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Observational Study
. 2013 Nov 6:12:163.
doi: 10.1186/1475-2840-12-163.

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

Tamio Teramoto  1 , Kazunori Abe, Takehiko Taneyama
Affiliations
Observational Study

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

Tamio Teramoto et al. Cardiovasc Diabetol. .

Abstract

Background: There are numerous reports describing the efficacy of fenofibrate in combination with ezetimibe for treating dyslipidemia. In contrast, a study combining bezafibrate and ezetimibe has not yet been conducted. In this study, we examined the safety, including the risk of gallstone formation, and the efficacy of long-term combination therapy with bezafibrate and ezetimibe for treating dyslipidemia.

Methods: Dyslipidemic patients treated with 400 mg/day bezafibrate in combination with 10 mg/day ezetimibe for the first time were eligible. We selected 157 institutions in Japan and conducted a 12-month prospective observational study, with patients enrolled on the day they started combination therapy. Safety of the combination was examined in terms of the type, onset, and severity of adverse drug reactions (ADRs). Efficacy was evaluated in terms of the changes in low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), triglyceride (TG), and non-HDL cholesterol (non-HDL-C) levels from the start of combination therapy (baseline) to the last observation carried forward (LOCF). Lipid levels were assessed at 1, 3, 6, and 12 months after starting combination therapy.

Results: We enrolled 665 patients in this observational study. Safety was evaluated in 659, and ADRs occurred in 42 patients (6.4%). The most frequent ADRs were blood creatine phosphokinase increase (1.5%) and myalgia (0.8%). Asymptomatic gallstones were observed in four patients (0.6%). Effectiveness was evaluated in 622 patients. LDL-C, HDL-C, TG, and non-HDL-C levels improved significantly from baseline to LOCF by -17.4%, 8.8%, -40.5%, and -21.6%, respectively (all, p < 0.001). Lipid levels also improved from baseline to each evaluation time-point.

Conclusions: Bezafibrate in combination with ezetimibe is safe and effective, and is potentially useful for comprehensive management of dyslipidemia.

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Figures

Figure 1
Figure 1
Changes in LDL-C, HDL-C, TG, and non-HDL-C levels from baseline to the LOCF. Data are expressed as mean ± standard deviation. The paired t test was used to examine the significance of within-group changes from baseline to the last observation carried forward (LOCF). *** p < 0.001. LDL-C levels were estimated using the Friedewald formula.
See this image and copyright information in PMC

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