Effect of Oral Alfacalcidol on Clinical Outcomes in Patients Without Secondary Hyperparathyroidism Receiving Maintenance Hemodialysis

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Abstract

Patients with chronic kidney disease have impaired vitamin D activation and elevated cardiovascular risk. Observational studies in patients treated with hemodialysis showed that the use of active vitamin D sterols was associated with lower risk of all-cause mortality, regardless of parathyroid hormone levels.

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Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention.

Mark J. Sarnak, Andrew Levey, Anton C Schoolwerth … (2003)

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Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial.

Julia Wenger, Rajiv Agarwal, B Taylor Thompson … (2012)

Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking. To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m(2). Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010. Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112). Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function. Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m(2.7) [95% CI, -0.14 to 0.83 g/m(2.7)] vs placebo group, -0.07 g/m(2.7) [95% CI, -0.55 to 0.42 g/m(2.7)]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, -0.01 cm/s [95% CI, -0.63 to 0.60 cm/s] vs placebo group, -0.30 cm/s [95% CI, -0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group. Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease. clinicaltrials.gov Identifier: NCT00497146.

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Fibroblast growth factor-23 and cardiovascular events in CKD.

Xiaoming Zhang, Akinlolu Ojo, Wei Yang … (2014)

An elevated level of fibroblast growth factor-23 (FGF-23) is the earliest abnormality of mineral metabolism in CKD. High FGF-23 levels promote left ventricular hypertrophy but not coronary artery calcification. We used survival analysis to determine whether elevated FGF-23 is associated with greater risk of adjudicated congestive heart failure (CHF) and atherosclerotic events (myocardial infarction, stroke, and peripheral vascular disease) in a prospective cohort of 3860 participants with CKD stages 2-4 (baseline estimated GFR [eGFR], 44±15 ml/min per 1.73 m(2)). During a median follow-up of 3.7 years, 360 participants were hospitalized for CHF (27 events/1000 person-years) and 287 had an atherosclerotic event (22 events/1000 person-years). After adjustment for demographic characteristics, kidney function, traditional cardiovascular risk factors, and medications, higher FGF-23 was independently associated with graded risk of CHF (hazard ratio [HR], 1.45 per doubling [95% confidence interval (CI), 1.28 to 1.65]; HR for highest versus lowest quartile, 2.98 [95% CI, 1.97 to 4.52]) and atherosclerotic events (HR per doubling, 1.24 [95% CI, 1.09 to 1.40]; HR for highest versus lowest quartile, 1.76 [95% CI, 1.20 to 2.59]). Elevated FGF-23 was associated more strongly with CHF than with atherosclerotic events (P=0.02), and uniformly was associated with greater risk of CHF events across subgroups stratified by eGFR, proteinuria, prior heart disease, diabetes, BP control, anemia, sodium intake, income, fat-free mass, left ventricular mass index, and ejection fraction. Thus, higher FGF-23 is independently associated with greater risk of cardiovascular events, particularly CHF, in patients with CKD stages 2-4.

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Author and article information

Journal

Title: JAMA

Abbreviated Title: JAMA

Publisher: American Medical Association (AMA)

ISSN (Print): 0098-7484

Publication date Created: December 11 2018

Publication date (Print): December 11 2018

Volume: 320

Issue: 22

Page: 2325

Affiliations

[1 ]Department of Vascular Medicine, Osaka City University Graduate School of Medicine, Japan

[2 ]Vascular Science Center for Translational Research, Osaka City University Graduate School of Medicine, Japan

[3 ]Department of Metabolism, Endocrinology, and Molecular Medicine, Osaka City University Graduate School of Medicine, Japan

[4 ]Division of Nephrology, Endocrinology, and Metabolism, Tokai University School of Medicine, Kanagawa, Japan

[5 ]Department of Nephrology, Musashino Red Cross Hospital, Tokyo, Japan

[6 ]Department of Drug and Food Evaluation, Osaka City University Graduate School of Medicine, Japan

[7 ]Blood Purification and Kidney Center, Konan Hospital, Hyogo, Japan

[8 ]Laboratory of Statistics, Osaka City University Graduate School of Medicine, Japan

[9 ]Department of Nephrology, Toho University School of Medicine, Tokyo, Japan

[10 ]Department of Urology, Tojinkai Hospital, Kyoto, Japan

[11 ]Division of Nephrology, Fukuoka Renal Clinic, Fukuoka, Japan

[12 ]Division of Nephrology, Department of Medicine, Showa University Koto Toyosu Hospital, Tokyo, Japan

[13 ]Department of Pathophysiology and Therapy in Chronic Kidney Disease, The Jikei University School of Medicine, Tokyo, Japan

[14 ]Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan

[15 ]Department of Nephrology, Fujita Health University School of Medicine, Aichi, Japan

[16 ]Yuseikai Clinic, Osaka, Japan

[17 ]Department of Nephrology, Osaka University Graduate School of Medicine, Japan

[18 ]Clinical Research Support Center, Tomishiro Central Hospital, Japan

[19 ]Department of Nephrology, Osaka City University Graduate School of Medicine, Japan

[20 ]Department of Nephrology, Itami Kidney Clinic, Hokkaido, Japan

[21 ]Department of Internal Medicine, Haga Red Cross Hospital, Tochigi, Japan

[22 ]Division of Nephrology, Endocrinology, and Metabolism, Tokai University Hachioji Hospital, Tokyo, Japan

[23 ]Medical Corporation Chuou Naika Clinic, Hiroshima, Japan

[24 ]Department of Artificial Organs, Tsuchiya General Hospital, Hiroshima, Japan

[25 ]Department of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kanagawa, Japan

[26 ]Akane Foundation Omachi Tsuchiya Clinic, Hiroshima, Japan

[27 ]Hemodialysis, Fujiidera Shirasagi Clinic, Osaka, Japan

[28 ]Nephrology, Honcho Yabuki Clinic, Yamagata, Japan

[29 ]Department of Kidney Disease, Kawashima Hospital, Tokushima, Japan

[30 ]Nephrology and Dialysis Center, Japanese Red Cross Fukuoka Hospital, Japan

[31 ]Department of Hematology, Dialysis, and Diabetes Mellitus, Kochi-Takasu Hospital, Kochi, Japan

[32 ]Department of Medicine, Endocrinology, and Hypertension, Tokyo Women’s Medical University, Japan

[33 ]Department of Cardiology, Nagoya University Graduate School of Medicine, Aichi, Japan

[34 ]Department of Urology, Osaka City University Graduate School of Medicine, Japan

[35 ]Department of Nephrology, Wakayama Medical University, Wakayama, Japan

[36 ]Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, Hyogo, Japan

[37 ]Meisei Memorial Hospital, Osaka, Japan

[38 ]Department of Medicine, Tokyo Women's Medical University Medical Center East, Tokyo, Japan

[39 ]Department of Urology, Kochi Takasu Hospital, Kochi, Japan

[40 ]Department of Internal Medicine, Kayashima Ikuno Hospital, Osaka, Japan

[41 ]Department of Internal Medicine, Kidney Center, Shirasagi Hospital, Osaka, Japan

[42 ]Department of Internal Medicine, Shimane University Faculty of Medicine, Shimane, Japan

[43 ]Department of Nephrology, Shinraku-En Hospital, Niigata, Japan

[44 ]Ikuno-Aiwa Hemodialysis Clinic, Osaka, Japan

[45 ]Department of Internal Medicine, Suiyukai Clinic, Nara, Japan

[46 ]Department of Transplant and Endocrine Surgery, Nagoya 2nd Red Cross Hospital Japan

[47 ]Department of Safety Management in Health Care Sciences, Graduate School of Health Care Sciences, Jikei Institute, Osaka, Japan

[48 ]Department of Internal Medicine, Inoue Hospital, Osaka, Japan

[49 ]Department of Nephrology, Nara Medical University, Japan

[50 ]Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus Graduate School of Medicine, Okinawa, Japan

[51 ]Kasugai Municipal Hospital, Aichi, Japan

[52 ]Department of Nephrology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan

[53 ]Kidney Center, Shirasagi Hospital, Osaka, Japan

[54 ]Department of Laboratory Medicine, Shimane University Faculty of Medicine, Japan

[55 ]Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan

[56 ]Hiroshima Kidney Organization, Japan

[57 ]Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Japan

[58 ]Hemodialysis Center, Inoue Hospital, Soryu Medical Corporation, Osaka, Japan

Article

DOI: 10.1001/jama.2018.17749

PMC ID: 6583075

PubMed ID: 30535217

SO-VID: c4dbe4b9-c3a1-4ee0-b8e0-592905f4cc58

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Effect of Oral Alfacalcidol on Clinical Outcomes in Patients Without Secondary Hyperparathyroidism Receiving Maintenance Hemodialysis : The J-DAVID Randomized Clinical Trial

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Most cited references 17

Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention.

Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial.

Fibroblast growth factor-23 and cardiovascular events in CKD.

Author and article information

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