This one pill could save millions of lives worldwide

A simple treatment that combines four heart medicines in one pill—a “polypill”—was able to cut the risk of heart attack, stroke, and other cardiovascular events by 21% in people at risk of heart disease, and by 31% when taken with aspirin, according to the results of a new clinical trial. The polypill has the potential to save countless lives worldwide, researchers said. 

“We could save millions of people from experiencing serious heart disease or stroke each year with effective use of the polypill and aspirin,” said cardiologist Salim Yusuf, MD, DPhil, co-principal investigator for the study and professor of medicine and clinical epidemiology & biostatistics at McMaster University, in Ontario, Canada. 

Dr. Yusuf estimated that the polypill plus aspirin could prevent 3–5 million cardiovascular deaths worldwide.

But not all heart specialists are enthusiastic about the news. 

The role of the polypill

Dr. Yusuf and colleagues announced the clinical trial results of the polypill at a virtual conference held by the American Heart Association and published simultaneously in The New England Journal of Medicine. 

The polypill is a combination of a statin (simvastatin 40 mg) and three blood pressure-lowering drugs (atenolol 100 mg, hydrochlorothiazide 25 mg, and ramipril 10 mg). The aspirin used in the study was a low-dose (75 mg) tablet. 

For this trial—the International Polycap Study (TIPS)-3—the researchers recruited 5,714 older adults from nine countries, mostly from India and the Philippines. Participants had no known cardiovascular history but were at intermediate risk for heart disease. Researchers randomly assigned the participants to receive the polypill alone, aspirin alone, or the polypill plus aspirin. Each group was compared with a control group that received matching placebos. 

Patients were followed for nearly 5 years for the occurrence of any major cardiovascular event, such as heart attack, stroke, heart failure, cardiac arrest, or cardiovascular death.  At the end of the follow-up period, cardiovascular events in the intervention groups, compared with the placebo groups, were reduced by: 

• 31% for polypill plus aspirin

• 21% for polypill alone 

• 14% for aspirin alone

“Aspirin should be prescribed with a polypill in primary prevention for patients at intermediate risk of heart disease,” concluded Dr. Yusuf. “Our study results provide important data regarding the role of the polypill in preventing the development of heart disease.”

A ‘terrible idea’

Modern medicine has been advancing steadily toward precision, or personalized medicine. But some experts say that a polypill runs counter to this strategy, and adds the risk of overmedicating patients. 

Steven Nissen, MD, chief academic officer of the Heart, Vascular, and Thoracic Institute at the Cleveland Clinic, told NBC News that the polypill is a “terrible idea,” and noted that all the drugs in the polypill have potential side effects. 

“Modern medicine is about giving medicines to patients thoughtfully,” Dr. Nissen said. But a polypill is “essentially throwing the kitchen sink at people.”

‘An attractive option’

The polypill may be most useful, though, in poorer nations and low-income communities—including those in the United States—where improvements in cardiovascular diseases continue to lag. 

Notably, about 18 million people worldwide die each year as a result of cardiovascular diseases, but more than 80% of these deaths occur in low- and middle-income countries.

“Tackling cardiovascular health disparities necessitates a renewed focus on high-risk populations, not just high-risk people,” wrote cardiovascular researchers in the journal Circulation last year. “Several features of the polypill make it an attractive option in this regard. The simplicity of a once-daily pill improves adherence and reduces the need for monitoring and dose titration. Furthermore, multiple medications at low doses are often better tolerated than 1 or 2 medications at higher doses, because side effects of most cardiovascular medications are dose-dependent.” 

Additionally, they wrote, using generic ingredients ensures that the pill can be made available to large populations at low cost.

“The results of the study have implications for reducing the burden of cardiovascular diseases globally,” said Prem Pais, MBBS, MD, co-principal investigator of the TIPS-3 trial and an adjunct professor at St. John’s Medical College and Research Institute, in Bangalore, India. “Even if only one third of eligible people receive a polypill, its use will likely avoid millions of individuals experiencing serious cardiovascular diseases worldwide.”

Cardiologist Philip Joseph, MD, MSc, second author of the study and associate professor of medicine at McMaster University, added, “The use of the polypill widely will benefit people in both the rich and poor countries as there are major gaps in treatments in populations all over the world.”