Combining three heart drugs into a single “polypill” may lower the risk of major cardiovascular events and death in older adults, according to a new study published in the New England Journal of Medicine.
Presented at the European Society of Cardiology Congress in Spain, the study showed that individuals who have a history of heart attacks experienced fewer heart issues when taking a 3-in-1 pill made up of multiple medications than those who took the medications separately.
"The use of a cardiovascular polypill as a substitute for several separate cardiovascular drugs could be an integral part of an effective secondary prevention strategy," the study said. "By simplifying treatment complexity and improving availability, the use of a polypill is a widely applicable strategy to improve accessibility and adherence to treatment, thus decreasing the risk of recurrent disease and cardiovascular death."
While the study's findings are new, the polypill has been around for quite some time. Here's a closer look at why the trial was unique and what its broader implications may be.
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Reduced Cardiovascular Events Among Polypill Users
The new study involved 2,499 patients located across 113 centers in Europe. All participants had a history of heart attacks—specifically type 1 myocardial infarction— and were also over the age of 75 or a minimum of age 65. Additionally, all participants had at least one risk factor ranging from diabetes to mild or moderate kidney dysfunction.
Patients were randomly assigned to either continue their usual course of treatment or begin taking a polypill instead. The polypill that was provided contained 100 milligrams of aspirin, 2.5, 5, or 10 milligrams of the ACE inhibitor ramipril, and 20 or 40 mg of atorvastatin.
“The concept is that instead of sending somebody home with a bunch of new medications in different categories, you’re sending them home with one pill that they would have to take to lower their cholesterol, lower their blood pressure, and prevent further heart attack,” Nicole Weinberg, MD, a cardiologist at Providence Saint John’s Health Center, who was not invovled in the study, explained.
Study participants were tracked for three years to determine whether they experienced any further heart complications. Follow-up visits involved recording a patient's blood pressure and taking fasting blood samples.
The results of this effort showed 48 cardiovascular deaths among the polypill group and 71 from within the group of patients that continued following their usual course of care. This finding translates into a relative risk reduction of 33% for cardiovascular death among those who took the polypill.
About 12.7% (118 of 1,237) patients either died from cardiac problems, had a nonfatal heart attack, had a nonfatal ischemic stroke, or required an emergency medical procedure to restore blood flow to blocked veins and arteries. In contrast, these types of cardiac events occurred in only 9.5% (156 of 1,229) of patients in the polypill group.
However, when people from both groups died, the researchers observed they were usually similar causes of cardiac death.
What Makes the Polypill Effective?
One explanation behind the effectiveness of the polypill is the convenience people felt taking one pill instead of multiple drugs. The study found that people were more likely to adhere to the treatment—taking it as directed and refilling it as needed—when taking the polypill versus their usual standard involving multiple medications.
"The issue is a lot of people come in for a heart attack and then find out when they're admitted that they're also diabetic or have high cholesterol," Dr. Weinberg says. "They'll leave with five or six medications, but putting them on one pill makes it more manageable for someone who has had 'no problems' before."
About 91.7% of people in the polypill group received a polypill containing a 40 mg dose of atorvastatin, while the usual-care group was treated with a high-potency statin. Over 90% of people in the usual-care group also received two separate drugs, aspirin and an antiplatelet agent.
The level of adherence was 70.6% in the polypill group and 62.7% in the usual-care group. After two years, 74.1% of people took the polypill as directed, compared to 63.2% in the usual-care group. A satisfaction survey revealed that people taking the polypill were happier with their treatment than those who continued their typical medication regimen.
Dr. Weinberg says it's no surprise the polypill worked so well since the drugs inside are constantly used for cardiac prevention. But "the biggest eye-opening situation for this is making a pill where everything is together and proving to people that once you're on this regimen, you have good outcomes," she explained. "It's more of a compliance type of study and less of a proof [of concept] that these medications work."
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Concerns Associated With Polypill Usage
There are of course risks of adverse drug reactions anytime you give someone multiple medications, said Dr. Weinberg. And by its very nature of combining three medications into one pill, the polypill could make it harder for doctors to pinpoint what is causing side effects for a patient.
"You could give someone a medication with three pills in it, and they break out in hives or severe diarrhea. You'll have to tease it out—Is it the blood pressure medicine or the cholesterol doing this?" Dr. Weinberg explained.
Yet another concern pointed out by Dr. Weinberg is that unless each polypill is personalized to each patient, there is no "one dose fits all" medicine that exists.
"If you have a patient who has a bit more resistance, blood pressure or cholesterol issues, and they need to be on a higher milligram dosage, then maybe you have to tweak one medication but not the others," Dr. Weinberg continued. "The manufacturer has to have multiple permutations for this drug. So putting multiple drugs together just amplifies the amount of permutations that you're going to need to make in order to include different milligram dosages."
Changing the type of medication or dosage however, makes part of the polypill kind of useless for that patient, Sanjiv Patel, MD, a cardiologist at MemorialCare Heart & Vascular Institute at Orange Coast Medical Center, told Health.
The best course of action may be to talk to your doctor before taking the polypill in order to find out more about what's in it and the potential side effects, Dr. Patel said.
The Future of the Polypill
Most research, including the current trial, involves testing the use of polypills to prevent further heart complications. But experts say using polypills in other fields of medicine is not out of the realm of possibility. For instance, combining medications has been seen in oncology and HIV treatments, said Dr. Patel.
Doctors may even eventually prescribe the polypill for non-cardiac conditions such as autoimmune disorders or gastroesophageal reflux disorder. "Maybe those patients will start off with just antacid, but then the acid builds up, and you need a proton pump inhibitor, so you add that to the mix," Dr. Weinberg said. "And then maybe you need to be on constant medication like Gaviscon or a Tums on top of that."
Although Dr. Weinberg warns that with these pills, doctors will need to consider the risks, benefits, and alternatives treatment options.
And while the current study involved age restrictions including being a minimum of 65 to participate, Dr. Patel says it's not unreasonable to give a polypill to someone younger than that.
"Logically, it would work on younger people, but we don't have concrete data yet for this particular pill," said Dr. Patel.
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