Is Polypill A Possible Means To Live Longer?
August 31, 2019 at 4:07 a.m.
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There is little good news these days about Iran and its nuclear ambitions and terrorist activities with at least one exception. A recent clinical trial conducted in that country indicated that an inexpensive combination drug could lower the rate of heart attacks by more than half and help all of us live longer. The pill, together with other suggestions like eating a balanced diet, consuming less fat from meat and dairy, focusing on fruits and vegetables, practicing daily exercise, nonsmoking, reducing stress, and having routine medical checkups could be significant. The major reason is that following this regimen can prevent the major causes of premature death – heart disease and stroke. Some experts have long believed that such life style changes should include taking multiple drugs. It may even be more advantageous to combine all of the recommended drugs into a single pill—a so called “ magic bullet” to extend life expectancy. Remarkably, there has been and is a product that may meet this requirement. Unfortunately it is not available in the United States. It is, however, well known in England where it is described as the “polypill.” The combination drug was first proposed in 2003 by cardiologists Nicholas Wald and Malcolm Law of Queen Mary, University of London. They studied and summed up the preventive effects of several drugs and concluded that combining the low doses of all six into a once a day pill would lower cholesterol and blood pressure. According to Wald and Law, the combination of drugs would decrease the incidence of cardiovascular disease in at-risk patients by up to 80%.
The Iranian study was much larger, it involved the participation of 6,800 rural villagers aged 50 to 75 and contained a cholesterol lowering statin, two blood pressure drugs and a low dose aspirin . It was conducted by doctors from Teheran University, the University of Birmingham in Britain and other institutions. Fortunately it was the first study of such a multidrug pill that was large and long-lasting enough to measure “clinical outcomes” including how many people actually had heart attacks, strokes, or episodes of heart failure while taking the pills, rather than just how many, for example, lowered their blood pressure or cholesterol. This study has greater significance as more residents of poor countries survive childhood into middle age and beyond—and as rising incomes contribute to their adoption of cigarette smoking and diets high in sugar and fate. About 18 million people a year die of cardiovascular disease, and 80 percent of them are in poor or middle income countries threatened by rising rates of obesity, diabetes, tobacco use and sedentary living. Similar studies are underway in many countries.
Constituents
The polypill used in the Iranian study included aspirin, atorvastatin (to reduce cholesterol), hydrochlorthiazide ( a diuretic), and either enalapril (an ACE inhibitor) or valsartan (angiotensin receptor blocker). Aspirin is used for its effects on platelets to reduce blood clots. Thiazides are diuretics that stimulate the flow of urine. Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers lower blood pressure and help keep blood vessels open.
The Pitfalls
Despite the good news from Iran there may be certain drawbacks to consider. For one, patients may rely on the pill rather than adhering to a healthy lifestyle. And, of course, it is imperative that the value of the polypill be clearly demonstrated through long term clinical studies in the United States rather than simply assume that it works. The U.S. Food and Drug Administration requires evidence of efficacy in populations with low risk as well, perhaps, as evidence that each component of the polypill adds something important. There are side effects to consider as well, i.e., aspirin induced bleeding. In the U.K. study mentioned above about 1 in 6 patients experienced a side effect in the short term. Most were mild but about 1 in 20 overall stopped treatment due to side effects, indicating that treatment is best targeted to those at raised risk of disease. Side effects may take five to seven years to emerge. Even though the drugs used are generic, there are doubts as to whether developing countries could afford to provide them broadly to everyone over 55 years of age. Cardiologists are critical of the one- size- fits- all treatment of patients who may not be at risk. Many physicians want to be involved in personalized care. The availability of the polypill may keep patients away from doctors for routine examinations. Not all patients are ready to assume self care and autonomy.
Final Thoughts
According to the Science News Daily, the polypill will be available soon in India and then elsewhere within a few years, based on regulatory timelines within each individual country. That may not be true in the United States where combination drugs are more difficult to gain approval.
Max Sherman is a medical writer and pharmacist retired from the medical device industry. He has taught college courses on regulatory and compliance issues at Ivy Tech, Grace College and Butler University. Sherman has an unquenchable thirst for knowledge on all levels. Eclectic Science, the title of his column, touches on famed doctors and scientists, human senses, aging, various diseases, and little-known facts about many species, including their contributions to scientific research. He can be reached by email at [email protected].
There is little good news these days about Iran and its nuclear ambitions and terrorist activities with at least one exception. A recent clinical trial conducted in that country indicated that an inexpensive combination drug could lower the rate of heart attacks by more than half and help all of us live longer. The pill, together with other suggestions like eating a balanced diet, consuming less fat from meat and dairy, focusing on fruits and vegetables, practicing daily exercise, nonsmoking, reducing stress, and having routine medical checkups could be significant. The major reason is that following this regimen can prevent the major causes of premature death – heart disease and stroke. Some experts have long believed that such life style changes should include taking multiple drugs. It may even be more advantageous to combine all of the recommended drugs into a single pill—a so called “ magic bullet” to extend life expectancy. Remarkably, there has been and is a product that may meet this requirement. Unfortunately it is not available in the United States. It is, however, well known in England where it is described as the “polypill.” The combination drug was first proposed in 2003 by cardiologists Nicholas Wald and Malcolm Law of Queen Mary, University of London. They studied and summed up the preventive effects of several drugs and concluded that combining the low doses of all six into a once a day pill would lower cholesterol and blood pressure. According to Wald and Law, the combination of drugs would decrease the incidence of cardiovascular disease in at-risk patients by up to 80%.
The Iranian study was much larger, it involved the participation of 6,800 rural villagers aged 50 to 75 and contained a cholesterol lowering statin, two blood pressure drugs and a low dose aspirin . It was conducted by doctors from Teheran University, the University of Birmingham in Britain and other institutions. Fortunately it was the first study of such a multidrug pill that was large and long-lasting enough to measure “clinical outcomes” including how many people actually had heart attacks, strokes, or episodes of heart failure while taking the pills, rather than just how many, for example, lowered their blood pressure or cholesterol. This study has greater significance as more residents of poor countries survive childhood into middle age and beyond—and as rising incomes contribute to their adoption of cigarette smoking and diets high in sugar and fate. About 18 million people a year die of cardiovascular disease, and 80 percent of them are in poor or middle income countries threatened by rising rates of obesity, diabetes, tobacco use and sedentary living. Similar studies are underway in many countries.
Constituents
The polypill used in the Iranian study included aspirin, atorvastatin (to reduce cholesterol), hydrochlorthiazide ( a diuretic), and either enalapril (an ACE inhibitor) or valsartan (angiotensin receptor blocker). Aspirin is used for its effects on platelets to reduce blood clots. Thiazides are diuretics that stimulate the flow of urine. Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers lower blood pressure and help keep blood vessels open.
The Pitfalls
Despite the good news from Iran there may be certain drawbacks to consider. For one, patients may rely on the pill rather than adhering to a healthy lifestyle. And, of course, it is imperative that the value of the polypill be clearly demonstrated through long term clinical studies in the United States rather than simply assume that it works. The U.S. Food and Drug Administration requires evidence of efficacy in populations with low risk as well, perhaps, as evidence that each component of the polypill adds something important. There are side effects to consider as well, i.e., aspirin induced bleeding. In the U.K. study mentioned above about 1 in 6 patients experienced a side effect in the short term. Most were mild but about 1 in 20 overall stopped treatment due to side effects, indicating that treatment is best targeted to those at raised risk of disease. Side effects may take five to seven years to emerge. Even though the drugs used are generic, there are doubts as to whether developing countries could afford to provide them broadly to everyone over 55 years of age. Cardiologists are critical of the one- size- fits- all treatment of patients who may not be at risk. Many physicians want to be involved in personalized care. The availability of the polypill may keep patients away from doctors for routine examinations. Not all patients are ready to assume self care and autonomy.
Final Thoughts
According to the Science News Daily, the polypill will be available soon in India and then elsewhere within a few years, based on regulatory timelines within each individual country. That may not be true in the United States where combination drugs are more difficult to gain approval.
Max Sherman is a medical writer and pharmacist retired from the medical device industry. He has taught college courses on regulatory and compliance issues at Ivy Tech, Grace College and Butler University. Sherman has an unquenchable thirst for knowledge on all levels. Eclectic Science, the title of his column, touches on famed doctors and scientists, human senses, aging, various diseases, and little-known facts about many species, including their contributions to scientific research. He can be reached by email at [email protected].
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