Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging
Evidence-based Cardioogy - 5-2 years of follow up rather than the planned 8.5 years. The reasons for stopping were that an Increased risk for breast cancer started emerging at 4 years, which by 5 years had crossed the prespecified monitoring boundary. In addition, there was evidence of overall harm. At the time of stopping, the hazard ratios (HR) for the ma)or adverse effects were: breast cancer 1*26 (95% Cl 1l00-159), CHD 1-29 (95% Cl 1-02-1-63), stroke 1-41 (95% Ca 107-1-85), and pulmonary embolism 2-13 195% Cl 1.39-3-25). There were benefits for colorectal cancer, H 0-63 (95% Cl 0-43-093), and for hip fracture, HR 066 (95% Ct 0.45498), while endometrtal cancer and all-cause mortality were not affected. The investigators conclude that the risk-benefit profnle found In this trial Is not consistent with the requIrements for a viable prevention treatment, and In particular that this regimen should not be initiated or continued for the primary prevention of CHD. In addition, the substantlal risks for cardiovascular disease and breast cancer must be weighed against the benefit for fracture in selecting from the available agents for osteoporosis. WHI has answered the question of whether combined estrogen phis progestin, given by mouth for several years, prevents cardiovascular disease: It does not, and It does In fact Increase the risk. However as stated by the investigators, the use lor a few years (less than 4 years) to treat the symptoms of menopause may be reasonable, since the benefits may outweIgh the small absolute risk of cardiovascular disease In younger women. Of importance, the WHI trial of estrogen only In women who have had a hysterectomy is continuing, because the overall balance of benefits and risks remains uncertain. Disclaimer The views expressed In this chapter are those of the author and do not necessarily reflect the views or policy of the National Heart, Lung, and Blood Institute, or of the Steering
21.Grodsteln F. Manson JE, Colditz GA, Witlen WC, Spelzer FE, Stampfer NU. A prospective, observational study of postmenopausal hormone therapy and primary prevention of cardiovascular disease. AnnIntemMed2000,133:933-4I. 22.Fatkebom M, Persson 1, Adaml HO et aL The risk of acute myocardtal Infarction aUter estrogen and estrogen-progestogen replacement Birtr Obstet G)"ecol t992,90.821-8. 23.Psaty BM, Hectbert SRP Aticdos D er zL The risk of myocardial Infarction associated with the combined use of estrogens and progestins in postnenopausal women. Arch Inten Med 1994;l54:1333-9. 24.Wlson PW, Garrison RJP Casteeil WP. Postmenopausal estrogen use, cigarette smoking, and cardiovascular moobidty In women over 50. The framingham study. N Engi J Med 1985; 313:1038-43. 25.Roisouw JE. Debate: the potential role of estrogen In the preventIon of heant disease in women after menopause. Cunr Control 771ts Cardvasc Med2000;:1A35-8. 26Sotelo MM, Johnson SR. The effects of hormone replacement therapy on coronary heart disease. Endoinotl Meaab Cl/n North Am 1997;26:313-28. 27.Grodsteln F, Stamapter Ml, Manson IE et al Postanenopausa estrogen and progestin use and the risk of cardiovascular dis, ease. NEngl/Med 1996,335:453-61. 28.Criqul MH, Suarez I, Barrent-Connor E, McPhillips I, Wingard DL, Garland C. Postnenopausal estrogen use and mortality. Results from a prospective study In a defined, homo geneous cotcmuntty. AmJEptdemt/ 1988;128:606-14. 29.Herandez Avila M, Walker AM, lick H. Use of replacement estrogesns and the risk of myocardisi Infarction. Epkk fokV 19901:128-33. 30SIdney 5, Pelitti DB, Ouesenberry CP Jr Myocardisi Inatrction and the use of estrogen and estrogenproggstogen in postmenopausal women. Ann Intem Med 1997;127:501-8. 3I.Rosenberg I, Slone D, Shapiro S, Kaufman D, Stottey PD, Miettinen OS. Noncontraceptive estrogens and myocardial Infarction In young women. 14MW 1980,244:339-42. 32.Heckbert SR Weiss NS, Koepse TID et lL Duration of estrugen replacement therapy in relation to the rink of incident myocardial htfarction in postoenopausal women. Arch Intem Med 1997;157:1330-6. 33.Hemmintd E, McPherson K. Impact of postnenopausal hormone therapy on cardiovascular events and cancer: pooled data from clitical traLL 8Mtt997;315:149-53. 3 4.Women's Health Initiative Study Group. Design of the Women's Health InItiatIve clinical trat and observatonal study. Crn0rol Cltn 11dls 1998l19-61-109. 35 hrl.//ww .nhdtibnlhpgv/wlsihrLhtm 36.Vlckers MR, Meade TW, Wlikes HC. Hormone replacement therapy and cardiovascular disease: the case for a randomized conrotiled trial. Clba FoundSymnp 1995;19:150-60. 37.COKeefe JH Jr, Kim SC, Hall RR, Cochran VC, Lawhorn SL, McCalgister BD. Estrogen replacement therapy after coronary angioplasty in women. JAm Coel Cardio 1997;291-5. 383Abu-Halawa SA, Thompson K, Kirkeelde R. et dL Estrogen replacemnent therapy and outcome of coronary balten angloplasty in posnmenopausal women. Am J Cantalo 1998j82: 409-13. 194 Postmenopausal hormone therapy and cardiovascular disease 39.Satiivan JM, Et-Zeky F, Vander Zwaag R, Ramanathan KB Effect on survival of estrogen replacement therapy after coronary artery bypass grafting AmJ CIr/Yol 1997;79'.847-50. 405hcteftbrd DP, Daniels S, Hoffman MK, Chitwood R. Estrogen therapy In women undergoing comnaly artety bypass gradl effect on surgical complicataons bet CQvneco 2000;9S: 732-S. 41Shlpak MG, Angela BG, Go AS, Frederick PD, Canto JG. Grady D. Hormone therapy and In-hospital survival after myocardtal infarction In postuenopausat women. Cmirulaf/on 2001; 104:2300-4. 42.Grodsteln F, Manson IE, Stanspfer MJ. Postmenopausarl hormone use and secondary prevention of comnary events in the nurses' health study a prospective, observational study. Ann InternMed200I;135:I-8. 43,Alexander KP, Newby LK, Hellkamp AS et ai Initiation of hormone replacement therapy after acute myocardial hfarction Is associated with more cardiac events during fotlow-up. J Am Coi Cardbf200L,31:l-7. 44.Heckbert SR, Kaplan RC, Weiss NS ed a Risk of recurrent coronary events in relation to use and recent intitiation of post menopausal hormone therapy. Arch Intem Med 2001;1611 1709-13. 45.Huttey S, Grady D, Bush T et al Randomized trial of estrogen plus progmestn for secondary prevention of coronary heart disease In postmenopausol women. 1AMA 1998,280:605-13. 46.Herrington DM, Reboussin DM, Brosntihan. KB et at Effects of estrogen repiacement on the progesston ofcoronary-artery atherosclerosis. N&W1Med2O00O343:522-4. 47.Schulman SP, Thiemano DR, Ouyang P et al Effects of acute hormone therapy on recurrent ischemla in postmenopausal women with mutable angna. J Am Coa Card/at 2002i39: 231-7. 48.Mendelsohn ME, Karas RH. The time has come to stop letting the HERS tale wag the dogma. Chculation 2001; 104: 2256-9. 49Rosano GM, FRo M. Postnenopausal women and carddovascular risin impact of hormone replacement therapy. Card/of Rev 2002;10t51-O. S0.osano GM, Simon T, Mercuro G et al Hormone replacement therapy'. where we stand in Europe. Eur Heart 1 2001; 22.439-41. 5 l.Wenger Nt, Knatterud CL, Canner PL Early risks of hormone therapy in patients with coronary heart disease. JAM4 2000',284:41-3. 52.Clatze S, Kelleher 1, Lloyd-Janes H, Sharples I, Slack M, Schofteld PM. Transdermal hormone replacement therapy for the secondary prevention of coronary artery disease in postmenopausal women (abstrac). Eur Heart I 2000; 21212. 53.Viscofi CM, Brass LK, Keroan WN, Sarrel PM, Sulssa S, Horwimz RL A clinical traia of estrogen-replacement therapy after ischeicsndtmke. NEngfJMed200l;345:1243-9. 54.htaan MA, Heagerty AM, Kitchener H, McNamee R, Cherry NM, Hannaford P. Oestrogen and women's heart diseasetr ESPRIT-UL 01Med2000,93:t99-702. 55.Barrets-Connor E, Grady D, Sasheqjy A et at MORE bnvestigatro Ralatoxne and cardiovarular events In osteporotic posnwatopousal wonten. IAMA 2002M27:847-57.
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- Page 149 and 150: 146 WHITE PAPER #1 DID YOU KNOW THA
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- Page 193 and 194: group (P= 04001), and In this subgr
- Page 195: Treatmnent recommendations Based on
- Page 199 and 200: _ ORWIGNAL CONTIuBUTION 196 Postmen
- Page 201 and 202: showed no striking differences in H
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- Page 213 and 214: 210 ,lmcCII na: CLI I tr: tarty ver
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- Page 245 and 246: 242 STATEMENT OF DAVID G. ADAMS On
21.Grodsteln F. Mans<strong>on</strong> JE, Colditz GA, Witlen WC, Spelzer FE,<br />
Stampfer NU. A prospective, observati<strong>on</strong>al study of postmenopausal<br />
horm<strong>on</strong>e therapy and primary preventi<strong>on</strong> of<br />
cardiovascular disease. AnnIntemMed2000,133:933-4I.<br />
22.Fatkebom M, Perss<strong>on</strong> 1, Adaml HO et aL The risk of acute<br />
myocardtal Infarcti<strong>on</strong> aUter estrogen and estrogen-progestogen<br />
replacement Birtr Obstet G)"ecol t992,90.821-8.<br />
23.Psaty BM, Hectbert SRP Aticdos D er zL The risk of myocardial<br />
Infarcti<strong>on</strong> associated with the combined use of estrogens and<br />
progestins in postnenopausal women. Arch Inten Med<br />
1994;l54:1333-9.<br />
24.Wls<strong>on</strong> PW, Garris<strong>on</strong> RJP Casteeil WP. Postmenopausal estrogen<br />
use, cigarette smoking, and cardiovascular moobidty In women<br />
over 50. The framingham study. N Engi J Med 1985;<br />
313:1038-43.<br />
25.Roisouw JE. Debate: the potential role of estrogen In the<br />
preventI<strong>on</strong> of heant disease in women after menopause. Cunr<br />
C<strong>on</strong>trol 771ts Cardvasc Med2000;:1A35-8.<br />
26Sotelo MM, Johns<strong>on</strong> SR. The effects of horm<strong>on</strong>e replacement<br />
therapy <strong>on</strong> cor<strong>on</strong>ary heart disease. Endoinotl Meaab Cl/n<br />
North Am 1997;26:313-28.<br />
27.Grodsteln F, Stamapter Ml, Mans<strong>on</strong> IE et al Postanenopausa<br />
estrogen and progestin use and the risk of cardiovascular dis,<br />
ease. NEngl/Med 1996,335:453-61.<br />
28.Criqul MH, Suarez I, Barrent-C<strong>on</strong>nor E, McPhillips I,<br />
Wingard DL, Garland C. Postnenopausal estrogen use and mortality.<br />
Results from a prospective study In a defined, homo<br />
geneous cotcmuntty. AmJEptdemt/ 1988;128:606-14.<br />
29.Herandez Avila M, Walker AM, lick H. Use of replacement<br />
estrogesns and the risk of myocardisi Infarcti<strong>on</strong>. Epkk fokV<br />
19901:128-33.<br />
30SIdney 5, Pelitti DB, Ouesenberry CP Jr Myocardisi Inatrcti<strong>on</strong><br />
and the use of estrogen and estrogenproggstogen in postmenopausal<br />
women. Ann Intem Med 1997;127:501-8.<br />
3I.Rosenberg I, Sl<strong>on</strong>e D, Shapiro S, Kaufman D, Stottey PD,<br />
Miettinen OS. N<strong>on</strong>c<strong>on</strong>traceptive estrogens and myocardial<br />
Infarcti<strong>on</strong> In young women. 14MW 1980,244:339-42.<br />
32.Heckbert SR Weiss NS, Koepse TID et lL Durati<strong>on</strong> of estrugen<br />
replacement therapy in relati<strong>on</strong> to the rink of incident myocardial<br />
htfarcti<strong>on</strong> in postoenopausal women. Arch Intem Med<br />
1997;157:1330-6.<br />
33.Hemmintd E, McPhers<strong>on</strong> K. Impact of postnenopausal horm<strong>on</strong>e<br />
therapy <strong>on</strong> cardiovascular events and cancer: pooled data<br />
from clitical traLL 8Mtt997;315:149-53.<br />
3<br />
4.Women's Health Initiative Study Group. Design of the<br />
Women's Health InItiatIve clinical trat and observat<strong>on</strong>al study.<br />
Crn0rol Cltn 11dls 1998l19-61-109.<br />
35 hrl.//ww .nhdtibnlhpgv/wlsihrLhtm<br />
36.Vlckers MR, Meade TW, Wlikes HC. Horm<strong>on</strong>e replacement<br />
therapy and cardiovascular disease: the case for a randomized<br />
c<strong>on</strong>rotiled trial. Clba FoundSymnp 1995;19:150-60.<br />
37.COKeefe JH Jr, Kim SC, Hall RR, Cochran VC, Lawhorn SL,<br />
McCalgister BD. Estrogen replacement therapy after cor<strong>on</strong>ary<br />
angioplasty in women. JAm Coel Cardio 1997;291-5.<br />
383Abu-Halawa SA, Thomps<strong>on</strong> K, Kirkeelde R. et dL Estrogen<br />
replacemnent therapy and outcome of cor<strong>on</strong>ary balten angloplasty<br />
in posnmenopausal women. Am J Cantalo 1998j82:<br />
409-13.<br />
194<br />
Postmenopausal horm<strong>on</strong>e therapy and cardiovascular disease<br />
39.Satiivan JM, Et-Zeky F, Vander Zwaag R, Ramanathan KB Effect<br />
<strong>on</strong> survival of estrogen replacement therapy after cor<strong>on</strong>ary<br />
artery bypass grafting AmJ CIr/Yol 1997;79'.847-50.<br />
405hcteftbrd DP, Daniels S, Hoffman MK, Chitwood R. Estrogen<br />
therapy In women undergoing comnaly artety bypass gradl<br />
effect <strong>on</strong> surgical complicata<strong>on</strong>s bet CQvneco 2000;9S:<br />
732-S.<br />
41Shlpak MG, Angela BG, Go AS, Frederick PD, Canto JG.<br />
Grady D. Horm<strong>on</strong>e therapy and In-hospital survival after<br />
myocardtal infarcti<strong>on</strong> In postuenopausat women. Cmirulaf/<strong>on</strong><br />
2001; 104:2300-4.<br />
42.Grodsteln F, Mans<strong>on</strong> IE, Stanspfer MJ. Postmenopausarl horm<strong>on</strong>e<br />
use and sec<strong>on</strong>dary preventi<strong>on</strong> of comnary events in the<br />
nurses' health study a prospective, observati<strong>on</strong>al study. Ann<br />
InternMed200I;135:I-8.<br />
43,Alexander KP, Newby LK, Hellkamp AS et ai Initiati<strong>on</strong> of horm<strong>on</strong>e<br />
replacement therapy after acute myocardial hfarcti<strong>on</strong> Is<br />
associated with more cardiac events during fotlow-up. J Am<br />
Coi Cardbf200L,31:l-7.<br />
44.Heckbert SR, Kaplan RC, Weiss NS ed a Risk of recurrent cor<strong>on</strong>ary<br />
events in relati<strong>on</strong> to use and recent intitiati<strong>on</strong> of post<br />
menopausal horm<strong>on</strong>e therapy. Arch Intem Med 2001;1611<br />
1709-13.<br />
45.Huttey S, Grady D, Bush T et al Randomized trial of estrogen<br />
plus progmestn for sec<strong>on</strong>dary preventi<strong>on</strong> of cor<strong>on</strong>ary heart disease<br />
In postmenopausol women. 1AMA 1998,280:605-13.<br />
46.Herringt<strong>on</strong> DM, Reboussin DM, Brosntihan. KB et at Effects of<br />
estrogen repiacement <strong>on</strong> the progesst<strong>on</strong> ofcor<strong>on</strong>ary-artery atherosclerosis.<br />
N&W1Med2O00O343:522-4.<br />
47.Schulman SP, Thiemano DR, Ouyang P et al Effects of acute<br />
horm<strong>on</strong>e therapy <strong>on</strong> recurrent ischemla in postmenopausal<br />
women with mutable angna. J Am Coa Card/at 2002i39:<br />
231-7.<br />
48.Mendelsohn ME, Karas RH. The time has come to stop letting<br />
the HERS tale wag the dogma. Chculati<strong>on</strong> 2001; 104: 2256-9.<br />
49Rosano GM, FRo M. Postnenopausal women and carddovascular<br />
risin impact of horm<strong>on</strong>e replacement therapy. Card/of Rev<br />
2002;10t51-O.<br />
S0.osano GM, Sim<strong>on</strong> T, Mercuro G et al Horm<strong>on</strong>e replacement<br />
therapy'. where we stand in Europe. Eur Heart 1 2001;<br />
22.439-41.<br />
5 l.Wenger Nt, Knatterud CL, Canner PL Early risks of horm<strong>on</strong>e<br />
therapy in patients with cor<strong>on</strong>ary heart disease. JAM4<br />
2000',284:41-3.<br />
52.Clatze S, Kelleher 1, Lloyd-Janes H, Sharples I, Slack M,<br />
Schofteld PM. Transdermal horm<strong>on</strong>e replacement therapy<br />
for the sec<strong>on</strong>dary preventi<strong>on</strong> of cor<strong>on</strong>ary artery disease<br />
in postmenopausal women (abstrac). Eur Heart I 2000;<br />
21212.<br />
53.Viscofi CM, Brass LK, Keroan WN, Sarrel PM, Sulssa S,<br />
Horwimz RL A clinical traia of estrogen-replacement therapy<br />
after ischeicsndtmke. NEngfJMed200l;345:1243-9.<br />
54.htaan MA, Heagerty AM, Kitchener H, McNamee R,<br />
Cherry NM, Hannaford P. Oestrogen and women's heart<br />
diseasetr ESPRIT-UL 01Med2000,93:t99-702.<br />
55.Barrets-C<strong>on</strong>nor E, Grady D, Sasheqjy A et at MORE<br />
bnvestigatro Ralatoxne and cardiovarular events In osteporotic<br />
posnwatopousal w<strong>on</strong>ten. IAMA 2002M27:847-57.