Raloxifene versus continuous combined estrogen/progestin therapy: densitometric and biochemical effects in healthy postmenopausal Taiwanese women.
We treated 116 healthy postmenopausal women (age 47-66 years, mean 57 years) in Taiwan with either raloxifene (RLX) 60 mg (n = 92) or 0.625 mg conjugated equine estrogen plus 5 mg medroxyprogesterone acetate (CCEP, n = 24) daily for 12 months in a randomized, double-masked, active-controlled fashion. The results showed that both regimens increased bone mineral density (BMD) at hip sites (means: RLX 2.5-4.9%, CCEP 4.6-7.9%, all p<0.005 compared with baseline), and the difference between the two regimens was not significant. The spinal BMD increased significantly in both groups (1.4% with RLX and 6.0% with CCEP, both p<0.01), and more with CCEP (p<0.003). Osteocalcin levels and urinary type I collagen C-telopeptide/creatinine ratios decreased significantly in both regimens, but the decreases were significantly larger with CCEP. Compared with baseline, both RLX and CCEP decreased the total cholesterol (median 4.9% and 8.6% respectively, p<0.001) and LDL-cholesterol (median 11% and 19% respectively, p<0.001), and increased HDL-cholesterol (median 8.6% and 10.7% respectively, p<0.01). Both regimens increased triglyceride levels (median 3.2% and 18.9% respectively, both p<0.05), although to a lesser extent with RLX than with CCEP (p<0.05). Only 3 subjects (3.3%) reported vaginal bleeding in the RLX group, as compared with 31% (7/22) with CCEP (p<0.05). We conclude that in healthy, postmenopausal Taiwanese women, RLX 60 mg given daily has favorable results in BMD, bone turnover and serum lipids, although the dosage we used showed a potency less than that of conventional CCEP.
Tsai
K S
KS
Department of Laboratory Medicine, National Taiwan University Hospital and Medical College, Taipei, ROC.
Yen
M L
ML
Pan
H A
HA
Wu
M H
MH
Cheng
W C
WC
Hsu
S H
SH
Yen
B L
BL
Huang
K E
KE
D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D004717:Endometrium / Q000033:anatomy & histology / Q000187:drug effects; D015914:Estrogen Replacement Therapy; D004966:Estrogens, Conjugated (USP) / Q000494:pharmacology; D005260:Female; D006621:Hip Joint / Q000502:physiology; D006801:Humans; D008055:Lipids / Q000097:blood; D008159:Lumbar Vertebrae / Q000502:physiology; D017258:Medroxyprogesterone Acetate / Q000494:pharmacology; D008875:Middle Aged; D017698:Postmenopause / Q000502:physiology*; D045167:Progesterone Congeners / Q000494:pharmacology; D020849:Raloxifene Hydrochloride / Q000494:pharmacology*; D020845:Selective Estrogen Receptor Modulators / Q000494:pharmacology; D014599:Uterus / Q000033:anatomy & histology / Q000187:drug effects
D004338:Drug Combinations; D004966:Estrogens, Conjugated (USP); D008055:Lipids; D045167:Progesterone Congeners; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D017258:Medroxyprogesterone Acetate