An older woman sitting on a couch holds a pill boxShare on Pinterest
Experts say it can be difficult for older adults to remember to take multiple medications every day. Fly View Productions/Getty Images
  • Researchers report that a polypill for people who’ve had a heart attack performed well in a recent clinical trial.
  • The pills contain aspirin, a statin, and a blood pressure medication.
  • Experts say the single pill can help people stay on a daily medication regimen.
  • They note there are drawbacks, including if someone has side effects from one of the three medications.
  • Combination pills have been authorized for other conditions such as HIV and hepatitis C, but so far they haven’t been approved for cardiovascular use.

As most people get older, the number of medications they take tends to increase and, with it, the increased risk of skipping a dose.

People who have previously suffered heart attacks are one group for whom daily medication is particularly important to help prevent future cardiac events.

Enter the “polypill.”

For decades, researchers have been trying to find the right proportions so they can squeeze several medications into a single pill for this group. They also need evidence to back up the value of a one-size-fits-all heart treatment.

The polypill, which contains aspirin in addition to a statin to treat high cholesterol and a blood pressure medication, is the subject of a recent phase 3 clinical trial.

In a study reporting the results, published in the New England Journal of Medicine, researchers stated that people taking a polypill had a significantly lower risk of major adverse cardiovascular events than people on a traditional care regimen.

The trial involved almost 2,500 adults who had experienced a heart attack within the previous 6 months. The participants were randomly assigned to receive either the polypill or a traditional care regimen. They were followed for a median of 36 months.

“Studies show similar or even improved risk-factor control in patients treated with a polypill as compared with usual care,” Dr. Thomas J. Wang, a professor at the UT Southwestern Medical Center in Texas, wrote in an editorial accompanying the study. “There is also robust evidence that the combination pills have an acceptable side-effect profile. However, previous trials were underpowered to examine the effect of polypills on cardiovascular outcomes.”

Experts say this clinical trial, with its thousands of participants, helps strengthen the argument for the use of polypills among people who’ve had heart attacks.

They say this could potentially lead to approval from the Food and Drug Administration (FDA), which would be a first for this particular medicine.

“These results are encouraging,” Dr. Ronald Grifka, the chief medical officer and chief clinical quality officer for University of Michigan Health-West, told Healthline. “By combining all three medications into a single pill, patient compliance would markedly improve, since a patient would only need to take one pill just once a day, rather than taking three separate pills once or several times a day. Also, the polypill uses generic forms of these medications, which are less expensive and readily available worldwide.”

“Studies like this confirm what the doctors in the market already know,” added Shaili Gandhi, PharmD, vice president of formulary operations at RxSense. “Heart issues are not caused by one specific issue in a patient. There can be many contributing factors to a heart event. Therefore, combating as many of these issues is the best way to see a decrease in heart events. Polypill therapy is not new and is seen frequently in practice.”

Other fixed-dose combination medications are currently used and approved to treat other conditions, including HIV and hepatitis C.

This cardiovascular polypill comes in a variety of potential formulations.

Each has a 100 mg dose of aspirin and then either a 2.5, 5, or 10 mg dose of the blood pressure medication ramipril, and a 20 mg or 40 mg of atorvastatin.

That’s convenient, but it also highlights one of the key limitations of polypills — the inability to fine-tune a dosage for a specific person.

And there are other related drawbacks.

“Not every patient needs all 3 medications to improve their cardiovascular health,” Grifka explained. “And if a patient has a reaction to one of the medications in the polypill, it might be difficult to determine which of the three medications is causing the reaction, and you can’t just eliminate or change that one medication.”

Still, the fact that polypill users reported greater adherence to their medication routine and had better cardiovascular outcomes suggest polypills are a worthwhile pursuit, at least for some people.

“Whether mass administration of a polypill is warranted remains an important unanswered question,” Wang wrote. “Nonetheless, the tool… is a safe and effective strategy to deliver indicated cardiovascular therapies, one that deserves a role in clinical practice.”

“The biggest benefit of polypills is that the patient is able to get under control multiple contributing factors that can lead to a heart event – control cholesterol levels and control blood pressure,” Gandhi told Healthline. “Most of these medications have a very mild side effect profile and are very safe to use together.”

Whether we’ll actually see the polypill authorized in the near term remains to be seen, however.

Wang noted that so far, polypills have received little commercial interest from major pharmaceutical manufacturers that would have to seek out FDA approval.

“Due to several confounding issues, the FDA has not approved a polypill for cardiovascular disease,” Grifka said. “Time will tell if a polypill is approved for cardiovascular diseases and becomes the standard of care.”