1

The Effects of Tibolone in Older Postmenopausal Women

: N Engl J Med 2008;359:697-708

: Steven R, Ettinger B, Delmas DP, Kenemans P,

Stathopoulos V, Verweij P

1.


The new england journal of
medicine


impact factor 52.589 2007
2.

The effect of tibolone in older
postmenopausal woman

tibolone

3.


vertebral
fracture
4.


Organon

5.

80 22
10 the United States

6.

7. objective, study design, setting,
patients, intervention, main outcome measures, results,
conclusions

8.



Tibolone
90 menopausal
45 osteoporosis metabolites
Tibolone estrogenic progestogenic androgenic
Tibolone
vaginal
Tibolone lowdensity-lipoprotein
cholesterol high-density-lipoprotein (HDL)
cholesterol triglycerides Tibolone
Fractures (LIFT)

tibolone
vertebral fracture modifies
 nonvertebral fracture, , deep-vein thrombosis,
osteoporosis
9.


Tibolone Fractures
(LIFT) tibolone
vertebral fracture
modifies nonvertebral fracture,
, deep-vein thrombosis,
osteoporosis

10.
(study design)

randomized, double-blind,
placebo-controlled clinical trial Tibolone

tibolone stroke
496
2006
tibolone stroke
11.



60 85 T
score 2.5 lumbar spine T
score 2.0
vertebral fracture
vertebral fractures
2 T score 4.0
spine
vertebral fracture
(other than nonmelanoma skin cancer) 5
,
thromboembolic mammographic
estrogen 3 , raloxifene
tamoxifen, bisphosphonate 1
, body-mass index (
)

transvaginal ultrasonography endometrial
2
4 mm
12.


4538
Tibolone 2267 Placebo 2267
power 90 %

13. (
)



60-85

14.


 interactive
voice-response
15.


interactive voice-response system

16.

1.25 mg tibolone
placebo 2 4 calcium
vitamin D (315 mg calcium citrate 200 IU vitamin
D3)
17.
(washout period)

(Washing period)
18. ()



calcium vitamin D (315 mg calcium citrate 200 IU
vitamin D3)



19. ( single blind, double blind
)
double-blind

20. ()
(blind technique)


(blind technique)
double-blind
21.
(Efficacy)
vertebral fracture
nonvertebral fracture, , deep-vein
thrombosis,
22.
Subjective Objective
fracture
binary
semiquantitative grading Mammograms
Objective
transvaginal
ultrasonography, endometrial biopsy, Cervical cytologic smears,
computed tomography magnetic resonance imaging
Objective
23.

24.
vertebral
clinical fractures Tibolone 3

endometrial Tibolone 5

25.

26.


vertebral fracture, nonvertebral fracture, ,
deep-vein thrombosis,
27.
(drop out)
 2005
tibolone stroke
496 2006
tibolone
stroke
28.
Cox regression
models relative hazards with 95% confidence
intervals Poisson regression models

potential limit
baseline stoke


stratum interactions in Cox models

29.

 vertebral fracture vertebral
nonvertebral fractures tibolone
fractures vertebral fracture

fracture(Table 3)
vertebral fracture tibolone
vertebral fracture 20.8 1000 person-years
relative hazard 61% vertebral fracture
tibolone nonvertebral fracture 17.7
1000 person-years relative hazard 47% (Table 3)
30.

osteoporosis tibolone
vertebral
nonvertebral fractures vertebral
fracture breast cancer
cancer
stroke
stroke Tibolone
estrogen progestin
tibolone

tibolone menopausal fracture
31.






32.





tibolone 5
breast
Cancer (relative risk,
1.21; 95% CI, 1.07 to 1.37)

 casecontrol the United Kingdom
breast cancer (relative risk, 0.86;95%
CI, 0.65 to 1.13) 6.5 tibolone

33.



coronary heart disease ndometrial cancer
3
stroke
tibolone
endometrial cancer