| Title | Raloxifene reduces risk of vertebral fractures [corrected] in postmenopausal women regardless of prior hormone therapy. | | Author(s) | Johnell O, Cauley JA, Kulkarni PM, Wong M, Stock JL | | Institution | Department of Orthopedics, Universitetssjukhuset MAS, SE-20502 Malmo, Sweden. olof.johnell@orto.mas.lu.se | | Source | J Fam Pract 2004 Oct; 53(10):789-96. | | MeSH | Adult
Aged
Bone Density
Breast Neoplasms
Cardiovascular Diseases
Cerebrovascular Disorders
Estrogen Replacement Therapy
Female
Humans
Logistic Models
Middle Aged
Osteoporosis, Postmenopausal
Raloxifene
Research Support, Non-U.S. Gov't
Risk
Selective Estrogen Receptor Modulators
Spinal Fractures
| | Abstract | OBJECTIVE: We examined whether past use of hormone therapy influences the effects of raloxifene on the risk of new vertebral fracture, cardiovascular events, or breast cancer.
STUDY DESIGN: The Multiple Outcomes of Raloxifene Evaluation (MORE) trial examined vertebral fracture incidence as the primary endpoint, breast cancer incidence as a secondary endpoint. Cardiovascular events were collected as secondary safety endpoints. POPULATION: The MORE trial enrolled 7705 postmenopausal women. Of the 7682 women who reported their previous HT use status, 29% used HT before screening. OUTCOMES MEASURED: Separate logistic regression models analyzed the relationships between prior HT use and the risk of vertebral fracture, cardiovascular events, or breast cancer. Interaction terms with P<.10 were considered to be statistically significant. Confidence intervals for relative risks (RR) were calculated using the Mantel-Haenszel method.
RESULTS: Raloxifene 60 mg/d, the clinically approved dose for osteoporosis prevention and treatment, reduced the risk of vertebral fractures by 54% (RR=0.46) and 29% (RR=0.71) in women with and without prior HT use, respectively (interaction P=.05). A lower incidence of invasive breast cancer in women with prior HT use (RR=0.23) and in women without prior HT use [RR=0.31; interaction P=.60] was observed in women receiving raloxifene (pooled doses). Irrespective of prior HT use, women treated with raloxifene (pooled doses) had no change in incidence of cardiovascular events (interaction P=.56).
CONCLUSIONS: The risk of vertebral fractures was lower in women treated with raloxifene, regardless of prior HT use, but there was a suggestion that the effect was greater in women who had used HT. Women randomized to receive raloxifene exhibited a decreased incidence of invasive breast cancer, compared with women receiving placebo. No change occurred in the incidence of cardiovascular events, regardless of prior HT use. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Randomized Controlled Trial
| | PubMed ID | 15469774 |
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