April 28, 2021
By Douglas L. Jennings, PharmD, FACC, FAHA, FCCP, FHFSA, BCPS
Volume 2, Issue 4
Recent data shows that despite all efforts from the heart failure community and in spite of contemporary guideline-directed medical therapy, deaths from heart failure (HF) continue to rise. The rates of death remain highest in certain subsets of patients with heart failure with reduced ejection fraction (HFrEF), particularly those with recently hospitalization related to HF. While newer agents such as ARNI and the SGLT2 inhibitors can greatly improve outcomes in patients with HFrEF, these agents have not been extensively studied in patients with ongoing symptoms of worsening HF. In this week’s issue of Talking Therapeutics, we explore the science and the promise of a recently approved novel medication for patients with HFrEF.
Point 1: Vericiguat Helps in HF
In the pivotal VICTORIA trial, over 5000 patients with HFrEF who had recently been hospitalized or had received intravenous diuretic therapy were randomized to vericiguat or placebo in addition to standard heart failure therapies. After a median of about 10 months of therapy, the risk for heart failure hospitalization was significantly reduced with a 10 mg daily dose of vericiguat. Deaths due to cardiovascular causes were similar between groups. Overall vericiguat was well tolerated, and rates of hypotension, syncope were similar to the placebo group. Notably, rates of anemia were slightly higher with vericiguat. It’s important to mention that in the 15% of patients already taking Entresto, vericiguat’s benefit with respect to HF hospitalizations was preserved, suggesting that they can be combined to provide additive benefit. Considering these positive findings, the FDA approved vericiguat for the “reduction of risk of cardiovascular death and HF hospitalization following a hospitalization for HF or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.”
Point 2: Vericiguat’s Role in the Decompensating Patient
The HF drug therapy landscape has grown quite crowded recently. With the discovery of the salutary effects of the SGLT2 inhibitors, nearly all patients with HFrEF should be on a regimen consisting of a minimum of four cornerstone therapies (ARNI + beta-blocker + aldosterone antagonist + SGLT2). Adding a 5th drug to the mix (and one with a branded copay) seems daunting at first glance. But considering the immense risk for further clinical deterioration in patients who are hospitalized for HF and the relative safety of vericiguat, I think that this new drug will definitely have a role. At this time, I would consider adding vericiguat to any patient who is deteriorating clinically on maximally tolerated guideline directed medical therapies for HFrEF. I think this recommendation would even stronger if patients are deteriorating clinically and not able to tolerate adequate doses of first-line agents for HF.
Dr Jennings is currently an Associate Professor of Pharmacy at Long Island University and the clinical pharmacist for the Heart Transplant and LVAD teams at New York- Presbyterian Hospital Columbia University Irving Medical Center. He is an active researcher in his field, and he has published over 120 peer-reviewed abstracts and manuscripts, primarily focusing on the pharmacotherapy of patients under mechanical circulatory support. As a recognized expert in this area, he has been invited to speak at numerous national and international venues, including meetings in France, Saudia Arabia, India. Finally, Dr. Jennings has been active in professional organizations throughout his career. He is a fellow of the American College of Clinical Pharmacy, the American College of Cardiology, the Heart Failure Society of America, and the American Heart Association.
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