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Low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo.
The combination of a polypill comprising statins, multiple blood-pressure-lowering drugs, and aspiring could reduce the overall risk of developing cardiovascular disease.
A team, led by Salim Yusuf, DPhil, MBBS, Population Health Research Institute, McMaster University and Hamilton Health Sciences, examined whether this combination therapy could result in a drop in cardiovascular deaths or severe outcomes when compared to a placebo.
The researchers used a 2-by-2-by-2 factorial design, the researchers randomly assigned 5713 patients without cardiovascular disease who had an elevated INTERHEART Risk Score to receive either a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly.
The results include outcomes for the polypill alone compared to a matching placebo, for aspirin alone compared to a matching placebo, and for the polypill with aspirin compared to the double placebo.
The investigators sought primary outcomes for the polypill-alone and polypill-plus aspirin arms of the study was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization.
They also sought primary outcomes for the aspirin comparison of death from cardiovascular causes, myocardial infarction, or stroke.
There was a mean follow-up of 4.6 years.
Overall, the low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo.
The investigators found the primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (HR, 0.79; 95% CI, 0.63-1.00).
For the aspirin group, the primary outcome occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (HR, 0.86; 95% CI, 0.67-1.10).
For the polypill-plus aspirin combination, the primary outcome occurred in 59 individuals (4.1%) in the treatment group and in 83 (5.8%) individuals in the double-placebo group (HR, 0.69; 95% CI, 0.50-0.97).
The incidence of hypotension or dizziness was higher in groups that received the polypill than it was in their respective placebo groups.
“Combined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk,” the authors wrote.
Past Research Shows Promise
In 2019, researchers from the PolyIran study found the polypill is effective at preventing major cardiovascular events.
The study, which followed more than 6000 participants for up to 60 months, found that use of a once-daily, fixed-dose polypill reduced the risk of major CV events in patients between the ages of 50-75 years old.
Investigators used 2 unique formulations of polypill during the study. Polypill 1 included 12.5 mg of hydrochlorothiazide, 81 mg of aspirin, 20 mg of atorvastatin, and 5 mg of enalapril. A second polypill was given to patients who developed cough during follow-up. Polypill 2 contained 40 mg valsartan instead of 5 mg enalapril.
The study, “Polypill with or without Aspirin in Persons without Cardiovascular Disease,” was published in The New England Journal of Medicine.