Hanmi Pharmaceutical's dyslipidemia treatment combination drug Rosuzet (rosuvastatin+ezetimibe) has demonstrated LDL-C reduction efficacy and safety in patients with dyslipidemia accompanied by rheumatoid arthritis, underscoring the need for initial combination therapy with rosuvastatin and ezetimibe.

This study was a multicenter, open-label clinical trial conducted jointly by four university hospitals in Korea, with a total of 281 patients diagnosed with rheumatoid arthritis (RA) or osteoarthritis (OA) enrolled. Of these, 250 patients (143 with RA and 107 with OA) who received Rosuzet 10/5 mg were included in the final analysis.

RA patients have a higher risk of cardiovascular disease than the general population, making lipid management important. However, the clear relationship between inflammation, lipid levels, and cardiovascular disease risk has not been established, making it challenging to develop effective treatment strategies.

This study evaluated the efficacy and safety of rosuvastatin as initial therapy in patients with dyslipidemia and concomitant RA or OA. The results showed consistent LDL-C lowering effects and favorable safety in the RA patient group, and these findings were published in the July 2025 issue of the international academic journal, “Medicine.”

The primary endpoint of the study was the proportion of patients achieving a 50 percent or greater reduction in LDL-C levels from baseline. The results showed 79.7 percent in the RA patient group and 70.1 percent in the OA patient group. Although there was no statistically significant difference between the two groups, the RA patient group showed a trend toward higher target achievement rates (p=0.1086).

The rate of achieving multiple lipid goals (TC < 200 mg/dL, LDL-C < 70 mg/dL, TG < 150 mg/dL) was 49.7 percent in the RA patient group and 30.8 percent in the OA patient group, with a statistically significant difference in favor of the RA patient group (p=0.0043). The incidence rates of major cardiovascular events, death, new-onset diabetes, rhabdomyolysis, significant elevations in liver enzymes, and increased creatinine levels were very low, and there were no significant differences between the two patient groups.

Analysis of factors associated with LDL-C reduction in the RA patient group revealed that only baseline LDL-C levels showed a significant independent correlation with LDL-C reduction (β = 0.7009, 95 percent CI 0.5113–0.8905, p < 0.001). Additionally, other factors such as inflammatory markers (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]), disease activity (DAS28-ESR), and daily glucocorticoid usage showed no significant association with LDL-C reduction.

“To reduce the risk of cardiovascular disease in patients with rheumatoid arthritis, it is necessary to actively treat traditional risk factors in addition to controlling inflammation,” said Professor Kim Hyun-sook of the Department of Rheumatology at Soon Chun Hyang University Hospital Seoul. “This study is the first clinical evidence confirming that Rosuzet maintains its lipid-lowering efficacy and can be used safely in inflammatory diseases such as rheumatoid arthritis, laying an important foundation for future studies in this area.”

Park Myeong-hee, head of the Domestic Business Division at Hanmi Pharmaceutical, said, “Rosuvastatin has demonstrated excellent LDL-C control efficacy and safety through a total of 17 SCIE-indexed papers, including this study. We will continue to conduct evidence-based research targeting diverse patient populations.”

Hanmi Pharmaceutical's Rosuzet recorded 110.3 billion won ($79.3 million) in outpatient prescription sales (as per the UBIST standard) in the first half of 2025.