The study of “Polypill” is one of the most important studies conducted at the Digestive Diseases Research Institute (DDRI), which resulted in the production of an effective drug for the prevention of heart attacks and brain strokes

According to statistics in Iran, 55%  of Iranians die under the age of 70 and  35%  of Iranians who die from heart attack are under 55 years old! An assessment of mortality rates and trends in 1990 showed that from 340,000 deaths, 277,000, equivalent to  81% , were premature (below the age of 70). Furthermore, in 2016, out of a total of 360,000 deaths, 193,000, equivalent to  53% , were premature, of which 124,000 were in men ( 57% of total deaths in men), and 69,000 deaths were in women ( 49%  of total deaths in women)

Premature deaths in Iran have become a bitter reality and of concern for the country’s health care system as the main cause of deaths in Iranians under the age of 70 are cardiovascular diseases, ensued by heart attack and / or brain stroke.

Lifestyle modification is considered one of the most important interventions for the prevention of cardiovascular diseases and controlling its risk factors for which relevant national and provincial policies are being developed at the Ministry of Health and Medical Education (MOHME). That said, the importance of medication interventions in the prevention of heart attack and brain stroke as well as other chronic diseases is continuously emphasized.

This is while a large number of various prophylactic drugs used for the prevention of Myocardial Infarction (MI) and Transient Ischemic Attack (TIA) cause fatigue, confusion and even discouragement of those individuals under treatment with these medications. On the other hand, the increase in the number of medications that are consumed accompanies a psychological burden for the affected individual.

While the objective of the Golestan Cohort Study was to determine the causes and prevention of esophageal and gastric cancer, six years after following up in the study, the research analyses of researchers from the Digestive Diseases Research Institute (DDRI) at of Tehran University of Medical Sciences (TUMS) demonstrated that half of the study population expired due to heart attacks and brain strokes. An assessment of the risk factors for MI and TIA also indicated that more than %50  of individuals over 50 years of age had hypertension.

Continuous assessments have shown that consuming aspirin, antihypertensive drugs, and lipid lowering agents, provided being used on a regular basis, along with lifestyle modifications can reduce up to  50% of deaths from cardiovascular diseases.

In obtaining the results from the Golestan Cohort Study, the study’s executive team sought a simple strategy for reducing MI and TIA rates, as well as premature deaths, while relying on data from more than 50,000 participants in the study and documented causes of deaths. In a study carried out by two English scholars, Wald and ... , a drug named "Polypill" was finally proposed for the prevention of MI and TIA.

 After a thorough review of the topic and the feasibility of conducting this study, meetings were held with and consultations were sought from leading international researchers from around the world, and the World Health Organization (WHO), as well as the Public Health Department of the University of Birmingham in England. In considering all aspects of the matter and scientific advice from cardiovascular, endocrinology and internal medicine specialists from Tehran University of Medical Sciences, Golestan University of Medical Sciences, and physicians in the region, following approval from the Medical Ethics Committee, the foundations of the study of "Polypill" were set in the context of the Golestan Cohort Study.

The Executive Team of the pilot study for “Polypill” at Kalaleh Heart Center

 

Dr. Malekzadeh and a group of collaborators from the “Polypill” study in the city of Kalaleh


Prof. Kiki Chang, a representative from the Cancer Research UK Center, visiting the “Polypill” study site

The “Polypill” pilot study in the town of Kalaleh was launched in collaboration with the city’s health and wellness network for a year (2016) on 475 patients aged 40 to 70, which produced positive results, indicating that the pill is well tolerated in consumers. The main phase of the study, which its implementation with 8,000 samples began in 2013, is currently in its final stages. The preliminary evaluations have demonstrated its efficacy in the primary and secondary prevention of complications in patients with a history of cardiovascular disease, as well as primary and secondary prevention in healthy individuals who are at risk for developing cardiovascular disease over the age of 50, and has not shown any significant side / adverse effects.

Dr. Malekzadeh's meeting with physicians during his explanation of the benefits from “Polypill” in the city of Kalaleh
 

 
Dr. Malekzadeh's speech among cardiovascular specialists in Tehran regarding the importance of the prevention of MI and TIA, and the effects of “Polypill

At the same time as implementing the Polypill project, the assessment of the effects of this medication on the liver also began. 1500 individuals over the age of 50 residing in the city of Gonbad participated in the Golestan Cohort Study and analysis of the results from the effect of Polypill on the liver after nearly 5 years demonstrated its positive effects on the prevention of MI and TIA in patients with fatty liver disease.

 

Ultrasound procedure by Dr. Radmard and imaging by Dr. Basharat, members of the Polypill pilot study, “The efficacy of Polypill in the prevention of heart attacks and brain strokes due to fatty liver disease"

The importance of studying the efficacy of Polypill in the prevention of MI and TIA in patients with fatty liver disease is particularly noticeable since at least  30% of Iranians are affected by fatty liver disease. Of note, serious complications of fatty liver disease do not only affect the liver. While most individuals with fatty liver disease may not experience liver problems during their lifetime are prone to MI and TIA, such that the most important cause of death in patients with fatty liver disease are heart attacks and brain strokes. While from every 375,000 deaths per year in the country, 100,000 deaths are premature (under the age of 70), fatty liver disease is also a major contributor to MI and TIA and as a result, premature deaths in the country; the prevalence and burden of which, as shown by are rapidly increasing in our country.

 Currently, Polypill which is sponsored by the Barakat Foundation, has entered Iran’s Pharmacopoeia and its manufacturing license has been issued by Alborz Drug Company. This medication is available in two types of Polypill 1: aspirin (81 mg), enalapril (5 mg), atorvastatin (20 mg) and hydrochlorothiazide (12.5 mg), and Polypill 2 (for those who suffer from coughing, a side effects induced by enalapril), which includes aspirin (81 mg), valsartan (40 mg), atorvastatin (20 mg) and hydrochlorothiazide (5.12 mg).

 

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