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Vol. 70. Issue 2.
Pages 123-124 (February 2017)
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Vol. 70. Issue 2.
Pages 123-124 (February 2017)
Scientific letter
DOI: 10.1016/j.rec.2016.10.018
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Selection of the Best of 2016 in Clinical Cardiology: Therapeutic Novelties
Selección de lo mejor del año 2016 en cardiología clínica. Novedades terapéuticas
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Vivencio Barriosa,
Corresponding author
vivenciobarrios@gmail.com

Corresponding author:
, Carlos Escobarb, Juan Cosin-Salesc, Domingo Marzald
a Servicio de Cardiología, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
b Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain
c Servicio de Cardiología, Hospital Arnau de Vilanova, Valencia, Spain
d Servicio de Cardiología, Hospital de Mérida, Mérida, Badajoz, Spain
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To the Editor,

The results of important clinical trials were published in 2016 with far-reaching implications for clinical cardiology practice.

The PARADIGM-HF trial1 compared the effects of valsartan/sacubitril (LCZ696) 200mg twice daily vs enalapril 10mg twice daily added to standard therapy in about 8500 patients with symptomatic heart failure (HF), New York Heart Association functional class II-IV, and ejection fraction ≤ 40%. The primary outcome was a composite of death from cardiovascular causes or HF hospitalization. The trial was stopped early after a median follow-up of 27 months due to the strength of the positive results achieved with valsartan/sacubitril. LCZ696 was associated with a 20% reduction in the risk of the primary outcome and a 16% reduction in death from any cause. In addition, LCZ696 reduced HF symptoms and improved functional class.1 These results have led the new European guidelines2 to recommend the use of valsartan/sacubitril instead of angiotensin-converting enzyme inhibitors to reduce the risk of HF hospitalization and death in ambulatory patients with HF and reduced ejection fraction who remain symptomatic despite optimal treatment (IB recommendation). It has also recently been shown that valsartan/sacubitril therapy can be cost-effective in this context.3

Diabetes mellitus is one of the major epidemics of the 21st century. As is well known, diabetes increases the risk of both microvascular and macrovascular complications. Glycemic control through antidiabetic therapy effectively reduces microvascular complications and even macrovascular complications in patients with less advanced disease. However, intensive lipid-lowering therapy can be harmful in patients with more advanced diabetes. Since 2008, due to doubts about the cardiovascular safety of some drugs, all antidiabetic drugs must demonstrate cardiovascular safety in specific clinical trials, in addition to reducing glycated hemoglobin levels, before they can be approved for use in clinical practice. In this context, the cardiovascular safety of dipeptidyl peptidase-4 inhibitors (saxagliptin, alogliptin, and sitagliptin) has been shown, although doubts have been raised about the risk of HF hospitalization with some of them.

The EMPA-REG OUTCOME trial was published in the past year. This study showed that empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces the risk of the primary composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke vs placebo in patients with type 2 diabetes and established cardiovascular disease.4 The recent guidelines for HF specify that empagliflozin should be considered for patients with type 2 diabetes to prevent or delay the onset of HF and prolong life; this is the first time that an antidiabetic drug has received a recommendation of this type.2 More recently, in the LEADER trial,5 liraglutide, a glucagon-like peptide-1 (GLP-1) analog, reduced the risk of the same primary composite outcome vs placebo in patients with type 2 diabetes at high cardiovascular risk. The results of these studies are discussed in greater detail in another scientific letter on the same topic.

One of the other therapeutic innovations of this year concerns PCSK9 inhibitors. Generally, previous studies performed with these antibodies have achieved considerable reductions in low-density lipoprotein-cholesterol (LDL-C), both in monotherapy and in combination with other lipid-lowering agents, as well as a good safety profile, at least during 1-year follow-up. Although the results on morbidity and mortality from large clinical trials are required, the currently available data indicate that their use might also be associated with a significant reduction in cardiovascular events. Additionally, because these drugs are injected every 2 to 4 weeks, they might lead to better therapeutic adherence than other lipid-lowering agents such as statins and ezetimibe that need to be taken every day. Finally, although these agents might not seem cost-effective in some health care systems due to their current price, they might be the only therapeutic alternative for certain patient groups to attain the recommended target LDL-C levels.6

We conclude with the polypill, which is a therapeutic approach of considerable interest for clinical cardiology, particularly in patients with treatment adherence problems. The advantages of these compounds are discussed in greater detail in another scientific letter.

References
[1]
J.J. McMurray, M. Packer, A.S. Desai, et al.
Angiotensin-neprilysin inhibition versus enalapril in heart failure.
N Engl J Med, 371 (2014), pp. 993-1004
[2]
P. Ponikowski, A.A. Voors, S.D. Anker, et al.
2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC.
Eur Heart J, 37 (2016), pp. 2129-2200
[3]
A.T. Sandhu, D.A. Ollendorf, R.H. Chapman, S.D. Pearson, P.A. Heidenreich.
Cost-effectiveness of sacubitril-valsartan in patients with heart failure with reduced ejection fraction.
Ann Intern Med, 165 (2016), pp. 681-689
[4]
B. Zinman, C. Wanner, J.M. Lachin, EMPA-REG OUTCOME Investigators, et al.
Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes.
N Engl J Med, 373 (2015), pp. 2117-2128
[5]
S.P. Marso, G.H. Daniels, K. Brown-Frandsen, LEADER Steering Committee on behalf of the LEADER Trial Investigators, et al.
Liraglutide and cardiovascular outcomes in type 2 diabetes.
N Engl J Med, 375 (2016), pp. 311-322
[6]
M. Anguita, A. Castro, A. Cordero, et al.
Necesidades no cubiertas con el tratamiento hipolipemiante oral. Identificación de pacientes prioritarios en el ámbito de la enfermedad coronaria.
Rev Esp Cardiol, 69 (2016), pp. 1083-1087
Copyright © 2016. Sociedad Española de Cardiología
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