Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy: a multicenter prospective 8 years follow up study

Ferdinando Carlo Sasso; Nadia Lascar; Antonella Ascione; Ornella Carbonara; Luca de Nicola; Roberto Minutolo; Teresa Salvatore; Maria Rosaria Rizzo; Plinio Cirillo; Giuseppe Paolisso; Raffaele Marfella

doi:10.1186/s12933-016-0463-9

Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy: a multicenter prospective 8 years follow up study

Ferdinando Carlo Sasso, Nadia Lascar, Antonella Ascione, Ornella Carbonara, Luca de Nicola, Roberto Minutolo, Teresa Salvatore, Maria Rosaria Rizzo, Plinio Cirillo, Giuseppe Paolisso, Raffaele Marfella,

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. Methods: We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Results: Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). Conclusions: These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy.

Original language	English
Article number	147
Journal	Cardiovascular Diabetology
Volume	15
Issue number	1
DOIs	https://doi.org/10.1186/s12933-016-0463-9
Publication status	Published - 13 Oct 2016

Bibliographical note

© 2016 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Keywords

CVD
diabetes
nephropathy
primary prevention
statin

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10.1186/s12933-016-0463-9Licence: CC BY 3.0

Patients with type 2 diabetes complicated by nephropathy
© 2016 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Final published version, 853 KBLicence: CC BY 3.0

http://cardiab.biomedcentral.com/articles/10.1186/s12933-016-0463-9Licence: CC BY 3.0

Cite this

Sasso, F. C., Lascar, N., Ascione, A., Carbonara, O., de Nicola, L., Minutolo, R., Salvatore, T., Rizzo, M. R., Cirillo, P., Paolisso, G., Marfella, R. (2016). Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy: a multicenter prospective 8 years follow up study. Cardiovascular Diabetology, 15(1), Article 147. https://doi.org/10.1186/s12933-016-0463-9

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title = "Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy: a multicenter prospective 8 years follow up study",

abstract = "Background: Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. Methods: We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Results: Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). Conclusions: These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy.",

keywords = "CVD, diabetes, nephropathy, primary prevention, statin",

author = "Sasso, {Ferdinando Carlo} and Nadia Lascar and Antonella Ascione and Ornella Carbonara and {de Nicola}, Luca and Roberto Minutolo and Teresa Salvatore and Rizzo, {Maria Rosaria} and Plinio Cirillo and Giuseppe Paolisso and Raffaele Marfella",

note = "{\textcopyright} 2016 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.",

year = "2016",

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doi = "10.1186/s12933-016-0463-9",

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Sasso, FC, Lascar, N, Ascione, A, Carbonara, O, de Nicola, L, Minutolo, R, Salvatore, T, Rizzo, MR, Cirillo, P, Paolisso, G, Marfella, R 2016, 'Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy: a multicenter prospective 8 years follow up study', Cardiovascular Diabetology, vol. 15, no. 1, 147. https://doi.org/10.1186/s12933-016-0463-9

Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy: a multicenter prospective 8 years follow up study. / Sasso, Ferdinando Carlo; Lascar, Nadia; Ascione, Antonella et al.
In: Cardiovascular Diabetology, Vol. 15, No. 1, 147, 13.10.2016.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy

T2 - a multicenter prospective 8 years follow up study

AU - Sasso, Ferdinando Carlo

AU - Lascar, Nadia

AU - Ascione, Antonella

AU - Carbonara, Ornella

AU - de Nicola, Luca

AU - Minutolo, Roberto

AU - Salvatore, Teresa

AU - Rizzo, Maria Rosaria

AU - Cirillo, Plinio

AU - Paolisso, Giuseppe

AU - Marfella, Raffaele

N1 - © 2016 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

PY - 2016/10/13

Y1 - 2016/10/13

N2 - Background: Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. Methods: We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Results: Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). Conclusions: These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy.

AB - Background: Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. Methods: We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Results: Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). Conclusions: These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy.

KW - CVD

KW - diabetes

KW - nephropathy

KW - primary prevention

KW - statin

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U2 - 10.1186/s12933-016-0463-9

DO - 10.1186/s12933-016-0463-9

M3 - Article

AN - SCOPUS:84994591788

SN - 1475-2840

VL - 15

JO - Cardiovascular Diabetology

JF - Cardiovascular Diabetology

IS - 1

M1 - 147

ER -

Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy: a multicenter prospective 8 years follow up study

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