Abstract 11958: Pitavastatin, but Not Bezafibrate, Decreases Carotic Intima-Media Thickness in Patients With Type IIb Hyperlipidemia (PItavastatin Or bezafibrate interventioN, assEssmEnt of antiarteRiosclerotic effect, PIONEER Study)
Introduction: Clinical management of patients with type IIb hyperlipidemia is important for preventing atherosclerotic cardiovascular diseases, but is difficult as they have both high levels of LDL cholesterol (LDL-C) and triglycerides (TG). In general, statins are effective in lowering LDL-C, while fibrates are effective in lowering TG. However, it has not been concluded which drugs are useful for preventing the development of atherosclerotic plaque in these patients and precautionary warnings for severe myopathy and rhabdomyolysis have been well publicized from the coadministration of statins and fibrates.
Hypothesis: We assessed whether the lipid-lowering therapy with pitavastatin or bezafibrate is more effective on carotid intima-media thickness (CIMT) in patients with type IIb hyperlipidemia.
Methods: The PIONEER Study is a prospective, randomized, open-labeled, two-arm parallel group study with blind end point evaluation conducted at 21 centers in Japan. We randomly enrolled 148 patients with type IIb hyperlipidemia, and 113 patients had evaluable CIMT at baseline and 12 months’ follow-up. Patients were randomly assigned to receive either 2mg/day of pitavastatin or 400mg/day of bezafibrate. The primary end point was the change in mean far wall common CIMT.
Results: LDL-C levels decreased from 154.6±12.3 to 94.9±21.3 mg/dl (-59.9 mg/dl) in the pitavastatin group and from 158.6±16.9 to 135.0±24.2 mg/dl (-23.2 mg/dl) in the bezafibrate group. TG decreased from 211.6±71.1 to 172.7±88.6 mg/dl (-39.7 mg/dl) in the pitavastatin group and from 218.2±72.8 to 121.0±45.9 mg/dl (-97.2 mg/dl) in the bezafibrate group. The change in mean CIMT was -0.007 (95% confidence interval -0.013 to 0.000) mm/year (p=0.04 vs. baseline) in the pitavastatin group, and 0.005 (95% confidence interval -0.003 to 0.013) mm/year (p=0.25 vs. baseline) in the bezafibrate group, respectively. The change in thickness differed significantly between the two groups (p=0.03).
Conclusions: Marked LDL-C reduction with pitavastatin provided superior efficacy for carotid atherosclerosis regression in patients with type IIb hyperlipidemia compared with bezafibrate.
- © 2013 by American Heart Association, Inc.