Once-daily polypill shows promise for CV prevention: PolyIran
A once-daily, fixed-dose polypill including aspirin, atorvastatin, hydrochlorothiazide and enalapril or valsartan was effective for the prevention of major CV events in adults living in low- and middle-income regions, with high adherence and low adverse events.
According to a new study published in The Lancet, in a cohort of participants living in the low- to middle-income Golestan region of Iran (n = 6,838; aged 40-75 years; 50.4% women; 10.8% preexisting CVD; 15% diabetes), a once-daily polypill in combination with educational training on healthy lifestyle, diet, weight control, and abstinence from smoking and opium, resulted in a lower incidence of major CV events (HR = 0.66; 95% CI, 0.55-0.8) compared with participants who did not receive the polypill. Further, the reduction in risk for major CV events improved with greater adherence to the polypill (HR = 0.43; 95% CI, 0.33-0.55).
Additionally, the researchers reported no significant difference in CV outcomes if participants had preexisting CVD (HR = 0.61; 95% CI, 0.49-0.75) or no CVD (HR = 0.80; 95% CI, 0.51-1.12; P = .19).
“For clinical practice, the main message is that we should not wait until heart attack or stroke [occurs] and then start treatment. Rather, we should prevent heart attack and stroke in apparently healthy people who have one or more risk factors by starting prevention with a once-daily polypill, which is very safe,” Reza Malekzadeh, MD, director of the Digestive Disease Research Institute at the Tehran University of Medical Science, Iran, told Cardiology Today. “In low- and middle-income countries, we should [aim to prevent] heart attack and stroke, which is presently one of the major etiologies of premature death and disability. We can do this using polypill.”
In other findings, the overall frequency of adverse CV events was similar between the minimal care group and the polypill group, for incidence of intracranial hemorrhage (polypill group, 0.6% vs. minimal care group, 0.3%) and gastrointestinal bleeding (polypill group, 0.4% vs. minimal care group, 0.3%).
The PolyIran study was a pragmatic, cluster-randomized trial nested in the Golestan Cohort Study. Researchers enrolled participants living in low- to middle-income areas in the Golestan region of Iran and divided participants into two groups: fixed-dose polypill treatment or minimal care. Both groups received educational training on a healthy lifestyle, diet, weight control, and abstinence from smoking and opium, which is a common practice among participants in this cohort. Educational training was provided by PolyIran field visit teams at 3 and 6 months, then every 6 months thereafter, with follow-up for 60 months.
The primary outcome was occurrence of major CV events, which included hospitalization for ACS, fatal MI, sudden death, HF, coronary artery revascularization procedures, and non-fatal and fatal stroke.
The polypill administered to participants contained aspirin 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg and enalapril 5 mg, unless a participant developed a cough, in which case he or she was switched to a formula containing valsartan 40 mg instead.
Median adherence to the polypill tablets was 80.5% (interquartile range, 48.5-92.92).
The researchers noted that research and extended follow-up will continue.
“This study was performed in rural North east Iran and 80% of participants were Turkmen,” Malekzadeh said. “We are presently doing another trial in Southern Iran where the ethnicity is 80% Persian, including participants who are somewhat more prone to heart attack and stroke, to ensure that the results of this study is generalizable to different ethnicities.” – by Scott Buzby
For more information:
Reza Malekzadeh , MD, can be reached at: email@example.com.
Disclosures: Malekzadeh reports no relevant financial disclosures. The other authors report no relevant financial disclosures.