Long-term safety and efficacy of raloxifene in the prevention and treatment of postmenopausal osteoporosis: an update

Figures & data

Table 1 “Over 1000 participants” trials with raloxifene (60 mg/day)

Trial	Population	Duration	Efficacy	Safety
Johnston et al^Citation42	1,145	3 years	Spine, hip and total body BMD preservation in healthy women	Tolerability profile comparable to placebo
MORE^Citation43,Citation44	7,705	4 years	Cumulative risk of new vertebral fractures, absolute number and severity, reduction in osteoporotic women. No effect on non-vertebral fracture risk (reduction in post hoc analysis of patients with severe prevalent vertebral fractures)	Venous thromboembolism risk increase. ER+ invasive breast cancer risk reduction. No effect on cardiovascular events, stroke, endometrial cancer and hyperplasia
CORE^Citation47,Citation60	4,011	4 years	Lumbar spine and femoral neck BMD increase in MORE population. No effect on non-vertebral fracture risk (reduction in post hoc analysis of patients with severe prevalent vertebral fractures)	Venous thromboembolism risk increase. ER+ invasive breast cancer risk reduction. No effect on cardiovascular events, stroke, endometrial cancer and hyperplasia
RUTH^Citation48	10,101	5.6 years	Clinical vertebral fracture risk reduction in older women with or at increased risk for coronary heart disease. No effect on non-vertebral fracture risk	Venous thromboembolism risk and fatal stroke increase. ER+ invasive breast cancer risk reduction. No effect on coronary heart disease
STAR^Citation62,Citation63	19,747	5 years	No statistical different rates of fracture in raloxifene and tamoxifen arms in women at increased risk for invasive breast cancer	Raloxifene as effective as tamoxifen in ER+ invasive breast cancer risk reduction. Less venous thromboembolism and uterine cancer risk for raloxifene versus tamoxifen. No difference in strokes and cardiovascular events in raloxifen and tamoxifen arms
EVA^Citation50,Citation51	1,412	1.5 years	No statistical difference in fracture risk in raloxifene and alendronate arms (greater BMD increase with alendronate)	Venous thromboembolism risk increase with raloxifene versus gastrointestinal problems risk increase with alendronate
CORAL^Citation99	1,497	1.5 years	High compliance	No significant discontinuation of therapy for adverse events

Abbreviations: MORE, Multiple Outcomes Raloxifene Evaluation; CORE, Continuing Outcomes Relevant to Evista; RUTH, Raloxifene Use for The Heart; STAR, Study of TAmoxifen and Raloxifene; EVA, EVista Alendronate comparison; CORAL, COmpliance with RALoxifene therapy.

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US Food and Drug AdministrationEVISTA label NDA no. 022042 approved on 09/13/2007

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