Comparing raloxifene with continuous combined estrogen-progestin therapy in postmenopausal women: Review of Euralox 1.
OBJECTIVE
To review the main findings of the Euralox 1 study - a multicentre, randomised, double-blind study conducted in 1008 healthy postmenopausal women allocated to raloxifene (n = 495) or continuous combined estrogen-progestin therapy (ccEPT; n = 513) for 6 months -- and provide an overview of the risks and benefits of raloxifene and ccEPT.


METHODS
A review is provided of previously published findings on uterine safety (bleeding rates and changes in endometrial thickness and uterine volume), gynaecological adjudication, cardiovascular risk (lipids, fibrinogen), adverse events, compliance, treatment satisfaction and quality of life. New data on biochemical markers of bone turnover (serum N-telopeptides and C-terminal telopeptides of type I collagen; NTX and CTX) assessed before and after 6 months' treatment are presented.


RESULTS
Raloxifene caused less uterine bleeding than ccEPT and, unlike ccEPT, did not alter endometrial thickness or uterine volume. Serum CTX and NTX levels were reduced in both treatment groups, but the reduction was significantly greater with ccEPT. The two treatments had differential effects on lipids and fibrinogen levels; raloxifene had more favourable effects on serum HDL, the LDL/HDL ratio, and plasma fibrinogen. Raloxifene was associated with fewer adverse events or discontinuations, and this was associated with higher treatment satisfaction and better self-reported compliance.


CONCLUSIONS
The clinical risk-benefit profile of raloxifene derived from the intermediate endpoints of this study suggests that it may be a better alternative to ccEPT for preventing long-term postmenopausal health risks in healthy postmenopausal women who are not suffering from vasomotor symptoms.
Neven
Patrick
P
Department of Gynaecological Oncology and Multidisciplinary Breast Centre, UZ-Gasthuisberg, Leuven, Belgium. patrick.neven@zu.kuleuven.ac.be
Quail
Deborah
D
Marin
Fernando
F
Creatsas
George
G
Depypere
Herman
H
Rechberger
Tomasz
T
Liu-Léage
Soyi
S
Pavo
Imre
I
Schmitt
Henri
H
Nickelsen
Thomas
T
D016723:Bone Remodeling / Q000187:drug effects; D004338:Drug Combinations; D004717:Endometrium / Q000187:drug effects; D004958:Estradiol / Q000627:therapeutic use*; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D006801:Humans; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D017698:Postmenopause; D011372:Progestins / Q000627:therapeutic use*; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*
D004338:Drug Combinations; D008055:Lipids; D011372:Progestins; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D004958:Estradiol; D005340:Fibrinogen