Drug Safety Evaluation of Exemestane

The document from March 24, 2011, evaluates the safety and efficacy of exemestane, a steroidal aromatase inhibitor used in treating estrogen-receptor-positive breast cancer in postmenopausal women. Exemestane has been shown to be superior to tamoxifen in terms of efficacy and safety in various trials and is used in both metastatic and early breast cancer treatment settings. It works by irreversibly binding to the aromatase enzyme, leading to a significant reduction in circulating estrogen levels. The recommended dosage is 25 mg daily, and it is approved for use after 2-3 years of tamoxifen therapy or for advanced breast cancer following tamoxifen therapy. Clinical studies have shown that exemestane improves disease-free survival and overall survival in postmenopausal women with early-stage breast cancer. The drug is metabolized by CYP3A4 and aldoketoreductases, and no dose adjustments are necessary for patients with renal or hepatic insufficiency. The safety profile is favorable, with the most common side effects being mild and manageable. The document also notes that exemestane may stimulate growth in children or adolescents with compromised height predictions, but long-term safety profiles need further investigation. The safety evaluation section details various adverse effects, and the document concludes that exemestane has a safety profile comparable to nonsteroidal AIs and has shown superior efficacy to tamoxifen, but further studies are required to fully understand its long-term effects.