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17th January 2024
The National Institute for Health and Care Excellence (NICE) has recommended that empagliflozin can be used as an option for treating chronic kidney disease (CKD) in adults under some circumstances.
It has to be prescribed as an add-on to standard care including the highest tolerated dose of angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker unless contraindicated, a Technology Appraisal has stated.
Under the recommendations, patients with CKD must also have an estimated glomerular filtration rate of:
Clinicians in both primary and secondary care should make prescribing decisions based on cost of suitable treatments including dapagliflozin after discussing the pros and cons with the patient, NICE said.
The committee noted that some patients already take dapagliflozin as an add-on to standard care and empagliflozin would be used in a similar way but with a potentially broader population.
Evidence from the EMPA-KIDNEY trial suggests that empagliflozin plus standard care is more effective than standard care alone for CKD but there were limits on who was included in the studies, NICE said.
There are also no trials directly comparing empagliflozin plus dapagliflozin but it is likely that effectiveness and safety is similar, the committee said.
It was acknowledged that CKD can progress more quickly in some ethnic minority groups in people under 55 with type 2 diabetes but this could not be considered in the decision making, the committee noted.
The SGLT2 inhibitor is already recommended by NICE for the treatment of adult patients with type 2 diabetes and adult patients with heart failure with reduced ejection fraction.
NICE’s decision to include empagliflozin as an option in some patients with CKD means it must be made available within three months.
In papers published by the NICE committee, it notes that the use of SGLT2 inhibitors is not yet well established in clinical practice and there is ‘scope to expand the use of this drug class in this indication to slow CKD disease progression’.
Empagliflozin was approved by the European Medicines Agency for the treatment of adult patients with CKD in July 2023.
A version of this article was originally published by our sister publication Pulse.
12th October 2023
NICE has recommended empagliflozin as a treatment option for some patients with chronic heart failure.
The drug (brand name Jardiance) can be considered as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults, final draft guidance states.
It becomes the second NICE-recommended treatment for the condition after the approval in June of dapagliflozin, which was also approved in the EU in February.
The European Commission granted marketing authorisation for empagliflozin as a treatment for adults with symptomatic chronic heart failure in March 2022.
An estimated 150,000 people in the UK will now be eligible for treatment with empagliflozin, which should be started on the advice of a heart failure specialist, NICE said.
If a clinician considers empagliflozin to be one of a range of suitable treatments, including dapagliflozin, they should opt for the least expensive after discussing the advantages and disadvantages with the patient.
This should include taking into account the administration costs, dosage, price per dose and commercial arrangements, NICE said.
Chronic heart failure with preserved or mildly reduced ejection fraction is usually treated with standard care such as loop diuretics and treatment for other conditions the person may have, the committee said.
But given dapagliflozin is already recommended as an option, empagliflozin works in a similar way and would be offered to the same population, NICE added.
Evidence presented to the committee showed that empagliflozin plus standard care reduces the combined risk of dying from cardiovascular causes or likelihood of first hospitalisation for heart failure compared with placebo plus standard care, the guidelines said.
But there is no clinical trial evidence directly comparing empagliflozin with dapagliflozin and there were differences in how the trials were done and populations used.
‘When adjustments for these differences are made, an indirect comparison suggests the treatments have similar clinical effectiveness and a similar effect on quality of life,’ NICE said.
Other analyses also suggest the two drugs are associated with similar costs with list prices the same for both at £477.30.
In the first round of draft guidance empagliflozin had not been approved because of uncertainties over cost-effectiveness.
A version of this article was originally published by our sister publication Pulse.
27th July 2023
Empagliflozin has become the first SGLT2 inhibitor to be approved by the European Medicines Agency (EMA) for the treatment of adult patients with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company have announced.
This EMA approval represents a major advance in the standard of care for the estimated 47 million patients living with the disease in Europe. CKD, characterised by a reduction in the glomerular filtration rate, is often progressive, and the presence of albuminuria is a key risk factor for the subsequent development of kidney failure. Hence, any treatment that slows disease progression offers a clinical benefit to patients.
In June 2023, the Committee for Medicinal Products for Human Use adopted a positive opinion to recommend a change to the terms of the marketing authorisation for the medicinal product Jardiance (empagliflozin). This was based on the findings of the EMPA-KIDNEY trial, which were published in the New England Journal of Medicine earlier in the year.
With existing indications in type 2 diabetes and heart failure, empagliflozin could help manage the risks of cardio-renal-metabolic conditions.
Leonard Glass, senior vice president, diabetes and obesity global medical affairs at Lilly, said: ’CKD is closely linked to other cardio-renal-metabolic conditions such as type 2 diabetes and heart failure – thus an integrated approach is vital for optimised treatment of these interconnected conditions. We look forward to continuing conversations with other regulatory bodies worldwide so that empagliflozin can be made available for as many people living with these conditions as quickly as possible.’
Commenting on the approval, Daniel Gallego, president of European Kidney Patients’ Federation, added: ’We celebrate this significant milestone in the field of chronic kidney disease. CKD is a silent killer and prevention and early detection are crucial in the general population.
’This new treatment option has the potential to further improve the management of cardiorenal metabolic syndrome and renal disease, offering renewed hope and improved quality of life for countless individuals living with CKD worldwide.’
The EMPA-KIDNEY trial enrolled patients with chronic kidney disease who had an estimated glomerular filtration rate (eGFR) of at least 20 but less than 45 ml per minute per 1.73 m2 of body-surface area. Alternatively, enrolled participants could have an eGFR of at least 45 but less than 90 with a urinary albumin-to-creatinine ratio of at least 200.
EMPA-KIDNEY showed that during a median of 2.0 years of follow-up, the use of empagliflozin was associated with a 28% lower risk of progression of kidney disease or death from cardiovascular causes, compared to the placebo (Hazard ratio, HR = 0.72, 95% CI 0.64 – 0.82, p < 0.001).
These findings were consistent among patients with or without diabetes and across subgroups defined according to eGFR ranges. In addition, the rate of hospitalisation from any cause was lower in the empagliflozin group (HR = 0.86, 95% CI 0.78 – 0.95, p = 0.003).
14th March 2022
Empagliflozin administered to patients once hospitalised with either de novo or decompensated heart failure leads to a clinically significant benefit over the next 90 days. This was the finding of a randomised trial by researchers from the University of Groningen Department of Cardiology, Groningen, The Netherlands.
Among patients with type 2 diabetes, sodium–glucose cotransporter 2 inhibitors such as empagliflozin, have been shown to reduce the risk of hospitalisation for heart failure and the risk of serious adverse renal events. Although an anti-diabetic agent and based on several recent clinical trials, empagliflozin is now also indicated for the treatment of symptomatic chronic heart failure with a reduced ejection fraction.
However, whether the drug would still provide a clinical benefit to patients if given to those already admitted to hospital with heart failure is unknown.
For the present study, the Dutch researchers were interested in exploring whether empagliflozin would be clinically advantageous for patients, not only hospitalisation with heart failure but also on reducing worsening heart failure events (HFEs) and on the improvement of symptoms.
They performed the Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd or EMPULSE trial.
Included patients were those who had a primary diagnosis of acute de novo or decompensated chronic heart failure, irrespective of left ventricular ejection fraction. Individuals were randomised 1:1 to empagliflozin 10 mg or placebo and this occurred after at least 24 hours but no later than 5 days after admission, as early as possible after stabilisation and while still in hospital.
The primary outcome of the study was the clinical benefit at 90 days, which was defined as a composite outcome of time to all-cause death, the number of HFEs, the time to the first HFE and a 5- point or greater difference in change from baseline in Kansas City Cardiomyopathy Questionnaire KCCQ after 90 days of treatment.
The KCCQ is patient-reported outcome instrument that provides a measure of symptoms and physical limitations associated with heart failure. Assessments were based on the win ratio, which offers greater statistical power to detect and quantify a treatment difference by using all available information contained in the component outcomes.
Empagliflozin and clinical outcomes
A total of 530 patients with a median age of 71 years (34% women) were randomised to active treatment or placebo, within a median of 3 days after admission to hospital. The proportion of patients with diabetes ranged from 46.8% to 43.8%.
Overall, 33 (6.2%) of all patients died, 11 in the empagliflozin group and there were 67 patients assigned to empagliflozin who experienced at least one HFE. The adjusted mean change in KCCQ total score from baseline to 90 days was 36.2 in the empagliflozin group and 31.7 in the placebo arm.
More patients taking empagliflozin had a clinical benefit compared to placebo (stratified win ratio = 1.36, 95% CI 1.09 – 1.68, p = 0.0054). This benefit was observed irrespective of the ejection fraction and for both de novo and decompensated heart failure in the presence or absence of diabetes.
The authors concluded that initiating empagliflozin as a component of usual clinical care for patients hospitalised with acute heart failure led to clinically meaningful benefits.
Citation
Voors AA et al. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med 2022
4th October 2021
As a drug class, the sodium-glucose cotransporter-2 inhibitors (SGLT2is) have been shown in a systematic review to have a moderate effect on major adverse cardiovascular events in patients with established atherosclerotic cardiovascular disease. Moreover, the same review identified how SGLT2is can also reduce hospitalisation for heart failure (HF) and progression of renal disease regardless of existing atherosclerotic cardiovascular disease. In addition to these positive effects on cardiovascular outcomes, SGLT2is have been shown to reduce 24-hour blood pressure (BP) in diabetic patients. Nevertheless, this blood pressure-lowering effect is of concern in those with HF, especially as between 15 and 20% of HF patients have low systolic BP and therefore at a higher risk of in-hospital and post-discharge mortality.
In an effort to evaluate whether the baseline systolic BP affected outcomes associated with the use of empagliflozin, an international team, led by researchers from Saarland University, Germany, enrolled patients in the Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction (EMPEROR-Reduced) trial. Patients with class II, III, or IV heart failure and an ejection fraction of less than 40% were randomised in a 1:1 fashion to either empagliflozin (10mg daily) or placebo in addition to their usual therapy for heart failure. For the study, patients were grouped according to their baseline systolic BP, as <110mmHg, 110–130mmHg or > 130mmHg and the primary outcome in the EMPEROR-Reduced trial was a composite of adjudicated cardiovascular death or hospitalisation for heart failure. For the present study, the researchers focused on whether the baseline systolic BP influenced the outcomes of cardiovascular death and hospitalisations for HF in patients given empagliflozin compared to placebo.
Findings
A total of 3730 patients were randomised to either empagliflozin (1863) or placebo and all patients had a left ventricular ejection fraction of less than 30%. Over a median of 16 months, the event rate per 100 patients years (pys) of follow-up, the primary outcome increased from 16.5 among the high SBP group to 20.8 for the intermediate group, and to 26.3 per 100 among the patients with low SBP (p=0.0015). Compared with placebo, treatment with empagliflozin significantly decreased the risk of cardiovascular death among the low systolic BP (hazard ratio, HR = 0.78, 95% CI 0.61–1.00), intermediate (HR = 0.71, 95% CI 0.58–0.87) and high (HR = 0.82. 95% CI 0.62–1.09) groups. However, while there were reductions in rates of HF hospitalisation with empagliflozin compared with placebo, this was only significant for patients with intermediate (110–130mmHg) systolic BP (HR = 0.66, 95% CI 0.50–0.88).
The authors concluded that empagliflozin reduced the risk of cardiovascular death and the number of HF hospitalisations and that this effect occurred independently of the baseline systolic BP.
Citation
Bohm M et al. Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure. J Am Coll Cardiol 2021.
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