[약업신문]Rosuzet proves non-inferiority to high-dose statin alone

The results of a domestic study that proved the non-inferiority of a combination of rosuvastatin and ezetimibe compared to a single high-dose statin have been published.

In this study, which was registered in the Lancet, Hanmi Pharm’s combination drug ‘Rosuzet’ for the treatment of dyslipidemia was used as the main drug. The company evaluated that Rosuzet, which is achieving over 100 billion won in prescription sales per year, has entered a new era of leap and innovation as a result of this research.

Also, it is expected to be a catalyst that will completely change the paradigm of dyslipidemia treatment, which was centered on a single high-dose statin.

At a press conference held at the Westin Chosun Hotel on the 8th, Professor Kim Byung-geuk of the Department of Cardiology at Severance Hospital, who led this study, named RACING, said, “A comparison between the statin and ezetimibe combination therapy with reduced dose and the existing high-nutrient statin monotherapy was 1 “There has been no long-term follow-up study for more than a year,” he said. “This large-scale clinical trial is meaningful in that the statin/ezetimibe combination (Rosuzet) has been presented as a useful treatment method as useful as a high-dose statin single drug.” said

Professor Kim said, “The results of this study are significant in that they suggested a new alternative to standard treatment to prevent secondary complications (myocardial infarction or stroke recurrence, etc.) in ASCVD patients. The combination of ezetimibe and the high-dose statin was found to be nearly twice as low as the single drug.”

The RACING study is a large-scale, researcher-led clinical trial conducted for 5 years on 3,70 patients with atherosclerotic cardiovascular disease (ASCVD) at 26 institutions in Korea. Professor Kim Byung-geuk and Hong Seong-jin of the Department of Cardiology at Severance Hospital were named as corresponding authors, and Professor Hong Myung-ki was named as the corresponding author.

From February 2017 to December 2018, 3,780 ASCVD patients recruited from 26 domestic institutions including Severance Hospital, Korea University Anam Hospital, Wonkwang University Hospital, and Gangnam Severance Hospital, ), 1,894 patients in the combination therapy group and 1,886 patients in the high-intensity statin (rosuvastatin 20mg) monotherapy group were randomized and followed up for 3 years.

According to the study results, the incidence of cardiovascular death, major cardiovascular event, or nonfatal stroke at 3 years after administration, the primary endpoint, was 172 patients (9.1%) in the combination therapy group and 186 patients (9.9%) in the monotherapy group. It was confirmed that the combination therapy showed an effect comparable to that of the monotherapy.

The rate of reaching the LDL-C target level (less than 70 mg/dL), a secondary endpoint, was 73% in the combination therapy group and 55% in the monotherapy group at 1 year, with a difference of about 18%. It was found to be significantly higher (absolute difference 17.5%).[95% CI 14.2~20.7])

Then, at 2 and 3 years, the combination therapy group showed 75% and 72%, respectively, and the monotherapy group observed 60% and 58%. group was found to be significantly superior (absolute difference; 14.9% at 2 years).[95% CI 11.6~18.2]14.8% at 3 years[95% CI 11.1~18.4])

The research team also identified the proportion of patients who reached an ‘LDL-C < 55 mg/dL' lower than the target value, which was 42%, 45%, and 42% at 1, 2, and 3 years in the combination therapy group, respectively, compared to the monotherapy group. 25%, 29%, and 25% of the group showed that the combination therapy had a significantly greater LDL-C reduction effect than the monotherapy.

In particular, in this study, the efficacy and safety of the combined administration of rosuvastatin and ezetimibe were confirmed. The proportion of patients who stopped taking the study drug or reduced the dose due to adverse events or statin intolerance was 88 patients (4.8%) in the combination therapy group and 150 patients (8.2%) in the monotherapy group (p<0.0001).

Professor Jang Ya-soo of Cha Medical School, who chaired the meeting, said, “The high-dose statin therapy prescribed to lower LDL-C in ASCVD patients may have to be reduced or stopped due to side effects such as muscle pain, liver damage, and diabetes.” A combination of rosuvastatin and ezetimibe, such as ‘Rosuzet’, is expected to be an effective treatment strategy for patients in need of LDL-C control based on excellent drug compliance.”

Hanmi Pharm, a sponsor of the RACING research, is showing expectations that ‘Rosuzet’ will firmly lay the foundation for a new leap forward with this research as a starting point.

On the same day, President Woo Jong-su of Hanmi Pharm said in his greeting, “The RACING study is a meaningful study that can change the paradigm of dyslipidemia treatment. You can’t tell how much my heart was beating when I first heard that it was published on The Lancet. “I was very proud that Hanmi Pharm sponsored it,” he said.

Meanwhile, Lancet recorded a number of important studies related to COVID-19 in recent years, beating the New England Journal of Medicine (NEJM), which has been ranked first in the Impact Factor (IF) for the past 45 years, for the first time in its history. did. Lancet’s IF evaluated by Clarivate, which publishes an annual journal citation report, was 202.731, far exceeding the NEJM of 176.079.

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