2011年9月2日,英国伦敦 在一项少见的2种竞争他汀药物用于冠心病患者的随机对照试验中,瑞舒伐他汀(可定,阿斯利康)和阿托伐他汀(立普妥,辉瑞)治疗2年主要终点——由血管内超声(IVUS)测定的斑块体积百分比(PAV)相似。
September 2, 2011 Steve Stiles
London, UK - In a rare randomized comparison of two competing statins in patients with documented coronary disease, treatment with rosuvastatin (Crestor, AstraZeneca) and with atorvastatin (Lipitor, Pfizer) had similar effects after two years on the trial’s primary end point, percent atheroma volume (PAV) by intravascular ultrasound (IVUS), trial sponsor AstraZeneca said today in a limited announcement for investors [1].
2011年9月2日,英国伦敦 在一项少见的2种竞争他汀药物用于冠心病患者的随机对照试验中,瑞舒伐他汀(可定,阿斯利康)和阿托伐他汀(立普妥,辉瑞)治疗2年主要终点——由血管内超声(IVUS)测定的斑块体积百分比(PAV)相似。
The primary end point in the Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN) targeted a prespecified >40 mm coronary segment. It started enrollment in 2008 and completed it last year , as reported by heartwire , and the company says "further data and analyses will be presented by the study’s academic investigators at the American Heart Association [2011] Scientific Sessions on Tuesday, November 15."
冠状动脉粥样斑块血管内超声研究——瑞舒伐他汀和阿托伐他汀疗效对比(SATURN)试验的主要重点聚焦于>40 mm的冠状动脉段。据heartwire 报道,SATURN试验于2008年纳入患者,去年结束。阿斯利康公司称“详细数据和分析将于2011年11月15日的AHA 2011 科学大会上由该研究的学术研究者发布”。
As stated in a company press release, The PAV results "demonstrated a numerically greater reduction in favor of [rosuvastatin] vs atorvastatin but did not reach statistical significance."
阿斯利康公司在新闻发布会上称,PAV结果“显示瑞舒伐他汀组数字上的降幅大于阿托伐他汀组,但未达统计学差异。”
For a secondary IVUS end point, change from baseline in total atheroma volume (TAV), rosuvastatin demonstrated a statistically significant reduction compared with atorvastatin.
对于次级IVUS终点,即总斑块体积(TAV)较基线的变化,瑞舒伐他汀组降幅显著高于阿托伐他汀组,差异有统计学意义。
The trial will also look at lipid and inflammation biomarkers.
该试验还将观察血脂和炎症标志物。
The 1385 patients in the trial, which wasn’t powered for clinical end points [2], were required to have a clinical indication for coronary angiography or at least one significant coronary lesion by angiography.
该试验纳入1385例有进行冠脉造影临床适应证或造影证实有至少1处显著冠脉病变的患者,样本数不足以评价临床终点。