“I MOVED FROM STUDYING A MOLECULE, OR MAYBE A CELL, AND I ENDED UP STUDYING SOCIETY”

Dr. Valentín Fuster

“Mexico Healthy Hearts”: Programme for the integral promotion of cardiovascular health in Mexico
As in the rest of the world, cardiovascular diseases are the first cause of death and disability in Mexico. Smoking, hypertension, diabetes mellitus, high cholesterol levels or obesity are cardiovascular risk factors that contribute to the increase in the prevalence rates of cardiovascular diseases. Given this situation, Mexican Social Security Institute (IMSS), in collaboration with Dr. Valentín Fuster, Hospital Mount Sinai in New York, the National Cardiovascular Research Center (CNIC) in Madrid (Spain) and the SHE Foundation, has started the strategy “Mexico Healthy Hearts“, within the IMMS program “With all the Heart“. The objective is to implement in the population different health promotion strategies of proven impact in cardiovascular health. The initiative will be mainly structured from three platforms: ChiquitIMSS (adaptation of the “SI Programme” for the promotion of healthy habits since childhood), PREVENIMSS (application of the “50/50 Program” for the detection and control of overweight/obesity, diabetes, hypertension and dyslipidemia) and the secondary prevention of cardiovascular complications (study of the efficacy of the cardiovascular polypill Sincronium in the improvement of treatment compliance).
Cardiovascular diseases rank as the first cause of death and disability in Mexico.[1,2] The growing rates of cardiovascular diseases have been attributed to the high prevalence of cardiovascular risk factors such as hypertension, high cholesterol levels, obesity, diabetes mellitus or smoking. In fact, in 2008 at least one cardiovascular disease risk factor was seen in 60% of the adult population of the country.[1,2]

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Despite the advances in the knowledge on the prevention and treatment of cardiovascular diseases, the control of risk factors has been poor. Being aware of its function as a health manager, the Mexican Social Security Institute (IMSS), in collaboration with Dr. Valentín Fuster, the National Cardiovascular Research Center (CNIC) in Madrid (Spain), the SHE Foundation, and the Mount Sinai Hospital in New York (US), have undertaken the strategy “Mexico Healthy Hearts”, within the programme “With all the Heart”. The primary objective is the prevention, early diagnosis and timely treatment of cardiovascular diseases, thanks to the implementation of different health promotion lines that have been shown to have a real impact in cardiovascular health in the population (Figure 1).

The IMMS programme “With All the Heart” intends to improve cardiovascular health through health promotion, primary prevention, management of acute events and better secondary prevention of cardiovascular disease. Overall, ”With all the Heart” is structured through seven major lines: 1) the promotion of healthy habits since childhood; 2) the detection and control of the main cardiovascular risk factors; 3) the primary prevention of events in patients at a high cardiovascular risk; 4) the initial diagnosis of cardiovascular events, emergency rooms and ambulances; 5) the reperfusion treatment in patients with ischemic heart disease; 6) the management and prevention of cardiovascular complications; 7) the rehabilitation and secondary prevention of complications and relapses in patients with cardiovascular disease. These 7 areas require efforts at three health care levels, including over 1,500 general medicine units in primary care, 250 secondary hospitals and 25 units of medical specialties, that must be efficiently coordinated to provide quality care.

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Figure 1. Implementation of health promotion strategies through science and education.
The programme “Mexico Healthy Hearts“, aimed at children, adults, families and communities, combines knowledge, experience and promotion of health throughout the life cycle of individuals, from childhood to the acquisition of cardiovascular risk factors and the development of cardiovascular diseases. The programme also approaches treatment accessibility, affordability and compliance in patients already suffering a myocardial infarction.

The Integral Health Programme Mexico Healthy Hearts is based on three strategic lines and intends to implement strategies of proven efficacy in each of these lines. Specifically, Mexico Healthy Hearts considers the development of three platforms: 1) ChiquitIMSS, for the promotion of healthy habits since childhood; 2) PREVENIMMS, for the detection and control of cardiovascular risk factors; and 3) platform for the secondary prevention of cardiovascular complications and relapses.

The ChiquitIMSS platform
This platform will be based on the previous experience obtained in Spain with the “SI Programme“, which had as an objective to promote cardiovascular health since the early life through the acquisition of healthy life habits (related to a good diet or practicing physical activity), the knowledge of the human body and learning to manage emotions. This programme will adapt to the social, educational and behavioral reality of the country by a three-year pilot study with the participation of 200,000 preschoolers, teachers and families of Mexico City. The participating schools will be randomly divided into two groups (1:1). In the first group of schools specific training will be given for the promotion of cardiovascular health (intervention group), in the rest of schools the regular study plan will be given (control group) (Figure 2). Therefore, in each school of the intervention group a coordinating teacher will be designated, who will receive a 30-hour training, conducted by experts, on the contents of the “SI Programme”. Each coordinator will lead the subsequent training of the other teachers and students of his/her school. The intervention will also include activities for the families of these schools during the weekends, as well as an annual health fair.
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Figure 2. Implementation of the “SI Programme” in Mexico.

The PREVENIMMS platform
The objective of the second platform is to detect and improve the control of cardiovascular risk factors in adults. For this, it is intended to perform a study in IMMS employees, that will be randomized into three groups, with an approximate total of 180 individuals per group:

Intervention group: The participants of this group will receive an intervention based on the previous experiences of the “50/50 Programme”, previously developed successfully in the Island of Granada and in Spain Therefore, these participants will attend monthly meetings (of 60-90 minutes duration) with other people with a similar cardiovascular risk profile. These “peer support” meetings will include group dynamics aimed at promoting an internal change in the participants with regard to the control of their cardiovascular risk factors and to develop new self-improvement tools.

Control groups: According to their individual risk profile, the participants of these groups will be also invited to attend informative meetings about nutrition, healthy physical activity, management of stress and reproductive health, as well as on the prevention of smoking and alcoholism. In addition, they will be asked to regularly visit the medical service of their workplace to measure blood pressure and control their progress in relation to their cardiovascular risk profiles.

The primary study objective will be to evaluate in each group, after one and two years of interventions, the average change in a score formed by variables such as blood pressure, exercise, weight, diet and smoking (Fuster-BEWAT, 0-15 score). The secondary objectives will include the individual change in blood pressure, weight, body mass index, total cholesterol levels, smoking cessation, physical activity, quality of life, compliance with diet change, and stress.

Platform for the secondary prevention of cardiovascular complications and relapses
In the third platform (integrated in the existing infrastructure of the IMSS programme
“Secondary prevention of recurrences and complications”), a pilot study will be performed for the purpose of investigating if the Sincronium polypill (grouping three components into a single pill: simvastatin 40 mg, acetylsalicylic acid 100 mg and ramipril 2.5, 5 or 10 mg) can improve treatment compliance in patients with cardiovascular disease and thus prevent the occurrence of new events, such as infarctions or stroke (secondary prevention). A total of 516 patients older than 40 years previously suffering a myocardial infarction will be included and randomized into two groups (1:1; one group will be treated with the polypill, and the other group with the current conventional treatment; Figure 3).

 

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Figure 3. Schedule of proposed visits for platform 3 of the programme “Mexico Healthy Habits”. MMAS: Morisky Medication Adherence 8 Item questionnaire; SBP, systolic blood pressure; DBP, diastolic blood pressure; LDL, LDL cholesterol, TSQ, treatment satisfaction questionnaire (medication); QoL, quality of life.

In a first phase (12 months), the study will focus on evaluating if the polypill can help patients improve their treatment compliance (thanks to the reduction in the number of pills to be taken every day). For this, a specific questionnaire called Morisky Medication Adherence Questionnaire will be used (primary objective). In addition, the impact of the polypill on several secondary objectives will be evaluated, such as the improvement of quality of life, the control of cardiovascular risk factors (cholesterol and blood pressure), drug safety and tolerability and degree of patient satisfaction. An economic analysis will also be performed comparing Sincronium to the conventional treatment to evaluate the differences of costs between the two treatments and their cost-efficacy.

After this first study phase, a randomized clinical trial will be performed with a greater participation and the primary objective of demonstrating that the patients treated with Sincronium will benefit from a reduction in some clinical events, such as death, non-fatal myocardial infarction, non-fatal stroke and revascularization. The implications of this study could be important, as the efficacy of a public health strategy already available in Mexico will be measured. In addition, the outcomes could be applied to other Latin American countries with a similar situation with regard to the cardiovascular disease.

References

  1. Health Secretariat. Available at: http://www.salud.gob.mx/unidades/cdi/documentos/enf_cardiovasculares.pdf. Seen on 07/15/2016.
  2. Instituto Nacional de Estadística y Geografía (INEGI). Available at: http://www3.inegi.org.mx/sistemas/mexicocifras/. Seen on 07/15/2016.