HealthTrust’s pharmacy resident reviews new cardiovascular drugs approved by the FDA in 2015 and a few in the pipeline that could help improve patient compliance.
Several promising and very costly cardiovascular drugs were introduced in 2015 that should get some ink in forthcoming versions of national clinical care guidelines. So too could pharmaceuticals in the pipeline that hold tremendous promise from the standpoint of patient compliance.
Eight drugs have been added so far this year to the drug arsenal against heart disease, which kills about 600,000 patients annually. Disease prevalence is particularly high in the southern United States, Michigan and West Virginia and, based on statistics from the Centers for Disease Control and Prevention, has a degree of correlation to unemployment rates. But nearly half the entire U.S. population has at least one of three risk factors (high blood pressure, high LDL cholesterol and smoking).
While weight control, exercise and smoking cessation are often the first lines of defense in preventing heart disease, the onset of disease typically requires one or more pharmaceuticals. Here’s a list of some of the cardiovascular drugs receiving FDA market approval in 2015 and their key features:
- Savaysa (Edoxaban) for treating deep vein thrombosis, pulmonary emboli and stroke risk—can be taken once daily, fewer non-major bleeds and low treatment cost, but has no reversal agent
- Corlanor (Ivabradine) for reducing the risk of hospitalization for worsening heart failure—lower likelihood of readmission among patients on background therapy, but no benefit in stable coronary artery disease with or without stable heart failure
- Kengreal (Cangrelor) as adjunct to percutaneous coronary intervention, potential for off-label use, higher rate of bleed and very costly
- Entresto (Sacubitril/Valsartan) for reducing the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure and reduced ejection fraction—more effective in reducing death risk, heart failure hospitalizations and all-cause mortality
- PCSK9 Inhibitors (Praluent/Alirocumab and Repatha/Evolocumab) for heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease— adequately lowers LDL-cholesterol levels, but effect on cardiovascular morbidity and mortality have yet to be determined; attempt to expand indication to cardiovascular risk reduction in 2017
- Praxbind (Idarucizumab) for direct reversal of dabigatran in emergency situations—first-of-its-kind drug providing a therapeutic alternative to treatment with clotting factors and other supportive therapy—an FDA-accelerated approval, so tested in a limited size study population
Of new cardiovascular drugs currently in the pipeline, it’s noteworthy that at least two PCSK9 inhibitors offer more patient-friendly dosing regimens than are currently available—one’s an oral medication and the other a once-yearly injection.
In terms of FDA approvals, 2015 welcomes at least quadruple the number of new cardiovascular drugs than were introduced in 2014. Drug budgets will undoubtedly be feeling the pressure.
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