New therapeutic option to reduce risk of cardiovascular deaths and repeated hospitalisations
Heart failure is extremely prevalent in Singapore. In 2015, 4.5 percent of Singaporeans live with heart failure, with the average age of a heart failure patient at 61 years old.
Bayer’s Verquvo (vericiguat), a soluble guanylate cyclase (sGC) stimulator, has been approved in Singapore for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45 percent, who are stabilised after a recent decompensation event requiring outpatient intravenous (IV) therapy, with no complications and are not at end-stage heart failure. Vericiguat is administered in combination with other heart-failure therapies to reduce the risk of cardiovascular death and heart failure.
The approval of Verquvo, the first treatment for worsening heart failure approved specifically for patients following a hospitalisation for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase III VICTORIA trial and follows a priority regulatory review.
Chronic heart failure is a substantial economic and public health burden affecting more than 60 million people worldwide where individuals face a one in five lifetime risk of developing heart failure. Heart failure is extremely prevalent in Singapore. In 2015, 4.5 percent of Singaporeans live with heart failure, with the average age of a heart failure patient at 61 years old, about 10 years before Europeans and Americans. The age-adjusted heart failure admission rose by approximately 40 percent in the last decade, making heart failure the most common cardiac cause of hospitalisation in Singapore. Following initial diagnosis of heart failure, many patients continue to experience a devastating cycle of escalating symptoms and repeated hospitalisations despite being on optimal current therapies.
Clinical Associate Professor David Sim, deputy head and senior consultant with the Department of Cardiology, director of the heart failure programme and clinical trials at the National Heart Centre Singapore (NHCS) said, “One in four patients are re-admitted for worsening heart failure within six months of discharge for decompensated heart failure. The cardiovascular mortality and all-cause mortality are in excess of 10 percent and 20 percent, respectively. The approval of new therapeutic option could potentially provide healthcare professionals with the opportunity to optimise patients’ therapies and reduce repeated heart failure hospitalisations.”
In VICTORIA, the primary efficacy objective was to determine whether verquvo is superior to placebo, both in combination with other heart failure therapies, in reducing the risk of cardiovascular death or heart failure hospitalisation in adults with symptomatic chronic heart failure and ejection fraction less than 45 percent following a worsening heart failure event. Verquvo met the primary efficacy objective. Also, over the course of the study, there was a 4.2 percent reduction in annualised absolute risk with verquvo compared with placebo. Therefore, 24 patients would need to be treated over an average of one year to prevent one primary endpoint event.
“The VICTORIA trial, exclusively performed in patients with worsening heart failure, found that the soluble guanylate cyclase stimulator, a new class of drugs, is effective in reducing hospitalisations in a high-risk population of patients with worsening heart failure and reduced ejection fraction,” said Professor Carolyn Lam, senior consultant in the Department of Cardiology and director of Women’s Heart Health at NHCS, and member of the global steering committee for VICTORIA.
Based on the VICTORIA study, vericiguat is also approved the US, Japan, Taiwan, Australia and EU under the brand name verquvo. In the EU it is indicated for symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy. Verquvo (2.5 mg, 5 mg, and 10 mg tablets) is being jointly developed with pharmaceutical company Merck & Co and is a once-daily stimulator.
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The French like to eat the garden snails frequently, but no medical benefit at all.