FDA approves new treatment for HF

There are major benefits that one may expect from the use of LCZ696 in patients with HF. First and foremost is the hardcore CV mortality benefit, which is substantial over and above that seen with standard of care. Second, there is a lot of focus on hospitalizations for HF, both in terms of clinical risk and costs to the society. There was a significant reduction in hospitalization risk with LCZ696 [in the data]. There has been no medication that has been shown to improve survival in a broad cohort of HF patients in over a decade. HF patients take multiple medications a day; the beauty of this drug is that is replaces one of the existing therapies and is not yet another add-on drug over several others that patients are taking. For almost three decades, the standard of care for HF has been the use of ACE inhibitors, and the use of LCZ696 will obviate the need to standard routine use of ACE inhibitors.

We have kind of been in a stalemate in the treatment of chronic HF in the past decade. The breakthroughs in this field in recent times have been cardiac resynchronization therapy and, to a lesser degree, the use of aldosterone antagonists. So, to now have a new drug that is well-tolerated and was tested in an 8,000-plus patient trial that reduces all-cause mortality and HF readmission is a huge thing for our patients and will be widely embraced by caregivers. My hope is that there are no significant financial barriers that impede the ability of patients to have access to this drug.

I think [the approval announcement] was an epiphany, if you will, for HF physicians, so there’s a lot of excitement. Having said that, there are many HF cardiologists who haven’t yet had their hands on this drug, because only those who were in a blinded clinical trial had any access. There’s always a “test-drive” period, if you will, for people to develop familiarity with a new medication and move forward.

The data that the FDA reacted to without a panel is compelling. In my career, I’ve lived through the introduction of ACE inhibitors in HF, I’ve lived through the introduction of beta-blockers, CRT and now this new drug, which holds that same promise to have a major impact on our patients. This is an exciting time for HF physicians, because it’s rare that we get a new medication or a new therapy that has the potential for this magnitude of impact on our patients.

The release of Entresto (formerly LCZ696) for patients with NYHA class II to IV HF represents a significant advance for the treatment of patients with HF with reduced ejection fraction (HFrEF). Unlike ivabradine (Corlanor), which was also approved recently by the FDA for the treatment of HF, Entresto has much broader indications for use and has effects on CV mortality and HF hospitalization, whereas ivabradine has modest effects on HF hospitalization. Entresto has the potential to replace ACE inhibitors or angiotensin receptor blockers as a main line therapy in the treatment of HFrEF, and will thus be important for the clinicians who care for HF patients. Although clinicians who care for patients with HF are used to dealing with relatively low BP, it may take time for physicians to get used to administering Entresto without creating hypotension in patients who have never been placed on an ACE inhibitor/angiotensin receptor blocker. Pricing may also be an obstacle to starting Entresto. Nonetheless, it should be recognized that the release of Entresto represents a significant and exciting new advance in the treatment of patients with HFrEF.