Hanmi’s Rosuzet ‘excellent in managing LDL-C in stent insertion patients’

Hanmi Pharm's Rosuz, a new combination drug treating dyslipidemia, has shown greater clinical usefulness than high-intensity statin monotherapy in a series of studies published in international journals.

Hanmi said Thursday that “eClinicalMedicine,” a sister publication of the international medical journal The Lancet, recently published the results of the third sub-analysis of Rosuzet’s lacing study.

After the result of the massive “lacing study” using Rosuzet was published in the Lancet in July 2022, its first and second sub-analysis results were published in the European Heart Journal and the Journal of the American College of Cardiology.

The latest and third sub-analysis was conducted by Professors Hong Beom-ki, Kim Joong-seon, and Lee Seung-joon of the Severance Hospital’s Cardiology Department and Professor Park Jong-il of the Circulatory Medicine Department at Yeungnam University Medical Center.

The results showed that among patients undergoing stenting (percutaneous coronary intervention, or PCI), Rosuzet showed no difference in cardiovascular events compared with high-intensity statin monotherapy and better LDL-C goal attainment and tolerability.

The study compared 2,467, or 67 percent of the total 3,780 patients, who underwent PCI in the lacing study randomized to receive a single high-intensity statin vs. rosuvastatin 10/10 mg (a medium intensity statin plus ezetimibe), with a three-year follow-up for the following outcomes; cardiovascular death, major cardiovascular events, stroke occurrence, target LDL-C attainment, and rates of drug discontinuation or dose reduction due to adverse events or intolerance.

Rosuvastatin 10/10 mg achieved a greater LDL-C lowering effect than rosuvastatin 20 mg (mean LDL-C from baseline to Year 3: Rosuvastatin 10/10 mg; 77 mg/dL to 58 mg/dL, rosuvastatin 20 mg; 76 mg/dL to 65 mg/dL), and there was no difference in the incidence of cardiovascular death, stroke, or cardiovascular events over three years of clinical follow-up.

Notably, the rate of drug discontinuation and reduction due to adverse events or intolerance was 4.2 percent in the rosuvastatin 10/10 mg arm, confirming superior tolerability compared to the rosuvastatin 20 mg arm (7.6 percent) (p=0.001).

“Patients who undergo PCI are at high risk, and statin therapy to prevent secondary cardiovascular events is critical,” said Professor Hong, the study’s corresponding author. “We confirmed no significant difference in secondary cardiovascular events between rosuvastatin 10/10 mg and rosuvastatin 20 mg, a high-intensity statin, providing further support for a new paradigm in treating dyslipidemia.”

Professor Park, the lead author, said, “By demonstrating superior LDL cholesterol goal attainment with fewer side effects in patients undergoing PCI, Rosujet could be an effective alternative to high-intensity statin monotherapy.”

Rosuzet, a treatment for dyslipidemia developed by Hanmi Pharm, achieved outpatient prescription sales of 149.8 billion won ($113.4 million) last year, according to UBIST.