Comparing pitavastatin alone to combination therapy with fenofibrate for reducing cholesterol levels

This study compared the effectiveness and safety of pitavastatin (Livalo) alone to combination therapy with fenofibrate (Tricor) for patients with dyslipidemia (high blood fats).

The study showed that combination therapy was more effective in lowering the levels of harmful fats in the blood.

Patients with dyslipidemia have unhealthy levels of fats (lipids) in the blood. High-density lipoprotein cholesterol (HDL-C) is a healthy lipid. Unhealthy fats include low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG). It is necessary to keep LDL and TG-values in a normal range. Dyslipidemia can lead to cardiovascular disease (CVD). This happens due to the buildup of fats in the blood vessels. CVD can lead to a stroke or a heart attack. 

Pitavastatin belongs to the statin-group of drugs. Statins decrease LDL-C levels. Statins are known to cause side effects such as muscle problems, elevated liver enzymes, and even diabetes. In patients with mixed dyslipidemia, statins alone may not be enough. Fenofibrate is another type of drug used to lower blood fat levels. It decreases both TGs and other types of cholesterol. The effectiveness and safety of pitavastatin alone (monotherapy) compared to combination therapy with fenofibrate remain under investigation.

The study included 347 patients with dyslipidemia and high CVD risk. In the beginning, all patients received 2mg pitavastatin for 4-6 weeks. After this period, all patients whose LDL-C was lower than 100mg/dL and TG between 150 to 500 mg/dL were randomly placed in one of two groups. The monotherapy group received 2mg of pitavastatin plus a placebo pill for 8 weeks. The combination group received 2mg of pitavastatin plus 160 mg fenofibrate for 8 weeks. Afterward, all patients with a non-HDL-C value lower than 130 mg/dL received combination therapy for 16 weeks. 

After 8 weeks, non-HDL-C levels reduced significantly more in the combination group (by 12.45%) compared to the monotherapy group. 88.3% of patients in the combination group and 77.98% of patients in the monotherapy group achieved non-HDL-C target levels after 8 weeks.

3.49% in the combination group showed side-effects compared to 1.75% in the monotherapy group. The most common side effects included elevated liver enzymes in both groups, nausea and gastritis in the combination group, and muscle problems in the monotherapy group.

The authors concluded that combination therapy improves blood fat levels more than pitavastatin monotherapy.

The study included Korean patients only. It was also financially supported by the pharmaceutical manufacturer Hanlim Pharmaceuticals Co Ltd.