This week we acknowledged World Heart Day, a day that global cardiovascular professionals, patients and their families raise awareness about cardiovascular disease (CVD) and highlight the advances we have achieved in fighting these conditions. This year we had a lot to celebrate.
Cardiovascular diseases are the number one cause of death globally, with more people dying annually from CVDs than from any other cause. Over the years we have developed a foundation of drugs, treatments and interventions to manage these conditions. Along with public health measures, death from CVDs has progressively declined in the US, From 2000-2011 the death rate fell by 39%. This is on top of a decades long decline starting in 1950.
Medical advances continue. In the past 18 months, the industry seen a number of advances in the diagnosis and treatment of CVD that could have a significant impact on patients around the world. Three in particular standout as potentially game-changing.
- New treatments for heart failure
In July, 2015 the US Food and Drug Administration (FDA) approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug was also given a Class I recommendation -- the strongest endorsement -- in updated clinical practice guidelines simultaneously released by the American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Failure Society of America (HFSA) in the US, and the European Society of Cardiology in the EU.
Entresto is the first new treatment for chronic heart failure to be made available in many years, and clinical trials showed impressive outcomes in its ability to reduce the rate of cardiovascular death and hospitalization related to heart failure.
- New options for patients who can’t handle statins
In the summer of 2015, FDA also approved two new lipid lowering therapies that address a unique sub-population of patients with high cholesterol. Praluent(alirocumab) is an injection for adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol; and Repatha(evolocumab) is an injection for patients with hereditary forms of high cholesterol and those with cardiovascular disease.
Praluent and Repatha are unique because they are the first two cholesterol-lowering treatments approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors, which fill an important need for people who cannot tolerate statins.
PCSK9 inhibitors are humanized monoclonal antibodies that block the action of the PCSK9 protein. PCSK9 reduces the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9’s ability to do so, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels.
These drugs promise significant relief for this patient population, however adoption rates have been slow. Cardiologists are also clamoring for additional health outcomes data demonstrating whether these drugs significantly cut the risk of heart attacks, strokes and cardiovascular death. Both Repatha and Praluent are being studied in large cardiovascular outcome trials. Results are expected within a year.
- New options for patients with aortic valvular disease
Transcatheter aortic valve replacement (TAVR) or implant (TAVI) has rapidly become the standard of care for patients with severe aortic stenosis, who are deemed too ill to withstand open heart surgery. Using catheters, a prosthetic aortic valve is positioned and deployed, pushing aside the diseased valve and replacing it with an artificial valve. This treatment, which has been around for more than a decade in the EU but was only approved in the US in 2012, can be credited with saving thousands of lives of patients who would otherwise die from end stage valve disease.
In April of this year, results were released showing that intermediate-risk patients with severe aortic stenosis who receive TAVR have similar rates of death and disabling strokes after two years compared to patients who had undergone open heart surgery. Patients receiving TAVR also experienced shorter hospital stays and lower incidence of some major complications compared with those undergoing surgery. These results could potentially affect clinical guidelines for treatment of all patients with aortic valve problems and the appropriate use of TAVR/TAVI in the future. Moving into larger patient populations, in January, FDA approved the launch of the first large, randomized trial of transcatheter aortic valve replacement in low-risk patients.
All three of these advances are incremental improvements to existing therapies, but they all represent real progress in the state of cardiovascular research and treatment options. More importantly, they promise to improve patients’ quality of life, reduce the risk of heart attacks and other complications, and lessen the trauma and cost associated with open heart surgery and long hospital stays.
They also underscore the importance of continuing to invest in cardiovascular research. While we have an excellent selection of treatments for CVD patients, there is always more progress to be made. These innovative treatments demonstrate the extraordinary benefits we can achieve when we support research that pushes the limits of what is possible.