Table 4. Proportions of patients with abnormal laboratory values by study group.
Laboratory test | Definition of abnormal value | Combination % (n) |
Fenofibrate % (n) |
Ezetimibe % (n) |
|
---|---|---|---|---|---|
Red blood cell count | Lower than the minimum of the standard range | Week 0 Last visit |
7.4 (7/94) 14.3 (14/98) |
7.7 (3/39) 26.7 (12/45) |
5.1 (2/39) 6.4 (3/47) |
Hemoglobin | Lower than the minimum of the standard range§ | Week 0 Last visit |
8.4 (8/95) 14.3 (14/98) |
2.5 (1/40) 20.0 (9/45) |
5.1 (2/39) 6.4 (3/47) |
Serum CPK | Higher than 2.5 times the maximum of the standard range | Week 0 Last visit |
1.0 (1/96) 0.0 (0/97) |
0.0 (0/41) 0.0 (0/45) |
0.0 (0/42) 0.0 (0/45) |
Serum uric acid | Higher than the maximum of the standard range | Week 0 Last visit |
19.0 (19/100) 11.0 (11/100) |
25.0 (11/44) 8.3 (4/48) |
23.3 (10/43) 25.0 (12/48) |
Serum creatinine | Higher than 1.5 times the maximum of the standard range | Week 0 Last visit |
0.0 (0/100) 1.0 (1/100) |
0.0 (0/44) 0.0 (0/48) |
0.0 (0/43) 4.2 (2/48) |
Values in parentheses are number of patients with abnormal value as denominator and total number of patients at the specified time as numerator.
The values for the last visit were based on the most recent visit during the treatment period (weeks 4, 8, 12, 24 or 52 or at the time of discontinuation).
In this study, abnormal hemoglobin findings were defined as “2 g/dL above the upper limit of the reference range,” and 0% of patients in any of the three groups met that definition either at week 0 or at the last visit. However, a number of patients showed hemoglobin levels lower than the standard reference range. Those findings have been included here for reference.
CPK, creatine phosphokinase