JW Pharmaceutical(JW Pharma) recently announced that its dyslipidemia treatment drug 'Livaro' (ingredient name pitavastatin) suppressed the occurrence of MACE(Major Adverse Cardiovascular Events) in clinical trials targeting human immunodeficiency virus (HIV)-infected patients.

MACE includes diseases such as myocardial infarction, stroke, and heart failure. According to JW Pharma, this clinical trial is the first study to verify the efficacy of pitavastatin in HIV-infected patients, and the study results were published in the August issue of the international academic journal 'New England Journal of Medicine (NEJM).'

A research team led by Professor Stephen Grinspoon of Harvard Medical School conducted clinical trials on 7769 HIV-infected people in 12 countries from March 2015 to July 2019. The research team divided the patients into two groups, administering 4 mg of pitavastatin daily to 3888 patients and a placebo to 3,881 patients in the control group.

As a result, the risk of cardiovascular disease in the pitavastatin-taking group was significantly lower by about 35% than the control group. A total of 136 cases of cardiovascular disease occurred in the control group, but 89 cases occurred in the pitavastatin group. Deaths from cardiovascular disease or other causes occurred in 170 people in the pitavastatin group, less than 216 in the control group.

An official from JW Pharma said, "HIV-infected people have a high risk of developing cardiovascular disease, and drug interactions must be considered when preventing or treating cardiovascular disease." He added, "The research results suggested the possibility of using pitavastatin in combination to prevent cardiovascular disease in HIV-infected people. "It is meaningful" 

Livaro is a dyslipidemia treatment jointly developed by Japanese pharmaceutical companies Kowa and Nissan Chemical. JW Pharma signed an exclusive license agreement for the domestic market in 2003, launched Livaro in 2005 after conducting clinical trials, and launched the improved version of Livarozet in 2021.

By_BK Min, KDFN kdf@kdfnews.com

The summary of this article in Korean is as follows.

■중외제약 `리바로` HIV환자 심혈관 질환 억제 입증

JW중외제약은 인체면역결핍바이러스(HIV) 감염자를 대상으로 한 리바로(성분명 피타바스타틴) 임상에서 심혈관 사건(MACE) 발생 억제를 확인했다고 13일 밝혔다.

이번 임상은 HIV 감염자 대상 피타바스타틴 제제의 약효를 검증한 첫 연구로 국제학술지 뉴 잉글랜드 저널 오브 메디신(NEJM) 8월호에 게재됐다.

미국 하버드의대 스티븐 그린스푼(Steven K. Grinspoon) 교수 연구팀은 12개국 7769명의 HIV 감염자를 대상으로 2015년 3월부터 2019년 7월까지 임상을 진행했다.

연구팀은 환자를 2개 그룹으로 나눠 3888명에게 하루 4㎎의 피타바스타틴을 투여하고 대조군인 3881명에게는 위약을 처방했다.

임상 결과 피타바스타틴 복용군의 심혈관 사건 위험이 위약군보다 35% 유의하게 낮았다. 위약군에서는 총 136명에게 심혈관 사건이 발생했으나 피타바스타틴 복용군에서는 89명에 그쳤다. 심혈관 사건 또는 기타 원인에 의한 사망 발생은 피타바스타틴 복용군에서 170명을 기록해 위약군 216명보다 낮았다.

JW중외제약 관계자는 “이번 연구결과가 HIV 감염자의 심혈관질환 예방을 위해 피타바스타틴 병용 가능성을 시사했다는 점에 의의가 있다”고 말했다.

사진=중외제약

박주범 기자 kdf@kdfnews.com