A randomised, double-blind trial comparing raloxifene HCl and continuous combined hormone replacement therapy in postmenopausal women: effects on compliance and quality of life

Abstract

A list of the Euralox Investigators Group may be found on pages 882 -883Objective To compare continuous combined hormone replacement therapy (ccHRT) and raloxifene with respect to compliance and quality of life, which were predefined secondary endpoints of a large, prospective study designed to investigate the uterine effects of both treatments. Design Double-blind, randomised controlled trial of six-month duration. Setting One hundred and twenty-nine gynaecology hospital departments, clinics or practices specialised in women's healthcare, located in Europe, South Africa and Israel. Population Healthy postmenopausal women (n ¼ 1008). Main outcome measures Changes in quality of life using the Women's Health Questionnaire (WHQ) and compliance using a compliance questionnaire and pill count. Adverse event and early discontinuation rates and satisfaction with treatment using a visual analogue scale (VAS). Results Women taking raloxifene reported greater satisfaction with their treatment as assessed on the VAS ( P ¼ 0.004),and a lower proportion, as compared with ccHRT, reported being worried by the treatment (9.6% vs 20.2%, P < 0.01). Women taking ccHRT reported greater deterioration in scores from the WHQ for depressed mood and menstrual symptoms than those taking raloxifene ( P < 0.01). For memory, vasomotor symptoms and sexual behaviour, the ccHRT group reported significantly greater mean improvements ( P < 0.05). Over half (58.8%) of those taking raloxifene noticed no effect, 37.7% felt better and 3.4% felt worse as measured using the compliance questionnaire. Fifty percent of the women taking ccHRT felt better, 37.8% noticed no effect but over 10% felt worse. More women on raloxifene (94.6%) than on ccHRT (85.9%) reported that they were taking their double-blinded medication regularly ( P < 0.01). Conclusions A lower rate of adverse event-related discontinuations, the lack of negative effects on quality of life and a smaller proportion of women being worried by the drug treatment were associated with higher treatment satisfaction and better compliance in postmenopausal women taking ccHRT or raloxifene.

A systematic review and economic evaluation of alendronate, etidronate, risedronate, raloxifene and teriparatide for the prevention and treatment of postmenopausal osteoporosis

“…In one quality of life study, 92 the only significant changes in quality of life associated with raloxifene were deterioration in menstrual symptom scores in the 150-mg group (p < 0.05) and improvement in mean anxiety/fears scores in the 60-mg group. The other study that reported quality of life outcomes 47 found that women taking raloxifene reported a significant improvement in sleep problems from baseline. Statistically significant between-group differences in relation to depressed mood and menstrual symptoms favoured raloxifene, whereas those relating to memory/concentration, vasomotor symptoms and sexual behaviour favoured HRT.…”

“…The percentage reduction is influenced by a number of factors. At younger ages there will be few osteoporotic and severely osteoporotic women (see Table 129 in Appendix 1), and thus the risk for women with average BMD scores will be close Background 6 (11) 0.35 (7) 0.08 (9) 60-64 0.06 (41) 0.13 (20) 0.41 (12) 0.11 (16) 65-69 0.10 (48) 0.20 (29) 0.46 (19) 0.10 (24) 70-74 0.27 (55) 0.34 (37) 0.51 (27) 0.17 (32) 75-79 0.35 (50) 0.37 (38) 0.49 (30) 0.20 (34) 80-84 0.67 (50) 0.41 (42) 0.50 (34) 0.23 (38) 85-89 1.34 (47) 0.62 (45) 0.63 (37) 0.21 (41) The percentage reduction in fracture incidence compared to the average for all women in that age band is shown in parentheses.…”

“…Continuance and compliance depend on a number of properties of the medication in question, including tolerability, convenience of administration, the patient's perception of its safety and quality of life while on treatment. 47 Adherence to, and compliance with, medication are clearly important in relation to the actual, rather than theoretical, efficacy of the interventions under study and therefore, as with adverse effects, data drawn from the studies under review will be supplemented with data from other sources when relevant.…”

“…Two additional RCTs 47,92 were identified that reported data relating to the impact of raloxifene on quality of life in healthy postmenopausal women without menopausal symptoms that required therapy. One of these studies 92 compared raloxifene both with oestrogen and with placebo, and the other 47 with continuous combined HRT (for details, see Appendix 10, Tables 156-158).…”

“…138 Another study found that 95% of women on raloxifene reported that they were taking their double-blinded medication regularly, compared with 86% of those on HRT (p < 0.01); however, pill counts did not indicate a significant difference between the groups in this respect. 47 In the USA, a retrospective search of a pharmacy prescription database 147 found that 56% of women who were members of the Kaiser Foundation Health Plan, a large health maintenancy organisation, who had been prescribed raloxifene, had discontinued treatment by 24 months.…”