Noncardiovascular Disease Outcomes During 6.8 Years of Hormone Therapy: Heart and Estrogen/Progestin Replacement Study Follow-Up (HERS II)
Noncardiovascular Disease Outcomes During 6.8 Years of Hormone Therapy: Heart and Estrogen/Progestin Replacement Study Follow-Up (HERS II)
复制标题
6.8 年激素治疗期间的非心血管疾病结果：心脏和雌激素/孕激素替代研究随访 (HERS II)
DOI：
10.1097/00006254-200210000-00021
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发表时间：
2002
影响因子：
6.2
通讯作者：
D. Hunninghake
中科院分区：
文献类型：
--
作者：
S. Hulley;C. Furberg;E. Barrett;J. Cauley;D. Grady;W. Haskell;R. Knopp;M. Lowery;S. Satterfield;H. Schrott;E. Vittinghoff;D. Hunninghake
The authors have reviewed data from the Heart and Estrogen/Progestin Replacement Study (HERS), a randomized trial of hormone replacement therapy (HRT) in postmenopausal women with coronary disease. The HERS trial, with an initial follow-up duration of 4.1 years and subsequent follow-up extending this to 6.8 years, is the first randomized study large enough to provide useful information on adverse events related to HRT, including (in addition to cardiovascular events) bone fracture, thromboembolism, biliary tract surgery, cancer, and overall mortality. Participants numbered 2763 women with an average age of 67 when enrolling in the HERS. HRT consisted of 0.625 mg of conjugated estrogens plus 2.5 mg of medroxyprogesterone acetate daily during the trial proper and open-label hormones prescribed by personal physicians during the extended follow-up period. The rate of adherence to at least 80% of prescribed hormone treatment was 81% in the first year of the trial and 45% in year 6. Both deep venous thrombosis (DVT) and pulmonary embolism increased 2- to 3-fold in women taking HRT during the trial proper, but the increase in DVT was not significant over the total follow-up period. In contrast, the risk of pulmonary embolism persisted during HERS II. The relative hazard for any venous thromboembolic event over 6.8 years was 2.08, 5.9 per 1000 person-years in hormone users and 2.8 in placebo recipients. Three deaths were ascribed to pulmonary embolism. There is some indication that aspirin attenuated the risk of thromboembolism in the hormone group. The overall relative hazard for biliary tract surgery in the HRT group was 1.48, or 1.44 after adjusting for statin therapy. Six women died within 30 days of biliary tract surgery, and one death was viewed as a result of the surgery. No significant group differences in cancer incidence were documented. The overall relative hazard for incident breast cancers, comparing the hormone and placebo groups, was 1.27; for lung cancers, 1.39; and for colon cancers, 0.81. Women assigned to HRT had more hip fractures than the placebo group, with an overall relative hazard during 6.8 years of observation of 1.61. The relative hazard for total mortality in HRT recipients was 1.06 during HERS, 1.14 during HERS II, and 1.10 overall. HRT increases the risk of venous thromboembolism and is associated with more frequent biliary tract surgery in older postmenopausal women having coronary artery disease. At the same time, it has not diminished overall rates of cardiovascular disease, bone fracture, or death from all causes. HRT therefore should be used only for symptomatic relief in the early postmenopausal years or any other indication supported by evidence from randomized trials, providing that the potential benefit outweighs any harmful effects.
