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The Polypill for prevention of cardiovascular disease was first proposed in 2003 and results of the first trials are eagerly anticipated. Regulatory agencies face the challenge of deciding which studies should be requested to meet reasonable demands regarding efficacy and safety of the Polypill in the intended (high-risk) target population. In this Viewpoint, Dr Forslund highlights the important issues that should be considered when generating these regulatory recommendations.
In this Viewpoint, Dr Xavier and colleagues discuss the rationale behind their choice to perform a study on a cardiovascular Polypill in the setting of primary prevention, and behind the drug combinations used in The Indian Polycap study. Results of The Indian Polycap study will be available in April 2009.
Drs Rosenson and Pitt review the pathophysiological mechanisms for the increased cardiovascular risk associated with elevated triglycerides, and provide a rationale for the need to conduct a randomized clinical trial of statin therapy versus combined statin and fibrate therapy in patients with acute coronary syndromes.
Secondary prevention of ischemic heart disease could have a huge impact on the global epidemic of cardiovascular disease. Here Ginés Sanz and Valentin Fuster consider the value of a 'polypill' for secondary prevention, examine the most efficacious combination of agents and explore whether widespread use could improve adherence and improve treatment affordability in low-income countries.
The pharmaceutical development of a cardiovascular polypill presents several unique challenges. In this Review, Dr Guglietta and Dr Guerrero highlight important considerations regarding the selection of the type and number of components, the type of pharmaceutical formulation, and approval by regulatory agencies.
The pericardium, myocardium, coronary arteries and pulmonary arteries are the main cardiac targets for disease in people who are infected with HIV. Mpiko Ntsekhe and Bongani Mayosi discuss the cardiac manifestations of HIV in sub-Saharan Africa, where approximately 70% of the 34 million people worldwide with HIV and AIDS live.
Treatment of patients with amyloidosis is centered on reducing the supply of the respective amyloid fibril precursor protein. This Case Study describes a patient with cardiac acquired monoclonal immunoglobulin-light-chain amyloidosis, who also has an incidental amyloidogenic transthyretin Val122Ile mutation, and illustrates the crucial need to characterize the presence, extent and—most importantly—fibril type of amyloid deposits in patients with amyloidosis.
The authors highlight the benefits of using a beating-heart technique during surgical correction of myocardial bridging in this 10-year-old patient with nonobstructive hypertrophic.cardiomyopathy.
Augoustides et al. present a risk stratification system based on ischemic pattern at presentation in patients with acute type A aortic dissection. The authors believe that, with further validation, the Penn classification system could be used to identify high-risk groups of patients for further intervention and to facilitate future trial design.
Ventricular assist devices (VADs) are associated with thromboembolic events. Aspirin hyporesponsiveness has been associated with an increased risk of future vascular atherothrombotic events, such as acute coronary syndromes and cerebrovascular accidents, but whether this disorder can predict future clinical thromboembolic events in patients with VADs remains unclear. In this article, the prevalence and clinical relevance of aspirin hyporesponsiveness before and after VAD implantation and the role of markers of coagulation and fibrinolysis were assessed.