Hanmi Pharmaceutical said Monday that it has published the results of phase 4 clinical trial of Rovelito, an anti-hypertension and dyslipidemia treatment, in an international journal.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
The drug is the only compound therapy in Korea that combines Irbesartan, a hypertension treatment, and Atorvastatin, a dyslipidemic therapy. It is also the first treatment that Hanmi and Sanofi-Aventis have collaborated from product development to launch and marketing.
The study, led by Professor Kim Cheol-ho of the Department of Cardiology at Seoul National University Hospital, administered the drug on 931 patients aged 19 or older, who previously received treatment for anti-hypertension and dyslipidemia or has recently been diagnosed with the disease at 74 medical institutions for 12 weeks.
The team then analyzed the research to confirm if the patients reached their target value for blood pressure and low-density lipoprotein cholesterol (LDL-C). As a result, about 86 percent of patients treated with Rovelito reached target blood pressure and LDL-C levels. The patients, who achieved their target, had a systolic blood pressure of 7.03 mmHg, and diastolic blood pressure was 4.40 mmHg, respectively, while patients who reached the LDL-C target level had an LDL-C reduction of 15.56 mg/dL.
Also, the concurrent rate patients that reached their blood pressure and LDL-C target was 75 percent.
“The company is pleased with the clinical results of Rovelito being published in a prestigious international journal,” said Park Myung-hee, executive director of Hanmi Pharmaceutical. “Hanmi Pharmaceutical will continue to promote the effectiveness of Korean compound drugs through evidence-based marketing.”
The results of the research were published in the Drug, Design, Development and Therapy.