Effect of raloxifene therapy on venous thromboembolism in postmenopausal women: A meta-analysis

Abstract

SummaryRaloxifene, a selective estrogen receptor modulator, is indicated for the prevention of osteoporosis in postmenopausal women. However, its effect on the risk of deep venous thrombosis (DVT) and pulmonary embolism (PE) is unclear. Therefore, we conducted a meta-analysis to evaluate the effect of raloxifene on these outcomes. To identify randomized controlled trials of raloxifene, a systematic search of PubMed, EMBASE, and Cochrane Collaboration databases was performed from the date of inception of these databases to October 2007. Search was limited to trials that were published in peer-reviewed English-language medical journals. Articles were included in the meta-analysis if they had reported on DVT, PE, or thromboembolic events. Nine trials, including 24,523 postmenopausal women, (median age 59.4 years, range 55 to 67 years; median follow-up 24 months, range 3 to 67 months) met inclusion criteria. Therapy with raloxifene was associated with a 62% increase in odds of either DVT or PE (odds ratio = 1.62; 95% confidence interval = 1.25 to 2.09; p-value < 0.001). Similarly, raloxifene therapy was associated with 54% increase in odds of DVT (odds ratio = 1.54; 95% confidence interval = 1.13 to 2.11; p-value = 0.006) and 91% increase in odds of PE alone (odds ratio = 1.91;95% confidence interval = 1.05 to 3.47; p-value = 0.03). Raloxifene increases the risk of DVT and PE in postmenopausal women.

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“…In most studies, raloxifene did not influence the risk of cardiovascular (coronary) events 44,47 and, in some groups, may even decrease the risk of myocardial infarction or unstable angina 48 . It increases the risk of venous thromboembolism to the same extent as HRT and increases the risk of fatal stroke mainly in women with high risk of stroke at baseline 44,49,50,51 .…”

Pharmacological Treatment of Osteoporosis

“…(Martino et al, 2005) In a meta-analysis of nine studies, therapy with raloxifene was associated with an increase in the risk of deep venous thrombosis and pulmonary embolism (OR=1.5; CI 95%: 1.1-2.1 and OR=1.9; 95% CI: 1.0-3.5, respectively). (Adomaityte et al, 2008) In the RUTH study (Raloxifene Use for The Heart), which included 10,101 postmenopausal women with coronary heart disease and an average age of 68 years, there was an association between Raloxifene and an increased risk of fatal stroke (HR=1.49; 95% CI: 1.00-2.24, an increase in the absolute risk of 0.7/1,000 women-years) and thromboembolism (HR=1.44; 95% CI: 1.06-1.95, an increase absolute risk of 1.2/1,000 women-years) compared with placebo. There was no increased risk of myocardial infarction or other coronary events in the RUTH study.…”

Epidemiology of venous thromboembolism

“…Hypertriglyceridemia doubles the risk of VTE in postmenopausal women [162]. However, the risk associated with atherosclerosis, or other risk factors for atherosclerosis, remains uncertain [118, [163][164][165][166][167] 172,176], and therapy with the selective estrogen receptor modulator, raloxifene [177]. First and third generation oral contraceptives convey higher risk than second generation oral contraceptives [173].…”