Secondary endpoints were hierarchically tested for non-inferiority and superiority. Superiority of roxadustat to darbepoetin alfa was demonstrated by a decrease in low-density lipoprotein cholesterol with a least square mean (LSM) difference of -0.403 mmol/L (95% CI -0.510, -0.296; [P8g/dL, and the change from BL in Hb levels of ?2g/dL if the BL Hb?8g/dL. For more information about this study, visit www.clinicaltrials.gov [NCT02021318].1
About CKD and Anemia
CKD is characterized by a progressive loss of kidney function caused by damage to the kidneys resulting from conditions such as hypertension, diabetes or immune-regulated inflammatory conditions.2 Worldwide 1 in 10 people are living with CKD.3 In Europe, 1 in 8 people are living with CKD,3 of whom 1 in 5 are affected by anemia; this rate increases to 1 in 2 in people with the most severe CKD (CKD stage 5).4 Globally, CKD is predicted to become the fifth most common cause of premature death by 2040.5 It is a critical worldwide healthcare issue that represents a large and growing unmet medical need.
Anemia is a common complication of CKD,6 resulting from the failing kidneys' ability to produce erythropoietin, reduced oxygen sensing, and increased hepcidin and iron deficiency resulting from chronic inflammation. It is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.7 CKD anemia increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients' quality of life.8-10
About Roxadustat
Roxadustat is approved and launched for the treatment of anemia associated with CKD in
Astellas and
About Astellas
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets and (vi) infringements of Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement or medical advice.
REFERENCES
1Clinicaltrials.gov. Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa (Dolomites). Available from: https://clinicaltrials.gov/ct2/show/NCT02021318 [Last accessed: June 2020].
2Ojo A. Addressing the Global Burden of
3International
4Dmitrieva O, de Lusignan S, Macdougall IC, et al. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. BMC Nephrol 2013;14:24.
5Institute
6McClellan W, Aronoff SL,
7Stauffer ME and Fan T. Prevalence of Anemia in Chronic Kidney Disease in
8Mohanram A, Zhang Z, Shahinfar S, et al. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. Kidney Int 2004;66:1131-1138.
9Weiner DE, Tighiouart H, Stark PC, et al. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. Am J Kidney Dis 2004;44:198-206.
10Eriksson D, Goldsmith D, Teitsson S, et al. Cross-sectional survey in CKD patients across
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