Table 3.
Adverse events and laboratory variables related to muscle, hepatic, and renal function
| Adverse events and laboratory variables | FA 135 mg (n = 123) | R 5 mg (n = 68) | R 5 mg + FA (n = 73) | R 10 mg (n = 52) | R 10 mg + FA (n = 52) | R 20 mg (n = 53) | R 20 mg + FA (n = 52) |
|---|---|---|---|---|---|---|---|
| Muscle-related | |||||||
| Myalgia, n (%)a | 3 (2.4) | 2 (2.9) | 1 (1.4) | 3 (5.8) | 1 (1.9) | 1 (1.9) | 2 (3.8) |
| CK increased, n (%)a | 4 (3.3) | 0 | 2 (2.7) | 1 (1.9) | 0 | 2 (3.8) | 0 |
| CK >5× ULN, n/N (%) | 0/119 | 0/68 | 0/71 | 0/50 | 1/51 (2.0) | 0/53 | 0/51 |
| CK >10× ULN, n/N (%) | 0/119 | 0/68 | 0/71 | 0/50 | 1/51 (2.0) | 0/53 | 0/51 |
| Hepatic-related | |||||||
| ALT >5× ULN, n/N (%) | 0/119 | 0/68 | 1/71 (1.4) | 0/50 | 0/50 | 0/53 | 0/51 |
| Renal-related | |||||||
| Creatinine increased, n (%)a | 3 (2.4) | 0 | 0 | 0 | 1 (1.9) | 0 | 3 (5.8) |
| Creatinine ≥50% increase from baseline and >ULN, n/N (%) | 12/119 (10.1) | 0/68 | 1/71 (1.4)b | 2/50 (4.0) | 2/50 (4.0) | 0/53 | 2/51 (3.9) |
| Creatinine ≥100% increase from baseline, n/N (%) | 1/119 (0.8) | 0/68 | 0/71 | 0/50 | 0/50 | 0/53 | 0/51 |
| Creatinine >2 mg/dL, n/N (%) | 8/119 (6.7) | 0/68 | 0/71b | 1/50 (2.0) | 2/50 (4.0) | 0/53 | 1/51 (2.0) |
FA fenofibric acid; R rosuvastatin; CK creatine phosphokinase; ULN upper limit of normal; ALT alanine aminotransferase; MedDRA Medical Dictionary for Regulatory Activities.
aMedDRA Version 11.1 preferred term.
b P < 0.05 for comparison between R + FA group and FA monotherapy group using Fisher’s exact text.