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      Relationship Between the Effect of Roxadustat and Comorbid Diabetes in Non-dialyzed Chronic Kidney Disease Patients: A Retrospective Observational Study

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          Abstract

          Introduction

          The dose of roxadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, required to treat anemia, the hemoglobin level and the rate of hemoglobin target achievement were retrospectively investigated in non-dialyzed chronic kidney disease (CKD) patients with and without type 2 diabetes.

          Methods

          As the full analysis set, 25 subjects (10 with diabetes and 15 without diabetes) were observed over six months among 44 non-dialyzed CKD patients who received roxadustat. The target hemoglobin level was set at 110-130 g/L.

          Results

          The comorbidities of diabetes and body weight at baseline were significantly associated with each dose of roxadustat at six months and the change in each dose of roxadustat from the initiation of roxadustat treatment. There was no significant difference in the amount of increase in the hemoglobin level (14±11 g/L vs. 15±8 g/L) and the rate of hemoglobin target achievement (70% vs. 67%) between patients with and without diabetes. Each dose of roxadustat gradually decreased in patients without diabetes, whereas it increased in those with diabetes. Each dose of roxadustat was significantly higher in patients with diabetes than in those without diabetes at 3 (60±21 mg vs. 42±14 mg) and 6 (61±22 mg vs. 41±14 mg) months after the initiation of roxadustat treatment.

          Conclusion

          Roxadustat is useful for the treatment of anemia in both CKD patients with and without diabetes. However, the dose required to achieve the target hemoglobin level may be higher in patients with diabetes than in those without diabetes.

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          Most cited references30

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          Revised equations for estimated GFR from serum creatinine in Japan.

          Seiichi Matsuo, Enyu Imai, Masaru Horio … (2009)
          Estimation of glomerular filtration rate (GFR) is limited by differences in creatinine generation among ethnicities. Our previously reported GFR-estimating equations for Japanese had limitations because all participants had a GFR less than 90 mL/min/1.73 m2 and serum creatinine was assayed in different laboratories. Diagnostic test study using a prospective cross-sectional design. New equations were developed in 413 participants and validated in 350 participants. All samples were assayed in a central laboratory. Hospitalized Japanese patients in 80 medical centers. Patients had not participated in the previous study. Measured GFR (mGFR) computed from inulin clearance. Estimated GFR (eGFR) by using the modified isotope dilution mass spectrometry (IDMS)-traceable 4-variable Modification of Diet in Renal Disease (MDRD) Study equation using the previous Japanese Society of Nephrology Chronic Kidney Disease Initiative (JSN-CKDI) coefficient of 0.741 (equation 1), the previous JSN-CKDI equation (equation 2), and new equations derived in the development data set: modified MDRD Study using a new Japanese coefficient (equation 3), and a 3-variable Japanese equation (equation 4). Performance of equations was assessed by means of bias (eGFR - mGFR), accuracy (percentage of estimates within 15% or 30% of mGFR), root mean squared error, and correlation coefficient. In the development data set, the new Japanese coefficient was 0.808 (95% confidence interval, 0.728 to 0.829) for the IDMS-MDRD Study equation (equation 3), and the 3-variable Japanese equation (equation 4) was eGFR (mL/min/1.73 m2) = 194 x Serum creatinine(-1.094) x Age(-0.287) x 0.739 (if female). In the validation data set, bias was -1.3 +/- 19.4 versus -5.9 +/- 19.0 mL/min/1.73 m2 (P = 0.002), and accuracy within 30% of mGFR was 73% versus 72% (P = 0.6) for equation 3 versus equation 1 and -2.1 +/- 19.0 versus -7.9 +/- 18.7 mL/min/1.73 m(2) (P < 0.001) and 75% versus 73% (P = 0.06) for equation 4 versus equation 2 (P = 0.06), respectively. Most study participants had chronic kidney disease, and some may have had changing GFRs. The new Japanese coefficient for the modified IDMS-MDRD Study equation and the new Japanese equation are more accurate for the Japanese population than the previously reported equations.
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            Primary medication non-adherence: analysis of 195,930 electronic prescriptions.

            Michael Fischer, Margaret Stedman, Joyce Lii … (2010)
            Non-adherence to essential medications represents an important public health problem. Little is known about the frequency with which patients fail to fill prescriptions when new medications are started ("primary non-adherence") or predictors of failure to fill. Evaluate primary non-adherence in community-based practices and identify predictors of non-adherence. 75,589 patients treated by 1,217 prescribers in the first year of a community-based e-prescribing initiative. We compiled all e-prescriptions written over a 12-month period and used filled claims to identify filled prescriptions. We calculated primary adherence and non-adherence rates for all e-prescriptions and for new medication starts and compared the rates across patient and medication characteristics. Using multivariable regressions analyses, we examined which characteristics were associated with non-adherence. Primary medication non-adherence. Of 195,930 e-prescriptions, 151,837 (78%) were filled. Of 82,245 e-prescriptions for new medications, 58,984 (72%) were filled. Primary adherence rates were higher for prescriptions written by primary care specialists, especially pediatricians (84%). Patients aged 18 and younger filled prescriptions at the highest rate (87%). In multivariate analyses, medication class was the strongest predictor of adherence, and non-adherence was common for newly prescribed medications treating chronic conditions such as hypertension (28.4%), hyperlipidemia (28.2%), and diabetes (31.4%). Many e-prescriptions were not filled. Previous studies of medication non-adherence failed to capture these prescriptions. Efforts to increase primary adherence could dramatically improve the effectiveness of medication therapy. Interventions that target specific medication classes may be most effective.
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              Anemia as a risk factor for cardiovascular disease and all-cause mortality in diabetes: the impact of chronic kidney disease.

              Panagiotis Vlagopoulos, Hocine Tighiouart, Daniel E Weiner … (2005)
              Anemia is a potential nontraditional risk factor for cardiovascular disease (CVD). This study evaluated whether anemia is a risk factor for adverse outcomes in people with diabetes and whether the risk is modified by the presence of chronic kidney disease (CKD). Persons with diabetes from four community-based studies were pooled: Atherosclerosis Risk in Communities, Cardiovascular Health Study, Framingham Heart Study, and Framingham Offspring Study. Anemia was defined as a hematocrit 0.2 for all outcomes). In persons with diabetes, anemia is primarily a risk factor for adverse outcomes in those who also have CKD.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Cureus
                Journal ID (iso-abbrev): Cureus
                Journal ID (issn): 2168-8184
                Title: Cureus
                Publisher: Cureus (Palo Alto (CA) )
                ISSN (Electronic): 2168-8184
                Publication date (Electronic, pub): 26 May 2023
                Publication date (Electronic, collection): May 2023
                Volume: 15
                Issue: 5
                Electronic Location Identifier: e39543
                Affiliations
                [1 ] Diabetes and Endocrinology, Edogawa Hospital, Tokyo, JPN
                [2 ] Nephrology, Edogawa Hospital, Tokyo, JPN
                Author notes
                Article
                DOI: 10.7759/cureus.39543
                PMC ID: 10290911
                SO-VID: 458fae28-abba-4390-826b-fb5c571b11f6
                Copyright © Copyright © 2023, Ito et al.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date accepted : 26 May 2023
                Categories
                Subject: Endocrinology/Diabetes/Metabolism
                Subject: Internal Medicine
                Subject: Nephrology

                Keywords: chronic kidney disease,renal anemia,diabetes,hypoxia-inducible factor prolyl hydroxylase inhibitor,roxadustat
                Data availability:
                Keywords: chronic kidney disease, renal anemia, diabetes, hypoxia-inducible factor prolyl hydroxylase inhibitor, roxadustat

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