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expert reaction to study looking at a polypill to prevent cardiovascular diseases

Research, published in The Lancet, reports on a new polypill combining four cardiovascular drugs in a single pill.

 

Prof Kausik Ray, Chair in Public Health, Imperial College London, said:

“Lowering blood pressure and lowering LDL-cholesterol (LDL-C) are known to reduce cardiovascular events, like heart attacks and stroke. But the magnitude of relative benefit relates to the absolute reduction in blood pressure and LDL-C.

“In terms of prevention, aspirin does not provide major benefits and any small benefits are offset by an increased risk of bleeding. In people with prior vascular disease aspirin can be beneficial, preventing more events than any bleeds it causes.

“Adherence to daily pills declines with medication burden, meaning the more tablets people have to take the less they comply in the long-term. For chronic disease this is a challenge as you are asking people to take multiple medications every day, for 30-40 years. To reduce that medication burden the ‘polypill’ concept was brought in.

“In the study, the blood pressure lowering combinations are weak and generally we would use longer-acting, slightly more potent drugs, if these needed to be given once a day. This in part reflects small difference in blood pressure of 2mmHg recorded. Differences in LDL cholesterol are not reported, just total cholesterol, which is less informative. There was also an excess of non-cardiovascular deaths, possibly bleeding-related (from other known data). But adherence was good and among those more adherent more benefit less adherent less benefit and over 80% seemed to adhere.

“This study shows that a ‘polypill’ is well-tolerated and has good adherence – meaning patients take the drug as frequently as they are meant to. The treatment helps to reduce blood pressure and cholesterol and shows some cardiovascular benefits.

“Overall, this study reinforces the health benefits of even small reductions in blood pressure and cholesterol. However, I do not agree that aspirin should be used in the polypill. Instead, perhaps a more potent once-daily, long-acting blood pressure-lowering agent could provide more benefit to patients.”

 

Dr Nicola King, Lecturer in Cardiac Physiology, University of Plymouth, said:

“This appears to be a robust study and press release. It’s good that limitations have been mentioned – the largest of which is generalisability given that the study population was based in rural Iran. The press release and article also emphasise the importance of lifestyle interventions and do not just place sole reliance on the polypill. As this was the first large scale trial with a 5-year follow-up it cannot be compared to other studies; however, the claims made appear to be evidence-based within the confines of the trial. I think more large-scale prospective trials conducted in several different countries are required before it is possible to make judgements as to whether the polypill would be beneficial to the UK population.”

 

Dr Amitava Banerjee, Senior Clinical Lecturer in Clinical Data Science and Honorary Consultant Cardiologist, University College London (UCL), said:

“This is the first trial to-date of a Polypill (a fixed combination of aspirin, two blood pressure-lowering drugs and a statin) in the prevention of cardiovascular diseases (heart disease and stroke), which remain the largest cause of mortality worldwide. Despite evidence that drugs can prevent cardiovascular disease in healthy individuals and in people with pre-existing disease, adherence (sticking to the therapy as prescribed) and persistence (continuing the drugs long-term) are poor, even in high-income countries. This is where combining the different component drugs in a single pill (the Polypill) holds much promise. The research team compared a Polypill once daily to minimal care which involved lifestyle advice in individuals aged 50-75, in a trial lasting 5 years, making this the longest follow-up study of a Polypill strategy.

“The trial is impressive for three reasons. First, it is set in a low middle-income country, Iran, albeit within an existing population-based study, rather than in the general population, suggesting that the results are applicable to low-resource settings, where 80% of the global burden lies. Second, it shows a 40% reduction in heart disease and stroke in those without a history of cardiovascular disease (primary prevention) and also a 20% reduction in those with known cardiovascular diseases (secondary prevention). Third, it shows 80% adherence to the Polypill which is considerably higher than what we see in routine practice, even in a high-income setting like the UK with universal healthcare coverage.

“Drugs do not work if they are not taken, and the Polypill can reduce cardiovascular disease worldwide and can improve adherence to therapy. The Polypill approach could become part of preventive programmes to reduce cardiovascular disease globally but must not detract from the need for lifestyle change, such as smoking cessation and physical activity. Future studies should compare the Polypill to the individual drugs taken separately with long-term outcomes, and also consider Polypills in the general population in different countries.”

 

Prof Jeremy Pearson, Associate Medical Director at the British Heart Foundation, said:

“This study shows that in low- and middle-income countries, where the use of medicines to reduce heart disease risk is low, a single pill combining several drugs is safe and effective.

“This is a large-scale study comparing a polypill (with four components to lower blood pressure and lipid levels) with minimal care (where no medicines were given).

“The findings are not transferable to high-income countries where baseline preventive medical care to reduce heart and circulatory disease risk is common. 

“In the UK, as many as a third of people with high blood pressure are undiagnosed and many of those who are diagnosed aren’t managing their condition properly, even though we already have several effective medicines.

“This means that the biggest priority in the UK is to identify more people who do not realise they have high blood cholesterol or high blood pressure, and to help people prescribed medications to take them as prescribed.”

 

Dr Kate Holmes, Assistant Director of Research, Stroke Association, said:

“This is a robust study which demonstrated that a polypill was effective in reducing cardiovascular disease (CVD) risk in people aged between 50 and 75 years old, in Iran.”

“We know that there is a growing problem of stroke and other cardiovascular diseases in low- and middle-income countries and that preventative strategies are urgently needed if we are to address this problem. Governments who can provide access to a low-cost polypill would be making significant progress towards the World Health Organization’s goal of Universal Health Coverage, that is, for all people to receive the health services they need without suffering financial hardship.”

 

Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial’ by Roshandel et al. was published in The Lancet at 23:30 UK time on Thursday 22nd August. 

 

Declared interests

Prof Kausik Ray: Professor Ray receives funding from several pharmaceutical companies developing novel lipid-lowering agents. He is also an investigator on several large-scale trials in lipid-lowering.

Dr Nicola King: No conflicts of internet.

Dr Amitava Banerjee:  Served on advisory boards for Boehringer Ingelheim, Astra Zeneca, Pfizer and Novo-Nordisk. He is a Trustee of the South Asian Health Foundation.  

Prof Jeremy Pearson: None

Dr Kate Holmes: No COIs to declare.

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