Vascular disease is the leading cause of death in many countries. Statins are usually only given to people who have heart disease and raised blood cholesterol. New findings from the Heart Protection Study (HPS) led by Rory Collins from the University of Oxford's Clinical Trial Service Unit show that statins also reduce the risk of heart attack and stroke in people who have diabetes, arterial disease, or in individuals who have previously had a stroke. Most strikingly, the study found substantial benefits even among those high-risk patients considered to have "normal" or "low" blood cholesterol concentrations. The HPS study provides definite evidence that guidelines should be changed so that a statin is considered for anybody at an increased risk of heart attack or stroke-regardless of their blood cholesterol concentration.
Over 20,000 UK adults (aged 40-80) with coronary disease, other occlusive arterial disease, or diabetes were randomly allocated to receive daily doses of 40 mg simvastatin or placebo for five years. Death from all causes was reduced from 14.7% (for patients given placebo) to 12.9% (for patients given simvastatin), mainly due to an 18% relative reduction in the coronary death rate in patients assigned simvastatin.
There were also relative reductions of around 25% for non-fatal heart attack or coronary death, for non-fatal or fatal stroke, and for coronary or non-coronary revascularisation. Simvastatin was well tolerated with no major side-effects, and its benefits were additional to those of other cardioprotective treatments such as aspirin, - -blockers, and ACE inhibitors.
HPS also assessed the effects of using antioxidant vitamin supplements (600mg vitamin E, 250mg vitamin C and 20mg beta-carotene daily) in people at high risk of vascular disease. Vitamin supplementation did not produce any significant reductions in the five-year risk of heart attack, stroke, cancer, or other major outcomes.
Rory Collins comments: " HPS shows unequivocally that statins can produce substantial benefit in a very much wider range of high-risk people than had been previously thought. These new findings are relevant to the treatment of some hundreds of millions of people worldwide. If now, as a result, an extra 10 million high-risk people were to go onto statin treatment, this would save about 50,000 lives a year-that's a thousand each week. In addition, this would prevent similar numbers of people from suffering non-fatal heart attack or stroke."
Richard Horton, Editor of THE LANCET, comments: "These findings should tear up the rule-book on statin prescribing. They are the most important and far-reaching results for the treatment and prevention of heart disease and stroke that we have seen in a generation. They should result in a dramatic change in clinical practice around the world. Previously there has been concern that statins have been used too much; after the results of HPS have been published there should be concern that they may not be used enough in the future."
In an accompanying Commentary (p 2), Salim Yusuf from McMaster University, Hamilton, Canada, concludes: "The past 25 years have seen the establishment of aspirin, ß-blockers, ACE-inhibitors, and lipid-lowering therapies to prevent the risk of future vascular events by about a quarter each, in high-risk patients. The benefits of each intervention appear to be largely independent, so that when used together in appropriate patients, it is reasonable to expect that about two-thirds to three-quarters of future vascular events could be prevented. Add to this the potential benefits of quitting in smokers (which lowers the risk of myocardial infarction by a half), and blood-pressure lowering (a 10 mm Hg reduction in systolic blood pressure could reduce the risk of vascular events by a quarter) in hypertensive patients, and it may be possible to lower the risk of future events by more than four-fifths in high-risk individuals. Therefore, the potential gains from the combination of currently known preventive strategies are large. Given that over 80% of cardiovascular disease occurs in developing countries, a priority is to make these interventions affordable, accessible, and convenient (perhaps even a combination pill). Ensuring that patients worldwide receive these treatments will lead to substantial clinical and public-health benefits."
** PRESS CONFERENCE ** - The main findings and public-health implications of the HPS study will be presented at 1000 H (UK time) on Thursday 4 July 2002 at the Royal Society of Medicine, London, UK. Further information from Richard Lane, The Lancet Press Office, T) +44 (0)20 7424 4949; E) richard.lane@lancet.com
Contacts: Chris Bray [CTSU] T) +44(0) 1865 404815; E) chris.bray@ctsu.ox.ac.uk
Margaret Willson [CTSU] T) from 29 June-3 July +43 (0) 1 260 69 2010/2011; M) +44 (0) 7973 853347; E) m.willson@mwcommunications.org.uk
Richard Lane (The Lancet), T) +44 (0)20 7424 4949; E) Richard.lane@lancet.com
Jo Hudson (British Heart Foundation) T) +44 (0) 20 7487 7178; E) hudsonj@bhf.org.uk
Professor Salim Yusuf, Population Health Research Institute, McMaster University, Hamilton, Ontario, L8L 2X2, Canada; T) +1 905 527 7327; F) +1 905 521 1166; E) yusufs@mcmaster.ca
Journal
The Lancet