Anastrozole (Page 3 of 9)
Second-Line Therapy
Anastrozole was tolerated in two controlled clinical trials (i.e., Trials 0004 and 0005), with less than 3.3% of the anastrozole-treated patients and 4.0% of the megestrol acetate-treated patients withdrawing due to an adverse reaction.
The principal adverse reaction more common with anastrozole 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:
Adverse Reaction | Anastrozole | Anastrozole | Megesterol Acetate | |||
---|---|---|---|---|---|---|
1 mg | 10 mg | 160 mg | ||||
(N=262) | (N=246) | (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) |
Other less frequent (2% to 5%) adverse reactions reported in patients receiving anastrozole 1 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
Cardiovascular: Hypertension; thrombophlebitis
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 0.5 mmol/L among patients receiving anastrozole. Increases in LDL cholesterol have been shown to contribute to these changes.
Musculoskeletal: Myalgia; arthralgia; pathological fracture
Nervous: Somnolence; confusion; insomnia; anxiety; nervousness
Respiratory: Sinusitis; bronchitis; rhinitis
Skin and Appendages: Hair thinning (alopecia); pruritus
Urogenital: Urinary tract infection; breast pain
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.
Anastrozole | Anastrozole | Megestrol Acetate | ||||
---|---|---|---|---|---|---|
1 mg | 10 mg | 160 mg | ||||
(n=262) | (n=246) | (n=253) | ||||
Adverse Reaction Group | 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) |
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