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The role of polypill in lowering cardiovascular events

M3 India Newsdesk May 10, 2022

This article scientifically explains why a polypill which substantially lowers cardiovascular events is a "need of the hour". 

The New England Journal of Medicine reports that polypill substantially lowers cardiovascular events. In individuals without established illness, using a polypill comprising a statin and four antihypertensives may reduce cardiovascular events by at least a third—and closer to half if taken consistently.

Scientific evidence

The latest research, published in the New England Journal of Medicine, is a randomised trial of a polypill (a statin plus three antihypertensives) with or without aspirin in 5713 individuals with a mean age of 64 who did not have documented cardiovascular disease but did have certain risk factors.

To put it another way, they're like the majority of individuals of their age across the globe. The polypill decreased the cardiovascular events by one-fifth and one-third over the following 4.6 years if individuals also took aspirin.

The study took place in nine countries (Bangladesh, Canada, Colombia, India, Indonesia, Malaysia, Philippines, Tanzania, and Tunisia), with half of the patients hailing from India, and supply issues exacerbated by the pandemic meant that roughly a third of the patients were not taking the medicines consistently. According to the researchers, individuals who consistently took the polypill with aspirin had a 40% decrease in cardiovascular events.

  1. The study included 7534 participants, however, 1821 were eliminated due to adverse events associated with the polypill and aspirin (715), non-adherence to the pills (560), or refusal to be randomised (458).
  2. Thus, individuals were chosen based on their lack of adverse effects and their consistency in taking the tablets.
  3. Nonetheless, more individuals receiving the polypill (2.7%) or the polypill with aspirin (3.1%) reported hypotension or dizziness than those receiving the placebo (1.1 per cent, 1.5 per cent).

These findings complement those of a pragmatic cluster-randomised study published in The Lancet on the use of a polypill (a statin, an aspirin, and two antihypertensives) in 6838 Iranians with and without cardiovascular disease. That study found a little over a third decrease in cardiovascular events in those using the polypill and a more than half reduction in those taking the polypill consistently.

However, the recent study published showed that participants did not achieve the reductions in blood pressure, heart rate, and blood lipids that the researchers anticipated based on their pilot studies.

What's our understanding?

We now have strong evidence that taking the polypill on a daily basis may decrease cardiovascular events and fatalities by at least a third, if not half, in individuals who take it consistently. Additionally, it is conceivable that even greater results may be obtained using the polypill's optimum components. However, with 18 million people dying each year from cardiovascular events (80% of fatalities in low- and middle-income countries) and widespread use of the polypill would have a significant effect.

If the study had included a novel and costly medication produced by a large pharmaceutical firm, the findings would have been broadcast worldwide and featured on the front pages of newspapers and major news organisations. Indeed, it has been lifted with hardly a squeak.

Not only does the polypill, which could likely be made accessible for considerably less money each month, lack the backing of a big pharmaceutical firm, but it also threatens rich markets currently held by the businesses. It also concerns cardiologists, who believe that customised therapies with frequent monitoring must be superior, notwithstanding the facts. Public health professionals oppose the polypill because they believe that healthy lifestyles must be improved even when the majority of people are unable to attain them for a variety of structural reasons. Additionally, there has been a dearth of randomised controlled trials demonstrating the advantages of mass medicine in individuals without proven illness, giving an excuse for those who object to the concept of mass medication for any reason. That justification is dwindling—it may have dwindled entirely.

WHO's comments

The WHO examined the polypill for inclusion on the list of essential medicines three times and rejected it each time. Although the list includes polypills for HIV and other diseases, the WHO is concerned about a tablet with four or five components.

Then there's the issue of what they're endorsing an idea, a strategy, or a specific pill combination? Let's hope that this additional data will result in the polypill being added to the list of critical drugs.

Is the "polypill" going to have a significant impact on India's cardiovascular sector?

The polypill has enormous promise in cardiovascular disease prevention efforts, particularly at the primary care and community level. It has the potential to decrease such illness by 30% in persons who do not currently have heart disease but have risk factors such as hypertension or diabetes (primary prevention). This will result in a significant decrease in morbidity and death in absolute terms. The polypill's effect may be increased even further if health systems allow non-physician health professionals to give it under adequate supervision, as South Africa is contemplating.

Perhaps most intriguing about the polypill is that the concept of combining inexpensive, off-patent medicines with distinct mechanisms of action could be successful in a variety of other diseases, including:

  • Diabetes
  • Depression
  • Asthma
  • Chronic respiratory diseases

Making affordable medicines widely accessible is a better path for global health (but not for business) than creating new, very costly treatments that only a few people can buy.

Click here to see references


Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.

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