Adverse events reported by postmenopausal women in controlled trials with raloxifene.
OBJECTIVE
To assess the incidence of adverse events in postmenopausal women treated with raloxifene compared with placebo, hormone replacement therapy (HRT), or unopposed estrogen.


METHODS
Common treatment groups were pooled across eight randomized, parallel clinical trials (6-30 months' duration) of raloxifene to create the following three databases: placebo-controlled, HRT-controlled, and estrogen-controlled databases. Incidence and severity of all treatment-emergent adverse events, defined as events that first occurred or worsened during treatment, were compared among groups in each of the databases.


RESULTS
Discontinuation rates overall, and those related to adverse events, were not significantly different between treatment groups in any database. There was no significant difference in incidence of vaginal bleeding or breast discomfort between women treated with raloxifene (60 mg/d) or placebo. Both of these events were reported more frequently in women receiving HRT or estrogen. Vaginal bleeding was responsible for significantly more discontinuations from the HRT groups compared with the raloxifene group. Hot flashes was the only event common to all three databases that was significantly increased in the raloxifene group, but this event did not increase the discontinuation rates. The incidence of leg cramps was greater in raloxifene-treated women compared with placebo-treated women in the placebo-controlled database, but did not cause any discontinuations of therapy. Raloxifene had no effect on the incidence of vaginal symptoms or central nervous system events.


CONCLUSIONS
Raloxifene had an adverse event profile distinct from HRT and unopposed estrogen and was well tolerated by postmenopausal women.
Davies
G C
GC
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA.
Huster
W J
WJ
Lu
Y
Y
Plouffe
L
L
Lakshmanan
M
M
D000328:Adult; D000368:Aged; D001941:Breast Diseases / Q000139:chemically induced; D004965:Estrogen Antagonists / Q000009:adverse effects*; D015914:Estrogen Replacement Therapy; D005260:Female; D019584:Hot Flashes / Q000139:chemically induced; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D010880:Piperidines / Q000009:adverse effects*; D017698:Postmenopause; D020849:Raloxifene Hydrochloride; D014592:Uterine Hemorrhage / Q000139:chemically induced
D004965:Estrogen Antagonists; D010880:Piperidines; D020849:Raloxifene Hydrochloride