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Table 4 : Number of Patients with Pre-specified Adverse Reactions in Trials 0030 and 0027 Adverse Reaction* Number (n) and Percentage of Patients ARIMIDEX 1 mg (N=506) n (%) NOLVADEX 20 mg (N=511) n (%) Depression 23 (5) 32 (6) Tumor Flare 15 (3) 18 (4) Thromboembolic Disease’ 18 (4) 33 (6) Venous’ 5 15 Coronary and Cerebral’ 13 19 Gastrointestinal Disturbance 170 (34) 196 (38) Hot Flushes 134 (26) 118 (23) Vaginal Dryness 9 (2) 3 (1) Lethargy 6 (1) 15 (3) Vaginal Bleeding 5 (1) 11 (2) Weight Gain 11 (2) 8 (2) * A patient may have had more than 1 adverse reaction. ARIMIDEX was tolerated in two controlled clinical trials (i. The principal adverse reaction more common with ARIMIDEX than megestrol acetate was diarrhea. Adverse reactions reported in greater than 5% of the patients in any of the treatment groups in these two controlled clinical trials, regardless of causality, are presented below: Table 5 :Number (N) and Percentage of Patients with Adverse Reactions in Trials 0004 and 0005 Adverse Reaction* ARIMIDEX 1 mg (N=262) ARIMIDEX 10 mg (N=246) Megestrol Acetate 160 mg (N=253) n % n % n % Asthenia 42 (16) 33 (13) 47 (19) Nausea 41 (16) 48 (20) 28 (11) Headache 34 (13) 44 (18) 24 (9) Hot Flashes 32 (12) 29 (11) 21 (8) Pain 28 (11) 38 (15) 29 (11) Back Pain 28 (11) 26 (11) 19 (8) Dyspnea 24 (9) 27 (11) 53 (21) Vomiting 24 (9) 26 (11) 16 (6) Cough Increased 22 (8) 18 (7) 19 (8) Diarrhea 22 (8) 18 (7) 7 (3) Constipation 18 (7) 18 (7) 21 (8) Abdominal Pain 18 (7) 14 (6) 18 (7) Anorexia 18 (7) 19 (8) 11 (4) Bone Pain 17 (6) 26 (12) 19 (8) Pharyngitis 16 (6) 23 (9) 15 (6) Dizziness 16 (6) 12 (5) 15 (6) Rash 15 (6) 15 (6) 19 (8) Dry Mouth 15 (6) 11 (4) 13 (5) Peripheral Edema 14 (5) 21 (9) 28 (11) Pelvic Pain 14 (5) 17 (7) 13 (5) Depression 14 (5) 6 (2) 5 (2) Chest Pain 13 (5) 18 (7) 13 (5) Paresthesia 12 (5) 15 (6) 9 (4) Vaginal Hemorrhage 6 (2) 4 (2) 13 (5) Weight Gain 4 (2) 9 (4) 30 (12) Sweating 4 (2) 3 (1) 16 (6) Increased Appetite 0 (0) 1 (0) 13 (5) * A patient may have had more than one adverse reaction. Other less frequent (2% to 5%) adverse reactions reported in patients receiving ARIMIDEX l mg in either Trial 0004 or Trial 0005 are listed below. These adverse experiences are listed by body system and are in order of decreasing frequency within each body system regardless of assessed causality. Body as a Whole: Flu syndrome; fever; neck pain; malaise; accidental injury; infection. Hepatic: Gamma GT increased; SGOT increased; SGPT increased Hematologic: Anemia; leukopenia. Metabolic and Nutritional: Alkaline phosphatase increased; weight loss. Mean serum total cholesterol levels increased by 0. Increases in LDL cholesterol have been shown to contribute to these changes. Musculoskeletal: Myalgia; arthralgia; pathological fracture. Nervous: Somnolence; confusion; insomnia; anxiety; nervousness. Skin and Appendages: Hair thinning (alopecia); pruritus. The incidences of the following adverse reaction groups potentially causally related to one or both of the therapies because of their pharmacology, were statistically analyzed: weight gain, edema, thromboembolic disease, gastrointestinal disturbance, hot flushes, and vaginal dryness. These six groups, and the adverse reactions captured in the groups, were prospectively defined. The results are shown in the table below. Table 6 : Number (n) and Percentage of Patients with Pre-specified Adverse Reactions in Trials 0004 and 0005 Adverse Reaction Group ARIMIDEX1 mg (N=262) ARIMIDEX10 mg (N=246) Megestrol Acetate160 mg (N=253) n (%) n (%) n (%) Gastrointestinal Disturbance 77 (29) 81 (33) 54 (21) Hot Flushes 33 (13) 29 (12) 35 (14) Edema 19 (7) 28 (11) 35 (14) Thromboembolic Disease 9 (3) 4 (2) 12 (5) Vaginal Dryness 5 (2) 3 (1) 2 (1) Weight Gain 4 (2) 10 (4) 30 (12) Post-Marketing Experience. These adverse reactions are reported voluntarily from a population of uncertain size. Therefore, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The following have been reported in post-approval use of Arimidex: Hepatobiliary events including increases in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-GT, and bilirubin; hepatitis Rash including cases of mucocutaneous disorders such as erythema multiforme and Stevens-Johnson syndrome Cases of allergic reactions including angioedema, urticaria and anaphylaxis [see CONTRAINDICATIONS ] Myalgia, trigger finger and hypercalcemia (with or without an increase in parathyroid hormone) QUESTION. Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the co-administration of anastrozole and tamoxifen did not affect the pharmacokinetics of tamoxifen or N-desmethyltamoxifen. At a median follow-up of 33 months, the combination of ARIMIDEX and tamoxifen did not demonstrate any efficacy benefit when compared with tamoxifen in all patients as well as in the hormone receptor-positive subpopulation. This treatment arm was discontinued from the trial [see Clinical Studies ], evista 60 mg antiestrogens evista.
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