New drug for heart failure now available in Canada

Bayer Canada is introducing Verquvo (vericiguat 2.5 mg, 5 mg, 10 mg tablets) for the treatment of symptomatic chronic heart failure. It is intended for use in adults with heart failure with reduced ejection fraction (HFrEF) who are stabilized after a recent heart failure decompensation event requiring hospitalization and/or intravenous diuretic therapy. The drug should be used in combination with standard of care therapy for heart failure.1 Heart failure is associated with impaired synthesis of nitric oxide and decreased cyclic guanosine monophosphate (cGMP) production. Vericiguat stimulates soluble guanylate cyclase (sGC), which catalyzes the synthesis of intracellular cGMP. cGMP, a signalling molecule, regulates critical physiological processes such as cardiac contractility, vascular tone and cardiac remodelling. Stimulation of sGC by vericiguat results in nitric oxide-independent production of cGMP and vasorelaxation. Vericiguat decreases mean arterial blood pressure and vascular resistance, accompanied by increases in heart rate and cardiac output.1 The recommended starting dose of vericiguat is 2.5 mg once daily. The dose should be doubled about every two weeks to reach the target maintenance dose of 10 mg once daily. If patients experience tolerability issues (e.g., symptomatic hypotension or systolic blood pressure < 90 mmHg), temporary down-titration or discontinuation is recommended; decrease the dose if a patient is currently on 5 or 10 mg/day, and interrupt treatment if currently receiving 2.5 mg/day. The maximum recommended dose is 10 mg once daily.1 Before starting vericiguat, patients must be clinically stabilized and managed with standard of care heart failure therapies after their heart failure decompensation event. Treatment should not be started in patients with systolic blood pressure < 100 mmHg.1 Vericiguat should be taken at approximately the same time each day, with food. For patients with swallowing difficulties, the tablets may be crushed and mixed with water immediately before administration.1 Hypotension, anemia, dizziness, syncope and nausea are the most common adverse effects. Symptomatic hypotension is a more serious possible adverse effect, particularly in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, history of hypotension, or concomitant treatment with antihypertensives or organic nitrates.1 In terms of drug interactions, vericiguat is contraindicated with other sGC stimulators (e.g., riociguat, which is used for pulmonary hypertension). Concomitant use with phosphodiesterase 5 (PDE-5) inhibitors (e.g., sildenafil) is not recommended.1 The 2021 Canadian Cardiovascular Society heart failure guidelines update recommends that vericiguat be considered in addition to optimal heart failure therapies for patients with HFrEF who have worsening symptoms and hospitalization for heart failure within the past six months, to reduce the risk of subsequent heart failure hospitalization (Conditional Recommendation; Moderate-Quality Evidence).2 In making this recommendation, the Canadian Cardiovascular Society placed value on the use of an additional medication to reduce the risk of hospitalization for heart failure in a high-risk patient population that experiences high rates of hospitalization and mortality despite the relatively modest relative benefits of vericiguat observed in the Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) trial. In addition, only a conditional recommendation was provided because vericiguat had not yet been approved in Canada at the time the 2021 guideline update was published. The Canadian Cardiovascular Society also pointed out that a subgroup analysis from the VICTORIA trial suggested that clinical response to vericiguat might be attenuated in patients with very elevated natriuretic peptide levels. 2 References 1. Bayer Inc. Verquvo (vericiguat tablets) product monograph. Mississauga, ON; April 27, 2023.(accessed September 26, 2023). 2. McDonald M, Virani S, Chan M, et al. CCS/CHFS heart failure guidelines update: defining a new pharmacologic standard of care for heart failure with reduced ejection fraction. Can J Cardiol 2021;37:531-46. (accessed September 26, 2023).

New drug for heart failure now available in Canada

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