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Doctors newspaper online, 23.08.2019
Prevention
The polypil seems to reduce the risk of cardiovascular disease. In the largest randomized study to date, the combination drug significantly reduced the number of cardiovascular events.
By Philipp Grätzel von Grätz
34 percent was the risk reduction for cardiovascular events in the lifestyle counseling plus polypil group compared to lifestyle counseling alone.
© FotografiaBasica / Getty Images
TEHERAN. The concept of the polypilla was born more than 15 years ago. One polypil combines ASA, one statin, and two antihypertensives, usually a RAAS inhibitor and a diuretic, at a low dose in a single tablet.
Thus, the medical cardiovascular prevention should be both cost-effective, and – thanks to better compliance, – be effective.
Polypillen are primarily regarded as a means of broad-based prevention in emerging countries where cardiovascular disease is currently on the increase.
PolyIran Study Published
Now, the results of the PolyIran study have been published, in which 6838 people, ages 50+, participated in rural Iran ( Lancet 2019; online August 23 ).
Mostly these were people without (diagnosed) cardiovascular disease. Cardiovascular disease was known in about one in ten subjects, and three out of four in this subgroup received medical treatment.
The PolyIran study was a simple lifestyle intervention consisting of repeated counseling sessions on diet, exercise, and other cardiovascular risk factors compared to lifestyle interventions plus polypil.
The polypilla contained 81 mg ASA, 12.5 mg HCT, 20 mg atorvastatin and 5 mg enalapril. Those who developed a dry cough, was switched to an analogous polypilla with 40 mg valsartan instead of enalapril. Other medications continued as normal.
The study's primary endpoint was severe cardiovascular events, broadly defined as fatal or non-fatal myocardial infarction or stroke, sudden death from any cause, hospitalization for heart failure, or revascularization of a coronary vessel. Randomization was not based on individuals, but as cluster randomization based on entire villages.
Study lasted five years
In addition to the high number of participants, the study duration is remarkable: it was five years. Over this period, 8.8 percent of subjects in the lifestyle counseling group suffered a cardiovascular event.
In the additional polyp group, it was 5.9 percent, a 34 percent relative risk reduction, and 34 percent Numberneeded-to-treat (NNT) over five years.
When only study participants with known cardiovascular disease were evaluated, the relative risk reduction was 20 percent, in absolute numbers 21 percent in the control group and 17 percent in the polypil group. In the primary prevention subgroup, which provided the vast majority of study participants, the relative risk reduction was 40 percent.
The effects were somewhat smaller after adjustment for other cardiovascular drugs but remained statistically significant.
Correlation Compliance and Effect
The scientists around Professor Reza Malekzadeh, University of Tehran, also found a clear link between polypole compliance and the effect size: those who had taken more than 70 percent of their tablets correctly, in which the relative risk reduction compared to the control group was 57 percent, in absolute frequencies 4 percent versus 9 percent. That's equivalent to an NNT of twenty over five years.
All this was not associated with significantly lower mortality, but the study was not designed for mortality.
5.9 percent of patients died in the study group and 6.5 percent in the control group in the 5-year study group. There were no differences in various adverse events, including intracranial haemorrhage, peptic ulcer, and upper gastrointestinal bleeding.
Overall, the polypole is therefore a very promising approach to improve the cardiovascular health at the population level, also in view of their low cost, said co-author. Nizal Sarrafzadegan from the University of Isfahan.
All the more so since more than three-quarters of people with cardiovascular disease lived in low- and middle-income countries.
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