Chris J Packard1, Ian Ford. 1. aCollege of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UKbRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
Abstract
PURPOSE OF REVIEW: 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. RECENT FINDINGS: 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. SUMMARY: 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.
PURPOSE OF REVIEW: 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. RECENT FINDINGS: 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. SUMMARY: 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.
Authors: Chris J Packard; Robin Young; Kevin Ross; Ian Ford; Baishali M Ambegaonkar; Philippe Brudi; Colin McCowan Journal: Eur Heart J Qual Care Clin Outcomes Date: 2017-10-01
Authors: Agnish Nayak; Andrew Hayen; Lin Zhu; Kevin McGeechan; Paul Glasziou; Les Irwig; Jenny Doust; Gabriel Gregory; Katy Bell Journal: BMJ Open Date: 2018-10-04 Impact factor: 2.692