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Lack of effect of aspirin in primary CV prevention in type 2 diabetic patients with nephropathy: results from 8 years follow-up of NID-2 study

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Abstract

The risk-to-benefit ratio for the use of low dose of aspirin in primary cardiovascular (CV) prevention in patients with diabetes mellitus remains to be clarified. We assessed the effect of aspirin on risk of CV events in type 2 diabetic patients with nephropathy, in order to verify the usefulness of Guidelines in clinical practice. We carried out a prospective multicentric study in 564 patients with type 2 diabetic nephropathy free of CV disease attending outpatient diabetes clinics . A total of 242 patients received antiplatelet treatment with aspirin 100 mg/day (group A), and 322 were not treated with antiplatelet drugs (group B). Primary end point was the occurrence of total major adverse cardio-vascular events (MACE). Secondary end points were the relative occurrence of fatal MACE. The average follow-up was 8 years. Total MACE occurred in 49 patients from group A and in 52 patients from group B. Fatal MACE occurred in 22 patients from group A and in 20 from group B; nonfatal MACE occurred in 27 patients from group A and in 32 patients from group B. Kaplan–Meier analysis did not show a statistically significant difference of cumulative MACE between the two groups. A not statistically significant difference in the incidence of both fatal (p = 0.225) and nonfatal CV events (p = 0.573) between the two groups was observed. These results were confirmed after adjustment for confounders (HR for MACE 1.11, 95 % CI 0.91–1.35). These findings suggest that low dose of aspirin is ineffective in primary prevention for patients with nephropathy.

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Acknowledgments

This work was partially supported by an Italian Government grant from M.I.U.R. (Ministero della Istruzione, Universita` e Ricerca) Rome, Italy. The study sponsor had no role in the collection, analysis and interpretation of data in the writing of the report and in the decision to submit the paper for publication. Sasso FC had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis .

Conflict of interest

Ferdinando Carlo Sasso, Raffaele Marfella, Antonio Pagano, Giovanni Porta, Giuseppe Signoriello, Nadia Lascar, Roberto Minutolo, Ornella Carbonara, Marcello Persico, Federico Piscione, Luca De Nicola, Roberto Torella, and Giuseppe Paolisso declare that they have no conflict of interest.

Human and animal rights

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.

Informed consent

Informed consent was obtained from all patients for being included in the study.

Author information

Authors and Affiliations

  1. Department of Internal and Experimental Medicine “Magrassi-Lanzara”, Second University of Naples, Via F. Petrarca, 64, 80122, Naples, Italy

    Ferdinando Carlo Sasso, Antonio Pagano, Giovanni Porta, Ornella Carbonara & Roberto Torella

  2. Department of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy

    Raffaele Marfella & Giuseppe Paolisso

  3. Unit of Medical Statistic, Department of Medicine and Public Health, Second University of Naples, Naples, Italy

    Giuseppe Signoriello

  4. School of Life and Health Sciences, Aston University, Birmingham, UK

    Nadia Lascar

  5. Unit of Nephrology, Second University of Naples, Naples, Italy

    Roberto Minutolo & Luca De Nicola

  6. Department of Medicine and Surgery, University of Salerno, Salerno, Italy

    Marcello Persico & Federico Piscione

Authors
  1. Ferdinando Carlo Sasso
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  2. Raffaele Marfella
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  7. Roberto Minutolo
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  8. Ornella Carbonara
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  9. Marcello Persico
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  11. Luca De Nicola
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  12. Roberto Torella
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  13. Giuseppe Paolisso
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Corresponding author

Correspondence to Ferdinando Carlo Sasso.

Additional information

Managed by Massimo Federici.

For the NID-2 Study Group.

NID-2 Study Group members are provided in the “Appendix” section.

Appendix: NID-2 (Nephropathy In Diabetes-type 2) Study Group

Appendix: NID-2 (Nephropathy In Diabetes-type 2) Study Group

F.C. Sasso, O. Carbonara, R. Torella, R. D’Urso, A. Lampitella Jr, N. Lascar, R. Nasti, A. Pagano, E. Pisa, L. Zirpoli, F. Zibella, M. Corigliano, G. Conte, L. De Nicola, R. Minutolo, P. Trucillo, V. Armentano, P. Calatola, G. Corigliano, E. Del Vecchio, N. De Rosa, G. Di Giovanni, A. De Matteo, O. Egione, A. Gatti, S. Gentile, L. Gesuè, L. Improta, A. Lampitella, A. Lanzilli, S. Masi, P. Mattei, V. Mastrilli, P. Memoli, E. Rossi, S. Sorrentino, R. Troise, A.A. Turco, S. Turco.

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Sasso, F.C., Marfella, R., Pagano, A. et al. Lack of effect of aspirin in primary CV prevention in type 2 diabetic patients with nephropathy: results from 8 years follow-up of NID-2 study. Acta Diabetol 52, 239–247 (2015). https://doi.org/10.1007/s00592-014-0623-x

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