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ARTICLE |

Venous Thromboembolic Events Associated With Hormone Replacement Therapy FREE

Deborah Grady, MD, MPH; Stephen B. Hulley, MD; Curt Furberg, MD
JAMA. 1997;278(6):477-477. doi:10.1001/jama.1997.03550060053030
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To the Editor.  —The Heart and Estrogen-Progestin Replacement Study (HERS) is a randomized, double-blind, placebocontrolled trial designed to test the effect of hormone replacement therapy on the rate of new coronary heart disease (CHD) events in 2763 postmenopausal women younger than 80 years who had preexisting CHD and an intact uterus at enrollment. Participants were randomly assigned to take 1 tablet daily, either a placebo or the combination of 0.625 mg of conjugated equine estrogens and 2.5 mg of medroxyprogesterone acetate. Recruitment for HERS was completed in September 1994, and the trial is scheduled to continue until mid 1998.In addition to the primary end point of CHD events, a number of secondary end points were specified in the HERS protocol for evaluation in planned interim monitoring; these include the occurrence of venous thromboembolic events (VTE), ie, deep vein thrombosis, pulmonary embolism, or both.Recently, 4 observational studies1-4 and

REFERENCES

Daly E, Vessey MP, Hawkins MM, Carson JL, Gough P, Marsh S.  Risk of venous thromboembolism in users of hormone replacement therapy . Lancet . 1996;;348:977-980.
Jick H, Derby LE, Myers MW, Vasilakis C, Newton KM.  Risk of hospital admission for idiopathic venous thromboembolism among users of postmenopausal oestrogens . Lancet . 1996;;348:981-983.
Grodstein F, Stampfer MJ, Goldhaber SZ, et al.  Prospective study of exogenous hormones and risk of pulmonary embolism in women . Lancet . 1996;;348:983-987.
Gutthann S, Rodriguez L, Castellsague J, Ollart A.  Hormone replacement therapy and risk of venous thromboembolism: population based case-control study . BMJ . 1997;;314:796-800.
The Writing Group for the PEPI Trial.  Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial . JAMA . 1995;;273:199-208.
Lan KKG, DeMets DL.  Discrete sequential boundaries for clinical trials . Biometrika . 1983;;70:649-653.

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Daly E, Vessey MP, Hawkins MM, Carson JL, Gough P, Marsh S.  Risk of venous thromboembolism in users of hormone replacement therapy . Lancet . 1996;;348:977-980.
Jick H, Derby LE, Myers MW, Vasilakis C, Newton KM.  Risk of hospital admission for idiopathic venous thromboembolism among users of postmenopausal oestrogens . Lancet . 1996;;348:981-983.
Grodstein F, Stampfer MJ, Goldhaber SZ, et al.  Prospective study of exogenous hormones and risk of pulmonary embolism in women . Lancet . 1996;;348:983-987.
Gutthann S, Rodriguez L, Castellsague J, Ollart A.  Hormone replacement therapy and risk of venous thromboembolism: population based case-control study . BMJ . 1997;;314:796-800.
The Writing Group for the PEPI Trial.  Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial . JAMA . 1995;;273:199-208.
Lan KKG, DeMets DL.  Discrete sequential boundaries for clinical trials . Biometrika . 1983;;70:649-653.
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To understand the clinical management of acute heart failure syndromes.
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