Liska Branislav, Khattab Ahmed A, Herrmann Lutz, Abdel-Wahab Mohamed, Westphal Ronja, Tölg Ralph, Geist Volker, Richardt Gert
The Heart and Vascular Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.
Herz. 2008 Jul;33(5):362-7. doi: 10.1007/s00059-008-3084-6. Epub 2008 Sep 5.
Though guidelines emphasize low-density lipoprotein cholesterol (LDL-C) lowering as an essential strategy for cardiovascular risk reduction, achieving target levels may be difficult.
The authors conducted a prospective, controlled, open-label trial examining the effectiveness and safety of high-dose fluvastatin or a standard dosage of simvastatin plus ezetimibe, both with an intensive guideline-oriented cardiac rehabilitation program, in achieving the new ATP III LDL-C targets in patients with proven coronary artery disease. 305 consecutive patients were enrolled in the study. Patients were divided into two groups: the simvastatin (40 mg/d) plus ezetimibe (10 mg/d) and the fluvastatin-only group (80 mg/d). Patients in both study groups received the treatment for 21 days in addition to nonpharmacological measures, including advanced physical, dietary, psychosocial, and educational activities.
After 21 days of treatment, a significant reduction in LDL-C was found in both study groups as compared to the initial values, however, the reduction in LDL-C was significantly stronger in the simvastatin plus ezetimibe group: simvastatin plus ezetimibe treatment decreased LDL-C to a mean level of 57.7 +/- 1.7 mg/ml, while fluvastatin achieved a reduction to 84.1 +/- 2.4 mg/ml (p < 0.001). In the simvastatin plus ezetimibe group, 95% of the patients reached the target level of LDL-C < 100 mg/dl. This percentage was significantly higher than in patients treated with fluvastatin alone (75%; p < 0.001). The greater effectiveness of simvastatin plus ezetimibe was more impressive when considering the optional goal of LDL-C < 70 mg/dl (75% vs. 32%, respectively; p < 0.001). There was no difference in occurrence of adverse events between both groups.
Simvastatin 40 mg/d plus ezetimibe 10 mg/d, on the background of a guideline-oriented standardized intensive cardiac rehabilitation program, can reach 95% effectiveness in achieving challenging goals (LDL < 100 mg/dl) using lipid-lowering medication in patients at high cardiovascular risk.
尽管指南强调降低低密度脂蛋白胆固醇（LDL-C）是降低心血管疾病风险的重要策略，但达到目标水平可能具有挑战性。
作者进行了一项前瞻性、对照、开放标签试验，研究大剂量氟伐他汀或标准剂量辛伐他汀加依折麦布，联合强化的以指南为导向的心脏康复计划，在确诊冠心病患者中实现新的ATP III LDL-C目标的有效性和安全性。连续纳入305例患者。患者分为两组：辛伐他汀（40mg/d）加依折麦布（10mg/d）组和单用氟伐他汀组（80mg/d）。两个研究组的患者除接受包括高级身体、饮食、心理社会和教育活动在内的非药物措施外，均接受治疗21天。
治疗21天后，与初始值相比，两个研究组的LDL-C均显著降低，然而，辛伐他汀加依折麦布组的LDL-C降低更为显著：辛伐他汀加依折麦布治疗使LDL-C平均降至57.7±1.7mg/ml，而氟伐他汀降至84.1±2.4mg/ml（p<0.001）。在辛伐他汀加依折麦布组中，95%的患者达到LDL-C<100mg/dl的目标水平。这一比例显著高于单用氟伐他汀治疗的患者（75%；p<0.001）。考虑LDL-C<70mg/dl的可选目标时，辛伐他汀加依折麦布的更大有效性更为显著（分别为75%对32%；p<0.001）。两组不良事件发生率无差异。
在以指南为导向的标准化强化心脏康复计划背景下，40mg/d辛伐他汀加10mg/d依折麦布，在心血管疾病高风险患者中使用降脂药物实现具有挑战性的目标（LDL<100mg/dl）时，可达到95%的有效性。
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