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- W2249777368 abstract "521 Background: Studies of aromatase inhibitors (AI) vs. tamoxifen (T) including the BIG 1–98 study have suggested a small numerical excess of cardiac adverse events (AEs) and increased incidence of hypercholesterolemia on AIs, and significantly higher incidence of thromboembolic AEs on T. Methods: 8,028 postmenopausal women with receptor-positive early breast cancer were randomized (double-blind) between March 1998 and May 2003 to receive 5 years letrozole (L), T, or a sequence of these agents. 7,963 patients who actually received therapy are included. AEs were recorded through 30 days after therapy completion or after switch on the sequential arms. Cardiovascular AEs were prospectively collected and graded. Cholesterol measurements were analyzed for percent change in total cholesterol from baseline by follow-up visit. Cox proportional hazards models were used to compare T and L according to time to first cardiovascular AE, adjusting for hypercholesterolemia at baseline or prior to the event, age, BMI, and history of smoking, hypertension, diabetes, and cardiac morbidity. The median follow-up was 30.1 months. Results: Baseline co-morbidities were balanced. Cox model results for time to first grade 3–5 cardiovascular AE are below. Cholesterol values decreased over time on both treatments, but to a greater extent and earlier on T. Conclusion: Taken together, cardiovascular AEs were relatively rare, and any excess of cardiac events on L seems to be outweighed by the superior control of recurrence afforded by L compared to T. An understanding of the nature, frequency and mechanism of such AEs is important to the optimization of the therapeutic ratio in adjuvant endocrine therapy with AIs. [Table: see text] No significant financial relationships to disclose." @default.
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- W2249777368 date "2007-06-20" @default.
- W2249777368 modified "2023-10-18" @default.
- W2249777368 title "Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: Updated safety analysis of trial BIG 1–98" @default.
- W2249777368 doi "https://doi.org/10.1200/jco.2007.25.18_suppl.521" @default.
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