Long-term follow-up of the randomised Heart Protection Study (HPS), published Online First in the Lancet, shows that the benefits of statin therapy (ie, reductions in heart attacks, strokes, and other vascular disease) increased as statin treatment continued and persisted for several years after treatment had stopped. Furthermore, it provides reassurance that statins are safe, with no emergence of hazards, such as increases in cancer incidence or other non-vascular morbidity or mortality, during an 11 year follow-up period. Thus, patients who are at increased risk of cardiovascular events should consider starting statin treatment promptly and continuing it long-term. The Article is by the Heart Protection Study Collaborative Group, Clinical Trial Service Unit, Oxford, UK.
In HPS, over 20 000 patients at increased risk of vascular disease were randomly allocated either 40 mg simvastatin daily, or placebo, for around 5 years, and analysis of this in-trial period provided clear evidence that lowering LDL (or "bad") cholesterol by around 1 mmol/L reduces the risk of heart attacks, strokes, and other vascular disease by around one quarter. Moreover, the absolute benefits increased as treatment continued during the 5 year period. However, the long-term efficacy and safety of statins continue to be debated.
Therefore, since the end of the randomised trial, all surviving HPS participants were followed-up for a further 6 years, during which time statin use (which was encouraged) and blood cholesterol concentrations were similar in both groups.
There are 2 important findings: firstly, the substantial reductions in fatal and non-fatal heart attacks, strokes, and other vascular disease seen among those participants allocated simvastatin during the 5-year trial period persisted largely unchanged during the post-trial period, despite similar use of statins among the surviving study population. Secondly, during a total 11 year follow-up period, there was no evidence that allocation to simvastatin was associated with any emergence of hazard, with no increase in cancer incidence or non-vascular mortality observed.
The authors conclude: "As well as providing reliable evidence about the long-term benefits of statin therapy, the large numbers of other major health outcomes recorded during prolonged follow-up in HPS provide considerable reassurance—both to prescribers and to patients—about the long-term safety of lowering LDL cholesterol substantially for about 5 years. These findings provide further support for the prompt initiation and long-term continuation of statin treatment in people at increased risk of vascular events."
Richard Bulbulia, one of the study authors, adds*: "The persistence of benefit we observed among participants originally allocated simvastatin during the subsequent 6 year post-trial period is remarkable. In addition, the reliable evidence of safety, with no excess risk of cancer or other major illnesses during over 11 years follow-up, is very reassuring for doctors who prescribe statins and the increasingly large numbers of patients who take them long-term to reduce their risk of vascular disease."
In a linked Comment, Dr Payal Kohli and Dr Christopher P Cannon, TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA, say: "We now have strong evidence from HPS and several other randomised controlled trials that prolonged treatment with statins is indeed efficacious, safe, and has long-lasting beneficial effects, even after discontinuation of therapy. For this reason, concerns should be put to rest and doctors should feel reassured about the long-term safety of this life-saving treatment for patients at increased cardiovascular risk."
Dr Richard Bulbulia, Heart Protection Study Collaborative Group, Clinical Trial Service Unit, University of Oxford, UK. T) 44-7884003439 E) email@example.com
Dr Christopher P Cannon, TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA. Please Contact Holly Brown-Ayers, Media Relations. T) 617-534-1603 E) HBROWN-AYERS@PARTNERS.ORG
Note to editors: *quote direct from Dr Bulbulia not found in text of Article
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