New Canadian HF Guidelines Make Room for Angiotensin Receptor-Neprilysin Inhibitor

November 03, 2014

VANCOUVER, BC — The new Canadian Cardiovascular Society guidelines for the management of patients with heart failure have been updated and are the first to include a recommendation on the use of the new angiotensin receptor-neprilysin inhibitor (ARNI) that recently shone in the PARADIGM-HF study[1].

Speaking with heartwire , Dr Gordon Moe (St Michael's Hospital, Toronto, ON), cochair of the new guidelines, said the data from PARADIGM-HF are so robust they felt the need to make a recommendation on its use. "There won't be another trial that will change the point estimate because it's such a large trial," said Moe. "These are going to be the data. We wanted to get in on the act at this point and make a recommendation. But this is a conditional recommendation because the drug is not yet approved and we don't know the price."

The new heart-failure guidelines, which were presented last week at the 2014 Canadian Cardiovascular Society Congress in Vancouver, BC, will be published in January.

As reported by heartwire when PARADIGM-HF was presented at the European Society of Cardiology Congress in Barcelona, Spain, heart-failure experts were extremely enthusiastic about the prospects of the new ARNI, some believing it to represent the future cornerstone of chronic-heart-failure therapy. The trial was concurrently published in the New England Journal of Medicine. The new Canadian recommendations come just two months after the trial was presented to the scientific community and published.

In PARADIGM-HF, patients treated with the drug, an awkwardly named LCZ696 (Novartis), which includes moieties of valsartan and sacubitril, fared significantly better in terms of cardiovascular death or heart-failure hospitalization over two to three years compared with patients treated with enalapril and other evidence-based therapies. The risks of those two end points, as a composite as well as individually, were reduced approximately 20% in patients with NYHA class 2–4 systolic heart failure who took the novel agent instead of the ACE inhibitor. All-cause mortality was reduced 16% with LCZ696.

Cochair Dr Justin Ezekowitz (University of Alberta, Edmonton) told heartwire they included a recommendation on LCZ696 because they "believe in efficient translation and assessment of important scientific information so that physicians and other healthcare professionals can make an active decision in how they treat their patients." In addition, they wanted to ensure that robust science is used to aid regulatory authorities, such as Health Canada, in their decision making so that patients can eventually access the best treatment options.

"Should Health Canada or other bodies that assess medications purely based on cost want to delay [LCZ696], they should be willing to also explain this to the general public why they are going to delay patients getting the best scientifically valid treatment option," said Ezekowitz.

Anemia and Biomarkers

In addition to the new ARNI, the Canadian heart-failure guidelines also provide management recommendations for patients with anemia and guidance on the use of biomarkers, such as brain natriuretic peptide (BNP). Moe told heartwire that Canadian physicians and other healthcare providers had expressed a need for guidance in these areas, particularly anemia.

The new guidelines recommend that patients with documented iron deficiency be treated with the goal of improving functional capacity. Such a treatment includes intravenous iron supplementation. They also recommend that erythropoietin-stimulating agents not be routinely used to treat anemia in heart failure. With such agents there is an increased risk of thrombosis, said Moe.

Finally, the Canadian guidelines focus on the use of natriuretic peptides in prevention, diagnosis, disease monitoring, and hospital-discharge scenarios. Ezekowitz said the guidelines advocate for these useful biomarkers and want them to be more broadly available to physicians so they can help guide treatment. "We wanted to ensure that the science was clearly presented, along with the gaps in our knowledge, and the recommendations articulated well so that individual physicians or health-advocacy groups could lobby their respective regions if they do not have these available."

To heartwire , Ezekowitz said the guidelines and their recommendations on biomarker testing also have implications for patients and patient-focused care.

"The clinical situations in which we recommended use of testing are also shown to be cost-effective, so the argument usually put up by many health regions is that the individual test is too expensive," he said. "We provided guidance on this and it is incorporated into the recommendation itself. The Canadian public would be surprised to learn that they do not have access to tests that are available elsewhere in the world even when they are proven to help in the treatment of their condition and are cost-effective."

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