Heart Disease Risk and Poly Pill

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There are questions about the side effects of the “poly pill,” which combines aspirin with three other drugs used to treat cardiovascular disease. Getty Images
  • Researchers say a combination of four already approved medications to prevent cardiovascular disease are effective in reducing the risk of heart disease in people 55 years and older.
  • If adopted, the so-called “poly pill” could significantly change the way doctors approach heart disease prevention.
  • But there are questions about the safety of some of the drugs in the pill.

About 1 of every 4 deaths in the United States is due to heart disease, according to the Centers for Disease Control and Prevention (CDC).

However, recent clinical trials have found that, compared to those who just follow lifestyle advice, people who took a “poly pill” reduced their risk of major cardiovascular disease from 25 percent in one U.S. study and up to 40 percent in a study based in Iran.

The polypill is a single pill designed to treat both high blood pressure and high cholesterol. Researchers can put in approved medications into one pill that treats both of these conditions as a way to combat the rise of heart disease and help patients stay healthy.

A new study published Wednesday in the New England Journal of Medicine of mostly low-income, black adults from a community health center in Mobile, Alabama, suggests how a single pill can have a big effect.

Over 300 participants received a medical exam, and had both blood pressure and cholesterol tested during an initial, a 2-month, and a 12-month visit.

Half the patients were given a polypill that contained four low-dose medications to treat high blood pressure and cholesterol levels. The drugs in pill included atorvastatin (a cholesterol-lowering statin), high blood pressure medications amlodipine, losartan, and hydrochlorothiazide.

All who had taken the polypill had significantly decreased blood pressure and cholesterol levels, reducing their cardiovascular disease risk by about 25 percent.

“The pill may address some of the barriers that contribute to disparities in health based on geography, socioeconomic class, and other parameters that we know have existed in this country and other countries for a while now,” senior author Dr. Thomas Wang, chief of the Division of Cardiovascular Medicine at Vanderbilt University Medical Center (VUMC) in a statement.

An earlier study published in August focused on assessing both the safety and effectiveness of a four-drug pill containing aspirin, atorvastatin (a cholesterol-lowering statin), and the blood pressure drugs hydrochlorothiazide, and either enalapril or valsartan.

“The poly pill uses a ‘shotgun’ approach to address cardiovascular disease risk factors. This study, and previous ones, show that a population-based approach can result in a significant reduction in both cardiovascular morbidity and mortality,” Dr. Nauman Mushtaq, medical director of cardiology at the Northwestern Medicine Bluhm Cardiovascular Institute at Central DuPage Hospital and Delnor Hospital in Illinois, told Healthline.

The trial, named the PolyIran study, was led by the Tehran University of Medical Sciences in Iran. The findings were published in the journal The Lancet.

Researchers found that people without a history of cardiovascular disease reduced their risk of heart disease by about 40 percent, while those with a history of cardiovascular issues experienced a reduction of 20 percent.

The trial included more than 6,800 people 55 years and older across 236 villages in northern Iran. About half of participants were women.

“Use of the poly pill was effective in preventing major cardiovascular events. Medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in low or middle-income countries,” concluded the study authors.

“The magnitude of benefit from the polypill is directly related to the baseline risk of cardiovascular disease in the target population. An elderly, male, obese, sedentary, diabetic population with poor diet and high prevalence of smoking is the most likely to benefit,” Mushtaq said.

Using an inexpensive pill composed of existing drugs that prevent heart attack is an idea that was first conceived about 20 years ago but was rarely studied.

The results of this latest trial are igniting renewed interest.

“However, to date, empirical data have been scarce,” said Anushka A. Patel, PhD, and Dr. Mark D. Huffman, PhD, both of the University of New South Wales in Australia, in an editorial published in August

They also explained that, unlike the PolyIran trial, previous studies included mostly male participants.

If other studies now under way find similar results, multi-drug pills given to a large number of seniors could significantly change the way cardiologists fight heart disease and stroke.

Study authors also pointed out that one important benefit of the polypill may be that people won’t have to remember to take four different tablets. This could help people adhere to the regime.

Not consistently taking medication has been an issue with cardiovascular disease prevention drugs such as statins.

“This study shows that a poly pill is well-tolerated and has good adherence — meaning patients take the drug as frequently as they are meant to. The treatment helps to reduce blood pressure and cholesterol and shows some cardiovascular benefits,” said Dr. Kausik Ray, chair of the public health division at Imperial College London and a fellow at the American Heart Association, in a statement about the Iranian study.

That said, experts stress that a healthy lifestyle still remains an important factor for maintaining cardiovascular health.

“Non-pharmacological measures to reduce risk of [cardiovascular disease] include smoking cessation, regular 20 to 30 minutes of moderate intensity exercise daily, and a heart-healthy, low salt diet. Following a low-stress lifestyle, having strong social connectivity and getting sufficient sleep are also recognized as important,” Mushtaq said.

While these studies show the benefits of pills to combat heart disease, all medication comes with a risk of side effects.

“Each of these drugs individually has side effects. For example, Atorvastatin has some liver side effects in people with underlying liver and muscle diseases,” said Dr. Tony S. Das, an interventional cardiologist at Texas Health Dallas and Texas Health Physicians Group.

And even aspirin carries a risk of major bleeding episodes.

  • Atorvastatin may cause symptoms such as diarrhea, heartburn, joint pain, memory loss, and confusion.
  • Enalapril and hydrochlorothiazide may cause cough, dizziness, headaches, excessive tiredness, muscle cramps, and decrease in sexual ability.
  • Valsartan may bring diarrhea, stomach pain, back pain, joint pain, blurry vision, cough, and rash.

“Therefore, all of these drugs should include some form of periodic blood test monitoring if possible,” Das told Healthline in an August interview.



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