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Cover of Hormone Replacement Therapy and Risk of Venous Thromboembolism

Hormone Replacement Therapy and Risk of Venous Thromboembolism

Systematic Evidence Reviews, No. 11

, MD, , MS, and , MD, MPH.

Oregon Health Sciences University Evidence-based Practice Center, Portland, Oregon

Structured Abstract

Context:

Although postmenopausal hormone replacement therapy is widely used, its risks and benefits are not well understood.

Objective:

To assess the risk of venous thromboembolism with the use of postmenopausal hormone replacement therapy (HRT) by literature review and meta-analysis.

Data Sources:

All relevant English-language studies identified in MEDLINE (1966 to December 2000), HealthSTAR (1975 to December 2000), Cochrane library databases, and reference lists of key articles. Studies of selective estrogen receptor modulators (SERMs) were identified in MEDLINE (1991 to December 2000).

Study Selection:

All studies of postmenopausal HRT or SERMs reporting venous thromboembolism as an outcome or adverse event.

Data Extraction:

Twelve studies of HRT (3 randomized controlled trials, 8 case-control studies, and one cohort study), and 5 randomized controlled trials of SERMs were identified. We extracted data on number of participants, interventions, event rates, and confounders. Two reviewers independently rated study quality based on established criteria.

Data Synthesis:

We used Bayesian meta-analysis. Current HRT use was associated with an increased risk of venous thromboembolism (relative risk [RR], 2.14; CI, 1.64-2.81). The absolute rate increase was 1.5 venous thromboembolic events per 10,000 women in one year. Five case-control studies reported highest risk within the first year of use (odds ratios [OR], 2.9-6.7). Data from 5 randomized controlled trials of SERMs were not included in the meta-analysis. The 2 largest trials reported a similar increased risk of venous thromboembolism.

Conclusions:

Postmenopausal HRT is associated with an increased risk of venous thromboembolism, and this risk may be highest in the first year of use. SERMs are associated with a similar increase in risk.

Contents

2101 East Jefferson Street, Rockville, MD 20852. www​.ahrq.gov

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-97-0018, Task Order No. 2, Technical Support of the U.S. Preventive Services Task Force. Prepared by: Oregon Health Sciences University Evidence-based Practice Center, Portland, Oregon.

This report may be used, in whole or in part, as the basis for development of clinical practice gdelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decisionmakers -- patients and clinicians, health system leaders, and policymakers -- make more informed decisions and improve the quality of health care services.

The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.

1

2101 East Jefferson Street, Rockville, MD 20852. www​.ahrq.gov

Bookshelf ID: NBK42678PMID: 20722106
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