CHF and arrhythmias:
Indications for: VERQUVO
To reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction <45%.
The approval of Verquvo was based on data from the double-blind, placebo-controlled phase 3 VICTORIA trial that included 5050 adult patients with symptomatic chronic heart failure (New York Heart Association class II-IV) and left ventricular ejection fraction (LVEF) less than 45% following a worsening heart failure event.
Patients were randomly assigned to receive vericiguat 10mg once daily (n=2526) or placebo (n=2524) in combination with heart failure standard of care therapy. The population was 64% Caucasian, 22% Asian, and 5% Black. The mean age was 67 years and 76% were male.
Results showed that vericiguat was superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization at a median follow-up of 11 months based on a time-to-event analysis (hazard ratio [HR] 0.90; 95% CI, 0.82-0.98; P =.019). Treatment with vericiguat was associated with a 4.2% annualized absolute risk reduction compared with placebo. Additionally, vericiguat reduced the incidence of heart failure hospitalizations (27.4% vs 29.6% for placebo; HR 0.90; 95% CI, 0.81-1.00) and cardiovascular death (16.4% vs 17.5% for placebo; HR 0.93; 95% CI, 0.81-1.06).
Among patients in the highest baseline NT-proBNP quartile, the estimated HRs for both cardiovascular death (HR, 1.16; 95% CI, 0.95-1.43) and first heart failure hospitalization (HR, 1.19; 95%CI, 0.9-1.44) were unfavorable, in contrast to the estimated HRs for patients in the 3 quartiles with lower NT-proBNP levels.
Tabs may be crushed and mixed with water, if unable to swallow whole. Take with food. Initially 2.5mg once daily; then double the dose approx. every 2 weeks. Target dose: 10mg once daily as tolerated.
Pregnancy. Concomitant other sGC stimulators.
Embryo-fetal toxicity. Exclude pregnancy status prior to initiation. Advise females of reproductive potential to use effective contraception during and for at least 1 month after the last dose. Nursing mothers: not recommended. Severe hepatic impairment or eGFR <15mL/min/1.73m2 at treatment initiation or on dialysis: not studied.
Soluble guanylate cyclase (sGC) stimulator.
See Contraindications. Concomitant PDE-5 inhibitors: not recommended.
Half-life of vericiguat is 30 hours.
Approximately 53% of the dose is excreted in urine and 45% in feces.
Generic Drug Availability:
Tabs 2.5mg, 5mg—14, 30, 100 (10×10 blisters); 10mg—30, 90, 100 (10×10 blisters)