Efficacy and safety of fenofibric acid in combination with a statin in patients with mixed dyslipidemia: Pooled analysis of three phase 3, 12-week randomized, controlled studies

Efficacy and Safety of Rosuvastatin and Fenofibric Acid Combination Therapy versus Simvastatin Monotherapy in Patients with Hypercholesterolemia and Hypertriglyceridemia

“…In the same studies, the incidence of hepatic transaminase elevations with combination treatment was similar to that observed with fenofibric acid monotherapy. [21,35] Consistent with the previous studies of rosuvastatin in combination with fenofibric acid, there was no indication in the current study that any dose of rosuvastatin fenofibric acid was associated with increased muscle-related AEs. The incidence of CK elevations 5-fold or 10-fold greater than ULN were observed only in the rosuvastatin fenofibric acid 20 mg 135 mg group (two of the four incidents were related to drug overdose by the patient) and were consistent with those observed when rosuvastatin 20 mg was coadministered with fenofibric acid in the prior 12-week study.…”

Efficacy and Safety of Fenofibric Acid Co-Administered with Low- or Moderate-Dose Statin in Patients with Mixed Dyslipidemia and Type 2 Diabetes Mellitus

“…Similar to the results observed in the overall population, [16] as well as previous reports with other fibrate and statin combination clinical trials, [17][18][19] smaller mean percentage decreases in LDL-C levels were observed with combination therapy compared with statin monotherapy. This may be interpreted by some clinicians to favor statin monotherapy.…”

“…Fenofibric acid + statin resulted in substantial, simultaneous improvement in multiple lipid apolipoprotein levels. The lipid efficacy was consistent with the integrated analysis of the overall population of patients with mixed dyslipidemia, [16] and was similar across all three trials, consistent with the expected efficacy associated with each statin. [11][12][13] The co-administration of low-dose statin with fenofibric acid resulted in similar LDL-C-lowering efficacy as low-dose statin monotherapy, with substantially greater improvements in HDL-C and TG.…”

“…[16] Specifically, there were no cases of rhabdomyolysis or new or unexpected safety concerns with combination therapy over 12 weeks. Although the duration of exposure to treatment was relatively short in this analysis, longterm (52-week) safety of fenofibric acid + moderate-dose statin combination therapy has been demonstrated in an open-label extension of these patients with mixed dyslipidemia, of which 20% had type 2 diabetes.…”

Effects of Fenofibric Acid on Carotid Intima-Media Thickness in Patients With Mixed Dyslipidemia on Atorvastatin Therapy

“…18 Therefore, the combination of FA with a statin may provide a reduction in cardiovascular events that cannot be achieved by either agent as monotherapy in a high-risk patient population with elevated triglycerides. The FIRST (Evaluation of Choline Fenofibrate (ABT-335) on cIMT in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy) trial is the first controlled prospective study to evaluate the effects of treatment with FA on cIMT progression in patients with hypertriglyceridemia and low HDL-C, whereas LDL-C was controlled on statin therapy (Figure 1).…”