Shioji Keisuke, Izuhara Masayasu, Mitsuoka Hirokazu, Uegaito Takashi, Matsuda Mitsuo
Department of Cardiology, Kishiwada City Hospital, Kishiwada City, Japan.
Cardiovasc Ther. 2014 Jun;32(3):97-104. doi: 10.1111/1755-5922.12066.
The Japan Atherosclerosis Society's 2007 Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases (JAS2007GL) advocate reducing LDL cholesterol (LDL-C) to target levels in patients with dyslipidemia, but achievement rates are frequently unsatisfactory even in the presence of lipid-lowering therapy. This multicenter, open-label, randomized, parallel-group study compared the efficacy of rosuvastatin and atorvastatin on JAS2007GL LDL-C goals in Japanese patients not achieving their target goal with atorvastatin treatment.
The study involved 20 clinical institutes in Japan (Kishiwada Atherosclerosis Prevention Study [KAPS] Group). Patients with category II or III risk of coronary artery disease (CAD), or those with a history of CAD (secondary prevention), who had not achieved their JAS2007GL LDL-C goals during treatment with atorvastatin for at least 4 weeks were switched either to rosuvastatin 5 mg/day (from atorvastatin 10 mg/day) or rosuvastatin 10 mg/day (from atorvastatin 20 mg/day) (n = 75) or continued to receive atorvastatin (n = 77). The primary endpoint was achievement of LDL-C goals at 3 months. The main secondary endpoint was achievement of LDL-C goal + high-sensitivity C-reactive protein level <1.0 mg/L at 3 months.
Achievement rates for the primary endpoint were 49.3% in the rosuvastatin group and 31.7% in the atorvastatin group (P = 0.022). Achievement rates for the main secondary endpoint were 40.0% in the rosuvastatin group and 20.8% in the atorvastatin group (P = 0.010). Rosuvastatin and atorvastatin were both well tolerated in this study.
Rosuvastatin is a useful treatment option for Japanese patients who are not achieving their JAS2007GL LDL-C goal with atorvastatin.
日本动脉粥样硬化协会2007年版动脉粥样硬化性心血管疾病预防指南(JAS2007GL)提倡将血脂异常患者的低密度脂蛋白胆固醇(LDL-C)降至目标水平,但即便采用了降脂治疗,达标率仍常常不尽人意。这项多中心、开放标签、随机、平行组研究比较了瑞舒伐他汀和阿托伐他汀在接受阿托伐他汀治疗未达目标的日本患者中实现JAS2007GL LDL-C目标的疗效。
该研究纳入了日本的20家临床机构(岸和田动脉粥样硬化预防研究[KAPS]组)。冠状动脉疾病(CAD)风险为II或III级的患者,或有CAD病史(二级预防)且在接受阿托伐他汀治疗至少4周期间未达到JAS2007GL LDL-C目标的患者,被换用瑞舒伐他汀5毫克/天(从阿托伐他汀10毫克/天换用)或瑞舒伐他汀10毫克/天(从阿托伐他汀20毫克/天换用)(n = 75),或继续接受阿托伐他汀治疗(n = 77)。主要终点是3个月时达到LDL-C目标。主要次要终点是3个月时达到LDL-C目标且高敏C反应蛋白水平<1.0毫克/升。
瑞舒伐他汀组主要终点的达标率为49.3%,阿托伐他汀组为31.7%(P = 0.022)。主要次要终点的达标率在瑞舒伐他汀组为40.0%,在阿托伐他汀组为20.8%(P = 0.010)。在本研究中,瑞舒伐他汀和阿托伐他汀耐受性均良好。
对于使用阿托伐他汀未达到JAS2007GL LDL-C目标的日本患者,瑞舒伐他汀是一种有效的治疗选择。