Safety and adverse effects associated with raloxifene: multiple outcomes of raloxifene evaluation.
OBJECTIVE
To examine the effect of raloxifene on major adverse events that occur with postmenopausal estrogen therapy or tamoxifen.


METHODS
The Multiple Outcomes of Raloxifene Evaluation, a multicenter, randomized, double-blind trial, enrolled 7,705 postmenopausal women with osteoporosis. Women were randomly assigned to raloxifene 60 mg/d or 120 mg/d or placebo. Outcomes included venous thromboembolism, cataracts, gallbladder disease, and endometrial hyperplasia or cancer.


RESULTS
During a mean follow-up of 3.3 years, raloxifene was associated with an increased risk for venous thromboembolism (relative risk [RR] 2.1; 95% confidence interval [CI] 1.2-3.8). The excess event rate was 1.8 per 1,000 woman-years (95% CI -0.5-4.1), and the number needed to treat to cause 1 event was 170 (95% CI 100-582) over 3.3 years. Risk in the raloxifene group was higher than in the placebo group for the first 2 years, but decreased to about the same rate as in the placebo group thereafter. Raloxifene did not increase risk for cataracts (RR 0.9; 95% CI 0.8-1.1), gallbladder disease (RR 1.0; 95% CI 0.7-1.3), endometrial hyperplasia (RR 1.3; 95% CI 0.4-5.1), or endometrial cancer (RR 0.9; 95% CI 0.3-2.7).


CONCLUSIONS
Raloxifene was associated with an increased risk for venous thromboembolism, but there was no increased risk for cataracts, gallbladder disease, endometrial hyperplasia, or endometrial cancer.


METHODS
I
University of California-San Francisco, 1634 Divisadero Street, Suite 600, San Francisco, CA 94115, USA. dgrady@itsa.ucsf.edu
Deborah
D
Grady
Bruce
B
Ettinger
Elena
E
Moscarelli
Leo
L
Plouffe
Somnath
S
Sarkar
Angelina
A
Ciaccia
Steven
S
Cummings
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D020849:Raloxifene Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects* / Q000627:therapeutic use; D014481:United States / Q000453:epidemiology; D020246:Venous Thrombosis / Q000139:chemically induced* / Q000453:epidemiology*
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride