A Prospective, Randomized, Placebo-Controlled Study of a Combination of Simvastatin and Chemotherapy in Metastatic Breast Cancer
Table 3
Most common grades 1 to 4 adverse events of chemotherapy and adverse events of special interest to simvastatin.
Adverse events n (%)
Chemotherapy + simvastatin (n = 40)
Chemotherapy + placebo (n = 40)
Grade 1/2
Grade 3/4
Grade 1/2
Grade 3/4
Anemia
34 (85)
8 (20)
32 (80)
8 (20)
Thrombopenia
5 (12.5)
1 (2.5)
4 (10)
2 (5)
Neutropenia
22 (55)
12 (30)
18 (45)
16 (40)
Clinical hemorrhage
—
—
1 (2.5)
—
Injection site reaction
7 (17.5)
—
5 (12.5)
—
Rash
—
—
1 (2.5)
—
Left ventricle function
1 (2.5)
—
—
1 (2.5)
Stomatitis
—
—
1 (2.5)
—
Creatinine elevation
6 (15)
—
5 (12.5)
—
Simvastatin special adverse events
—
ALT elevation
12 (30)
—
13 (32.5)
—
CK elevation
1 (2.5)
—
4 (10)
—
None of the elevated levels of ALT exceed more than 3 times the upper limit of the reference range. None of the elevated levels of CK exceed more than 5 times the upper limit of the reference ranges value >>0.05 for all comparisons
