This news story was first published in print and online by The Medical Republic on 9th March 2016.
The first of a new class of heart failure drugs has been approved by the TGA, that is being heralded by some experts as a new first-line alternative to ACE inhibitors.
The drug, sacubitril, acts by inhibiting neprilysin, an enzyme responsible for degrading vasoactive peptides. It will be sold as a combination formulation with the angiotensin receptor blocker, valsartan under the brand name Entresto.
A 2014 trial supported by manufacturer Novartis was stopped when Entresto was shown early on to be superior to the ACE inhibitor, enalapril in treating patients with chronic heart failure and a reduced ejection fraction.
Published in the NEJM, the study found Entresto significantly reduced deaths from cardiovascular causes and hospitalisations for heart failure by 20% compared to enalapril and standard therapy.
One death from cardiovascular causes was prevented for every 32 patients treated and an Australian expert said “the science is clear and unequivocal.”
“This is a clinically superior drug without a downside that we can see; it’s time to use it as a first line drug,” said Associate Professor David Colquhoun, consultant cardiologist at Brisbane’s Wesley Hospital.
“Remember that these effects were seen in all patient sub-groups on top of all the beta-blockers, diuretics and standard therapies,” Professor Colquhoun told The Medical Republic.
The side-effect profile was also impressive, he said. The treatment group experienced fewer potassium spikes and less coughing, which caused non-adherence in one fifth of his patients using ACE inhibitors.
Dr Luke Galligan, Clinical Practice Advisor for the Cardiac Society of Australia and New Zealand, said the society had yet to take a position on the new medication. Some caution was warranted over the initial trial results, given that the comparator enalapril was given at a dose of 10 mg twice daily, he said, which was not considered maximal treatment for this drug class.
“Nonetheless, it’s been a while since a new class of drug has been available for what is a big problem. So watch this space.”
Entresto costs around $230 per month on private prescription. An application for PBS listing is currently being considered, with a decision expected in late April.