Results of the PolyIran study, which examined more than 6000 patients, found that use of a polypill reduced the risk of major cardiovascular events.
Results of the PolyIran study are shining a new light on the impact of polypill in preventing major cardiovascular (CV) 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 and 75 years old.
In an effort to assess the efficacy and safety of a 4-component polypill, which included aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan, for prevention of primary and secondary cardiovascular events, investigators carried out a 2-group randomized trial using participants from the Golestan Cohort study. Investigators randomized clusters to receive either package of non-pharmacological preventative interventions alone or in combination with a once-daily polypill tablet.
For the PolyIran study, investigators included 28,660 participants between the ages of 50 and 75 years old from rural areas in Iran. The PolyIran study included multiple inclusion criteria including hypersensitive to one of the components of the polypill, a history of angioedema, history of GI bleeding, history of stroke, or were pregnant.
All participants in the study received minimal care, which included multiple non-pharmacological interventions including exercise, weight control, educational information on a healthy diet, and abstinence from smoking and opium. Of the 28,660 patients identified, 13,875 were invited to participate in the the PolyIran study.
The primary outcome of the study was the occurrence of major CV events during the 60-month follow-up period. Major CV events were defined as acute coronary syndrome, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularization procedures, and non-fatal and fatal stroke. Secondary outcomes were classified as the second occurrence of each major CV event individually.
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.
Of the 6838 participants, 3417 were randomized to the minimal care group and 3421 were randomized to the polypill group. Investigators noted that median adherence in the polypill group was 80.5%.
During the follow-up period, 8.8% (n=301) in the minimal care group experienced major CV events compared with 5.9% (n=202) of participants in the polypill group. Investigators found no statistically significant interaction with the presence (HR 0.61, 95% CI, 0.49-0.75) or absence (HR 0.80; 0.51-1.12, P=0.19) of preexisting CV disease.
When analyzing only those with the highest adherence in the polypill group, investigators noted greater reduction in the risk of major CV events compared with the minimal care group (aHR 0.43, 95% CI, 0.33-0.55). Investigators also noted similar rates of adverse events between the 2 groups.
The study, “Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial,” was published online in The Lancet.