New medications prompt changes to US, European HF guidelines

Societies from the United States and Europe have altered guidelines for HF as a result of the introduction of two new HF medications.

The American College of Cardiology, the American Heart Association and the Heart Failure Society of America published an update to the 2013 American College of Cardiology Foundation/AHA Guideline for the Management of Heart Failure that includes discussion of two new HF medications, sacubitril/valsartan (Entresto, Novartis) and ivabradine (Corlanor, Amgen).

In addition, the European Society of Cardiology issued a new guideline for diagnosis and treatment of HF, part of which covers appropriate roles for the new medications.

US updated guideline

According to the ACC/AHA/HFSA updated guideline, the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan and the sinoatrial node modulator ivabradine are now included in the drug options for patients with stage C HF and reduced ejection fraction along with ACE inhibitors and angiotensin II receptor antagonists, aldosterone antagonists, beta-blockers, the combination of isosorbide dinitrate and hydralazine, and diuretics.

“Not every patient is a good candidate for every drug; these guidelines can help physicians decide who best fits which treatment,” Clyde W. Yancy, MD, MSc, MACC, FAHA, FHFSA, professor of medicine and chief of cardiology at the Northwestern University Feinberg School of Medicine and chair of the writing committee, said in a press release. “This document details the benefits and risks of these new therapies so that patients at high risk can be directed toward alternative therapies.”

Clyde W. Yancy

The societies recommend that an ACE inhibitor or angiotensin II receptor antagonist or angiotensin receptor-neprilysin inhibitor be prescribed along with a beta-blocker and an aldosterone antagonist. For patients with mild to moderate HF who are tolerating standard therapies and who have stable BP, an angiotensin receptor-neprilysin inhibitor should replace ACE inhibitors.

Angiotensin receptor-neprilysin inhibitors, however, should not be used by patients with a history of angioedema and should never be taken with an ACE inhibitor, according to the release from the societies.

In addition, sinoatrial node modulators are recommended for patients with symptomatic stable chronic HF with reduced EF and a heart rate of 70 beats per minute or greater at rest, according to the release.

“Treatment options for patients with [HF] have expanded considerably. There is more hope than ever before for patients with [HF],” Mariell Jessup, MD, FACC, FAHA, professor of medicine at the University of Pennsylvania School of Medicine and vice chair of the writing committee, said in the release. “These guideline recommendations will serve as a tool to guide the choice of therapy and in turn improve outcomes.”

Mariell Jessup

Novartis stated in a press release that, “The new guideline underscores the potential of [sacubitril/valsartan] to significantly reduce risk of death due to [CV] causes or [HF] hospitalization, and the critical need to reduce the impact of this devastating disease on patients and our health care system.”

European guideline

The ESC published updated guidelines for the diagnosis and treatment of HF in the European Heart Journal and held sessions on them at Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure in Florence, Italy.

According to a press release from the ESC, sacubitril/valsartan is now recommended as a replacement for the ACE inhibitor enalapril for patients with HF with reduced EF based on data from the PARADIGM-HF trial.

A new category of HF called HF with mid-range EF was added for patients with a left ventricular EF ranging from 40% to 49%. There are no evidence-based treatments for this population, so the designation could lead to increased research into therapies that could benefit them, Piotr Ponikowski, MD, PhD, head of the department of heart diseases at Medical University and head of the department of cardiology at Clinical Military Hospital, both in Wroclaw, Poland, and chairperson of the guidelines task force, said in the release.

The new guideline advises against using cardiac resynchronization therapy in patients with a QRS duration less than 130 msec, based on data from the EchoCRT study suggesting that CRT may be associated with an increased mortality risk in this population.

An emphasis is put on earlier diagnosis and appropriate treatment, and a new algorithm that evaluates HF probability is suggested for diagnosing HF in a non-acute setting, according to the release.

The committee wrote that adaptive servo-ventilation is no longer recommended for patients with HF with reduced EF and central sleep apnea after it was found to increase mortality during the SERVE-HF trial.

Other suggestions in the document for preventing or delaying the onset of HF include treatment of hypertension, statin therapy for patients with or at high risk for CAD and treatment with the sodium-glucose cotransporter 2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim) for patients with type 2 diabetes.

“[HF] is becoming a preventable and treatable disease. Implementing the guidelines ... will give patients the best chance of a positive outcome,” Ponikowski said in the release. – by Tracey Romero

References:

Ponikowski P, et al. 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. Presented at: Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure; May 21-24, 2016; Florence, Italy.

Ponikowski P, et al. Eur Heart J. 2016; doi:10.1093/eurheartj/ehw128.

Yancy CW, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.05.011.

Disclosures: Jessup and Yancy report no relevant financial disclosures. Ponikowski reports receiving consultant fees and speakers’ honoraria from Abbott Vascular, Amgen, Bayer, Berlin Chemie, Cardiorentis, Cibiem, Johnson & Johnson, Merck, Novartis, Respicardia, Servier, Trevena and Vifor Pharma; and research support from Servier, Singulex and Vifor Pharma. Please see the full guidelines for a list of the other authors’ relevant financial disclosures.