GENEVA (29 August 2021) – A combination therapy of aspirin, statins and at least two blood pressure medications given in fixed doses can slash the risk of fatal cardiovascular disease (CVD) by more than half, says an international study involving researchers from the World Heart Federation and published today in The Lancet.
The fixed-dose combination (FDC) therapies were examined both with and without aspirin versus control groups in a combined analysis of more than 18,000 patients without prior CVD from three large clinical trials. FDCs including aspirin cut the risk of heart attacks by 53 per cent, stroke by 51 per cent, and deaths from cardiovascular causes by about 49 per cent.
The researchers report approximately 19 million people worldwide die of CVD and twice as many experience heart attacks or strokes every year. About 80 per cent of cardiovascular events occur in individuals without a prior history of such illness, meaning effective preventative strategies including medications in people without CVD are essential if we are to prevent the majority of heart attacks, strokes and related deaths in the world.
“This combination, either given separately or combined as a polypill, substantially reduces fatal and non-fatal CVD events,” said lead author Phil Joseph, Associate Professor of Medicine at McMaster University and an investigator at the Population Health Research Institute, at McMaster and Hamilton Health Sciences in Hamilton, Canada. “The largest effects are seen with treatments that include blood pressure lowering agents, a statin and aspirin together, which can reduce fatal and non-fatal cardiovascular events by about half. The benefits of fixed-dose combination therapy are consistent at different blood pressure levels, cholesterol levels and with or without diabetes, but larger benefits may occur in older populations.”
Prof Joseph is the lead author of the meta-analysis study by the Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences, with more than 18 investigators from 13 countries, which was led by Professor Salim Yusuf, Executive Director of PHRI, Distinguished Professor at McMaster University and Past President of the World Heart Federation. The study included participants from 26 countries across five continents.
Today the study was published by The Lancet, and concurrently presented to the European Society of Cardiology Congress.
“These results are huge, and its wide use can avoid between 5 and 10 million individuals experiencing a stroke, heart attack or dying from these conditions yearly. I could see a future with development of a stronger polypill where we could see a lowering of cardiovascular disease by 70 per cent around the world and leading to even greater benefits,” said Prof Yusuf. “Given that all the components of the polypill are generic and low-cost, polypills can be provided to people at modest costs and are likely to be very cost effective.”
FDC treatment strategies trialed by the researchers were previously thought to substantially reduce CVD events and are called ‘polypills’ when used in a single-tablet drug formula.
The concept of a combination pill was first proposed 20 years ago as a strategy to substantially reduce CVD in both secondary prevention and at the population level.
Early trials demonstrated improved patient adherence to treatment regimens and better risk control with a strategy including the inexpensive and safe polypill, compared to the use of single drugs, usual care, or placebos.
Researchers gleaned their findings from combining data from three big studies on a total of 18,000 people followed for about five years – these included the International Polycap Study (TIPS)-3, the Heart Outcomes Prevention Evaluation (HOPE)-3 study and the PolyIran trial.
“The World Heart Federation (WHF) is committed to promoting cardiovascular health to everyone by reducing the CVD burden worldwide – in both developed and developing countries,” said Professor Fausto Pinto, President of the World Heart Federation. “The demonstration that a low-cost approach using fixed dose combinations can reduce CVD by about 50% is extraordinary and represents a huge opportunity to tackle CVD globally with a major potential impact on people’s lives. WHF has been a supporter of the use of the polypill for the last decade and these results provide robust evidence to strengthen our global advocacy strategy.”
The study was funded by the Public Health Research Institute (PHRI). In addition to WHF Past President Prof Salim Yusuf, the co-authors of the study include Immediate Past President Prof Karen Sliwa, Past President Prof Valentin Fuster, and current Chair of the WHF Science Committee Prof Dorairaj Prabhakaran.
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Borjana Pervan, Director of Communications, [email protected]