#B176 Effect of Tamoxifen on Venous Thromboembolic Events in a Prevention Trial in Hysterectomized Women. Andrea Decensi,1 Patrick Maisonneuve,1 Nicole Rotmensz,1 Donato Bettega,2 Alberto Costa,3 Virgilio Sacchini,1 Roberto Travaglini,4 Giuseppe D'Aiuto,5 Marcella Gulisano,6 Giacomo Gucciardo,7 Maria Grazia Muraca,8 Maria Antonietta Pizzichetta,9 Maura Zottar,10 Antonio Rulli,11 Silvia Milani,12 Davide Serrano,1 Umberto Veronesi.1 European Institute of Oncology,1 Milan, Italy, Ospedale Moriggia Pelascini,2 Gravedona, Como, Italy, Maugeri Foundation,3 Pavia, Italy, Comitato Prevenzione Tumori al seno,4 Milan, Italy, Istituto per lo Studio e la Cura dei Tumori "Fondazione Pascale",5 Naples, Italy, Ospedale San Bartolo,6 Vicenza, Italy, Ospedale San Camillo-Forlanini,7 Rome, Italy, Centro per lo Studio e la Prevenzione Oncologica,8 Florence, Italy, Centro Regionale di Riferimento Oncologico,9 Aviano, Italy, Ospedale Civile di Gorizia,10 Gorizia, Italy, Policlinico Monteluce,11 Perugia, Italy, Centro Oncologico,12 Trieste, Italy. Tamoxifen is associated with an increased risk of venous thromboembolic events (VTE), but neither the co-factors nor the mechanisms are well-defined. We assessed the effect of tamoxifen on VTE in a primary prevention trial and studied its association with putative risk factors for VTE measured at entry. The incidence of VTE was studied in 5408 hysterectomized women randomly assigned to tamoxifen 20 mg/day or placebo during the 5-year intervention period. A total of 72 VTEs occurred during intervention, 28 on placebo and 44 on tamoxifen (hazard ratio=1.63, 95% CI, 1.02-2.62). Eighty-one percent of VTE were cases of superficial phlebitis, which accounted for all the excess in the tamoxifen arm. Compared with placebo, the risk of VTE associated with tamoxifen was significantly greater in women with BMI greater than/or equal to 25 Kg/m2, elevated systolic blood pressure, high total cholesterol level, family history of coronary heart disease and those who ever smoked (P for the interaction, <0.05). Multivariate Cox model showed that age above 60 years, BMI greater than/or equal to 25 Kg/m2, diastolic blood pressure >90 mmHg, presence of angina, total cholesterol >300 mg/dl and current smoking had independent detrimental effect on VTE risk while on tamoxifen. Conversely, ever use of estrogen therapy was associated with a borderline significantly lower risk of VTE while on tamoxifen.Women with conventional risk factors for atherosclerosis are at increased risk for VTE while on tamoxifen and should be counseled regarding their risk:benefit ratio of taking tamoxifen, particularly in the prevention setting. Conversely, use of estrogen therapy and tamoxifen showed a potential favorable interaction. Cox Model for VTE (Tamoxifen vs Placebo) ----------------------------------------------------------- Baseline Risk Factors Tamoxifen ----------------------------------------------------------- HR (95% CI) Age 60+ 2.32 (1.18-4.57) BMI >25 Kg/m2 1.51 (0.81-2.83) Diastolic pressure >90 2.04 (1.09-3.84) Ever use HRT 0.40 (0.16-1.04) Angina 8.93 (1.16-68.8) Cholesterol >300mg 2.16 (0.90-5.20) Current smoker 1.92 (0.96-3.85) Hypertension 1.76 (0.89-3.49) HRT, Hormone Replacement Therapy Frontiers in Cancer Prevention Research, 2003 AACR Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.