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Recent News and Articles on the Keywords: ruth trial + venous thromboembolic + raloxifene  Related to the article below (Last Update: 7/1/2008)

Raloxifene (Evista) Reduces Risk of ER-Positive Invasive Breast Cancer
MedPage Today, NJ - Jun 11, 2008
Raloxifene was associated with an increased risk of venous thromboembolism and fatal stroke in RUTH. Assuming that the relative risks of the trial apply to ...
Source: Google News

… Women Four-Year Results From the MORE (Multiple Outcomes of Raloxifene Evaluation) Randomized Trial -
E Barrett-Connor, D Grady, A Sashegyi, PW Anderson … - JAMA, 2002 - Am Med Assoc
... but increased the risk of venous thromboembolic events to an ... being tested prospectively
in the Raloxifene Use for The Heart (RUTH) trial, which enrolled 10 ...

Design and methods of the Raloxifene Use for The Heart (RUTH) study. -
L Mosca, E Barrett-Connor, NK Wenger, P Collins, D … - Am J Cardiol, 2001 - ncbi.nlm.nih.gov
... placebo-controlled, randomized clinical trial of 10,101 ... clinical fractures, and venous
thromboembolic events, in ... RUTH will provide important information about ...

… Risk Reduction in Postmenopausal Women Treated with Raloxifene: 4-Year Results from the MORE Trial -
JA Cauley, L Norton, ME Lippman, S Eckert, KA … - Breast Cancer Research and Treatment, 2001 - Springer
... raloxifeneuse for the heart [RUTH] trial [9]). The ... The trial enrolled 7,705
postmenopausal women at ... history of stroke or venous thromboembolic disease during ...

[CITATION] Rationale and Overview of the Raloxifene Use for the Heart (RUTH) Trial -
L MOSCA - Annals of the New York Academy of Sciences, 2001 - Blackwell Synergy
... necessarily extrapolate to the RUTH trial for several ... a multicenter randomized clinical
trial of 390 ... Risk for venous thromboembolic disease (VTE) is increased ...

… : Breast Cancer Incidence in Postmenopausal Osteoporotic Women in a Randomized Trial of Raloxifene -
S Martino, JA Cauley, E Barrett-Connor, TJ Powles, … - jnci, 2004 - jnci.oxfordjournals.org
... most life-threatening complication of thromboembolic disease is ... for breast cancer
incidence and venous thromboembolism in ... Use for The Heart (RUTH) trial (24,25 ...

Cardiovascular effects of raloxifene: the arterial and venous systems -
RS Blumenthal, B Baranowski, SA Dowsett - American Heart Journal, 2004 - Elsevier
... Although raloxifene does increase venous thromboembolic events, there is ... positive
data from the Raloxifene Use for The Heart (RUTH) trial will lead to ...

Risk of Venous Thromboembolism in Users of Hormone Replacement Therapy. -
E Daly, MP Vessey, MM Hawkins, JL Carson, P Gough, … - Obstetrical & Gynecological Survey, 1997 - obgynsurvey.com
... replacement therapy reverses altered venous contractility in ... Lesly A. MS; McBride,
Ruth BS; Rothbart ... in Postmenopausal Women: A Randomized Controlled Trial. ...

… for Breast Cancer Risk Reduction Including Tamoxifen, Raloxifene, and Aromatase Inhibition -
RT Chlebowski, N Col, EP Winer, DE Collyar, SR … - Journal of Clinical Oncology, 2002 - jcojournal.org
... found the incidence of both venous thromboembolic events and ... 14 Since nearly half
of thromboembolic events seen ... 46 The RUTH trial, with baseline breast cancer ...

Hormone Replacement Therapy and Cardiovascular Disease A Statement for Healthcare Professionals From … -
L Mosca, P Collins, DM Herrington, ME Mendelsohn, … - Circulation, 2001 - Am Heart Assoc
... the Women?s Estrogen for Stroke Trial (WEST ... hormone therapy increases risk for venous
thromboembolic disease: the ... the Raloxifene Use for the Heart (RUTH) Study ...

Prospective Study of Exogenous Hormones and Risk of Pulmonary Embolism in Women. -
F Grodstein, MJ Stampfer, SZ Goldhaber, JAE Manson … - Obstetrical & Gynecological Survey, 1997 - obgynsurvey.com
... Receptor 1) Gene Polymorphism Toward Venous Thromboembolism. ... Lesly A. MS; McBride,
Ruth BS; Rothbart ... in Postmenopausal Women: ARandomized Controlled Trial. ...

Source: Google Scholar
 
 

RUTH trial: Raloxifene linked to increased risk of venous thromboembolism and fatal stroke

 
 
The RUTH ( Raloxifene Use for The Heart ) trial is a randomized, placebo-controlled, double-blind trial designed to determine whether Raloxifene 60 mg/day compared with placebo lowers the risk of coronary events ( coronary death, nonfatal myocardial infarction, or hospitalized acute coronary syndromes other than myocardial infarction ) and reduces the risk of invasive breast cancer in women at risk for a major coronary event.

Raloxifene ( Evista ) is a selective estrogen receptor modulator ( SERM ).

Between June 1998 and August 2000, 10,101 women were enrolled.
Approximately half of the women had documented coronary heart disease ( CHD ) ( n = 5,031 ); the remainder had multiple CHD risk factors that increased their risk for a CHD event ( n = 5,070 ). The mean age of participants was 68 years ( 39% were >70 years old ), and did not differ between those with documented CHD and those at increased CHD risk.
Most women were Caucasian ( 84% ); 60% had a body mass index ( BMI ) >/=27 kg/m(2), 46% had diabetes mellitus, 78% had systemic hypertension, and 14% had low-density lipoprotein cholesterol >160 mg/dl.
Compared with women at increased CHD risk, women with documented coronary heart disease had higher cardiovascular risk scores, a higher prevalence of abnormal electrocardiograms, greater use of cardiovascular medications, were more likely to have had cardiac rehabilitation, and were more likely to have previously used estrogen or oral contraceptives, but had a slightly lower prevalence of CHD risk factors such as smoking, obesity, diabetes mellitus, and systemic hypertension, and had lower serum levels of total and low-density lipoprotein cholesterol.

When the MORE trial results became known, invasive breast cancer was added as a second primary outcome.

The women were followed-up for a median of 5.6 years.

As compared with placebo, Raloxifene had no significant effect on the risk of primary coronary events ( 533 vs. 553 events; hazard ratio, HR = 0.95 ), and it reduced the risk of invasive breast cancer ( 40 vs. 70 events; HR= 0.56; absolute risk reduction, 1.2 invasive breast cancers per 1000 women treated for one year ); the benefit was primarily due to a reduced risk of estrogen-receptor–positive invasive breast cancers.

There was no significant difference in the rates of death from any cause or total stroke, but Raloxifene was associated with an increased risk of fatal stroke ( 59 vs. 39 events; HR = 1.49; absolute risk increase, 0.7 per 1000 woman-years ) and venous thromboembolism ( 103 vs. 71 events; HR = 1.44; absolute risk increase, 1.2 per 1000 woman-years ).

Raloxifene reduced the risk of clinical vertebral fractures ( 64 vs. 97 events; HR = 0.65; absolute risk reduction, 1.3 per 1000 ).

“ Raloxifene did not significantly affect the risk of coronary heart disease. The benefits of Raloxifene in reducing the risks of invasive breast cancer and vertebral fracture should be weighed against the increased risks of venous thromboembolism and fatal stroke, “ the authors conclude.

Source: The New England Journal of Medicine, 2006
 
 
 
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