What Is the Polypill?
Several leading public health figures have proposed a "polypill" as an inexpensive and effective way of mitigating factors that contribute to heart disease. Between high blood pressure, high cholesterol, and related complications, afflictions of the heart claim between 15 and 20 million lives worldwide each year. The "polypill" would be a combination of several well-known drugs, each of which has been proven to reduce one of the causative elements of heart disease.
"Red Heart Pill" Clinical Trials
The new "Red Heart Pill," which contains aspirin, statins, and two blood pressure lowering medications, is undergoing a well-publicized two-year trial in the UK, the Netherlands, and (pending approval) India. A similar polypill began trials in Australia and New Zealand earlier in 2010, and trials are pending in China, Brazil, South Africa and Canada. Known as UMPIRE (Use of Multidrug Pill In Reducing cardiovascular Events), this world-wide trial will test the polypill on over 7,000 people to see if it lowers blood pressure, reduces cholesterol, and decreases the chance of heart disease. Researchers are also testing the theory that that people will be more likely to take preventive measures against heart disease if all the necessary medications are contained in a single pill.
This will be the first time the polypill has been tested on a large human population. Each element of the polypill has been tested separately, however, and proven to reduce incidence of heart disease.
The term "polypill" was first used by Drs. Wald and Law in a June 2003 article in BMJ (British Medical Journal) addressing the effectiveness of six well-known, inexpensive drugs as treatments for heart disease. Positive findings caused them to postulate that combining all of these drugs in a single pill would reduce cardiovascular disease by over 80%. This means that strokes, heart attacks, and other adverse effects would be reduced by over 80%.
Since this initial study on the effectiveness of individual polypill elements, another test, known as the Indian Polycap Study, was undertaken in March 2009 by Dr. Salim Yusuf and Dr. Prem Pais. This study showed that giving individuals multiple treatment pills was as effective in treating heart disease as giving them a single pill containing ingredients from all the pills.
The "Red Heart Pill" study, begun in May 2010, was the first world-wide test of the Polypill's effectiveness.
What Medicines do Cardiovascular Polypills Typically Contain?
The "Red Heart Pill" contains:
The two other elements tested by Wald and Law were:
Presumably, these weren't included because experimental evidence of their effectiveness in treating heart disease wasn't strong enough.
The results of a small UK study released in July 2012 showed a four-in-one pill was effective in lowering blood pressure and cholesterol levels in people past age 50, even if those people were healthy. The common side effect of muscle weakness was reported by some participants. This polypill formulation included the ACE-inhibitor amlodipine, the antihypertensive diruetic hydrochlorothiazide, the blood pressure medicine angiotensin losartan and simvastatin.
How Much Will It Cost?
Because there aren't yet any producers of polypills for cardiovascular disease, we don't know how much they'll sell for. However, one of the main points of the polypill is that it consists of low-cost ingredients, making it a potentially affordable drug for treating people all over the world, even in third-world countries. In India, 80% of health care costs are paid out of pocket, and current heart disease medications are not affordable to the majority of the people there. If the polypill is proven effective, it will be produced to be affordable to people all around the world, so it is likely that it will be inexpensive.
Other Diseases Treated by Polypills
HIV, tuberculosis, and diabetes have all been treated with varying degrees of success with the theory that a combination of low-cost drugs can be more effective than a single, expensive wonder drug. However, not enough testing has been done to prove that cardiovascular disease could be treated similarly effectively. There is research showing lovastatin can help reduce brain inflammation and prevent neurological damage in mice with cerebral malaria. Some have proposed adding lovastatin to malaria treatment regimens but this is not done routinely yet.
A 2011 meeting of the European Society of Cardiology in Paris brought criticism that polypill use would be a great waste of money, and it was suggested that CT scans for high risk people would be a better management strategy. Other experts continue to say that polypills are the best hope against an epidemic in common aging diseases.
Pfizer sells a drug under the brand name Caduet, which is a combination of atorvastatin and the blood pressure medication amlodipine. Since the patent on atorvastatin has expired, the drug company Ranbaxy will start offering a generic version of Caduet.