A single pill that combines four medications meant to lower blood pressure and cholesterol plus an aspirin may cut the risk for the world’s No. 1 killer: heart disease. That finding is the result of a large new study presented on November 28, last month at the annual meeting of the American Heart Association and published simultaneously in the New England Journal of Medicine. Researchers showed that cheap, daily polypill with low-dose aspirin can cut the risk of heart attacks, strokes and heart-related deaths by nearly one third.
For more than a decade, doctors have been testing whether the cheap, “all-in-one combo pills” could make it easier to prevent heart disease, the top killer worldwide. In November this year at last, results of a major trial showed the value of the polypill — and not just for poor nations. “It’s for every country,” said Dr Salim Yusuf of McMaster University in Hamilton, Ontario. He helped lead the study. Study participants were over 50 and had heart disease risk factors, such as high blood pressure or type 2 diabetes. Most were recruited from diverse countries and none had suffered a heart attack or stroke.
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What is a Polypill? It is a single pill that contains five life-saving drugs to combat bad cholesterol, high blood pressure and clotting, at one go. Its ingredients are 1) STATIN, to lower levels of blood cholesterol. 2) ASPIRIN, to thin blood. 3) BETA-BLOCKER, to reduce the effect of harmful adrenaline on the heart. 4) ACE INHIBITOR, to lower the levels of an enzyme that can raise blood pressure. 5) DIURETIC, to bring about salt and water loss from body to lower blood pressure.
At least half a dozen companies already sell polypills outside the United States, including several in Europe, but they are not widely used or marketed especially in US. Doctors, except in India, had been reluctant to use partly because no big, international studies had shown they can lower heart attacks and deaths — not just risk factors such as high blood pressure. However, the newer results are encouraging. “If rich countries somehow don’t want the benefit of such a pill, that’s their prerogative,” says Yusuf.
Years ago fixed drug combinations started mushrooming in the market as pharma companies in their quest for newer products — and often to beat price control — began to mix and match ingredients into a single molecule to market them as newer remedies.
For over a decade, doctors have been dreaming of having a single daily pill combining aspirin, cholesterol medicine and blood pressure drugs; everything people need to prevent heart attacks and strokes in a cheap, generic form. This dream became a reality with the advent of the so-called “polypill”.
It was apparent that in fixed-dose combinations some people would get more drugs than they need, others would get too little. “One-size-fits-all” could turn out to fit very few. Polypill nevertheless secures now wholehearted FDA approval though establishing proper doses of ingredients in it became a regulatory nightmare. Many doctors among the skeptics, hold the viewpoint that the “miracle-pill” or “magic bullet” is nothing more, or nothing less, than uncalled-for “shotgun therapy” – to further the interests of pharma companies. Predictably, Indian pharmaceutical companies lost no time in introducing “drug combos” especially now that current evidence is strongly supportive of the polypill hypothesis.
A Lancet study years ago also had claimed that a new “ultra-low dose pill” is 100% effective in lowering BP. High blood pressure — which affects around 1.1 billion people worldwide — is one of the major risk factors for heart attack, stroke, dementia and kidney disease.
Yusuf stresses that the polypill approach can have benefits in both rich and poor countries. “Why wouldn’t the wealthy people benefit from something that is easily taken and can reduce risk by 30 to 40%?” he asked, arguing that there is no basis for the “myth created” that “this is for poor people.” The polypill may serve as background therapy for most. But people at a very high risk could necessitate additional treatments”, according to Yusuf.
Patients who consume the commonly available hypertension-lowering drugs singly at prescribed doses often experience side-effects which can vary from swollen ankles to kidney abnormalities depending on the type and class of the drug. However, “the new pill has no such side-effects”, the researchers said.
Dr Steven Nissen, chief academic officer of the Heart, Vascular and Thoracic Institute at the Cleveland Clinic, who poses himself as the devil’s advocate dubs the polypill is a “terrible idea.” A polypill, on the other hand, is “essentially throwing the kitchen sink at people.”
But there are compelling reasons to embrace the polypill. We know that high blood pressure is a precursor to stroke, diabetes and heart attack. The need for even lower blood pressure levels than we often achieve has been widely accepted in the last few years. So this could be an incredibly important step in helping to reduce the burden of disease globally. Will the study prove its worth in the long run? Sit expectare et videre!
Earl Wilson wrote, “One way to get high blood pressure under control is to go mountain climbing over molehills.” For those of us prone to be over-reactive and histrionic even over minor issues, any medical innovation that promises control of blood-pressure with least side-effects must prove to be good news indeed.
(Dr Francisco Colaço is a seniormost consulting physician, pioneer of Echocardiography in Goa)
