Hanmi Pharmaceutical announced on the 25th that the results of the third sub-analysis of the Rosujet race study were recently published in ‘eClinicalMedicine (IF 17.033)’, the sister journal of the world-renowned international academic journal The Lancet.
This sub-analysis was led by Professor Beomki Hong, Jungseon Kim, and Seungjun Lee, who are members of the Department of Cardiology at Dismissal Hospital, Yonsei University, and Professor Jongil Park, Department of Cardiology, Yeungnam University Hospital.
In the study, among patients who underwent ‘stent implantation (percutaneous coronary interventionㆍPCI)’, there was no difference in the incidence of cardiovascular events in the Rosuzet group compared to the high-intensity statin single drug group , reaching low density cholesterol. (LDL-C) goals and tolerance showed better results.
The research team randomized 2467 patients (67% of all patients) who underwent PCI out of 3780 patients in the study into a high-intensity ‘single agent statin’ administration group and a ‘Rosuzet 10/10mg (high-intensity statin) administration group medium + ezetimibe). ■ 3-year follow-up outcomes were compared and analyzed for cardiovascular death, major cardiovascular events, stroke, rate of reaching LDL-C target, rate of discontinuation or dose reduction due to side effects or intolerance.
As a result, when Rosuzet was administered, a more excellent LDL-C lowering effect was shown than when ‘Rosuvastatin 20mg’ was administered, a high-intensity statin (baseline → 3rd year average LDL-C value Rosuzet 10/10mg 77 ㎎ /dL→58㎎/dl , rosuvastatin 20㎎ 76㎎/dL→65㎎/dL), there was no difference between the two groups in the rates of cardiovascular death, stroke, and cardiovascular events after 3 years of clinical follow-up .
In particular, the rate of discontinuation and reduction of the drug due to side effects or intolerance was 4.2% in the Rosuzet 10/10mg group, which Hanmi Pharm explains is that it shows a higher tolerance compared to the Rosuvastatin group 20mg (7.6%).
Professor Beomki Hong said, “Patients who have undergone PCI are a high-risk group, and statin treatment to prevent secondary cardiovascular events is very important.” “The fact that there was no significant difference in the number of secondary cardiovascular events was confirmed. provide another basis for supporting the new paradigm of dyslipidemia treatment.”
Professor Jong-Il Park said, “Rosuzet, which has been proven to achieve excellent LDL cholesterol goals while reducing side effects in patients who have undergone PCI, may be an effective alternative to high-intensity statin monotherapy.”
Meanwhile, this racing research sub-analysis listing is Rosuzet’s 10th research result. In the case of a large-scale clinical race study using Rosujet, the results of the first and second sub-analyses have been published in the European Heart Journal and the Journal of the American College of Cardiology, respectively, since that. was published in The Lancet in July last year.
