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27th December 2024
The sodium glucose cotransporter 2 (SGLT-2) inhibitors dapagliflozin and empagliflozin cut mortality in patients with heart failure with reduced ejection fraction whether or not patients have diabetes, a large real-world study has concluded.
The analysis of SGLT-2 inhibitor drugs in patients on a national Danish registry found they were associated with a 25% lower risk of all-cause mortality, ‘supporting their effectiveness in routine clinical practice’.
Reporting in the BMJ, the researchers examined outcomes in patients with heart failure aged over 45 years with left ventricular ejection fraction less than 40% between 2020 and 2023.
In their dataset, they reviewed 6,776 patients who started SGLT-2 inhibitors (79% on dapagliflozin, 21% prescribed empagliflozin) and 14,686 patients taking other standard-of-care heart failure drugs, while taking into account time since diagnosis and other baseline characteristics.
Around 70% of patients taking SGLT-2 inhibitors were men, with an average age of 71 years, and 20% of the cohort had type 2 diabetes.
The results showed 374 deaths among SGLT-2 inhibitor users at a rate of 5.8 per 100 person-years compared with 1,602 among non-users equating to 8.5 per 100 person-years.
The 25% reduction in the risk of all-cause death compared with non-use was consistent across all patient groups, including those with and without type 2 diabetes, they found.
Analysis also showed that SGLT-2 inhibitors were associated with a 23% lower risk of cardiovascular death.
But there was no reduction in a combined measure of cardiovascular death or hospitalisation for heart failure or heart failure hospitalisation alone.
The ‘real-world’ data matches that seen in the clinical trials that had led to the recommendation of SGLT-2 inhibitors in several guidelines, including from NICE, the team concluded.
NICE recommended empagliflozin for chronic heart failure with preserved or mildly reduced ejection fraction in October 2023, following its recommendation to extend dapagliflozin use in heart failure to reduce hospitalisations in May.
‘These results support the benefits of SGLT-2 inhibitors observed in clinical trials and provide novel and important data regarding their effectiveness in real-world clinical settings and across key clinical subgroups, including patients with and without diabetes,’ the researchers from the University of Copenhagen said.
A linked editorial noted that the findings were observational but ‘provide assurance that no unexpected harm results from SGLT-2 inhibitors when they are used for treatment of heart failure outside the clinical trial setting’.
But it also stressed that SGLT-2 inhibitors are still underused, and efforts are needed to ‘tackle barriers to prescribing’ in line with best-practice guidelines.
A version of this article was originally published by our sister publication Pulse.
24th October 2024
Mineralocorticoid receptor antagonists (MRAs) should be considered for all patients with heart failure, say Scottish researchers who found benefits across the board.
The drugs, which include spironolactone, had already shown clear benefit for patients with heart failure and reduced ejection fraction but their use in other categories had been unclear.
Now, a meta-analysis of four trials with more than 13,800 patients presented at the European Society of Cardiology Congress 2024 has also shown positive results in patients with mildly reduced or preserved ejection fraction.
The results, which were also published in The Lancet, support use of the drugs in all heart failure patients without a contraindication, the researchers concluded.
Data was analysed from four placebo-controlled trials which either looked at spironolactone, eplerenone or finerenone.
It showed that MRAs reduced the risk of cardiovascular death or hospitalisation for heart failure by 23%.
The treatment did show greater efficacy in patients with heart failure and reduced ejection fraction with a 34% reduction in the death or hospitalisation.
But there was a 13% reduction in heart failure with mildly reduced or preserved ejection fraction.
The effects were consistent in all subgroups across the four trials and in all categories of heart failure, the researchers from the University of Glasgow said.
Significant reductions in hospitalisation for heart failure were observed in the trials of reduced ejection fraction (37%) and mildly reduced or preserved ejection fraction (18%).
And the same pattern was seen for total heart failure hospitalisations with or without cardiovascular death, they found.
The risk of hyperkalaemia was doubled with an MRA compared with placebo, but the incidence of serious hyperkalaemia, defined as a laboratory potassium >6.0 mmol/L, was low and the risk of hypokalaemia was halved.
Study leader Professor Pardeep Jhund, professor of cardiology and epidemiology at the University of Glasgow’s School of Cardiovascular and Metabolic Health, said that MRAs were widely available but several studies had shown they were underused.
‘This analysis confirms the benefits of MRAs in patients with heart failure, across the spectrum of ejection fractions,’ he said. ‘Our findings indicate that treatment with an MRA may be considered in all patients with heart failure without a contraindication.
‘In patients with mildly reduced or preserved ejection fraction, management should include finerenone in addition to a SGLT2 inhibitor,’ he said.
Meanwhile, a recent study found semaglutide could be beneficial in helping to treat patients with type 2 diabetes and obesity-related heart failure. In the trial of more than 600 patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to several benefits after one year.
A version of this article was originally published by our sister publication Pulse.
30th September 2024
Early and timely recognition of congestion and decompensation may prevent heart failure hospitalisations and improve patient outcomes. But with the clinical signs and symptoms of fluid overload often difficult to elucidate on examination, emerging technological advancements in invasive and non-invasive haemodynamic monitoring are increasingly valuable, as consultant cardiologist Pardeep Jhund discusses.
Heart failure is a common condition that affects around 5% of the population in the UK and 64 million patients worldwide.1
It often develops insidiously, causing breathlessness or an inability to carry out activities of daily life. Fluid accumulates over several days and weeks and is often indolent until it becomes so severe that the patient must seek help. When this occurs, there is usually no option but to admit the individual to hospital and administer intravenous diuretics for the relief of fluid overload or congestion.
Heart failure reduces life expectancy but also places a considerable burden on healthcare systems globally. Patients are often hospitalised for many days, which contributes to healthcare costs.
Furthermore, hospital admissions for heart failure are associated with poorer outcomes. Therefore, preventing hospitalisations would benefit patients and healthcare systems by improving clinical outcomes and providing substantial cost savings.
The signs and symptoms of congestion are often difficult to elucidate on examination. Therefore, there has been much interest in developing technologies to monitor the fluid status and determine whether the patient is developing congestion so that healthcare providers can intervene promptly and hopefully prevent hospitalisation.
Invasive haemodynamic monitoring of patients with heart failure is now possible. In a day-case procedure, a small sensor is placed in the pulmonary artery under local anaesthesia. The device communicates with a mobile reader, which can then relay telemetry data to the healthcare provider.
By monitoring pulmonary artery pressure and determining any increase, which is a sign of congestion, the healthcare team can intervene and suggest changes to the patient’s management, which might prevent further congestion and deterioration that would require hospitalisation.
Clinical trials and a meta-analysis of the previous randomised controlled trials have suggested that this technique can reduce hospitalisations for heart failure.2 However, the technique is costly and requires a specific set-up to monitor patients.
Pacemakers or implantable defibrillators have been able to monitor congestion for some time.3,4 These pacemakers use an algorithm that detects fluid in the chest alongside the general parameters recognised by the pacemaker.
By integrating these measures, the patient’s fluid status can be determined, and, again, healthcare systems can be alerted to impending congestion, thereby allowing physicians to intervene and reduce the risk of hospitalisation.
Unlike pulmonary artery pressure monitoring, there have been no large-scale randomised trials demonstrating that this method of monitoring congestion can reduce hospitalisations. A major disadvantage of this method is that it is also only valuable for patients needing a pacemaker.
There has been much interest in non-invasive monitoring of fluid status and congestion in patients with heart failure. These methods could be less costly, more acceptable to patients and more straightforward to deploy on a larger scale.
Wearables that continuously measure thoracic impedance to determine if the patient is retaining fluid and becoming congested are available. The devices communicate the findings and alert the healthcare team and patient to any developing congestion via an app on a mobile device. However, they rely mainly on only one parameter for congestion.
Some innovations go one step further by only being worn twice daily for a few minutes rather than continuously. The sensors gather data on thoracic impedance, electrocardiogram and heart sounds, lung function and tidal volume, heart rate and respiratory rate, alongside other measures. The device then integrates these data into a measure of congestion, relayed to a Cloud-based system that can alert the patient and healthcare team.
At the University of Glasgow, UK, we have recently examined the effectiveness of one such novel cardiopulmonary wearable sensor in accurately measuring congestion compared to gold-standard clinical measures.5
The CONGEST-HF trial enrolled 66 patients across three cohorts: patients with heart failure receiving diuretics, haemodialysis patients and patients undergoing right heart catheterisation. There was good agreement between the device and our currently used measures of assessing congestion. Thoracic impedance and a measure of the heart sounds taken by the device could detect changes in weight in patients undergoing decongestion with intravenous diuretics.
We also found that thoracic impedance performed well compared with ultrasound assessment of the lung fluid when tracking the fluid removed during a dialysis session in patients with kidney failure.
Our results suggest that wearable devices that measure multiple parameters could potentially be very useful tools for monitoring congestion in patients with heart failure. Ultimately, we hope to show that these technologies can effectively prevent hospitalisations.
Pardeep Jhund MBChB MSc PhD
Professor of cardiology and epidemiology, School of Cardiovascular & Metabolic Health, University of Glasgow, and honorary consultant cardiologist at the Queen Elizabeth University Hospital, Glasgow, UK
6th September 2024
Following a cancer diagnosis, patients with heart failure with reduced ejection fraction (HFrEF) are less likely to continue or maintain the use of guideline-directed medical therapies (GDMTs), according to a new longitudinal study.
Researchers from University College London Hospitals NHS Foundation Trust analysed data from patients with heart failure in UK Clinical Practice Research Datalink between 2005 and 2021. Based on diagnostic and prescription records, patients with probable HFrEF were selected, and trends in the use and dosing of GDMTs before and after receiving a new cancer diagnosis were analysed.
The researchers matched 4,890 HFrEF patients with incident cancer to controls without cancer. The majority of the participants were male (73.9%), and the mean age was 75.7 years.
Patients with cancer were found to be 51% more likely to have poor adherence to renin-angiotensin-system inhibitors (RASIs), 22% more likely to have poor adherence to beta-blockers and 31% more likely to have poor adherence to mineralocorticoid receptor antagonists (MRAs) compared to non-cancer controls (RASIs: OR = 1.51, 95% CI = 1.35–1.68; beta-blockers: OR = 1.22, 95% CI = 1.08–1.37; MRAs: OR = 1.31, 95% CI = 1.08–1.59).
Cancer patients are also less likely to continue taking the GDMTs over time, with 104% more likely to stop taking RASIs, 35% more likely to stop taking beta-blockers and 49% more likely to stop taking MRAs than non-cancer controls.
Titration doses for RASIs and beta-blockers were more likely to be reduced after a cancer diagnosis (OR = 1.69, 95% CI = 1.40–2.04 and OR = 1.31, 95% CI = 1.05–1.62, respectively). None of the patients started new heart medications or had their medication doses increased after a cancer diagnosis, the researchers noted.
The reduction, interruption or cessation of heart failure treatments has a potentially negative impact on cardiovascular outcomes, the researchers said, adding that ‘this issue is even more concerning if the [heart failure] patient eventually needs cardiotoxic cancer treatments’.
Since heart failure leads to increased hospitalisation, and mortality is higher in patients with poor adherence or persistence to GDMTs, the researchers have called for better medical management of heart failure after a cancer diagnosis.
They also highlighted the need for further research, including targeted strategies for heart failure treatment optimisation, patient and clinician education at the time of cancer diagnosis, and an increase in multidisciplinary working between cardiologists, oncologists, general practitioners, pharmacists and specialist nurses.
Reference
Ju, C et al. Use of heart failure medical therapy before and after a cancer diagnosis: A longitudinal study, ESC Heart Failure 2024; Jul 23: doi.org/10.1002/ehf2.14981.
14th August 2024
Heart failure with preserved ejection fraction disproportionately affects women. Dr Pankaj Garg, lead author of a recent study published in the European Heart Journal Open, discusses the necessity of sex-specific approaches in cardiovascular diagnostics and treatment to address this disparity, and summarises how this research paves the way for future studies and clinical guidelines to embrace personalised medicine.
Despite known differences in cardiac structure and function between the sexes, there are no validated sex-specific diagnostic tools for heart failure.
Specifically focusing on heart failure with preserved ejection fraction (HFpEF), which has a higher prevalence in women versus men, our recent research investigated whether sex influences the assessment of left ventricular filling pressure (LVFP) using cardiac magnetic resonance (CMR), which is crucial for diagnosing heart failure regardless of ejection fraction.
Our study’s motivation lay in enhancing diagnostic accuracy and enabling personalised treatment strategies by considering sex-specific physiological variations.
In the derivation cohort of 835 patients (60% female), participants were suspected of having pulmonary hypertension and heart failure. Each patient underwent invasive right heart catheterisation and CMR within a 24-hour period.
We utilised multivariable regression to develop a sex-specific CMR model for estimating LVFP, measured by pulmonary capillary wedge pressure (PCWP). This model included left atrial volume (LAV) and left ventricular mass (LVM) to account for the structural differences between sexes.
The study further validated the model using a cohort of 454 patients with confirmed heart failure, of which 36% were female. This validation assessed primary endpoints, including heart failure hospitalisation and major adverse cardiovascular events (MACE).
The derivation cohort was meticulously selected, and the close timing between the invasive right heart catheterisation and CMR ensured accuracy in correlating the two measurements.
Multivariable regression allowed for incorporating relevant cardiac parameters that differ between sexes, such as LAV and LVM. These parameters are crucial as they reflect the anatomical and functional differences in the cardiac structure between men and women.
The validation cohort provided a robust testing ground for the model, ensuring its applicability in a real-world clinical setting. The primary endpoints of heart failure hospitalisation and MACE are clinically relevant, reflecting the model’s potential to predict significant adverse outcomes.
The findings that the sex-specific CMR-derived PCWP was significantly associated with these endpoints over a considerable follow-up period underline the model’s prognostic value.
The comparison between the generic and sex-specific CMR-derived PCWP models revealed significant differences in LVFP estimates between males and females when using the generic model (14.7 ± 4 vs. 13 ± 3.0 mmHg, P < 0.001). These differences were absent when using the sex-specific model (14.1 ± 3 vs. 13.8 mmHg, P = 0.3), underscoring the importance of a tailored approach.
Unlike the generic model, the sex-specific CMR-derived PCWP demonstrated a significant association with heart failure hospitalisation (hazard ratio (HR) 3.9, P = 0.0002) and MACE (HR 2.5, P = 0.001) over a mean follow-up period of 2.4 ± 1.2 years.
This indicates that accounting for sex improves the precision and prognostic performance of CMR biomarkers for heart failure.
Our study emphasises the substantial differences in cardiac structure and function between men and women. Women typically have smaller cardiac dimensions, higher heart rates and distinct patterns of cardiac remodelling compared with men.
These differences are crucial as they affect the interpretation of diagnostic tests and the effectiveness of subsequent treatments. HFpEF, which is more prevalent in women, is characterised by a stiffer left ventricle, leading to increased LVFP and LAV. In contrast, men are more prone to heart failure with reduced ejection fraction (HFrEF), which follows different pathophysiological mechanisms.
Using generic models for estimating LVFP often leads to misdiagnosis or underestimation of disease severity in women, resulting in inadequate treatment. The sex-specific models developed in this study offer a more accurate assessment of cardiac function, enhancing risk stratification and enabling personalised treatment plans.
Indeed, our study demonstrated that the sex-specific CMR model is more effective than traditional diagnostics in predicting heart failure hospitalisation and MACE, highlighting the necessity of tailored diagnostic tools. Improved diagnostic accuracy facilitates timely and appropriate interventions, ultimately enhancing clinical outcomes for both men and women.
Recognising and addressing sex differences in cardiovascular diseases is essential for developing clinical guidelines that incorporate sex-specific diagnostic and treatment approaches.
Our research underscores the importance of considering sex differences in cardiovascular physiological models and the need for more studies focused on these differences to enhance the overall quality of care and reduce health disparities between men and women.
By developing and validating a sex-specific CMR model for assessing LVFP, we have shown that accounting for sex-specific factors significantly improves diagnostic accuracy and prognostic performance in heart failure patients.
Incorporating these factors into clinical practice can refine heart failure diagnosis and treatment, leading to better health outcomes and personalised patient care. The findings advocate for integrating sex-specific approaches in clinical guidelines and practices, ensuring that both men and women receive optimal and tailored cardiovascular care.
This approach enhances diagnostic precision and facilitates better management of heart failure, having profound implications for clinical practice and potentially reducing the burden of this condition globally.
Furthermore, our study highlights the necessity of personalised medicine and advocates for a paradigm shift in how heart failure is diagnosed and treated. The significant differences found in LVFP estimates between males and females using the generic but not the sex-specific model illustrate the potential for misdiagnosis and inappropriate management if sex differences are not accounted for.
Our findings are a call to action for the healthcare community to prioritise research on sex differences in cardiovascular diseases. This will lead to developing diagnostic tools and treatment protocols that reflect sex-specific physiological differences, ultimately improving patient outcomes.
Dr Pankaj Garg MD MRCP PhD
Associate professor in cardiovascular medicine, University of East Anglia, and honorary consultant cardiologist, Norfolk and Norwich University Hospitals Foundation Trust, UK
22nd April 2024
Semaglutide could be beneficial in helping to treat patients with type 2 diabetes and obesity-related heart failure, a study has shown.
In a trial of more than 600 patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to several benefits after one year.
This included larger reductions in heart failure-related symptoms and improvement in physical limitations, researchers reported in the New England Journal of Medicine (NEJM).
It follows previous research suggesting benefit of the glucagon-like peptide-1 (GLP-1) receptor agonist in obesity-related heart failure in people without type 2 diabetes, the researchers said.
But it was not clear if the same would be true of those who also had type 2 diabetes for several reasons including that they tend to present with more advanced disease and are already likely to be receiving treatment with a sodium-glucose cotransporter-2 inhibitor for their heart disease.
After 12 months, the researchers reported that a once-weekly 2.4mg dose of semaglutide not only led to a larger reduction in heart failure symptoms in this group but also increased the six-minute walk distance.
It was also associated with fewer serious adverse events than placebo, the researchers noted.
But the trial was not designed to evaluate the number of hospitalisations or urgent doctor visits for heart failure symptoms, they added.
Those taking semaglutide lost more weight compared with placebo, but the weight reduction was 40% lower than reported in people with heart failure but not diabetes in a previous study.
Writing in the NEJM, the researchers concluded that the findings suggested ‘the mechanisms of benefit with semaglutide may extend beyond weight loss’.
This could be due to the effects of the drug on the heart and blood vessels, inflammation, insulin resistance and other factors, they said.
The consistency between the findings of this and the previous trial in patients without type 2 diabetes ‘provides greater reassurance that semaglutide is an efficacious treatment option with a favourable safety profile in a broad population of patients with obesity-related heart failure,’ they said.
Commenting on the study results, Professor Naveed Sattar, professor of cardiometabolic medicine at the University of Glasgow, said: ‘This new well conducted trial suggests once again we have underestimated the impact of excess weight in the development of heart failure with preserved ejection fraction.
‘Preventing obesity remains critically important but newer treatments that help people living with obesity lose decent amounts of weight could help improve the lives of many living with heart failure, and many other conditions associated with obesity.
‘Robust randomised trials are needed to also ensure these drugs are not only beneficial but also safe and the evidence here is also mounting and reassuring.’
Earlier this month, a review by the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee concluded that available evidence does not support a causal association between GLP-1 and suicidal and self-injurious thoughts and actions.
A version of this article was originally published by our sister publication Pulse.
26th October 2023
Virtual wards should be expanded to include heart failure patients to help reduce recovery times and ease pressure on hospital beds during the winter season, new NHS clinical guidance has outlined.
NHS England has now pushed for integrated care boards to work with cardiac clinical networks to better understand their heart failure population needs and workforce competencies.
The expansion is set to build on the use of and learning from virtual wards for acute respiratory infection and frailty.
It comes after the NHS met its target last month to deliver 10,000 virtual ward beds, through which more than 240,000 patients treated successfully since April 2022.
There are currently a dozen heart failure virtual wards up and running, NHS England said. This includes Liverpool University Hospitals NHS Foundation Trust and Mersey Care NHS Foundation Trust, which together have supported more than 500 people on virtual wards for heart failure.
According to the guidance, as a minimum requirement the new virtual wards should ensure people with heart failure have access to rapid specialist advice and guidance, including via video or telephone, where necessary.
ICBs must also make sure these digital wards feature a daily virtual review with the heart failure team or a multidisciplinary team, with robust processes for escalating concerns.
NHS England also advised an ICB’s approach support ‘seamless patient care’, which may include:
NHS England’s national clinical director for heart disease Professor Sir Stephen Powis said: ‘More than 240,000 patients have already benefitted from virtual wards, and now we are growing this service to patients with heart failure.
‘This is a positive development in how the NHS can treat patients, and testament to the hard work of our staff after hitting our target of 10,000 virtual ward beds last month.
‘The expansion has been implemented at a key time just before winter, when there will be a lot more pressure on our hospitals and will free up beds for those who need them the most.’
Around 200,000 people a year are diagnosed with heart failure and often require significant NHS support, including long or frequent hospital stays. Some 5% of all emergency hospital admissions in the UK are attributed to the condition.
A version of this story was originally published by our sister publication Healthcare Leader.
12th September 2023
Percutaneous coronary intervention (PCI) combined with implantable defibrillators and optimal medical therapy (OMT) may benefit high-risk heart failure patients with low left ventricular ejection fractions, according to a recent study.
Patients with ischaemic left ventricular dysfunction normally undergo either coronary artery bypass graft or PCI before the insertion of implantable defibrillators. This is based on the assumption that PCI lowers the incidence of potentially fatal ventricular arrhythmias, avoiding the need to insert such defibrillators.
However, a randomised trial by researchers at King’s College London and funded by the British Heart Foundation (BHF) has revealed that PCI does not reliably improve the heart’s ability to pump or reduce the risk of these life-threatening ventricular arrhythmias. As a result, the team has suggested high-risk patients should no longer have to wait the standard 90 days following PCI before assessing the need for insertion of an implantable defibrillator.
Patients with heart failure and a low ejection fraction benefit from a cocktail of drug therapy which includes ACE inhibitors, beta-blockers and amiodarone. Consequently, the study protocol dictated that all patients should receive OMT as part of the standard treatment.
Some 700 patients with ischaemic left ventricular systolic dysfunction were randomised to receive either PCI with OMT or OMT alone. Although the use of an implantable defibrillator was considered to be an integral component of OMT for all patients, the decision to implant such a device was at the discretion of heart teams at recruiting centres.
The researchers set a composite primary outcome of all-cause death or aborted sudden death, which was defined as an appropriate implantable defibrillator therapy or a resuscitated cardiac arrest, at a minimum of 24 months.
The median left ventricular ejection fraction was low at 28%, and 53.1% of patients had an implantable defibrillator inserted before randomisation or during the study follow-up.
All-cause death or aborted sudden death occurred in a similar proportion of patients in each group (hazard ratio, HR = 1.03, 95% CI 0.82 – 1.30, p = 0.80). There was also no between-group difference in the occurrence of any of the secondary outcomes.
Commenting on these findings, one of the research team, Dr Holly Morgan, BHF clinical research fellow at the King’s College London BHF Centre of Research Excellence, said: ‘Our findings have revealed that many patients with a high-risk of heart failure could benefit from receiving an ICD [implantable cardioverter defibrillator device] straight away, rather than facing a 90-day wait.‘
She continued: ‘We hope our findings will influence existing guidance, so patients can be spared unnecessary waits to receive a potentially lifesaving defibrillator.‘
Dr Sonya Babu-Narayan, associate medical director at the BHF, added: ‘The results from this large UK-wide trial could lead to re-evaluation of how best to treat people living with severe heart failure due to coronary heart disease. The findings suggest that the current “wait and see“ approach to find out whether a patients’ heart function improves with medication and stents isn’t always best, and that an unnecessary wait could even be the difference between life and death.‘
30th August 2023
The use of intravenous ferric carboxymaltose (FCM) in heart failure patients with iron deficiency reduces the risk of hospitalisation and cardiovascular death, according to research presented at the recent European Society for Cardiology (ESC) Congress 2023 in Amsterdam.
Researchers undertook a meta-analysis of individual participant data from three randomised, placebo-controlled trials of FCM in adult patients with heart failure and iron deficiency: CONFIRM-HF, AFFIRM-HF and HEART-FID.
Across the three trials, a total of 4,501 patients with heart failure and reduced or mildly reduced left ventricular ejection fraction and iron deficiency were randomly assigned to FCM (n = 2,251) or placebo (n=2,250) for 52 weeks. The mean age of the total population was 69 years, 63% were men and the mean left ventricular ejection fraction was 32%.
Researchers set the primary efficacy endpoints as a composite of total cardiovascular hospitalisations and cardiovascular death, as well as a composite of total heart failure hospitalisations and cardiovascular death. Key secondary endpoints included individual components of the composite endpoints.
The trial results revealed FCM therapy significantly reduced the co-primary composite endpoint of total cardiovascular hospitalisations and cardiovascular death compared with the placebo (rate ratio, RR = 0.86, 95% CI 0.75 – 0.98, p = 0.029).
Although there was a trend towards reduction of the co-primary composite endpoint of total heart failure hospitalisations and cardiovascular death, this was not statistically significant (RR = 0.87, 95% CI 0.75 b- 1.02, P = 0.076).
Nevertheless, FCM therapy was associated with a 17% relative rate reduction in total cardiovascular hospitalisations (RR = 0.83, 95% CI 0.73 – 0.96, p = 0.009) and a 16% relative rate reduction in total heart failure hospitalisations (RR = 0.84, 95% CI 0.71 – 0.98 p = 0.025). Despite these benefits, FCM therapy had no effect on mortality.
Professor Piotr Ponikowski, the principal investigator and vice-rector of Wroclaw Medical University, Poland, said: ‘This was the largest and most up-to-date analysis of the effect of FCM in iron-deficient heart failure patients with reduced or mildly reduced ejection fraction.‘
He added: ‘The findings indicate that intravenous FCM should be considered in iron-deficient patients with heart failure and reduced or mildly reduced ejection fraction to reduce the risk of hospitalisation due to heart failure and cardiovascular causes.‘
Heart failure is one of the leading causes of avoidable hospitalisations and iron deficiency is present in over 30% to 50% of patients.
Although iron therapy is known to improve functional capacity, symptoms, and quality of life, until the current meta-analysis, no studies have examined whether treatment impacts on clinical events such as hospitalisation.
22nd May 2023
NICE has recommended the extension of dapagliflozin as a treatment option for symptomatic chronic heart failure in patients with preserved or mildly reduced ejection fraction.
In final draft guidelines, the committee said it had reviewed evidence from AstraZeneca that adding dapagliflozin (Forxiga) to standard care with diuretics reduces the combined risk of dying from cardiovascular causes or hospital admission with heart failure.
The committee noted in its decision that hospitalisations for heart failure with preserved or mildly reduced ejection fraction place a substantial burden on the NHS and this is the first NICE-recommended treatment for this type of heart failure.
This follows EU approval of dapagliflozin across all ejection fractions in heart failure in February 2023.
More than 550,000 people in England have heart failure and around 50% have preserved or mildly reduced ejection fraction, of whom up to 150,000 would be eligible for treatment with dapagliflozin, NICE said.
Figures show 94,185 hospitalisations in England for heart failure in 2019/20, making it one of the leading causes of avoidable hospitalisations.
And around a quarter of people with heart failure die within the first year and over half within five years.
Results from the DELIVER trial considered by NICE (a global study but with no UK patients) showed dapagliflozin plus standard care reduced the composite outcome of cardiovascular death or worsening heart failure by 18% over a median follow-up of 2.3 years.
The committee said the population in the trial were about 10 years younger than would be expected in real-world the but said results were generalisable to NHS clinical practice.
An economic analysis took into account hospitalisations but also GP appointments, the final draft guidance said. Overall it found cost effectiveness to be below £20,000 per quality of life year gained – below the NICE threshold for an acceptable use of NHS resources.
Helen Knight, director of medicines evaluation at NICE, said: ‘Until now there have been no treatments available to delay or slow the progression of this type of heart failure.
‘The committee heard from patient and clinical experts who described how the lack of research and available treatments in this area led to a lack of hope and support that impacts the quality of life and mental health of people with the condition.
‘And we know that chronic heart failure also places a significant burden on the NHS through hospitalisations.’
She added: ‘Today’s draft guidance means that for the first time there is an effective treatment available on the NHS for people with this type of heart failure.
‘Not only does dapagliflozin have the potential to help them live well for longer, but it could also save the NHS money and free up space by reducing their risk of having to go to hospital for unplanned emergency treatment.’
A version of this story was originally published by our sister publication Pulse.
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