Giving people an inexpensive pill containing a combination of generic drugs that prevent heart attacks––an idea first proposed 20 years ago but rarely tested—worked quite well, according to a study in The Lancet, slashing the heart attack rate by more than half among those treated.
Such multidrug cocktails (or “polypills”) could radically change the way cardiologists fight the soaring rates of heart disease and strokes. Each year, almost 18 million people die of cardiovascular disease, and 80% are in poor and middle-income countries threatened by rising rates of obesity, diabetes, tobacco use, and sedentary living.
The study, PolyIran, was designed 14 years ago, and involved 6,800 Iranian villagers aged 50 to 75 years old. Of those, 3,421 were given a fixed-dose pill containing a statin, two blood-pressure drugs, and a low-dose aspirin. Participants assigned to take pills experienced one-third fewer cardiac events over five years than the control participants, who received face-to-face advice and monthly text reminders to lose weight, stop smoking, eat healthy food, and exercise. (Because the study was conducted in northern Iran, they were also advised to avoid another local habit: opium smoking.)
However, medical experts are sharply divided over the polypill concept. Advocates point to the study as evidence that the World Health Organization should endorse distributing such pills without a prescription to hundreds of millions of people aged over 50 around the globe. Some have estimated that the pills’ widespread use could cut cardiac death rates by 60% to 80%.
Others consider the approach unethical and dangerous. Because aspirin, statins, and blood-pressure drugs all have side effects, they argue, no one should get them without first being assessed for risk factors like high blood pressure or high cholesterol or having their family history reviewed.
“I’m a skeptic of the one-size-fits-all, four-drugs-for-everyone approach,” said Dr. Steven E. Nissen, head of the department of cardiovascular medicine at the Cleveland Clinic. “It runs counter to what most of us in the United States consider good medical practice.”
Dr. Thomas R. Frieden, president of Resolve to Save Lives, which seeks to lower worldwide cardiac deaths, believes that a four-drug pill such as the one used in the study was appropriate only for people who had suffered a cardiac event. Some blood pressure medications are safe enough to give to untested people, he said. But aspirin, which can cause bleeding in the brain, is not; and statins, which can in rare cases cause liver and muscle damage, may not be.
The Iran study, conducted by doctors from Tehran University, the University of Birmingham in England, and other institutions, is the first study of a multidrug pill that is sufficiently large and long-lasting (participants were followed for 60 months) to measure clinical outcomes. Similar studies are underway in many countries.
Adherence was high—more than 80%—a “fantastic” rate, according to Dr. Rekha Mankad, director of the Women’s Heart Clinic at the Mayo Clinic in Minnesota, who was not involved in the Iran study. Poor adherence, she said, is one of the main problems that polypills are intended to overcome.
Source: The New York Times, August 22, 2019