FDC treatments, or polypills, are "widely applicable, low cost, and this approach can substantially reduce cardiovascular disease in the population," said lead author Dr. Philip Joseph during a presentation of the results at the European Society of Cardiology Congress 2021.
"The trials included participants from high-, middle- and low-income countries, and therefore our results are globally applicable, and even moderate uptake of such a strategy can avoid between five to 10 million CVD events each year," said Dr. Joseph of the Population Health Research Institute at McMaster University, in Hamilton, Canada.
Therefore, an FDC treatment strategy "could be a key strategy to assist achieving UN sustainable development goals to reduce premature deaths from noncommunicable diseases by one-third by 2030," he added.
The findings, also published in The Lancet, are based on data from more than 18,000 adults (mean age, 63 years; 50% women) with no known vascular disease who participated in the TIPS-3, HOPE-3, and PolyIran trials.
The TIPS-3 trial randomized individuals to a daily polypill containing 40 mg simvastatin, 10 mg ramipril, 100 mg atenolol and 25 mg hydrochlorothiazide, with 74 mg aspirin and monthly oral vitamin D (60,000 IU) or matching placebos.
The HOPE-3 trial randomized participants to a daily polypill containing 10 mg rosuvastatin, 16 mg candesartan and 12.5 mg hydrochlorothiazide or matching placebos.
The regimen in the PolyIran study was a polypill containing 20 mg atorvastatin, 12.5 mg hydrochlorothiazide, 5 mg enalapril (or 40 mg valsartan) and 81 mg aspirin.
The primary outcome was time to first occurrence of a composite of cardiovascular death, myocardial infarction (MI), stroke, or arterial revascularization.
During a median follow-up of five years, the primary outcome occurred in 3.0% of participants taking polypills compared with 4.9% in the control strategy (placebo or usual care), a 38% reduction (hazard ratio, 0.62; 95% confidence interval, 0.53 to 0.73, P<0.0001).
"These effects became apparent even within one year of follow-up and continued to diverge during the course of follow-up," Dr. Joseph reported.
In addition to the reduction in the composite primary outcome, "each individual component was also substantially reduced - CV death by 35%, MI by 48%, stroke by 42% and revascularization by about 46% - and all of these were statistically significant. The largest effects were observed when polypills were combined with daily aspirin."
"The benefits were consistent at different metabolic risk factor levels, but appeared to be larger in older populations," Dr. Joseph said.
The U.K.-based authors of a Lancet comment say the "striking consistency" in the results of the three individual trials, despite the different drugs used, provides "further confidence in the conclusion that a fixed-dose combination strategy is effective."
"Guideline writers and policy makers should consider how to incorporate this evidence base into guidelines and policies," write Dr. Jonathan Mant of the University of Cambridge and Dr. Richard McManus of the University of Oxford.
Funding for this research was provided by the Population Health Research Institute. Several authors report ties to drugmakers.
SOURCE: https://bit.ly/38up63C and https://bit.ly/3h6ZK0L The Lancet, online August 29, 2021.
By Megan Brooks
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