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비알코올성 지방간 치료제 Oltipraz, 미국 의학전문저널 게재 기사(2014 보스톤 간학회 임상발표 내용)HIT : 558,010



(주)파마킹이 현재 임상 3상 진행 중인 비알코올성 지방간 치료신약 Oltipraz(PMK-N01GI1)에 대한 임상 발표가 지난  11 9, 미국 보스턴에서 있었던 2014 간학회(The Liver Meeting 2014)에서 진행되었습니다.


이번 Oltipraz 발표 내용은 의학 분야의 전문가들에게 큰 주목을 받으며 미국의 의학 전문 저널 Healio.com에 게재되었습니다. Healio.com은 여러 전문 분야의 임상 정보 등 다양한 의학전문 콘텐츠를 제공하는 저널입니다.


이번 발표는 올티프라즈 임상을 진행하고 있는 서울대 보라매 병원 김원 교수가 진행하였으며, 그 동안의 다기관, 이중 맹검 2상 연구를 시행한 결과를 토대로 비알코올성 지방간 질환에 특별한 부작용 없이 간 지방과 신체질량지수 등을 감소시키는 올티의 효능과 안전성 등에 대해 자세한 발표가 이루어졌습니다.


아래 링크를 통해 접속하시면 이번 보스톤 간회의에 대해 보다 상세한 내용을 확인하실 수 있습니다.







Oltipraz safely, effectively reduced liver fat, BMI in patients with NAFLD

“Oltipraz is a synthetic dithiolethione and functions as an antisteatotic agent against NAFLD by inhibiting the activity of liver X receptor alpha,” Won Kim, MD, department of internal medicine and Liver Research Institute, Seoul National University Boramae Medical Center, said in a presentation. “The aim of this study was to evaluate the efficacy and safety of oltipraz for reducing liver fat in subjects with NAFLD.”

Kim and colleagues performed a multicenter, double-blind phase 2 study of patients with greater than 20% liver fat content and elevated aminotransferase levels. Participants were randomly assigned to receive placebo (n=22), or oltipraz 30 mg (n=22) or 60 mg (n=24) twice daily for a 24 week treatment period. Change in liver fat content through the study period was measured by magnetic resonance spectroscopy, and changes in BMI, liver enzymes, lipids, insulin resistance, cytokines, and NAFLD fibrosis and activity scores were also measured.

Absolute reductions in liver fat content corresponded to oltipraz dose, with –3.21%±11.09% in the placebo group, –7.65%±6.98% in the 30 mg group and –13.91%±10.65% in the 60 mg group. The percentage of reductions in liver fat, BMI and fibrosis scores were also significantly greater in the 60 mg group compared with placebo. Adverse event incidence was similar throughout groups.

“In conclusion, 24-week oltipraz treatment was well tolerated and significantly reduced liver fat amount and BMI without worsening of liver fibrosis in patients with NAFLD,” Kim said.

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Kim W. Abstract 55. Presented at: The Liver Meeting, Nov. 7-11, 2014; Boston, MA.

Disclosure: Kim reports financial ties to PharmaKing.