Packard Chris J, Ford Ian
aCollege of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UKbRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
Curr Opin Lipidol. 2015 Dec;26(6):572-9. doi: 10.1097/MOL.0000000000000230.
Most LDL-lowering trials are limited in duration while the disease process occurs over decades. It is informative, therefore, to evaluate the long-term effects of treatment by undertaking extended observation beyond the formal double-blind phase of intervention studies. The current review brings together the findings of major trials that have conducted such long-term follow-up.
Extended observation of trial cohorts has reinforced the long-term safety of LDL-lowering therapy (with statins and other agents), with no evidence of late development of cancers or other adverse outcomes. Post-trial follow-up reveals also legacy benefits in terms of improved survival (due principally to decreased cardiovascular death rates), and lower hospitalization rates for cardiovascular disease. A number of trials report further risk reduction even after the formal intervention has ceased, and the appearance of delayed benefits such as reduced rate of heart failure.
The perceived value of LDL lowering is enhanced significantly by the legacy benefits that persist after administration of treatment to individuals with established coronary heart disease or to those at high risk of developing disease. Safety, efficacy and the economics of intervention can be judged more fully in light of the knowledge gained from extended observation in clinical trials.
大多数降低低密度脂蛋白（LDL）的试验持续时间有限，而疾病过程会持续数十年。因此，通过在干预研究的正式双盲阶段之后进行长期观察来评估治疗的长期效果是很有意义的。本综述汇集了进行此类长期随访的主要试验结果。
对试验队列的长期观察强化了降低LDL治疗（使用他汀类药物和其他药物）的长期安全性，没有证据表明会出现癌症或其他不良后果的后期发展。试验后的随访还显示，在改善生存率（主要由于心血管死亡率降低）和降低心血管疾病住院率方面存在遗留益处。一些试验报告称，即使在正式干预停止后，风险仍会进一步降低，并且会出现延迟益处，如心力衰竭发生率降低。
对于已患有冠心病的个体或有患冠心病高风险的个体，在给予治疗后持续存在的遗留益处显著提高了降低LDL的可感知价值。根据从临床试验长期观察中获得的知识，可以更全面地判断干预的安全性、有效性和经济性。
