Tamoxifen and Thromboembolism

Hendrick, Alex; Subramanian, Vanitha

doi:10.1001/jama.1980.03300320012005

Cited by 39 publications

(7 citation statements)

References 2 publications

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“…To our knowledge, this is the first formal observational study on tamoxifen‐related VTE. A case‐series of 18 women with thromboembolism among 441 tamoxifen‐treated women [24], and several case‐reports of women who developed deep vein thrombosis or pulmonary embolism while being treated with tamoxifen [9–12] have been reported. However, the interpretation of these reports is difficult due to lack of comparison groups and because most of these women had several other risk factors for venous thromboembolism, such as cardiovascular diseases, prior history of VTE, metastases or recent chemotherapy or radiation.…”

Section: Discussionmentioning

confidence: 99%

“…Several case‐reports of women with breast cancer have been described who developed deep vein thrombosis or pulmonary embolism while being treated with tamoxifen [9–12], and there is growing evidence from randomized clinical trials that the incidence of VTE is indeed higher among tamoxifen exposed women than in the comparison groups, suggesting a possible causal role of tamoxifen [13–19]. However, those women who developed VTE were not necessarily free of cardiovascular risk factors, and they often received additional cancer treatment, such as chemo‐ or radiotherapy.…”

Section: Introductionmentioning

confidence: 99%

“…General practitioners have been trained to record medical information in a standard manner been described who developed deep vein thrombosis or pulmonary embolism while being treated with tamoxifen and to supply it anonymously. Information about symptoms, diagnoses, referrals, hospitalizations as well as all drug [9][10][11][12], and there is growing evidence from randomized clinical trials that the incidence of VTE is indeed higher prescriptions are recorded prospectively and on an ongoing basis by over 400 general practices. The database furthermore among tamoxifen exposed women than in the comparison groups, suggesting a possible causal role of tamoxifen contains demographics of the patients as well as information with regard to smoking status, height, weight, hysterectomy [13][14][15][16][17][18][19].…”

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confidence: 99%

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Tamoxifen and risk of idiopathic venous thromboembolism

Meier

Jick

1998

Brit J Clinical Pharma

164

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AimsTo evaluate a possible positive association between tamoxifen treatment and the risk of developing idiopathic venous thromboembolism (VTE) in women with breast cancer in the absence of clinical risk factors for venous thromboembolism other than breast cancer itself. Methods Using information from the large UK-based General Practice Research Database, we identified, within a cohort of more than 10 000 women with breast cancer, all women who developed a first-time diagnosis of deep vein thrombosis or pulmonary embolism of uncertain cause between January 1, 1991 and December 31, 1996. In a case-control analysis, we compared their tamoxifen exposure experience prior to the thromboembolic event with that of a randomly selected group of control women with breast cancer who were matched to cases on age, year of the breast cancer diagnosis and calendar time. Results We identified 25 cases of idiopathic VTE and 172 controls, all of whom had breast cancer, but were otherwise free from other risk factors for VTE. Past tamoxifen exposure was not materially associated with an elevated risk of developing VTE, and we therefore combined never and past users as reference group. The relative risk estimate of VTE for current tamoxifen exposure, as compared with never and past use combined, was 7.1 (95% CI 1.5-33), adjusted for body mass index, smoking status and hysterectomy status. High body mass index was an independent predictor of VTE itself. Conclusions Our study provides evidence that current use of tamoxifen increases the risk of idiopathic venous thromboembolism.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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confidence: 99%

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Tamoxifen and risk of idiopathic venous thromboembolism

Meier

Jick

1998

Brit J Clinical Pharma

164

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“…Tamoxifen commonly causes a range of side effects such as hot flashes and occasionally causes more serious adverse events such endometrial hyperplasia or endometrial cancer [4–6] and venous thromboembolic disease [7]. Other side effects attributed to tamoxifen are night sweats, gynecologic symptoms (vaginal dryness, vaginal discharge), depression, forgetfulness, sleep alterations, weight gain, and diminished sexual functioning [8–12].…”

Section: Introductionmentioning

confidence: 99%

Clinical and biomarker predictors of side effects from tamoxifen

Lorizio

Beattie

et al. 2011

Breast Cancer Res Treat

120

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Tamoxifen decreases breast cancer recurrence, mortality, and breast cancer risk in high-risk women. Despite these proven benefits, tamoxifen use is often limited due to side effects. We identified predictors of tamoxifen-induced side effects based on clinical variables and serum tamoxifen metabolite biomarkers in a cross-sectional study of patients taking tamoxifen. We enrolled 241 women and collected data on demographics, tamoxifen use and side effects, as well as potential clinical and serum predictors. We used logistic regression models and adjusted for age, body mass index, ethnicity, education, prior post-menopausal hormone therapy, tamoxifen duration, and endoxifen levels to identify factors associated with side effects. Common tamoxifen attributed side effects were hot flashes (64%), vaginal dryness (35%), sleep problems (36%), weight gain (6%), and depression, irritability or mood swings (6%). In multi-variate models, tamoxifen duration, age, prior post-menopausal hormone therapy, and endoxifen levels all predicted side effects. Women who had been on tamoxifen for >12 months were less likely to report side effects (OR 0.15, 95% CI, 0.04–0.58) or severe side effects (OR 0.05, 95% CI, 0.005–0.58) compared to women on tamoxifen for <12 months. Compared to women younger than 50, women who were age 60–70 and older than 70 were less likely to report side effects (OR 0.22, 95% CI, 0.03–1.35; OR 0.13, 95% CI, 0.01–0.99; respectively). Women who previously took post-menopausal hormone therapy were more likely to report severe side effects. Women with higher endoxifen levels were more likely to report side effects (OR 1.67, 95% CI, 1.01–2.77 per standard deviation increase in endoxifen). Clinicians should consider closely monitoring adherence in women taking tamoxifen, especially in younger women, and women who previously took hormone therapy. The association between endoxifen levels and side effects is consistent with the data that suggest that endoxifen is the most highly active metabolite of tamoxifen.

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“…Both surgical and medical options exist to treat EPS, but conservative treatment is the current standard approach, although it may be insufficient 2) . Tamoxifen, which is used to treat malignancies such as breast cancer, increases the risk of thromboembolism in addition to thromboembolic effect of malignancy itself 3) . Although it is not clear how tamoxifen increases the risk of thromboembolism, its thromboembolic effect seems to be related to the factor V Leiden mutation and other mechanism 4,5) .…”

Section: Introductionmentioning

confidence: 99%

Liver Infarction and Venous Thromboembolism after Tamoxifen Use in an ADPKD Patient with Encapsulating Peritoneal Sclerosis: A Case Report

Kwak

Choi

Shim

et al. 2020

Electrolyte Blood Press

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Encapsulating peritoneal sclerosis (EPS) is a potentially fatal complication after long-term peritoneal dialysis, and tamoxifen can be used for its prevention and treatment. However, tamoxifen is known to increase the risk of venous thromboembolism. A 49-year-old woman was admitted with sudden abdominal pain. The patient had received peritoneal dialysis for 20 years and switched to hemodialysis after the diagnosis of EPS. Tamoxifen (10 mg) and prednisolone (20 mg) had been administered for 8 months. On computed tomography, the left hepatic lobe was hardly illuminated, leading to a diagnosis of liver infarction. A month later, she was re-admitted due to abdominal pain and extensive deep vein thrombosis of the leg. The administration of tamoxifen was stopped and prednisolone was reduced to 10 mg. As her malnutrition progressed, she succumbed to death of gram negative sepsis. The patient was concluded to have liver infarction and extensive venous thrombosis as a side effect of tamoxifen.

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Tamoxifen and Thromboembolism

Cited by 39 publications

References 2 publications

Tamoxifen and risk of idiopathic venous thromboembolism

Tamoxifen and risk of idiopathic venous thromboembolism

Clinical and biomarker predictors of side effects from tamoxifen

Liver Infarction and Venous Thromboembolism after Tamoxifen Use in an ADPKD Patient with Encapsulating Peritoneal Sclerosis: A Case Report

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