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Unmet Needs in Cardiovascular Risk Reduction

Unmet Needs in Cardiovascular Risk Reduction

Cardiovascular Disease Overview
Cardiovascular disease (CVD) poses a substantial burden on global health as the leading cause of deaths worldwide, accounting for over 17.3 million per year.1 Diseases and conditions affecting the heart and vascular system fall under the umbrella of CVD. This article focuses on the treatment of high-risk patients with such CVDs as coronary heart disease (CHD), cerebrovascular disease, and hypertensive heart disease.

Atherosclerosis is a causative factor in CHD, cerebrovascular disease, and aortic and arterial diseases, including hypertension and peripheral vascular disease (PVD).1 CHD is the narrowing of the blood vessels that supply blood and oxygen to the heart, and this may lead to unstable angina, myocardial infarction (MI), and heart failure (HF). Cerebrovascular disease, or ischemic stroke, occurs as a result of atherosclerosis, where lipid deposits obstruct circulation to the brain. Hypertensive heart disease is specific to the blood vessels and may include aneurysm, high blood pressure, and peripheral arterial disease (PAD). PAD is characterized by vascular proliferation and remodeling of the small pulmonary arteries, where these changes may result in a progressive increase in pulmonary vascular resistance, ultimately leading to HF and premature death.

Most risk factors for CVD are manageable with lifestyle modifications and effective treatment; however, genetic risk factors have been identified that predispose patients to CVD. Behavioral risk factors for CVD include smoking, sedentary lifestyle, and unhealthy diet; metabolic risk factors include hypertension, diabetes, elevated body weight, and raised blood cholesterol.

Control of lipid levels is one of the most effective strategies for cardiovascular (CV) event prevention.1 Low-density lipoprotein cholesterol (LDL-C) plays an important role in arterial plaque development and progression of atherosclerosis in the pathogenesis of CV events. Circulating LDL-C molecules penetrate the arterial wall endothelium and become oxidized to promote inflammation. In turn, this causes injury to the overlying endothelium and smooth muscle cells, which promotes deposition of cholesterol in the arterial wall.2 Elevations in LDL-C levels directly link to progression from early stage fatty streaks to advanced-stage lipid-rich plaques. Over time, vessels stiffen and atherosclerotic plaques can rupture, triggering thrombus formation in 1 or more coronary arteries. The resulting decreased myocardial blood flow and cardiomyocyte necrosis lead to CHD, MI, and cardiac death. Thrombus development in the brain as a result of atherosclerosis leads to stroke and PVD.1,3

The results of many clinical trials have demonstrated the efficacy of statins at reducing circulating LDL-C levels, primarily to reduce major CV events and related deaths. The evidence from these trials has been useful in designing cholesterol-lowering treatment targets and guidelines that aim to prevent and manage CVD. However, several clinical trials indicate that a large proportion of patients, particularly those at high or very high CV risk, fail to achieve lipid goals. Despite statin efficacy in achieving LDL-C targets, addressing residual CV risk (incidence of CV events in patients receiving statin treatment) is of great importance for the development of novel therapeutics that will reduce CV events.

Burden of CVD in the United States
Since 1918, CVD has been responsible for more American deaths than any other major cause of death, exceeding the mortality rates of cancer and chronic lower respiratory disease combined.4 In fact, deaths due to CVD substantially contributed to the total number of American deaths compared with the other top 10 leading causes of death: cancer (22.5%); chronic lower respiratory disease (5.6%); unintentional injuries (5.2%); Alzheimer’s disease (3.6%); diabetes (2.9%); influenza and pneumonia (2.1%); nephritis, nephrotic syndrome, and nephrosis (1.8%); and suicide (1.6%) (Figure 15 and Table 15).5 Approximately 2200 Americans die of CVD each day, which translates to an average of 1 death every 40 seconds.4 Of the 2,626,418 all-cause deaths in the United States in 2014, CVD, including heart disease and cerebrovascular disease, accounted for 28.5% of them. In addition, CVD is associated with high morbidity, as CV events such as MI and stroke are associated with an increased risk of a recurrent event.6

An estimated 85.6 million American adults are living with 1 or more types of CVD,4 and because the risk increases with age, CVD poses a tremendous burden on the elderly population. More than half (or 43.7 million individuals) of the population affected by CVD comprises adults 60 years and older.4

US Prevalence and Impact of MI and Stroke

CHD may manifest as an MI, which can be both an early predictor of CHD from the first coronary event or a causative factor in a recurrent event.3 In 2012, of the estimated 15.5 million Americans living with CHD at that time, an initial or recurrent MI affected nearly half of that population (7.6 million). In the United States, an MI occurs approximately every 42 seconds, leading to 1 death every minute. In 2013, CHD was responsible for 370,213 US deaths, 116,793 of which were due to an MI; an additional 538,239 deaths were associated with a CHD comorbidity.4

Stroke posed a substantial burden to the United States as the fifth leading cause of death in 2014 (Figure 15 and Table 15).5 Approximately 795,000 Americans experience an ischemic or hemorrhagic stroke each year, with 185,000 having a recurrent stroke (second or subsequent stroke) and most (610,000) experiencing a first stroke. The impact of stroke on the US population translates to 1 stroke event every 40 seconds, leading to 1 stroke-related death every 4 minutes. In 2013, stroke was responsible for 1 out of every 20 deaths in the United States (Table 24).4

Economic Burden of CVD

CVD is associated with a formidable economic burden in the United States, with both high direct medical costs, including hospital and medical resource use, and indirect costs stemming from productivity loss due to CVD-related premature deaths. From 2011 to 2012, direct and indirect CVD healthcare expenditures totaled $316.6 billion, representing a higher burden than any other diagnostic group (Figure 24, Figure 34, Table 34).4 It is estimated that of every $6 spent on healthcare in the United States, $1 is spent on treatment for CVD.7 Of the total $193.1 billion CVD-related direct costs, the most substantial payments were for inpatients, with hospital stays totaling $90.1 billion and emergency department visits adding $7.6 billion. In contrast, outpatient care, including home healthcare and hospital or office provider visits, cost $62.6 billion. Additionally, prescription medication for the treatment of CVD totaled $32.8 billion.4

Despite substantial improvement in CVD outcomes with appropriate medical treatment, the high rates of hospital readmission and event recurrence contribute to the economic burden of CVD. Approximately 24% of patients with HF hospitalizations are readmitted within 30 days after discharge and over 50% of patients with HF are readmitted within 6 months of discharge. Although is it is difficult to predict the cause of CVD-related early readmissions due to the comorbidities and risk factors associated with CVD, it is estimated that up to 75% of early readmissions may be preventable.8

Mortality Burden of CVD

In an effort to reduce the mortality burden of CVD and stroke by 20% in the United States by 2020, the American Heart Association (AHA) addressed the need for behavior modification associated with cardiometabolic risk in their 2020 Impact Goal. Specific measurable targets of CV health improvements are outlined in 7 risk factor categories: blood pressure, physical activity, cholesterol, healthy diet, healthy weight, smoking cessation, and blood glucose.4

Deaths related to CVD and stroke decreased rapidly from 2000 to 2011, with an annual decline of 3.79% for all CVD, 3.69% for heart disease, and 4.53% for stroke. This substantial decline in mortality was associated with marked improvements in smoking prevalence, high cholesterol, and high blood pressure, and increased use of statins in at-risk patients. However, the decrease in CVD mortality substantially slowed from 2011 to 2014, averaging only 0.65% during those years.9 Alarming increases in the prevalence of obesity and diabetes coupled with minimal changes in healthy diet scores and physical inactivity are unlikely to impact projected goals for CV health by 2020 despite overall declines in smoking and hypertension risk factors.9,10 As a result, given substantial increases in the prevalence of behavioral risk factors, the AHA’s 2020 Impact Goal is unlikely to be successful, indicating the continued threat of CVD on overall population health.

Risk Factors Associated With CVD
Genetic Risks and Interaction With Lifestyle Factors

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