Raggi Paolo, Davidson Michael, Callister Tracy Q, Welty Francine K, Bachmann Gloria A, Hecht Harvey, Rumberger John A
Tulane University Health Sciences Center, New Orleans, LA 70112-2699, USA.
Circulation. 2005 Jul 26;112(4):563-71. doi: 10.1161/CIRCULATIONAHA.104.512681. Epub 2005 Jul 11.
Women have been underrepresented in statin trials, and few data exist on the effectiveness and safety of statins in this gender. We used sequential electron-beam tomography (EBT) scanning to quantify changes in coronary artery calcium (CAC) as a measure of atherosclerosis burden in patients treated with statins.
In a double-blind, multicenter trial, we randomized 615 hyperlipidemic, postmenopausal women to intensive (atorvastatin 80 mg/d) and moderate (pravastatin 40 mg/d) lipid-lowering therapy. Patients also submitted to 2 EBT scans at a 12-month interval (mean interval 344+/-55 days) to measure percent change in total and single-artery calcium volume score (CVS) from baseline. Of the 615 randomized women, 475 completed the study. Mean+/-SD percent LDL reductions were 46.6%+/-19.9% and 24.5%+/-18.5 in the intensive and moderate treatment arms, respectively (P<0.0001), and National Cholesterol Education Program Adult Treatment Panel III LDL goal was reached in 85.3% and 58.8% of women, respectively (P<0.0001). The total CVS% change was similar in the 2 treatment groups (median 15.1% and 14.3%, respectively; P=NS), and single-artery CVS% changes and absolute changes were also similar (P=NS). In both arms, there was a trend toward a greater CVS progression in patients with prior cardiovascular disease, diabetes mellitus, and hypertension, whereas hormone replacement therapy had no effect on progression.
In postmenopausal women, intensive statin therapy for 1 year caused a greater LDL reduction than moderate therapy but did not result in less progression of coronary calcification. The limitations of this study (too short a follow-up period and the absence of a placebo group) precluded determination of whether progression of CVS was slowed in both arms or neither arm compared with the natural history of the disease.
他汀类药物试验中女性参与者比例过低，关于他汀类药物在该性别群体中的有效性和安全性的数据很少。我们使用连续电子束断层扫描（EBT）来量化冠状动脉钙化（CAC）的变化，以此作为他汀类药物治疗患者动脉粥样硬化负担的一项指标。
在一项双盲、多中心试验中，我们将615名血脂异常的绝经后女性随机分为强化降脂治疗组（阿托伐他汀80毫克/天）和中度降脂治疗组（普伐他汀40毫克/天）。患者还需每隔12个月（平均间隔344±55天）接受两次EBT扫描，以测量总钙体积分数（CVS）和单动脉钙体积分数相对于基线的变化百分比。在615名随机分组的女性中，475名完成了研究。强化治疗组和中度治疗组的低密度脂蛋白（LDL）平均降低百分比±标准差分别为46.6%±19.9%和24.5%±18.5%（P<0.0001），分别有85.3%和58.8%的女性达到了美国国家胆固醇教育计划成人治疗小组第三次报告（National Cholesterol Education Program Adult Treatment Panel III）的LDL目标（P<0.0001）。两个治疗组的总CVS变化百分比相似（中位数分别为15.1%和14.3%；P=无显著差异），单动脉CVS变化百分比和绝对变化也相似（P=无显著差异）。在两组中，既往有心血管疾病、糖尿病和高血压的患者中，CVS进展有增加的趋势，而激素替代疗法对进展无影响。
在绝经后女性中，强化他汀类药物治疗1年比中度治疗能使LDL降低更多，但并未使冠状动脉钙化进展减缓。本研究的局限性（随访期过短且无安慰剂组）妨碍了确定与疾病自然病程相比，两组中CVS进展是都减缓了还是都未减缓。
