Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus

Abstract

Objective: The objective of this study was to assess the proportion of patients with type 2 diabetes mellitus (T2DM) attaining individual and combined targets of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), non-HDL-C, and apolipoprotein B (ApoB) after treatment with rosuvastatin (R) + fenofibric acid (FA) compared with corresponding-dose R monotherapy.

Methods: This post hoc analysis evaluated data from the T2DM subset of patients with mixed dyslipidemia (LDL-C ≥130 mg/dL, HDL-C <40/50 mg/dL in men/women, and TG ≥150 mg/dL) from 2 randomized studies. Patients included in the analysis (N = 456) were treated with R (5, 10, or 20 mg), FA 135 mg, or R (5, 10, or 20 mg) + FA 135 mg for 12 weeks. Attainment of LDL-C <100 mg/dL, HDL-C >40/50 mg/dL in men/women, TG <150 mg/dL, non-HDL-C <130 mg/dL, ApoB <90 mg/dL, and the combined targets of these parameters was assessed.

Results: Treatment with R + FA resulted in a significantly higher proportion of patients achieving optimal levels of HDL-C (46.8% vs. 20.8%, P = 0.009 for R 10 mg + FA), TG (60.0% vs. 34.0%, P = 0.02 for R 10 mg + FA; 54.0% vs. 26.4%, P = 0.005 for R 20 mg + FA), non-HDL-C (55.1% vs. 36.4%, P = 0.04 for R 5 mg + FA), ApoB (58.0% vs. 36.4%, P = 0.02 for R 5 mg + FA); and the combined targets of LDL-C, HDL-C, and TG (28.3% vs. 8.3%, P = 0.02 for R 10 mg + FA) and all 5 parameters (26.1% vs. 8.3%, P = 0.03 for R 10 mg + FA) than corresponding-dose R monotherapies.

Conclusions: A significantly greater proportion of T2DM patients achieved individual and combined lipid targets when treated with the combination of R + FA than corresponding-dose R monotherapies.

Trial registration: ClinicalTrials.gov NCT00300482 NCT00463606.

Fig. 1

Patient flowchart. ^aThe R 40 mg group was not included in predefined statistical comparisons. ^bPatients may have been counted for more than one reason for discontinuation. ^cOther reasons for discontinuation included: FA: protocol violation and physician decision; R 5 mg: protocol violation; R 5 mg + FA: error by study coordinator, patient randomized in error, and physician decision; R 10 mg: personal reason, investigator decision, and physician decision; R 10 mg + FA: concomitant illness; and R 20 mg + FA: investigator decision, physician decision, and patient unable to comply with protocol. FA, fenofibric acid 135 mg; R, rosuvastatin (5, 10, or 20 mg)

Fig. 2

a–e. Proportion of T2DM patients achieving individual target of (a) LDL-C <100 mg/dL; (b) HDL-C >40/50 mg/dL in men/women; (c) TG <150 mg/dL; (d) non-HDL-C <130 mg/dL; and (e) ApoB <90 mg/dL at final visit. P-values were obtained using Fisher’s exact test to test for a difference between each rosuvastatin (R) + fenofibric acid (FA) combination-therapy group and the corresponding-dose R monotherapy group. ApoB, apolipoprotein B; FA, fenofibric acid 135 mg; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; R, rosuvastatin (5, 10, or 20 mg); T2DM, type 2 diabetes mellitus; TG, triglycerides

Fig. 3

a–c. Proportion of T2DM patients achieving combined targets of (a) LDL-C and non-HDL-C; (b) LDL-C, HDL-C, and TG; and (c) LDL-C, HDL-C, TG, non-HDL-C, and ApoB. Targets were defined as LDL-C <100 mg/dL, HDL-C >40/50 mg/dL in men/women, TG <150 mg/dL, non-HDL-C <130 mg/dL, and ApoB <90 mg/dL at final visit. ApoB, apolipoprotein B; FA, fenofibric acid 135 mg; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; R, rosuvastatin (5, 10, or 20 mg); T2DM, type 2 diabetes mellitus; TG, triglycerides