References

References

  1. The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 2008;9(1):45-53.
  2. The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002;359(9324):2131-2139.
  3. The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet. 2005;365(9453):60-62.
  4. Coleman RE; for the ATAC Trialists' Group. Effect of anastrozole on bone mineral density: 5-year results from the "Arimidex," Tamoxifen, Alone or in Combination (ATAC) trial. Abstract presented at: Annual Meeting of the American Society of Clinical Oncology; June 2-6, 2006; Atlanta, GA. Abstract 511.
  5. Hillner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol. 2003;21(21):4042-4057.
  6. Shapiro CL. Aromatase inhibitors and bone loss: risks in perspective. J Clin Oncol. 2005;23(22):4847-4849.
  7. Buzdar AU; for the ATAC Trialists' Group. Clinical features of joint symptoms observed in the "Arimidex," Tamoxifen, Alone or in Combination (ATAC) trial. Poster presented at: Annual Meeting of the American Society of Clinical Oncology; June 2-6, 2006; Atlanta, GA. Poster 551.
  8. Felson DT, Cummings SR. Aromatase inhibitors and the syndrome of arthralgias with estrogen deprivation. Arthritis Rheum. 2005;52(9):2594-2598.
  9. The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group. Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Lancet Oncol. 2006;7(8):633-643.
  10. Arimidex [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2008.
  11. Harris Interactive. Large numbers of people are not very confident in their own knowledge and the safety of prescription medications and this often leads to non-adherence. April 18, 2007. http://www.harrisinteractive.com/ NEWS/ printerfriend/ index.asp?NewsID=1205. Accessed June 13, 2008.
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  16. Goss PE, Gwyn KM. Current perspectives on aromatase inhibitors in breast cancer. J Clin Oncol. 1994;12(11):2460-2470.
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  18. Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol. 2008;26(4):556-562.
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Important Information About Arimidex® (anastrozole) Tablets

Arimidex is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

Arimidex is indicated for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Arimidex.

Important Safety Information About Arimidex

  • Arimidex is only for postmenopausal women. Arimidex can cause fetal harm when administered to a pregnant woman. Before starting treatment with Arimidex, pregnancy must be excluded (see WARNINGS section of full Prescribing Information)
  • In women with preexisting ischemic heart disease 465/6186 (7.5%), an increased incidence of ischemic cardiovascular events occurred with Arimidex (17%) vs tamoxifen (10%). In this patient population, angina pectoris was reported in 25/216 (11.6%) vs 13/249 (5.2%) and myocardial infarction was reported in 2/216 (0.9%) vs 8/249 (3.2%) patients receiving Arimidex and tamoxifen, respectively
  • Compared to baseline, Arimidex showed a mean decrease in both lumbar spine and total hip bone mineral density. Tamoxifen showed a mean increase in these measurements. Nine percent of patients receiving Arimidex had an elevated serum cholesterol vs 3.5% of patients receiving tamoxifen
  • Common side effects seen with Arimidex vs tamoxifen in the early breast cancer trial after 5 years of treatment include hot flashes (36% vs 41%), joint disorders (including arthritis, arthrosis, arthralgia) (36% vs 29%), asthenia (19% vs 18%), mood disturbances (19% vs 18%), pain (17% vs 16%), pharyngitis (14% vs 14%), nausea and vomiting (13% vs 12%), rash (11% vs 13%), depression (13% vs 12%), hypertension (13% vs 11%), osteoporosis (11% vs 7%), peripheral edema (10% vs 11%), lymphedema (10% vs 11%), back pain (10% vs 10%), insomnia (10% vs 9%), and headache (10% vs 8%). Fractures, including fractures of the spine, hip, and wrist, occurred more often with Arimidex vs tamoxifen (10% vs 7%)
  • In the advanced breast cancer studies, the most common (occurring with an incidence of >10%) side effects occurring in women taking Arimidex included hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis, and peripheral edema. Joint pain/stiffness has been reported in association with the use of Arimidex
  • Clinical and pharmacokinetic results suggest that tamoxifen should not be administered with Arimidex. Estrogen-containing therapies should not be used with Arimidex as they may diminish its pharmacologic action

Please click here for full Prescribing Information.