Results of a safety study to evaluate safety in the adjuvant setting comparing the effect on lumbar spine (L2-L4) BMD of adjuvant treatment with Letrozole to that with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4.1% in the Letrozole arm compared to a median increase of 0.3% in the tamoxifen arm (difference = 4.4%) ( In the adjuvant trial (BIG 1-98) the incidence of bone fractures at any time after randomization was 14.7% for Letrozole and 11.4% for tamoxifen at a median follow-up of 96 months. Weight Gain Selected baseline characteristics for the study population are shown in Table 6.The primary endpoint of this trial was disease-free survival (DFS) (i.e., interval between randomization and earliest occurrence of a local, regional, or distant recurrence, or invasive contralateral breast cancer, or death from any cause). Yes. The incidence of new osteoporosis was 14.5% for Letrozole and 7.8% for placebo.During treatment or within 30 days of stopping treatment (median duration of treatment 60 months) the incidence of cardiovascular events was 9.8% for Letrozole tablets and 7.0% for placebo.Based on 62 months median duration of follow-up in the randomized Letrozole arm in the safety population the incidence of cardiovascular disease at any time after randomization was 14.4% for Letrozole and 9.8% for placebo.In study P025 a total of 455 patients were treated for a median time of exposure of 11 months in the Letrozole tablets arm (median 6 months in the tamoxifen arm). The ACTH stimulation test performed after 6 and 12 weeks of treatment with daily doses of 0.1, 0.25, 0.5, 1, 2.5, and 5 mg did not indicate any attenuation of aldosterone or cortisol production. There was no statistically significant difference in overall survival. Feel Like Throwing Up 5. In the adjuvant trial (BIG 1-98), hypercholesterolemia was reported in 52.3% of Letrozole patients and 28.6% of tamoxifen patients. Cerner Multum, Inc. "Australian Product Information." 2.5 mg tablets: Yellow colored, film-coated, round shaped tablets debossed with one side 'N' and other side 'L'.Use of Letrozole tablets may cause decreases in bone mineral density (BMD). The incidence of self-reported osteoporosis was higher in patients who received Letrozole tablets 6.9% (176) than in patients who received placebo 5.5% (141). Clinical experience in the second-line breast cancer trials (AR/BC2 and AR/BC3) indicates that the therapeutic effect of Letrozole tablets therapy is not impaired if Letrozole tablets are administered immediately after tamoxifen.A pharmacokinetic interaction study with cimetidine (study P004) showed no clinically significant effect on Letrozole pharmacokinetics.An interaction study (P017) with warfarin showed no clinically significant effect of Letrozole on warfarin pharmacokinetics.There is no clinical experience to date on the use of Letrozole tablets in combination with other anticancer agents.Based on post-marketing reports, findings from animal studies and the mechanism of action, Letrozole tablets can cause fetal harm and are contraindicated for use in pregnant women. Excessive Sweating 4. Common side effects of Femara include: hot flashes, ; warmth in your face or chest, After the unblinding of the study at a median follow-up of 28 months, approximately 60% of the selected patients in the placebo arm opted to switch to Letrozole tablets.In this updated analysis shown in Table 10, Letrozole tablets significantly reduced the risk of breast cancer recurrence or contralateral breast cancer compared with placebo (HR 0.75; 95% CI 0.63, 0.89; A randomized, double-blind, multinational trial (P025) compared Letrozole tablets 2.5 mg with tamoxifen 20 mg in 916 postmenopausal patients with locally advanced (Stage IIIB or loco-regional recurrence not amenable to treatment with surgery or radiation) or metastatic breast cancer. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration for Letrozole tablets was 60 months. Most adverse reactions reported were Grade 1 and Grade 2 based on the CTC Version 2.0. 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