The "PolyIran study", conducted by the Digestive Diseases Research Institute of Tehran University of Medical Science in collaboration with Golestan, and Isfahan Universities of Medical Science and researchers from international research institutes in the United States and the United Kingdom, and lead by Professor Reza Malekzadeh, the main PI of the Golestan Cohort Study and Persian Cohort Study , is published in an article entitled Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial in "the Lancet".
Dr.Gholamreza Roshandel Dr. Hossein Poustchi Dr. Masoud Khoshnia
Dr.Tom Marshall Dr. Nizal Sarrafzadegan Dr. Shahin Merat Dr. Alireza Nateghi
The results of this study show that using PolyPill could prevent myocardial infarction and strokes and deaths due to them up to 34%, and its effect will be increased by improving patients' adherence to continuous use of this drug. So that in the PolyIran study, with 70% participants' adherence to PolyPill, the effect of the drug on primary prevention of myocardial infarction and strokes reached more than 57%.
The PolyIran study was conducted nested in the Golestan Cohort Study, the largest cohort study in the Middle East and North Africa. It was a study which was carried out since 1997 to identify the causes of esophageal cancer outbreak high prevalence in northeastern Iran with more than 50,000 participants aged 40 to 75 years. Following achieving important national and international results in the field of gastrointestinal cancers, this study evaluated the non-communicable diseases especially CVD which is the main etiology premature draths.
The results of the Golestan Cohort Study showed that half of the participants died of cardiovascular diseases and myocardial infarction and strokes. Furthermore 30% of the deaths due to cardiovascular diseases occurred under the age of 60 years and 64% happened under the age of 70 years.
In the five-year PolyIran study which was conducted on 6,838 individuals over 50 years old, 236 villages in the province were divided into two intervention and control groups. Then 116 villages with 3,417 participants received healthy lifestyle training (healthy diet, exercise, smoking cessation, etc.) without taking PolyPills, and 3,421 residents in 120 villages took one PolyPill tablet daily in addition to receiving healthy lifestyle training.
The PolyPill tablet used in this study, was developed by Irania researchers in 2010 and was a combination of 81 mg Aspirin, 5 mg Enalapril (40 mg Valsartan for those who have cough with Enalapril), 20 mg Atorvastatin and 12 mg Hydrochlorothiazide which was considered the most important essential medicines for prevention cardiovascular diseases .
The number of men and women in this study was equal. Over 82% of the participants were Turkmen, 10% reported a history of cardiovascular diseases, 15% had diabetes, 49% had hypertension and 5% had a history of smoking. The majority of the participants were similar to the general population.
Professor Reza Malekzadeh
According to Professor Reza Malekzadeh, the findings of this study indicate that overall 71% of the participants have been adhered to "PolyPill ".
However, he emphasized that since the effect of PolyPill on reducing cardiovascular diseases and myocardial infarction and strokes is strongly correlated with patients' adherence to it, the results of the PolyIran study showed that overall, PolyPill reduced cardiovascular events by 34%, but in people whose adherence was 70%, the effect of the drug was 57%.
The longest and largest community-based clinical trial to prove PolyPill's potential to reduce premature CVD deaths
According to the Digestive Diseases Research Institute of Tehran University of Medical Science, prior to this long-term follow-up clinical trial by Iranian researchers, short-term follow-up clinical trials in a number of countries including the UK, have shown that using PolyPill combinations for cardiovascular diseases can decrease blood pressure and lipid profile and also prevent myocardial infarction and strokes. But Dr. Gholamreza Roshandel, the first author of the "PolyIran" study and Associate Professor Golestan University of Medical Sciences, says that what has made the study of "PolyIran" leading the world is that it is the longest and largest "community-based" clinical trial which by proving increased patients adherence to PolyPill use, has shown the potential of this idea in opening new doors to primary and secondary prevention of cardiovascular diseases and myocardial infarction and strokes, and also has significantly reduced the burden of these diseases at the community level for the first time in the world with the strongest scientific evidence.
Iranian research team's historic effort to combat premature deaths as the major global health problem
" The Lancet", describes the study by Iranian researchers as a historic effort by a research team to understand the potential value of PolyPill in combating premature deaths as the major global health problem, which has been achieved based on a strong research infrastructure for doing long-term clinical trials.
" The Lancet" also emphasize the findings of Iranian researchers in the "PolyIran" study very useful especially for middle- and low-income countries which bear 80% of the global burden of myocardial infarction and strokes, as well as for other countries in the field of prevention of cardiovascular events.
Who can use "PolyPill"?
"PolyPill" is usable for people over 50 and has two prophylactic uses:
At the primary prophylactic level (those who have at least one risk factor among the risk factors for hypertension, hyperlipidemia, diabetes, smoking, drugs, obesity and inactivity, and also have a moderate risk for cardiovascular diseases), the daily intake of one tablet reduces the risk of cardiovascular attacks significantly.
At the secondary prophylactic level (those who have two or more risk factors and have a history of coronary heart disease, myocardial infarction or stroke), daily intake is also very important and essential. This medicine is only contraindicated in patients who have specific allergies or contraindications to this drug.
In this regard Professor Malekzadeh emphasizes that taking PolyPill tablets will have better results if combined with a healthy lifestyle. Taking this medicine should not disrupt the healthy lifestyle.
Why has PolyPill been a global strategy for preventing myocardial infarction and strokes?
According to the statistics, cardiovascular diseases kill 18 million people each year, with 75% of these deaths occurring in low-income and middle-income countries.
Also the number of years lost due to disabilities caused by cardiovascular diseases has increased by 16% in the past decade.
But the most remarkable point is premature deaths due to cardiovascular diseases and myocardial infarction and stroke.
The share oflow-income and middle-income countries in the early deaths due to these diseases is 80%
According to international researchers, with the current trend, achieving the goal of "reducing premature deaths caused by cardiovascular diseases to one third in the world by 2030" would not be possible.
Half of Iran's population does not see the age of 70 years!
The incidence of premature (under 70 years of age) and very premature (under 50 years of age) deaths in Iran is much more worrying.
Half of Iran's 83 million population does not reach the age of 70 and die prematurely.
Of Iran's 380,000 annual deaths, half of them are under 70 years of age and premature.
According to Professo Malekzadeh, the Deputy Minister of Health Research, cardiovascular diseases and myocardial infarction account for half of all premature deaths in Iran, and the age of myocardial infarction in Iran is 10 years below the average of European countries.