Safety and efficacy of long-term combination therapy with bezafibrate and ezetimibe in patients with dyslipidemia in the prospective, observational J-COMPATIBLE study

Table 3 Changes in safety parameters

Parameter	n	Baseline	LOCF	p-value
Body mass index (kg/m²)	362	25.49 ± 3.72	25.40 ± 3.77	0.087
Total bilirubin (mg/dL)	292	0.64 ± 0.25	0.58 ± 0.22	<0.001
Creatinine (mg/dL)	449	0.76 ± 0.17	0.78 ± 0.19	<0.001
Blood urea nitrogen (mg/dL)	392	15.30 ± 3.92	16.35 ± 4.84	<0.001
AST (IU/L)	479	30.8 ± 19.7	28.8 ± 15.1	0.007
ALT (IU/L)	479	31.9 ± 28.2	26.8 ± 21.3	<0.001
GGT (IU/L)	451	66.1 ± 96.1	48.4 ± 69.6	<0.001
ALP (IU/L)	309	224.1 ± 87.9	184.7 ± 67.5	<0.001
CPK (mg/dL)	301	127.8 ± 82.9	132.0 ± 95.6	0.416
SBP (mmHg)	489	130.4 ± 13.5	128.6 ± 12.4	0.002
DBP (mmHg)	486	76.0 ± 9.5	74.8 ± 8.8	0.004
HbA1c (%)	308	6.46 ± 1.41	6.39 ± 1.29	0.187

Data are expressed as mean ± standard deviation safety parameters from baseline to LOCF. The paired t test was used to examine the significance of within-group changes. LOCF: last observation carried forward; AST: aspartate aminotransferase; ALT: alanine aminotransferase; GGT: gamma-glutamyl transpeptidase; ALP: alkaline phosphatase; CPK: creatine phosphokinase; SBP: systolic blood pressure; DBP: diastolic blood pressure; HbA1c: glycated hemoglobin.

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