Latest news with #HFrEF
Medscape
14 hours ago
- Health
- Medscape
Speeding Up Vericiguat Target Dose in HFrEF Shown Safe
Ditching the standard two-step pathway to the target 10-mg dose of vericiguat in patients with heart failure with reduced ejection fraction (HFrEF) and instead employing a one-step protocol can be done safely and overcome the clinical inertia many of these patients encounter, the lead investigator of a prospective clinical trial of the one-step approach said. The 2022 American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines recommend starting patients with HFrEF on a 2.5-mg dose of vericiguat, a soluble guanylate cyclase activator, then stepping up to a 5-mg dose enroute to reaching a target of 10 mg. VELOCITY Study Results Stephen Greene, MD However, the VELOCITY study found nine of 10 patients safely tolerated starting on the 5-mg dose and skipping the recommended 2.5-mg step, Stephen Greene, MD, an advanced heart failure specialist at Duke Cardiology Clinic in Durham, North Carolina, reported at the Heart Failure Association of the European Society of Cardiology (HFA-ESC) 2025. The study was simultaneously published in the European Journal of Heart Failure . 'We know from real-world evidence studies that, in US practice, there are many patients who are initiated on 5-mg vericiguat already, but now we have, actually, clinical data to suggest that this 5-mg initiation dose does appear to be safe among our patients that haven't had recent hypotension,' Greene told Medscape Medical News. The VELOCITY results make the case for updating the clinical guidelines for vericiguat, he added. The rationale for the study was to determine if starting patients closer to the target dose would give them a better chance of getting to and staying on the 10-mg target dose, according to Greene. 'Simplifying this process is one of the best ways to improve implementation for all our guideline-directed medical therapies,' Greene said. VELOCITY was a single-arm, two-week-long prospective trial that enrolled 106 patients with heart failure with an ejection fraction < 45% who were well-treated with background guideline-directed medical therapies. The primary endpoint was tolerability of 5-mg vericiguat dose after 2 weeks. Overall, 93.4% of patients tolerated the dose, including 90.6% in the group with worsening heart failure and 96.2% whose condition remained stable. Fourteen patients (13.2%) had an adverse event associated with treatment. One, a case of facial angioedema, was severe but the rest were considered mild. Four patients (3.8%) discontinued treatment because of an adverse event. VELOCITY also compared outcomes of those starting on the 5-mg dose with outcomes in the VICTORIA trial, which started patients on the 2.5-mg dose. In VICTORIA, 97.2% of patients tolerated the 2.5-mg starting dose over 2 weeks. Among patients with worsening heart failure, again 97.2% of VICTORIA patients tolerated the 2.5-mg treatment well, compared with 90.6% taking the 5-mg starting dose in VELOCITY. Greene also noted that patients in VELOCITY had 'the exact same mean reduction' in systolic blood pressure as those in VICTORIA: Both up to 3.2 mm HG on average. In VICTORIA, the placebo group also experienced a reduction in systolic blood pressure, he said, and the difference between the treatment and placebo groups was 1-to-2 mm HG. Had VELOCITY been a placebo study, the 3.2 mm HG reduction observed with the 5 mg dose 'likely would've been even further attenuated,' Greene said. 'This goes with what we already know about vericiguat, in that it seems to have minimal to no effect on systolic blood pressure.' Starting patients with HFrEF on 5 mg of vericiguat can help overcome 'clinical inertia' and increase the likelihood they will get to the 10-mg target dose, Greene said. 'Many of our patients with HFrEF never achieve target doses of guideline-directed medical therapies, and despite clinic visit after clinic visit, medication changes are, unfortunately, relatively rare,' Greene said. 'We see minimal medication titration, even when our patients have robust blood pressure, even when they have normal kidney function, even when we're talking about our inexpensive generic medications, we don't see many medication changes.' Time for Change, or 'Unique Strategy'? Ankeet S. Bhatt, MD, MBA, ScM Calling for a rewrite of clinical guidelines for using vericiguat in patients with HFrEF based on the VELOCITY results might be premature, Ankeet S. Bhatt, MD, MBA, ScM, a cardiologist and intensivist at Kaiser Permanente San Francisco Medical Center, told Medscape Medical News. 'VELOCITY really tests a unique strategy, reducing one of the steps in the titration of vericiguat, which may, if the clinical efficacy is confirmed in dedicated trials, bolster the confidence around early implementation at a higher dose of this therapy, without the need for an intra-dose titration,' Bhatt said. Validating the VELOCITY findings in a clinical trial 'might improve both acceptance from clinicians and the clinical implications about implementation of the therapy,' he added. Pairing the randomized clinical trial evidence with larger-scale real-world evidence would provide stronger evidence, he said. 'It's possible that there might be late effects or add-on effects that might either promote tolerability or might have safety concerns that we couldn't see in the context of this trial,' Bhatt said. 'So this is an important area that sets the stage, and when it's confirmed in real-world evidence, then I think we can make a compelling case that this might be an important addition to the guidance we already have.' This study was funded by Bayer and Merck Sharp & Dohme. Greene reported financial relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Corcept, Corteria Pharmaceuticals, CSL Vifor, Cytokinetics, Idorsia, Lexicon, Lilly, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche Diagnostics, Sanofi, scPharmaceuticals, Sumitomo, and Tricog Health. Bhatt reported consulting for Merck.
Medscape
a day ago
- Health
- Medscape
NICE Recommends Earlier Treatments for Chronic Heart Failure
Thousands of patients in England with early-stage chronic heart failure could benefit from earlier access to effective drug therapies under new draft guidance from the National Institute for Health and Care Excellence (NICE). The guidance, which updates NICE's 2018 clinical recommendations, advises earlier treatment for heart failure with reduced ejection fraction ( HFrEF). NICE said that clinical practice is changing and that medicines should be offered up to a year earlier in the treatment pathway. The changes could prevent 3000 deaths and 5500 hospital admissions annually in England, the regulator estimated. Earlier Use of Combination Therapies The four pillars of treatment for HFrEF include: Angiotensin-converting enzyme inhibitors (ACEIs) Beta-blockers (BBs) Mineralocorticoid receptor antagonists (MRAs) Sodium-glucose cotransporter-2 (SGLT2) inhibitors NICE said these drugs should be prescribed earlier, without the need to optimise the dose of any one medicine before introducing another. SGLT2 inhibitors such as empagliflozin and dapagliflozin should now be offered at the start of the treatment pathway, rather than after other medications have been fully titrated – a process that could take over a year. NICE also advised that angiotensin receptor neprilysin inhibitors (ARNIs) should be offered if a person cannot tolerate an ACEI, rather than only to patients stabilised on ACEIs or angiotensin receptor blockers (ARBs). Both SGLT2 inhibitors and ARNIs could now be initiated by GPs with advice from heart failure specialists, potentially speeding up patient access. Responding to Evolving Evidence 'We've been able to review the emerging evidence quickly to keep pace with changes in the treatment landscape and make recommendations that will widen access to effective treatments,' said Eric Power, deputy director in NICE's centre for guidelines. He added that the new approach could help reduce emergency hospital admissions and improve quality of life for people living with heart failure. Updated Diagnostic and Monitoring Advice NICE also updated guidance on diagnosis and monitoring, particularly for iron deficiency and anaemia in patients with HFrEF. Clinicians should: Assess iron status and check for anaemia using transferrin saturation (TSAT), serum ferritin, and haemoglobin Consider intravenous iron for patients with haemoglobin under 150 g/L and TSAT under 20% or ferritin under 100 ng/mL If iron deficiency anaemia is found, alternative causes beyond heart failure should be investigated. Revised Biomarker Recommendations In addition, NICE advised clinicians to be aware that: An NT-proBNP level of less than 400 nanogram per litre (47 pmol per litre) in an untreated person makes a diagnosis of heart failure less likely. The level of serum natriuretic peptide does not differentiate between heart failure with preserved, mildly reduced, and reduced ejection fraction. Obesity, African or African-Caribbean ethnic background, or treatment with a diuretic, an ACEI, an ARNI, an ARB, a beta-blocker, or a MRA could reduce serum natriuretic peptide levels. High levels of natriuretic peptides may also be caused by non-cardiac conditions such as COPD, diabetes, sepsis, and liver or kidney disease. Heart Failure Prevalence Almost one million people in the UK are currently living with heart failure, with 200,000 new diagnoses each year. The average age at diagnosis is 76. Rising life expectancy and obesity are driving the increased incidence and prevalence of the disease.
The Independent
3 days ago
- Health
- The Independent
Thousands could be saved by making this small change to heart failure treatment
New guidelines for treating heart failure could save 3,000 lives and prevent 5,500 hospital admissions every year, according to the National Institute for Health and Care Excellence (Nice). The draft guidelines recommend that medicines be administered up to a year earlier for a specific type of heart failure known as heart failure with reduced ejection fraction (HFrEF). This condition occurs when the left side of the heart struggles to pump blood effectively throughout the body. HFrEF affects approximately 387,000 of the 614,000 adults in England who suffer from heart failure. The new Nice guidelines aim to improve outcomes for these patients by ensuring timely and effective treatment. Nice said medics are already changing practice to ensure that the four pillars of treatment – angiotensin-converting enzyme inhibitor (ACEI), a beta-blocker (BB), a mineralocorticoid receptor antagonist (MRA) and a sodium-glucose cotransporter-2 (SGLT2) inhibitor – can be used earlier without the need to optimise the dose of any one medicine before introducing another. Nice is recommending widespread earlier use of the SGLT2 inhibitors empagliflozin and dapagliflozin – giving them at the start of treatment rather than waiting up to a year for dosage of other drugs to be optimised. Generally, Nice said the drugs can also be started by GPs with advice from a heart failure specialist, rather than having to refer people to hospitals. Eric Power, deputy director in Nice's centre for guidelines, said: 'Heart failure is common, with currently around 614,000 adults in England living with a diagnosis. 'Although there's no cure, it is treatable, and the growing number of people living with heart failure is testament to the improvements in care introduced over recent years. 'For this update we've been able to review the emerging evidence quickly to keep pace with changes in the treatment landscape and make recommendations that will widen access to effective treatments. 'This should have a big impact on the lives of people living with heart failure as well as freeing up space in hospitals by reducing their risk of having to go to hospital for unplanned emergency treatment.'
