Despite advances in cardiovascular (CV) research, global disparities concerning life expectancy, health care resource allocation, and clinical implementation remain. In 2005, the global rate of death from CV causes was 3.3 times greater than AIDS, tuberculosis, and malaria combined. Additionally, four-fifths of all CV events occur in developing countries [Sanz G & Fuster V. Nature Clin Practice Cardiovasc Med 2009]. Due to the magnitude of the problem, biomedical research in developing countries is essential.

Magdi Yacoub, FRS, Imperial College and Founder Patron of Chain of Hope, London, UK, discussed the Chain of Hope program, which has taken measures to promote research and health care in Africa and other regions in need. The objective is to develop local expertise and educate local providers while building a global network and generating region-specific solutions to health care issues, noted Prof. Yacoub. In early 2009, the first Heart Research Center was opened in Addis Ababa, Ethiopia. This new state-of-the-art facility will allow for advanced research in local “neglected” diseases at epidemiological, cellular, and molecular levels and will include continentwide databases, translational research studies, educational programs, and international collaborative efforts. These components are the key to sustainable solutions for global health care, added Prof. Yacoub. Similar projects are also underway in Kenya and Mozambique.

Valentin Fuster, MD, PhD, FACC, Mt. Sinai Medical Center, New York, NY, discussed the global challenges of cardiovascular disease (CVD) and what the future may hold. Conventional CVD risk factors, such as abnormal lipids, smoking, hypertension, diabetes, and abdominal obesity, will contribute to more than 90% of serious CV events (including coronary death, myocardial infarction, and stroke) worldwide in the next decade [Yusuf S et al. Lancet 2004; Vasan RS et al. Ann Intern Med 2005; Pencina MJ et al. Circulation 2009]. Therefore, risk factors, early detection, and prevention must remain a focus moving forward.

Bioimaging is a critical component of early CVD detection. Dr. Fuster and colleagues (in collaboration with the Humana Health Plan) have launched a bioimaging study in the United States that consists of 7300 participants, 6000 of whom will be characterized with respect to their Framingham risk score and imaging features, including coronary calcification, carotid intima-media thickness, the presence of atherosclerotic plaques, and lower extremity arterial insufficiency, as determined by ankle brachial index. The remaining 1300 participants will be excluded from the imaging arm of the study.

The purpose of this study is to identify imaging and/or circulating biomarkers that predict 3-year CV events, improve upon traditional risk assessment, and determine the predictive value of biological and/or imaging markers for 1- to 3-year outcomes. Enrollment began in January 2008, and the study will continue through July 2012. Results from this study could impact CVD detection and prevention approaches worldwide.

Pharmacological therapy is another strategy for prevention that may help with the mounting global CVD crisis in the coming years. However, 50% of patients do not take the prescribed medication [Sanz G & Fuster V. Nat Clin Pract Cardiovasc Med 2009]. Dr. Fuster pointed out that several factors may impede adherence, including complexity of treatment, limited availability of medications, the financial burden of treatment, and inadequate prescription of medication. Therefore, a fixed-dose combination therapy (“polypill”) approach may be a better solution for low-income countries.

The ongoing Centro Nacional de Investigaciones Cardiovasculares fixed-dose combination (CNIC-FDC) therapy project focuses on patients who have suffered an acute myocardial infarction (AMI) and will introduce a polypill that consists of aspirin, a statin, and an angiotensin-converting enzyme inhibitor along with behavioral modification strategies as part of a worldwide prevention program. Another CNIC program, the FOCUS study, will test the efficacy of the polypill post-AMI and assess the magnitude of inadequate prevention and factors that contribute to poor adherence in different socioeconomic environments.

The first phase (n=4000) of the FOCUS study will evaluate economic and health care characteristics, such as the accessibility of care and treatment, out-of-pocket expenditure, food prices, and affordability of treatment. Adherence evaluations, clinical variables, demographics, and patient psychosocial factors will also be assessed during this phase of the study. The second phase (n=1340) of the study will evaluate the efficacy of the three drugs taken separately compared with the polypill. Participants will be seen at 1 month, 4 months, and 6 to 9 months for evaluation of clinical status, adverse effects, adherence and pill counting, lipid profile, and blood pressure.

Results from The Indian Polycap Study (TIPS) indicated that tolerability of the fixed-dose combination pill was similar to that of individual treatments, with no evidence of increased intolerability that resulted from the consolidation of the medications into one pill. The polypill may reduce multiple risk factors and CV risk while offering a convenient adherence solution [TIPS. Lancet 2009]. Based on these data and preliminary findings from CNIC-FDC and FOCUS, Dr. Fuster noted that a polypill might improve secondary prevention worldwide due to its affordability and reduction in treatment complexity.

The polypill has the potential to impact CVD on a global scale, particularly in developing countries, where resources are scarce and adherence is more problematic. Further outreach initiatives and biomedical research programs are needed in order to manage the growing CVD challenges. Identifying biomarkers and sustainable treatment solutions are the first steps in decreasing the global prevalence of CVD and mortality.