Finnian R Mc Causland1, Brian Claggett2, Emmanuel A Burdmann3, Kai-Uwe Eckardt4, Reshma Kewalramani5, Andrew S Levey6, John J V McMurray7, Patrick Parfrey8, Giuseppe Remuzzi9, Ajay K Singh10, Scott D Solomon2, Robert D Toto11, Marc A Pfeffer2. 1. Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA. Electronic address: fmccausland@partners.org. 2. Harvard Medical School, Boston, MA; Cardiology Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA. 3. Division of Nephrology, University of Sao Paulo Medical School, Sao Paulo, Brazil. 4. Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany. 5. Global Clinical Development, Amgen, Thousand Oaks, CA. 6. Division of Nephrology, Tufts Medical Center, Boston, MA. 7. Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland. 8. Health Sciences Centre, Memorial University of Newfoundland, St. John's, Newfoundland, Canada. 9. IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Bergamo, Italy; Unit of Nephrology and Dialysis, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy; Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy. 10. Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA. 11. Renal Division, University of Texas Southwestern, Dallas, TX.
Abstract
BACKGROUND: To better understand a potential association of elevated C-reactive protein (CRP) level with progression of chronic kidney disease (CKD), we examined the relationship of CRP level with the development of end-stage renal disease (ESRD) in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). STUDY DESIGN: Post hoc analysis of a randomized controlled trial. SETTING & PARTICIPANTS: 4,038 patients with type 2 diabetes, CKD, and anemia in TREAT. PREDICTOR: Baseline serum CRP concentrations. OUTCOMES: The primary outcome was development of ESRD; secondary outcomes included doubling of serum creatinine level, a composite of ESRD/serum creatinine doubling, and a composite of death or ESRD. MEASUREMENTS: We fit unadjusted and adjusted Cox regression models to test the association of baseline CRP level with time to the development of the outcomes of interest. RESULTS:Mean age of participants was 67 years, 43% were men, and 64% were white. Approximately half (48%) the patients had CRP levels > 3.0mg/L; 668 patients developed ESRD, and 1,270 developed the composite outcome of death or ESRD. Compared with patients with baseline CRP levels ≤ 3.0mg/L, those with moderately/markedly elevated CRP levels (≥6.9mg/L; 24% of patients) had a higher adjusted risk for ESRD (HR, 1.32; 95% CI, 1.07-1.63) and the composite outcome of death or ESRD (HR, 1.41; 95% CI, 1.21-1.64). Although nonsignificant, similar trends were noted in competing-risk models. LIMITATIONS: Results may not be generalizable to nondiabetic CKD or diabetic CKD in the absence of anemia. CONCLUSIONS:Elevated baseline CRP levels are common in type 2 diabetic patients with anemia and CKD and are associated with the future development of ESRD and the composite of death or ESRD.
RCT Entities:
BACKGROUND: To better understand a potential association of elevated C-reactive protein (CRP) level with progression of chronic kidney disease (CKD), we examined the relationship of CRP level with the development of end-stage renal disease (ESRD) in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). STUDY DESIGN: Post hoc analysis of a randomized controlled trial. SETTING & PARTICIPANTS: 4,038 patients with type 2 diabetes, CKD, and anemia in TREAT. PREDICTOR: Baseline serum CRP concentrations. OUTCOMES: The primary outcome was development of ESRD; secondary outcomes included doubling of serum creatinine level, a composite of ESRD/serum creatinine doubling, and a composite of death or ESRD. MEASUREMENTS: We fit unadjusted and adjusted Cox regression models to test the association of baseline CRP level with time to the development of the outcomes of interest. RESULTS: Mean age of participants was 67 years, 43% were men, and 64% were white. Approximately half (48%) the patients had CRP levels > 3.0mg/L; 668 patients developed ESRD, and 1,270 developed the composite outcome of death or ESRD. Compared with patients with baseline CRP levels ≤ 3.0mg/L, those with moderately/markedly elevated CRP levels (≥6.9mg/L; 24% of patients) had a higher adjusted risk for ESRD (HR, 1.32; 95% CI, 1.07-1.63) and the composite outcome of death or ESRD (HR, 1.41; 95% CI, 1.21-1.64). Although nonsignificant, similar trends were noted in competing-risk models. LIMITATIONS: Results may not be generalizable to nondiabetic CKD or diabetic CKD in the absence of anemia. CONCLUSIONS: Elevated baseline CRP levels are common in type 2 diabeticpatients with anemia and CKD and are associated with the future development of ESRD and the composite of death or ESRD.
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