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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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202<br />

HORMONE THERAPY USE AND RISK OF CARDIOVASCULAR DISEASE<br />

tial modificati<strong>on</strong> of horm<strong>on</strong>e effects by COMMENT have adequate statistical power to asage<br />

or years since menopause. Other Although not statistically significant sess outcomes in the women aged 50<br />

models suggested a time-dependent these sec<strong>on</strong>dary analyses suggest that to 54 years or less than 5 years since<br />

effect of horm<strong>on</strong>e therapy in the com- the effect ofhorm<strong>on</strong>es <strong>on</strong> CHD may be menopause. As previously reported.<br />

bined trials for CHD (but not stroke), modifiedbyyearssincemenopauseand CEE appeared to be associated with<br />

with higherrisks in the first 2years and by the presence of vasomotor symp- lower risk of CHD than CEE + MPA.'<br />

decreasing risk thereafter (P= .01). Even toms, with the highest risks in women Importantly, the risk of stroke was not<br />

though power was limited by small whowere20ormoreyearssincemeno- influenced by years since menopause.<br />

numbers of events, the directi<strong>on</strong> of pause (or aged 270 years). Cor<strong>on</strong>ary the presence of vasomotor sympt<strong>on</strong>s,<br />

time-dependent effects were similar heart disease tended to be n<strong>on</strong>signifi- ordrugregimen, althoughtherewasno<br />

within categories of age or years since cantly reduced by horm<strong>on</strong>e therapy in increased risk of stroke in women aged<br />

menopause, and there were no inter- younger women or women with less 50 to 59 years.<br />

acti<strong>on</strong>s of time-dependent effects <strong>on</strong> than 10 years since menopause, and the Our findings are c<strong>on</strong>sistent with find-<br />

HRs across the age or years since meno- risk of total mortality was reduced in ings from observati<strong>on</strong>al studies of the<br />

pause categories. women aged 50 to 59 years. We did not associati<strong>on</strong> of years sitce menopause<br />

Table 4. Cardiovascuitar and Global tnde" Events by Age at llaseline<br />

AUe Group at Randomiratio-<br />

6 9<br />

so-sa y<br />

8- y 70-79 y<br />

i ~~~~~I<br />

I I,<br />

No. of Cases No. ol Case No. of Cases<br />

I I ~ ~ ~ ,I ~ ~ ~ ~~~~I P<br />

Ha<strong>on</strong>r<strong>on</strong>e I-Hkrroie Ho ne Valuse<br />

Therapy Placebo HR Therapy Placebo HR Thery Pi ..ebo HR for<br />

(n . 4476) In . 4358) (95% Ct) (i = 6240) tn e61 22) (95% Ct) (n e3100) (n . 3053) (95% CQlO Teenat<br />

C-oNbned Tlals<br />

CtiDt 59 61 0.93 174 178 0.98 183 131 1.26 .16<br />

Stroke<br />

Totalimslty<br />

Global rda§<br />

44<br />

69<br />

278<br />

37<br />

g9s<br />

278<br />

1.13<br />

(0.73-1.76)<br />

070<br />

(0.5-0.98)<br />

0.98<br />

(081-.14)<br />

156<br />

240<br />

717<br />

102<br />

225<br />

661<br />

1.50<br />

(1.17-1-92)<br />

1.05<br />

(087-1 26)<br />

1.08<br />

0.97-1 20)<br />

127<br />

237<br />

608<br />

100<br />

208<br />

528<br />

1.21 .97<br />

(0.93-1.59)<br />

114 .06<br />

(0.94-1.37)<br />

1,14 .09<br />

102-1.29)<br />

CHLlt<br />

GEE Placebo<br />

(n1637) tn=16731<br />

21 34 083<br />

036-1.09)<br />

CEE Trial<br />

GEE Placebo CEE<br />

( I.n387) l 2465) (n.1286)5<br />

96 106 0.94 84<br />

(0.71-1.24)<br />

Placebo<br />

jnl291)<br />

77 1.13<br />

(02-i s4)<br />

.12<br />

Stroke<br />

Tate]ornality<br />

Ook~oalsto-fe<br />

18<br />

34<br />

"14<br />

21<br />

48<br />

10<br />

0.89<br />

(0.47-1.69)<br />

0.71<br />

(0.49-1.11)<br />

0.82<br />

(.64-1.05)<br />

84<br />

129<br />

333<br />

54<br />

131<br />

342<br />

1.62<br />

(1.15-2.27)<br />

1.02<br />

(0.0-1.30)<br />

1.01<br />

(0.6-1.17)<br />

66<br />

134<br />

300<br />

52<br />

113<br />

262<br />

1.21<br />

(0584-1.75)<br />

1.20<br />

(0.93-1.55)<br />

1.16<br />

(0.981.37)<br />

.62<br />

.18<br />

.01<br />

CEE, MPA Tria<br />

CEEvMPA Placebo CEE+MPA Placebo CEE+MPA Placebo<br />

(I. -28391 (26831 (n 38531)n=.3657) (n.1814) (n. 1762)<br />

CHDt 38 27 1.29 78 72 1.03 79 54 1.48 .70<br />

(0.792. 21 (0.74-1.43) (1o04_2.11)<br />

Siroke 26 18 1.41 72 48 1.37 61 48 1.21 .<br />

(0.7-2.65) (0951-97) (0.82-I.78)<br />

Tote4 m<strong>on</strong>ttiy 35 47 0.69 III 94 1.09 103 95 1.06 .19<br />

(0.44-1.07) (0.3-1 .44) (090-1 41)<br />

Global inttex§ 164 138 1.10 384 319 1.15 306 266 113 .98<br />

(087-1.39 (0899-1.34) (0.9- 5133)<br />

Arerraso- CrE, raa I rr s as .esay narl or a. Ci t : HFI. 5azar rt5k lIPA rooboargslralae.<br />

car risrossul11151 illoSe 0r51al- 1080c c't svrave Isornor cws oacod 01 as vsosrd 0Žrdr05t<br />

(tD hrs MXlbO and ol, 115n<br />

I<strong>on</strong>s *oaIe txcttrentrtm ago 81.50.0,00004049<br />

t1)e5=40. Gl40esas. <strong>on</strong>latld rly<strong>on</strong>o59 iearuc5. or rdoiree sanr cr00h19 i-crn 6 0 s.951 0r S.D.<br />

s005.e4 05s Cr40. 0a10. trirorran orbolom t ctrolar <strong>on</strong>wol, octe aracor. ernicrelro teras 8 MPA s hot criy lop fr95r0cre dIttra, 1o 0r eeslr.<br />

02007 Amerkae Medioal A.-odiaflo. All digbls res d. (ftpbtld) JoA, Apdl 4, 2007-V.t 297. N.. 13 1471<br />

Downloaded born wswjacr.eoo at Nati<strong>on</strong>al ntsiaittr of Hlth, <strong>on</strong> Apil 5.2007

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