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Generalizability of SPRINT-CKD cohort to CKD patients referred to renal clinics

  • Roberto MinutoloEmail author
  • Luca De Nicola
  • Ciro Gallo
  • Paolo Chiodini
  • Michele Provenzano
  • Giuseppe Conte
  • Carlo Garofalo
  • Silvio Borrelli
  • Collaborative Study Group on the Conservative Treatment of CKD of the Italian Society of Nephrology
Original Article
  • 33 Downloads

Abstract

Background

The Systolic Blood Pressure Intervention Trial-CKD substudy (SPRINT-CKD) has suggested a lower blood pressure (BP) target in CKD patients. However, it is questionable whether the SPRINT-CKD results may be generalized to CKD patients under nephrology care.

Methods

To compare SPRINT-CKD cohort versus referred CKD patients in terms of patients’ risk profile and outcomes, we pooled four prospective cohorts of consecutive CKD patients referred to 40 Italian renal clinics. We implemented the same inclusion/exclusion criteria adopted in SPRINT and same endpoints: (1) a composite of fatal and non-fatal cardiovascular (CV) events (2) all-cause mortality and (3) ESRD (composite of chronic dialysis, transplantation or 50% eGFR decline). Findings were compared with those attained in the control arm of SPRINT-CKD trial that mirrored standard BP management in clinical practice.

Results

Out of 2847 patients referred to renal clinics, only 20.1% (n = 571) were identified as eligible for SPRINT-CKD. Age (72 ± 9 years), gender (42.2% female) and systolic BP (142 ± 10 mmHg) did not differ from the SPRINT-CKD while referred patients had a worse risk profile at baseline: larger prevalence of prior CV disease (25.7% versus 19.5%), higher Framingham risk score (31.9 ± 14.6% versus 27.2 ± 24.7%) and lower GFR (38 ± 11 versus 48 ± 10 mL/min/1.73 m2). During 4.0 years of follow-up, 86 CV events (50 fatal), 78 all-cause death and 59 ESRD occurred with annual incidence rates higher than those observed in the SPRINT-CKD control group (CV events 4.18 vs 3.19; all-cause death 3.64 vs 2.21; ESRD 2.80 vs 0.41%/year).

Conclusions

The SPRINT-CKD cohort is poorly representative of the CKD population under nephrology care, thus suggesting that conclusions may not apply to patients referred to nephrologist.

Keywords

Chronic kidney disease SPRINT trial Hypertension Cardiovascular risk 

Notes

Acknowledgements

This work was endorsed by the Italian Society of Nephrology (Gruppo di Studio sul Trattamento Conservativo della Malattia Renale Cronica) without any financial support. We thank all the Italian Nephrologists that collaborated to data collection for this study (see ESM Appendix for the complete list).

Funding

This study did not receive any funding and support.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary material

40620_2019_588_MOESM1_ESM.pdf (167 kb)
Supplementary material 1 (PDF 166 KB)

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Copyright information

© Italian Society of Nephrology 2019

Authors and Affiliations

  • Roberto Minutolo
    • 1
    Email author
  • Luca De Nicola
    • 1
  • Ciro Gallo
    • 2
  • Paolo Chiodini
    • 2
  • Michele Provenzano
    • 1
  • Giuseppe Conte
    • 1
  • Carlo Garofalo
    • 1
  • Silvio Borrelli
    • 1
  • Collaborative Study Group on the Conservative Treatment of CKD of the Italian Society of Nephrology
  1. 1.Division of Nephrology, Department of Scienze Mediche e Chirurgiche AvanzateUniversity of Campania “Luigi Vanvitelli”NaplesItaly
  2. 2.Medical Statistics UnitUniversity of CampaniaNaplesItaly

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