Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for The Heart trial: results of subgroup analyses by age and other factors.
BACKGROUND
The Raloxifene Use for The Heart (RUTH) trial showed that raloxifene, a selective estrogen receptor modulator, had no overall effect on the incidence of coronary events in women with established coronary heart disease or coronary heart disease risk factors. We provide detailed results of the effect of raloxifene on coronary outcomes over time and for 24 subgroups (17 predefined, 7 post hoc).


RESULTS
Postmenopausal women (n=10 101; mean age, 67 years) were randomized to raloxifene 60 mg/d or placebo for a median of 5.6 years. Coronary outcomes were assessed by treatment group in women with coronary heart disease risk factors and those with established coronary heart disease. Raloxifene had no effect on the incidence of coronary events in any subgroup except in the case of a post hoc age subgroup analysis using age categories defined in the Women's Health Initiative randomized trials. The effect of raloxifene on the incidence of coronary events differed significantly by age (interaction P=0.0118). The incidence of coronary events in women <60 years of age was significantly lower in those assigned raloxifene (50 events) compared with placebo (84 events; hazard ratio, 0.59; 95% confidence interval, 0.41 to 0.83; P=0.003; absolute risk reduction, 36 per 1000 women treated for 1 year). No difference was found between treatment groups in the incidence of coronary events in women > or =60 and <70 or > or =70 years of age.


CONCLUSIONS
In postmenopausal women at increased risk of coronary events, the overall lack of benefit of raloxifene was similar across the prespecified subgroups.
Collins
Peter
P
Department of Cardiology, Royal Brompton and Harefield NHS Trust and NHLI, Imperial College London, Sydney Street, London, UK. peter.collins@imperial.ac.uk
Mosca
Lori
L
Geiger
Mary Jane
MJ
Grady
Deborah
D
Kornitzer
Marcel
M
Amewou-Atisso
Messan G
MG
Effron
Mark B
MB
Dowsett
Sherie A
SA
Barrett-Connor
Elizabeth
E
Wenger
Nanette K
NK
D000367:Age Factors; D000368:Aged; D001794:Blood Pressure; D003327:Coronary Disease / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008875:Middle Aged; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D012307:Risk Factors; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride