Diabetes and Metabolism Journal

Korean Diabetes Association (대한당뇨병학회)
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Efficacy Evaluation of Atorvastatin in Korean Hyperlipidemic Patients with Type 2 Diabetes Mellitus

당뇨병을 동반한 한국인 고지혈증 환자에서의 atorvastatin의 유효성 평가

Choi, Dong-Seop;Kim, Duk-Kyu;Kim, Doo-Man;Kim, Seong-Yeon;Nam, Moon-Suk;Park, Yong-Soo;Shon, Ho-Sang;Ahn, Chul-Woo;Lee, Kwan-Woo;Lee, Ki-Up;Lee, Moon-Kyu;Chung, Choon-Hee;Cha, Bong-Yeon
최동섭;김덕규;김두만;김성연;남문석;박용수;손호상;안철우;이관우;이기업;이문규;정춘희;차봉연

  • Published : 2006.07.31
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Abstract

Background: NCEP ATP III Guideline recommends aggressive treatments of diabetic dyslipidemia, recognizing diabetes mellitus as CHD risk equivalents. This study was conducted to evaluate the effectiveness and safety of atorvastatin in hyperlipidemic patients with Type 2 diabetes mellitus through post-marketing drug use investigation of atorvastatin. Methods: An open, multi-center, non-comparison, titrated dosage study was conducted in hyperlipidemic patients, who were treated with atorvastatin at first visiting hospitals from Mar. 2004 to Sep. 2004. 96 endocrinologists participated from 66 centers in this study. Total 2,182 hyperlipidemic patients were enrolled and 1,514 patients among them were accompanied by diabetes mellitus. Efficacy was evaluated at later than 4-week treatment by % change of total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from baseline. Percent of patients reaching LDL-cholesterol level less than 100 mg/dL was also analyzed. The adverse events incidence and abnormalities of clinical laboratory values were evaluated for safety monitoring. Results: Total cholesterol, triglycerides, and LDL-cholesterol level were reduced by 26.6%, 12.0%, and 34.8%, respectively, in diabetic hyperlipidemic patients after atorvastatin treatment. The patients with LDL-cholesterol level of less than 100 mg/dL were increased from 2.8% to 52.6%. Atorvastatin was considered to be safe because adverse drug reactions were reported in 32 patients (1.5%) of total 2,182 patients. Conclusion: Atorvastatin was effective and safe in hyperlipidemic patients with type 2 diabetes mellitus.

연구배경: NCEP ATP III 가이드라인에 의하면 당뇨병을 관상동맥질환 위험인자로 분류하여, 당뇨병을 동반한 고지혈증 환자의 적극적 치료를 권장하고 있다. 이에 시판 후 조사를 통해 당뇨병을 동반한 고지혈증 환자에서의 atorvastatin의 유효성과 안전성을 평가하기 위해 본 연구를 시행하였다. 방법: 2004년 3월부터 2004년 9월까지 내분비내과를 방문한 고지혈증 환자 중 atorvastatin을 처음 투여 받은 환자를 대상으로 개방표지, 다기관, 비비교, 가변용량 연구를 실시하였다. 전국 66개 병원에서 96명의 내분비 전문의가 본 연구에 참여하였다. 총 2,182명의 환자가 등록되었으며, 이 중 당뇨병을 동반한 환자는 1,514명이었다. 유효성 평가는 atorvastatin을 4주 이상 복용하고, 기초 및 4주 이후에 총콜레스테롤 수치가 측정된 환자를 대상으로 이루어졌고, 안전성 평가는 atorvastatin을 1회 이상 투여한 모든 환자를 대상으로 이루어졌다. 연구자들은 환자 등록 시점에 당뇨병 동반 여부를 확인하였다. Atorvastatin을 최소 4주 이상 투여한 후, 총콜레스테롤, 중성지방, 고밀도지단백 및 저밀도지단백 콜레스테롤을 측정하도록 하였으며, 투여 전후의 각 수치의 변화율로부터 유효성을 평가하였다. 저밀도지단백 콜레스테롤의 치료목표인 100 mg/dL 미만을 달성한 환자의 비율도 분석하였다. 또한 이상반응 발현 여부 및 임상검사치의 이상 여부로부터 안전성을 평가하였다. 결과: Atorvastatin 투여 후 당뇨병성 고지혈증 환자에서 총콜레스테롤, 중성지방, 저밀도지단백 콜레스테롤의 수치가 각각 26.6%, 12.0%, 34.8%의 높은 감소율을 나타냈으며, 100 mg/dL 미만의 저밀도지단백콜레스테롤을 가진 환자도 2.8%에서 52.6%로 크게 증가하였다. 총 2,182명의 환자 중에서 32명의 환자가 이상약물반응을 보고하여 1.5%의 발현율을 보였으며 매우 안전한 것으로 생각되었다. 결론: Atorvastatin은 시판 후 의료환경에서 당뇨병성 고지혈증 환자의 지질저하를 안전하고 효과적으로 유도하였으며, 이러한 효과는 당뇨병을 동반하지 않은 환자에서도 비슷하게 나타남을 알 수 있었다.

Keywords

References

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