Objective:To observe the effect of different doses and frequencies of roxadustat on low-risk patients with myelodysplastic syndromes(MDS).Methods:This study was conducted using a comparative treatment observation appr...Objective:To observe the effect of different doses and frequencies of roxadustat on low-risk patients with myelodysplastic syndromes(MDS).Methods:This study was conducted using a comparative treatment observation approach.Low-risk MDS patients admitted to our hospital from February 2022 to February 2023 were selected,excluding patients with a history of severe drug allergies or known allergies to roxadustat.A total of 60 patients were included and randomly divided into observation group A(20 cases,100 mg,twice weekly),observation group B(20 cases,50 mg,once daily),and observation group C(20 cases,150 mg,twice weekly).Patient recovery,adverse reaction rate,and hemoglobin recovery time were compared and statistically analyzed.Results:The recovery rate of group B in the observation group was significantly higher than that in the other two groups,and the incidence of adverse reactions and the time to Hb recovery were also better in group B than in the other two groups(p<0.05).Conclusion:Low-dose,high-frequency(50 mg,once daily)administration can effectively improve the hemoglobin level of low-risk MDS patients and help improve their general survival.展开更多
BACKGROUND Hyporesponsiveness to erythropoiesis-stimulating agents(ESAs)is a prevalent problem in patients with chronic kidney disease.It is associated with increased morbidity and mortality in patients who undergo di...BACKGROUND Hyporesponsiveness to erythropoiesis-stimulating agents(ESAs)is a prevalent problem in patients with chronic kidney disease.It is associated with increased morbidity and mortality in patients who undergo dialysis.A significant proportion of patients do not respond to iron supplementation and conventional ESAs.We report a case of severe ESA hyporesponsiveness-related anemia that was successfully treated with oral roxadustat.CASE SUMMARY A 59-year-old Chinese woman had high blood glucose for 25 years,maintenance hemodialysis for 7 years,and recurrent dizziness and fatigue for more than 2 years.Laboratory tests showed severe anemia(hemoglobin level of 54 g/L),though bone marrow biopsy,fluorescence in situ hybridization,and hemolysis tests were within normal ranges.We initially administered first-line therapies and other adjuvant treatments,such as blood transfusions,ESAs,and adequate dialysis,but the patient did not respond as anticipated.Her erythropoietinresistant anemia was probably not only due to chronic renal insufficiency.The patient received the hypoxia-inducible factor prolyl hydroxylase inhibitor roxadustat(100 mg,three times weekly).After 12 wk of treatment,the patient’s hemoglobin increased significantly,and her symptoms were alleviated.During the follow-up period,adverse drug reactions were controllable and tolerable.CONCLUSION Oral roxadustat is effective and tolerable for the treatment of ESA hyporesponsiveness-related anemia in patients undergoing hemodialysis.展开更多
BACKGROUND Erythropoiesis-stimulating agents(ESAs)have revolutionized the therapeutic strategy for anemia in chronic kidney disease.However,some cases are resistant or hyporesponsive to ESAs.Roxadustat is an oral hypo...BACKGROUND Erythropoiesis-stimulating agents(ESAs)have revolutionized the therapeutic strategy for anemia in chronic kidney disease.However,some cases are resistant or hyporesponsive to ESAs.Roxadustat is an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism.Here,we describe a hemodialysis patient with refractory anemia who did not respond to traditional treatments and depended on blood transfusion for more than 1 year.After applying Roxadustat,the patient’s anemia improved significantly.CASE SUMMARY A 44-year-old man was diagnosed with uremia accompanied by severe anemia with a hemoglobin(Hb)level ranging from 30-40 g/L.His anemia did not improve after sufficient dialysis or high doses of active ESAs;other causes of anemia were excluded.The patient required approximately 600-1000 mL of red blood cell suspension every 15-30 d for more than 1 year.After accepting Roxadustat therapy,the patient’s anemia symptoms improved significantly;his Hb level gradually increased to 50 g/L,and no further blood transfusions were administered.His Hb level reached 69 g/L by the 34th week.Although a Hb level of 60-70 g/L cannot be considered satisfactory,he no longer required blood transfusions and his quality of life was substantially improved.Roxadustat showed good efficacy and safety in this case.CONCLUSION Roxadustat represents an innovative and effective agent for the clinical treatment of renal anemia caused by multiple complex factors.展开更多
BACKGROUND There are no studies on the use of roxadustat in patients on regular peritoneal dialysis in China.AIM To observe the efficacy and safety of roxadustat in treating renal anaemia in peritoneal dialysis patien...BACKGROUND There are no studies on the use of roxadustat in patients on regular peritoneal dialysis in China.AIM To observe the efficacy and safety of roxadustat in treating renal anaemia in peritoneal dialysis patients.METHODS Patients with renal anaemia who were regularly followed at the Peritoneal Dialysis Center of the First Affiliated Hospital of China Medical University from November 1,2019 to June 30,2020 were selected.A before-and-after self-control design was performed to retrospectively analyse the treatment effects on anaemia in patients treated with recombinant human erythropoietin(EPO)and roxadustat.RESULTS A total of 31 patients with renal anaemia on long-term peritoneal dialysis treated with roxadustat were included.Haemoglobin(Hb)levels were maintained or increased in all patients(100%),and no patients had a decrease in Hb compared with the previous phase.Patients had a mean Hb of 86.2±14.8 g/L with Hb compliance(Hb≥110 g/L)of 16.1%during the EPO phase and a mean Hb of 112.4±18.5 g/L with Hb compliance of 67.7%during the roxadustat phase.No major adverse cardiovascular events occurred in any patient.CONCLUSION The application of roxadustat in peritoneal dialysis patients with renal anaemia can effectively improve the Hb compliance rate.展开更多
BACKGROUNDMost cancer patients are accompanied by anemia, which will be more seriouswhen combined with end-stage renal disease (ESRD). At present, cancer-relatedanemia and renal anemia treatments mainly include erythr...BACKGROUNDMost cancer patients are accompanied by anemia, which will be more seriouswhen combined with end-stage renal disease (ESRD). At present, cancer-relatedanemia and renal anemia treatments mainly include erythropoiesis-stimulatingagents (ESAs), iron supplementation, and blood transfusion, but their effects areoften poor with several safety concerns. We have used roxadustat to treat anemiain a cancer patient with ESRD and achieved a successful outcome for the firsttime.CASE SUMMARYA 64-year-old man was diagnosed with right renal cancer (clear cell renal cellcarcinoma). He did not receive surgery or radiotherapy before admission. He wastreated with oral soltan (sunitinib malate) on April 18, 2017. During oral chemotherapy,he had numerous complications, including anemia, hypertension,thyroid hypofunction, skin pigment loss, and renal function deterioration. At last,he progressed to ESRD and began hemodialysis treatment. We initially treated thepatient with high-dose ESAs, iron supplementation, adequate dialysis, and evenblood transfusion, but his anemia did not improve. Roxadustat is a newlydeveloped drug for renal anemia treatment, but not for cancer-related anemia, letalone to treat anemia in cancer patients with ESRD. We prescribed oral roxadustatto the patient. After a period, his hemoglobin gradually increased. He did nothave obvious discomfort symptoms, and his tumor did not progress significantly.CONCLUSIONOral roxadustat could achieve good results in treating anemia in cancer patients with ESRD.展开更多
Objective:To analyze the short-term curative effect of roxadustat in the treatment of renal anemia in patients with peritoneal dialysis.Methods:70 patients with peritoneal dialysis renal anemia admitted to the dialysi...Objective:To analyze the short-term curative effect of roxadustat in the treatment of renal anemia in patients with peritoneal dialysis.Methods:70 patients with peritoneal dialysis renal anemia admitted to the dialysis department of our hospital from March 2021-March 2023 were selected as research objects,divided into a research group and a reference group according to random number drawing method,with each group consisting of 35 cases.The patients in the research group were treated with roxadustat,and those in the reference group were treated with recombinant human erythropoietin.The total efficacy,anemia index,iron metabolism index,and occurrence of adverse reactions were compared between the two groups.Results:The total efficacy of the treatment received in the research group was significantly higher than that in the reference group(P<0.05).In terms of anemia indicators,there was no statistically significant difference between the hemoglobin(Hb),the red blood cell(RBC),and the hematocrit(HCT)of both groups(P>0.05)before treatment.After treatment,the anemia indicators of the patients in the research group were significantly better than those in the reference group,(P<0.05).In terms of iron metabolism,before treatment,there was no significant difference between the total iron-binding capacity(TIBC),the transferrin(TRF),the ferritin(FER),and iron(Fe)of both groups(P>0.05).After treatment,the research group’s iron metabolism indicators were significantly better than those of the reference group(P<0.05).The incidence of adverse reactions in the research group was significantly lower than that in the reference group(P<0.05).Conclusion:The short-term curative effect of roxadustat in the treatment of peritoneal dialysis patients was demonstrated through this study,making it a viable treatment option.展开更多
BACKGROUND Hypoxia-inducible factor prolyl hydroxylase inhibitor is a new class of drugs for treating renal anemia.It is a second-generation hypoxia-inducible factor prolyl hydroxylase-2(PHD2)inhibitor.Roxadustat can ...BACKGROUND Hypoxia-inducible factor prolyl hydroxylase inhibitor is a new class of drugs for treating renal anemia.It is a second-generation hypoxia-inducible factor prolyl hydroxylase-2(PHD2)inhibitor.Roxadustat can effectively increase hemoglobin in patients with dialysis-dependent chronic kidney disease,with an adverse events profile comparable to that of epoetin alfa.We administered roxadustat to a maintenance hemodialysis patient who was allergic to erythropoiesis-stimulating agents(ESAs)and depended on blood transfusion for five years.After applying Roxadustat,the patient’s anemia improved significantly.CASE SUMMARY A 77-year-old Chinese man had type 2 diabetes for 16 years,underwent maintenance hemodialysis for five years,and had fatigue for five years.Laboratory tests showed severe anemia(hemoglobin concentration of 42 g/L).The patient was administered a subcutaneous injection of ESAs before dialysis.He suffered an allergic shock immediately and fainted.His blood pressure dropped to undetectable levels.He was not administered ESAs henceforth.The patient was prescribed iron supplements and received blood transfusions occasionally for five years.His hemoglobin concentration ranged from 42-68 g/L.After taking six weeks of oral roxadustat three times weekly(100 mg TIW),the patient’s hemoglobin concentration increased significantly,and his symptoms decreased.We adjusted the doses of roxadustat,and the hemoglobin concentration was maintained between 97 and 126 g/L.CONCLUSION Oral roxadustat is effective in treating anemia in maintenance hemodialysis patients who cannot be administered ESAs.展开更多
Background:Chronic kidney disease(CKD)-associated anemia(CKD-anemia)is associated with poor survival,and hemoglobin targets are often not achieved with current therapies.Phase 3 trials have demonstrated the treatment ...Background:Chronic kidney disease(CKD)-associated anemia(CKD-anemia)is associated with poor survival,and hemoglobin targets are often not achieved with current therapies.Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia.This phase 4 study aims to evaluate the long-term(52-week)safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China.Methods:This Phase 4 multicenter,open-label,prospective study,conducted from 24 November 2020 to 11 November 2022,evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China.Patients aged≥18 years with CKD-anemia with or without dialysis were included.The initial oral dose was 70-120 mg(weight-based followed by dose adjustment)over 52 weeks.The primary endpoint was safety based on adverse events(AEs).The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin≥100 g/L.Effectiveness evaluable populations 1(EE1)and EE2 included roxadustat-naïve and previously roxadustat-treated patients,respectively.The safety analysis set(SAF)included all patients who received≥1 occasion.Results:The EE1,EE2,and SAF populations included 1804,193,and 2021 patients,respectively.In the SAF,the mean age was 50±14 years,and 1087 patients(53.8%)were male.Mean baseline hemoglobin was 96.9±14.0 g/L in EE1 and 100.3±12.9 g/L in EE2.In EE1,the mean(95%confidence interval)hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2(13.5-14.9)g/L and 14.3(13.5-15.0)g/L,respectively.Over weeks 24-36 and 36-52,83.3%and 86.1%of patients in EE1 and 82.7%and 84.7%in EE2 achieved mean hemoglobin≥100 g/L,respectively.In the SAF,1643(81.3%)patients experienced treatment-emergent AEs(TEAEs).Overall,219(10.8%)patients experienced drug-related TEAEs.Thirty-eight(1.9%)patients died of TEAEs(unrelated to the study drug).Vascular access thrombosis was uncommon.Conclusions:Roxadustat(52 weeks)increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety,supporting its use in real-world settings.展开更多
To the Editor:Anemia is a critical complication of chronic kidney disease(CKD),causing high mortality and morbidity.[1]The standard treatment involves erythropoiesis-stimulating agents(ESAs)and iron supplementation.Ho...To the Editor:Anemia is a critical complication of chronic kidney disease(CKD),causing high mortality and morbidity.[1]The standard treatment involves erythropoiesis-stimulating agents(ESAs)and iron supplementation.However,concurrent inflammation is always associated with a poor response to ESA therapy,requiring a higher ESA dosage to maintain hemoglobin(Hb)level.[1]Roxadustat,the first oral hypoxia-inducible factor prolyl-hydroxylase inhibitor(HIF-PHI),presents an effective alternative.It physiologically promotes endogenous erythropoietin production,improves iron metabolism,and demonstrates reduced susceptibility to inflammation.展开更多
Objective To evaluate the efficacy and safety of roxadustat in patients with refractory non-severe aplastic anemia (NSAA).Methods The clinical data of patients with refractory NSAA who had been treated with roxadustat...Objective To evaluate the efficacy and safety of roxadustat in patients with refractory non-severe aplastic anemia (NSAA).Methods The clinical data of patients with refractory NSAA who had been treated with roxadustat continuously for at least 3 months and followed up for more than 6 months at Peking Union Medical College Hospital from October 2020 to August 2022 were retrospectively collected.展开更多
文摘Objective:To observe the effect of different doses and frequencies of roxadustat on low-risk patients with myelodysplastic syndromes(MDS).Methods:This study was conducted using a comparative treatment observation approach.Low-risk MDS patients admitted to our hospital from February 2022 to February 2023 were selected,excluding patients with a history of severe drug allergies or known allergies to roxadustat.A total of 60 patients were included and randomly divided into observation group A(20 cases,100 mg,twice weekly),observation group B(20 cases,50 mg,once daily),and observation group C(20 cases,150 mg,twice weekly).Patient recovery,adverse reaction rate,and hemoglobin recovery time were compared and statistically analyzed.Results:The recovery rate of group B in the observation group was significantly higher than that in the other two groups,and the incidence of adverse reactions and the time to Hb recovery were also better in group B than in the other two groups(p<0.05).Conclusion:Low-dose,high-frequency(50 mg,once daily)administration can effectively improve the hemoglobin level of low-risk MDS patients and help improve their general survival.
基金Supported by the National Natural Science Foundation of China,No.81770730and the Hunan Provincial Natural Science Fund,No.2017JJ2352.
文摘BACKGROUND Hyporesponsiveness to erythropoiesis-stimulating agents(ESAs)is a prevalent problem in patients with chronic kidney disease.It is associated with increased morbidity and mortality in patients who undergo dialysis.A significant proportion of patients do not respond to iron supplementation and conventional ESAs.We report a case of severe ESA hyporesponsiveness-related anemia that was successfully treated with oral roxadustat.CASE SUMMARY A 59-year-old Chinese woman had high blood glucose for 25 years,maintenance hemodialysis for 7 years,and recurrent dizziness and fatigue for more than 2 years.Laboratory tests showed severe anemia(hemoglobin level of 54 g/L),though bone marrow biopsy,fluorescence in situ hybridization,and hemolysis tests were within normal ranges.We initially administered first-line therapies and other adjuvant treatments,such as blood transfusions,ESAs,and adequate dialysis,but the patient did not respond as anticipated.Her erythropoietinresistant anemia was probably not only due to chronic renal insufficiency.The patient received the hypoxia-inducible factor prolyl hydroxylase inhibitor roxadustat(100 mg,three times weekly).After 12 wk of treatment,the patient’s hemoglobin increased significantly,and her symptoms were alleviated.During the follow-up period,adverse drug reactions were controllable and tolerable.CONCLUSION Oral roxadustat is effective and tolerable for the treatment of ESA hyporesponsiveness-related anemia in patients undergoing hemodialysis.
基金Sichuan Clinical Research Center for Nephropathy,No.2019YFS0537-3.
文摘BACKGROUND Erythropoiesis-stimulating agents(ESAs)have revolutionized the therapeutic strategy for anemia in chronic kidney disease.However,some cases are resistant or hyporesponsive to ESAs.Roxadustat is an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism.Here,we describe a hemodialysis patient with refractory anemia who did not respond to traditional treatments and depended on blood transfusion for more than 1 year.After applying Roxadustat,the patient’s anemia improved significantly.CASE SUMMARY A 44-year-old man was diagnosed with uremia accompanied by severe anemia with a hemoglobin(Hb)level ranging from 30-40 g/L.His anemia did not improve after sufficient dialysis or high doses of active ESAs;other causes of anemia were excluded.The patient required approximately 600-1000 mL of red blood cell suspension every 15-30 d for more than 1 year.After accepting Roxadustat therapy,the patient’s anemia symptoms improved significantly;his Hb level gradually increased to 50 g/L,and no further blood transfusions were administered.His Hb level reached 69 g/L by the 34th week.Although a Hb level of 60-70 g/L cannot be considered satisfactory,he no longer required blood transfusions and his quality of life was substantially improved.Roxadustat showed good efficacy and safety in this case.CONCLUSION Roxadustat represents an innovative and effective agent for the clinical treatment of renal anemia caused by multiple complex factors.
基金Liaoning Province Key R&D Guidance Program,No.2019JH8/10300016Liaoning Province Grassroots Health and Family Planning Appropriate Technology Promotion Project,No.LHATP-201801.
文摘BACKGROUND There are no studies on the use of roxadustat in patients on regular peritoneal dialysis in China.AIM To observe the efficacy and safety of roxadustat in treating renal anaemia in peritoneal dialysis patients.METHODS Patients with renal anaemia who were regularly followed at the Peritoneal Dialysis Center of the First Affiliated Hospital of China Medical University from November 1,2019 to June 30,2020 were selected.A before-and-after self-control design was performed to retrospectively analyse the treatment effects on anaemia in patients treated with recombinant human erythropoietin(EPO)and roxadustat.RESULTS A total of 31 patients with renal anaemia on long-term peritoneal dialysis treated with roxadustat were included.Haemoglobin(Hb)levels were maintained or increased in all patients(100%),and no patients had a decrease in Hb compared with the previous phase.Patients had a mean Hb of 86.2±14.8 g/L with Hb compliance(Hb≥110 g/L)of 16.1%during the EPO phase and a mean Hb of 112.4±18.5 g/L with Hb compliance of 67.7%during the roxadustat phase.No major adverse cardiovascular events occurred in any patient.CONCLUSION The application of roxadustat in peritoneal dialysis patients with renal anaemia can effectively improve the Hb compliance rate.
文摘BACKGROUNDMost cancer patients are accompanied by anemia, which will be more seriouswhen combined with end-stage renal disease (ESRD). At present, cancer-relatedanemia and renal anemia treatments mainly include erythropoiesis-stimulatingagents (ESAs), iron supplementation, and blood transfusion, but their effects areoften poor with several safety concerns. We have used roxadustat to treat anemiain a cancer patient with ESRD and achieved a successful outcome for the firsttime.CASE SUMMARYA 64-year-old man was diagnosed with right renal cancer (clear cell renal cellcarcinoma). He did not receive surgery or radiotherapy before admission. He wastreated with oral soltan (sunitinib malate) on April 18, 2017. During oral chemotherapy,he had numerous complications, including anemia, hypertension,thyroid hypofunction, skin pigment loss, and renal function deterioration. At last,he progressed to ESRD and began hemodialysis treatment. We initially treated thepatient with high-dose ESAs, iron supplementation, adequate dialysis, and evenblood transfusion, but his anemia did not improve. Roxadustat is a newlydeveloped drug for renal anemia treatment, but not for cancer-related anemia, letalone to treat anemia in cancer patients with ESRD. We prescribed oral roxadustatto the patient. After a period, his hemoglobin gradually increased. He did nothave obvious discomfort symptoms, and his tumor did not progress significantly.CONCLUSIONOral roxadustat could achieve good results in treating anemia in cancer patients with ESRD.
文摘Objective:To analyze the short-term curative effect of roxadustat in the treatment of renal anemia in patients with peritoneal dialysis.Methods:70 patients with peritoneal dialysis renal anemia admitted to the dialysis department of our hospital from March 2021-March 2023 were selected as research objects,divided into a research group and a reference group according to random number drawing method,with each group consisting of 35 cases.The patients in the research group were treated with roxadustat,and those in the reference group were treated with recombinant human erythropoietin.The total efficacy,anemia index,iron metabolism index,and occurrence of adverse reactions were compared between the two groups.Results:The total efficacy of the treatment received in the research group was significantly higher than that in the reference group(P<0.05).In terms of anemia indicators,there was no statistically significant difference between the hemoglobin(Hb),the red blood cell(RBC),and the hematocrit(HCT)of both groups(P>0.05)before treatment.After treatment,the anemia indicators of the patients in the research group were significantly better than those in the reference group,(P<0.05).In terms of iron metabolism,before treatment,there was no significant difference between the total iron-binding capacity(TIBC),the transferrin(TRF),the ferritin(FER),and iron(Fe)of both groups(P>0.05).After treatment,the research group’s iron metabolism indicators were significantly better than those of the reference group(P<0.05).The incidence of adverse reactions in the research group was significantly lower than that in the reference group(P<0.05).Conclusion:The short-term curative effect of roxadustat in the treatment of peritoneal dialysis patients was demonstrated through this study,making it a viable treatment option.
文摘BACKGROUND Hypoxia-inducible factor prolyl hydroxylase inhibitor is a new class of drugs for treating renal anemia.It is a second-generation hypoxia-inducible factor prolyl hydroxylase-2(PHD2)inhibitor.Roxadustat can effectively increase hemoglobin in patients with dialysis-dependent chronic kidney disease,with an adverse events profile comparable to that of epoetin alfa.We administered roxadustat to a maintenance hemodialysis patient who was allergic to erythropoiesis-stimulating agents(ESAs)and depended on blood transfusion for five years.After applying Roxadustat,the patient’s anemia improved significantly.CASE SUMMARY A 77-year-old Chinese man had type 2 diabetes for 16 years,underwent maintenance hemodialysis for five years,and had fatigue for five years.Laboratory tests showed severe anemia(hemoglobin concentration of 42 g/L).The patient was administered a subcutaneous injection of ESAs before dialysis.He suffered an allergic shock immediately and fainted.His blood pressure dropped to undetectable levels.He was not administered ESAs henceforth.The patient was prescribed iron supplements and received blood transfusions occasionally for five years.His hemoglobin concentration ranged from 42-68 g/L.After taking six weeks of oral roxadustat three times weekly(100 mg TIW),the patient’s hemoglobin concentration increased significantly,and his symptoms decreased.We adjusted the doses of roxadustat,and the hemoglobin concentration was maintained between 97 and 126 g/L.CONCLUSION Oral roxadustat is effective in treating anemia in maintenance hemodialysis patients who cannot be administered ESAs.
文摘Background:Chronic kidney disease(CKD)-associated anemia(CKD-anemia)is associated with poor survival,and hemoglobin targets are often not achieved with current therapies.Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia.This phase 4 study aims to evaluate the long-term(52-week)safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China.Methods:This Phase 4 multicenter,open-label,prospective study,conducted from 24 November 2020 to 11 November 2022,evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China.Patients aged≥18 years with CKD-anemia with or without dialysis were included.The initial oral dose was 70-120 mg(weight-based followed by dose adjustment)over 52 weeks.The primary endpoint was safety based on adverse events(AEs).The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin≥100 g/L.Effectiveness evaluable populations 1(EE1)and EE2 included roxadustat-naïve and previously roxadustat-treated patients,respectively.The safety analysis set(SAF)included all patients who received≥1 occasion.Results:The EE1,EE2,and SAF populations included 1804,193,and 2021 patients,respectively.In the SAF,the mean age was 50±14 years,and 1087 patients(53.8%)were male.Mean baseline hemoglobin was 96.9±14.0 g/L in EE1 and 100.3±12.9 g/L in EE2.In EE1,the mean(95%confidence interval)hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2(13.5-14.9)g/L and 14.3(13.5-15.0)g/L,respectively.Over weeks 24-36 and 36-52,83.3%and 86.1%of patients in EE1 and 82.7%and 84.7%in EE2 achieved mean hemoglobin≥100 g/L,respectively.In the SAF,1643(81.3%)patients experienced treatment-emergent AEs(TEAEs).Overall,219(10.8%)patients experienced drug-related TEAEs.Thirty-eight(1.9%)patients died of TEAEs(unrelated to the study drug).Vascular access thrombosis was uncommon.Conclusions:Roxadustat(52 weeks)increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety,supporting its use in real-world settings.
文摘To the Editor:Anemia is a critical complication of chronic kidney disease(CKD),causing high mortality and morbidity.[1]The standard treatment involves erythropoiesis-stimulating agents(ESAs)and iron supplementation.However,concurrent inflammation is always associated with a poor response to ESA therapy,requiring a higher ESA dosage to maintain hemoglobin(Hb)level.[1]Roxadustat,the first oral hypoxia-inducible factor prolyl-hydroxylase inhibitor(HIF-PHI),presents an effective alternative.It physiologically promotes endogenous erythropoietin production,improves iron metabolism,and demonstrates reduced susceptibility to inflammation.
文摘Objective To evaluate the efficacy and safety of roxadustat in patients with refractory non-severe aplastic anemia (NSAA).Methods The clinical data of patients with refractory NSAA who had been treated with roxadustat continuously for at least 3 months and followed up for more than 6 months at Peking Union Medical College Hospital from October 2020 to August 2022 were retrospectively collected.
