) laboratory parameters (total plasma cho- lesterol, LDL and HDL cholesterol, triglyc- erides and blood glucose) at week -1 and 24; Results and (4) results of ultrasound scan and mam- mography at week 0 and 24. Percentage of Demographic and Clinical Data patients reporting climacteric symptoms, im- A total of 162 patients were randomised to provement of sexual life or vaginal bleeding treatment and took at least one dose of study was also calculated for each study visit. drugs. Of these, 42 discontinued the study be- The analysis was carried out on patients cause of adverse events, lost to follow-up, with all valid efficacy variables and who ter- consent withdrawal, lack of efficacy or other minated the study without major protocol vi- minor problems.
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