Study indicates inexpensive polypill pill may significantly reduce risk of heart attack and stroke. Should you consider it?

On the March 30th edition of the ABC World News, Charles Gibson reported, “Some of the country’s leading heart doctors heard results” yesterday at the American College of Cardiology (ACC) conference “about … just one pill that could revolutionize the way heart disease is treated. This pill combines five commonly used medications, and new findings show it to be safe and effective.” Should you get your doctor to prescribe this to you?

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The same evening, on the CBS Evening News, Katie Couric explained that the “single pill to fight heart disease and stroke,” the “polypill…combines aspirin, three blood pressure medicines, and a statin to lower cholesterol. A study shows that one a day could cut the risk of heart disease and stroke roughly in half.”

And, on the NBC Nightly News, Brian Williams said that a study “looking at over 2,000 people” found that “a simple combination of…a low-dose statin, low-dose aspirin, and three commonly used blood pressure medications” now “dubbed the polypill,” reduced the “risk of heart disease by 50…to 60 percent” in “people with no known heart disease.”

USA Today reports that, according to a study published online Mar. 30 in The Lancet  and presented at the ACC meeting, the “once-a-day polypill … sharply reduces the risk of heart attack and stroke, potentially offering an inexpensive way to save millions of lives.” 

The Lancet also ran an editorial, “Can the polypill save the world from heart disease?”

Specifically, “the experimental five-drug combination proved about as safe and effective as each drug given alone,” and “cut a patient’s risk of heart attack by 62 percent and stroke by 48 percent.” 

The polypill “was the brainchild of study leader” Salim Yusuf, MD, of Canada’s McMaster University, “and a few other experts intent on halting a heart-disease epidemic that claims 18 million lives each year, most of them in countries with little access to healthcare.”

The AP points out that the one-pill “approach needs far more testing – as well as approval from the Food and Drug Administration, something that could take years.” 

Still, “it could make heart disease prevention much more common and more effective, doctors say.” 

For the study, the researchers “tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India,” containing “low doses of three blood pressure medicines” atenolol, ramipril, thiazide, “plus the generic version of the cholesterol-lowering statin drug Zocor [simvastatin], and a baby aspirin (100 milligrams).” 

MedPage reports that participants were randomized to the polypill:

  • thiazide (12.5 mg, a diuretic [fluid pill] that is used to treat high blood pressure), 
  • atenolol (50 mg, a beta-blocker that is used to treat high blood pressure), 
  • ramipril (5 mg, an ACE inhibitor that is used to treat high blood pressure), 
  • simvastatin (20 mg, a statin that is used to treat high cholesterol), and 
  • low-dose aspirin (100 mg) …

or to one of eight comparator groups: 

  • aspirin alone, 
  • simvastatin alone, 
  • thiazide alone, 
  • thiazide plus ramipril, 
  • thiazide plus atenolol, 
  • ramipril plus atenolol, 
  • all three blood pressure drugs, and 
  • all three blood pressure drugs plus aspirin.

To lessen the risk of hypotension, patients randomized to an arm that included ramipril were initiated at a dose of 2.5 mg for seven days then titrated up to 5 mg.

The investigators recruited “about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease,” such as “high blood pressure, high cholesterol, obesity, diabetes, or smoking.” 

Of the participants, “400 were given the polypill,” and the “rest were placed in eight groups of 200 and given individual components of the pill or various combinations” for 12 weeks.

Among the findings:

  • The polypill reduced 11-dehydrothromboxane B2 by 283.1 ng/mmol creatinine. This was similar to reductions achieved by aspirin alone (348.8 ng/mmol creatinine) and aspirin in combination with three blood pressure drugs (350.0 ng/mmol creatinine).
  • Heart rate reductions with the polypill and in treatment groups taking atenolol averaged 7 beats/min, which was significantly lower than groups not taking the beta blocker (P<0.0001).
  • BP reductions increased with the number of drugs used. One drug reduced systolic pressure by an average of 2.2 mmHg and diastolic by 1.3 mmHg. With two drugs the reduction was 4.7 mmHg/3.6 mmHg, and with three, the drop was 6.3 mmHg/4.5 mmHg.

Dr. Yusuf, one of the investigators, estimated that the combined blood pressure and LDL reductions achieved by the polypill “could reduce heart disease by 60% and stroke by 50%.”

Nevertheless, no everyone is singing the praises of this single study. Writing in the Los Angeles Times Booster Shots blog, Shari Roan observed, “The polypill should undergo a larger, phase-three clinical trial,” Christopher Cannon, MD, of Harvard Medical School, said “in a news release.” 

Still, Dr. Cannon said, the study “raises hope that, in conjunction with other global efforts on improving diet and exercise, the polypill could one day substantially reduce the burden of cardiovascular disease in the world.”

HealthDay pointed out that “some major regulatory changes by the US Food and Drug Administration (FDA) would be necessary for the polypill to be available in the United States.” 

Dr. Cannon went on to say, “The current mandates of the FDA are that a combination pill would have to be tested for every combination of every drug included in that pill. That obviously would not be feasible in this case.” 

Koon Teo, MBBCH, one of the study’s authors, said that “the next step would be a major trial of the polypill among people with clear risk of cardiovascular disease.”

Capturing reaction of those skeptical of the study’s findings, MedPage Today reported that Robert Bonow, MD, professor of medicine at Chicago’s Feinberg School of Medicine at Northwestern University, “cautioned restraint,” saying, “We already have a polypill – it’s called exercise.” 

And, “Hani N. Sabbah, PhD, of Henry Ford Hospital in Detroit, agreed that data from a 12-week feasibility study – even positive data – were not reason to shelve diet, exercise, and smoking cessation as the first line of defense against heart disease.” 

So, what do I say?

Number one, current recommendations for primary prevention of cardiovascular disease focus on lifestyle-diet, exercise, and smoking cessation – not pharmacologic therapy.

And, this report describes an investigational formulation of several FDA approved drugs, but the combination is not clinically available.

You should know that the polypill is one of three strategies developed by the World Heart Federation to combat what has been described as a worldwide epidemic of cardiovascular disease. The first two strategies are weight loss and smoking cessation.

So, if you are over fifty, you may want to discuss this study with your doctor. The combination has some potential risks, but also some potential benefits.

You’d have to take five different tablets, but the four prescription drugs are available in their generic forms for a little as $10 for a three month’s supply – in other words, for about $45 every three months, the potential combined blood pressure and LDL reductions achieved by the polypill “could reduce heart disease by 60% and stroke by 50%.”

I think it’s worth discussing with your doctor.

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