GC Biopharma said Monday that the results of a large-scale big data analysis study on fenofibrate, a treatment for hypertriglyceridemia, have been published in the journal Diabetes, Obesity and Metabolism.

The study, led by Professor Park Cheol-young of Kangbuk Samsung Hospital's department of internal medicine, analyzed data from over 1.46 million Korean patients who were prescribed fenofibrate while taking statins for hypertriglyceridemia between 2010 and 2017. The data was divided into two groups: 413,715 patients who took fenofibrate and an equal number of matched controls who did not.

The analysis found that the fenofibrate group had a 24 percent lower risk of developing end-stage renal disease (ESRD) compared to the control group. 

The renal protective effect was particularly significant in patients with hypertension, proteinuria, or moderate kidney disease (glomerular filtration rate below 60 mL/min/1.73 m²). Among patients with hypertension or proteinuria, fenofibrate reduced the risk of ESRD by 27 percent, while in those with moderate kidney disease, the risk reduction was 50 percent.

“These findings suggest that fenofibrate not only lowers triglycerides and raises HDL cholesterol levels but also provides renal protection through its anti-inflammatory properties,” a GC Biopharma official said.

Previous studies, including the ECLIPSE-REAL study, have shown that combining fenofibrate with statins significantly reduced the risk of major cardiovascular events in patients with metabolic syndrome compared to statins alone. In addition, a study comparing fenofibrate and omega-3 fatty acids in statin-treated patients with high triglycerides found that fenofibrate reduced the risk of major cardiovascular events.

Building on its known cardiovascular benefits, the GC Biopharma official added that this new study highlights fenofibrate's potential to slow the progression of chronic kidney disease (CKD) in statin-treated adults.

The company recently launched the Neofeno tab (fenofibrate 145mg), a product that improves bioavailability, enhancing absorption and allowing administration regardless of meals. 

“East Asians tend to have higher triglyceride levels than Western populations due to genetic factors and traditional carbohydrate-based diets,” the GC Biopharma official said. “High triglyceride levels can lead to additional lipid disorders, so we launched the Neofeno tab to effectively manage hypertriglyceridemia and improve patient convenience by eliminating dietary restrictions.”

Additionally, GC Biopharma has developed a low-dose formulation for patients with impaired renal function and is seeking approval. In the U.S., CKD guidelines recommend adjusting fenofibrate dosage based on glomerular filtration rate, and while low-dose formulations are available in North America, Europe, and Australia, they have not been available in Korea. 

The company official said the upcoming launch of Neofeno tab 48mg formulation is expected to address this gap and provide new treatment options for patients with renal dysfunction.