REVEAL-CKD data show alarming prevalence of undiagnosed Stage 3 chronic kidney disease across France, Germany, Italy, Japan and US.
Findings from INSIDE-CKD demonstrate that Farxiga could cut 33 percent of healthcare costs by delaying disease progression and reducing incidence of cardiorenal events.

AstraZeneca, a leader in cardiorenal research, presented new data at the American Society of Nephrology (ASN) Kidney Week 2022 in Orlando, Florida, US on the importance of earlier screening and diagnosis of chronic kidney disease (CKD) and the impact of Farxiga on reducing healthcare costs^1,2. These findings were also simultaneously published in the Journal of the American Society of Nephrology.

CKD affects 850 million people worldwide with increasing prevalence³, yet the vast majority of patients go undiagnosed⁴. Data from the REVEAL-CKD multinational study found high rates of underdiagnosis, 61.6% to 95.5%, in the countries studied (US, Italy, Germany, Japan and France). Country-specific electronic medical records and insurance claims were analysed for patients with estimated glomerular filtration rate (eGFR) between ≥30 and <60 mL/min/1.73 m², equal to CKD Stage 3, who lacked a diagnosis of CKD. This analysis further demonstrated that once a diagnosis was made, patients did receive timely CKD monitoring and management of their disease, leading to real-life patient benefits¹.

The importance of receiving a CKD diagnosis can be seen in its impact on annual kidney function decline, i.e., the eGFR slope. The REVEAL-CKD trial evaluated eGFR decline before and after CKD diagnosis was recorded for 27,000 patients in the US TriNetX database. These patients had a median eGFR decline in the two-year period prior to CKD diagnosis of -4.12 (95% confidence interval [CI]: -4.23, -4.02) and in the two-year period after diagnosis of only -0.30 (95% CI: -0.44, -0.14)⁵.  

Dr Navdeep Tangri, Professor of Medicine at University of Manitoba Department of Internal Medicine, Winnipeg, Manitoba, Canada said: “The level of underdiagnosis of chronic kidney disease, even in countries with well-established and -financed healthcare systems, is alarming. These data from REVEAL-CKD reinforce the need to proactively screen and diagnose early-stage kidney disease so that patients can receive guideline-directed monitoring and treatment. This can prevent or delay progression to kidney failure and other serious comorbidities.”

In addition to the patient need, there are significant healthcare costs associated with CKD, especially as it progresses to kidney failure and cardiorenal events. INSIDE-CKD estimated the direct medical care cost-offsets of a reduced incidence of clinical events, showing that Farxiga significantly reduces healthcare resource utilisation by delaying CKD progression and reducing incidence of cardiorenal events. Across 23 countries and 100,000 patients, there was a 33% cost reduction when patients were treated with Farxiga in addition to standard of care, compared to standard of care alone, resulting in savings of $205M USD over a 3-year period².

Another analysis of DAPA-CKD data presented at ASN furthermore found that Farxiga treatment reduced the rate of all-cause hospital admissions among patients with CKD, with or without type 2 diabetes (T2D)⁶. These findings demonstrate implications not only for patient quality of life, but also on the overall healthcare burden and expenditure attributed to CKD care.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Chronic kidney disease is a silent, progressive killer that remains underdiagnosed. These data presented at ASN Kidney Week 2022 not only provide a comprehensive view of the costs associated with chronic kidney disease and the toll it takes on patient lives, but also how Farxiga can cut this significant burden with reduced rates of all-cause hospital admissions and healthcare resource utilisation. If clinical treatment guidelines were fully implemented, highlighting the need for preventive treatment strategies, patients’ risk of adverse kidney, mortality and cardiovascular outcomes can be ameliorated.”    

In addition to presenting data at ASN Kidney Week 2022 on the urgent need for earlier diagnosis and screening, AstraZeneca supported the International Society of Nephrology in creating this quick one-minute quiz to offer insight into whether a patient may be at risk for CKD and to provide them with more information on the risk factors to be aware of to help start the conversation with their doctor.

CKD
CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced eGFR or markers of kidney damage, or both, for at least three months)⁴. The most common causes of CKD are diabetes, hypertension and glomerulonephritis⁷. CKD is associated with significant patient morbidity and an increased risk of cardiovascular (CV) events, such as heart failure (HF) and premature death⁸. In its most severe form, known as kidney failure, kidney damage and deterioration of kidney function have progressed to the point where dialysis or kidney transplantation are required⁸. The majority of patients with CKD will die from CV causes before reaching kidney failure⁹. 

DAPA-CKD
DAPA-CKD was an international, multi-centre, randomised, double-blinded Phase III trial in 4,304 patients designed to evaluate the efficacy of Farxiga 10mg, compared with placebo, in patients with CKD Stage 2-4 and elevated urinary albumin excretion, with and without T2D. Farxiga was given once daily in addition to standard of care. The primary composite endpoint was worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, onset of kidney failure or death from CV or renal cause). The secondary endpoints included the time to first occurrence of the renal composite (sustained ≥50% eGFR decline, kidney or renal death), the composite of CV death or hospitalisation for HF (hHF), and death from any cause. The trial was conducted in 21 countries.Detailed results from the trial were published in The New England Journal of Medicine¹⁰.

Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown Farxiga’s efficacy in preventing and delaying cardiorenal disease, while also protecting the organs – important findings given the underlying links between the heart, kidneys and pancreas^10-12. Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including T2D, HF and chronic kidney disease (CKD)^4,13-15.

Farxiga is approved for adults and children aged 10 years and above for the treatment of insufficiently controlled T2D mellitus as an adjunct to diet and exercise. Farxiga is also approved for the treatment of HFrEF and the treatment of CKD based on the findings of the DAPA-HF and DAPA-CKD Phase III trials.

DapaCare is a robust programme of clinical trials to evaluate the potential CV, renal and organ protection benefits of Farxiga. It includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience. Farxiga is currently being tested in patients without T2D following an acute myocardial infarction or heart attack in the DAPA-MI Phase III trial – a first of its kind, indication-seeking registry-based randomised controlled trial.

AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca’s main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improving outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

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References

1. Tangri N, et al. REVEAL-CKD: Management and Monitoring of Patients with CKD Stage 3 in France, Germany, Italy, Japan, and the USA. Presented at: American Society of Nephrology (ASN) Kidney Week 2022, 3-6 November 2022, Orlando, Florida, USA.
2. McEwan, et al. Translating the Findings of DAPA-CKD to Reductions in Healthcare Resource Utilization from a Global Perspective. Presented at: American Society of Nephrology (ASN) Kidney Week 2022, 3-6 November 2022, Orlando, Florida, USA.
3. Jager KJ, et al. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Nephrol Dial Transplant. 2019;34(11):1803-1805.
4. Bikbov B, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709-733.
5. Tangri N, et al. REVEAL CKD: Estimated Glomerular Filtration Rate (eGFR) Decline Before and After a CKD Diagnosis Among Patients with CKD Stage 3. Presented at: American Society of Nephrology (ASN) Kidney Week 2022, 3-6 November 2022, Orlando, Florida, USA.
6. Schechter M, et al. Dapagliflozin effect on hospital admissions in patients with chronic kidney disease: A post hoc analysis of the DAPA-CKD trial. Presented at: American Society of Nephrology (ASN) Kidney Week 2022, 3-6 November 2022, Orlando, Florida, USA.
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12. Wiviott SD, et al. for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type-2 diabetes [article and supplementary appendix]. N Engl J Med 2019; 380(4):347–57.
13. Vos T, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100):1211–59.
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15. Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States, 2020; [cited 2022 Oct 11]. Available from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html.
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