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Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus?
INTRODUCTION: Appropriate algorithms for the prediction of cardiovascular risk are strongly suggested in clinical practice, although still controversial. In type 2 diabetes mellitus (T2DM), the beneficial effect of phosphodiesterase (PDE)-5 inhibitors is demonstrated on endothelial function but not...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023114/ https://www.ncbi.nlm.nih.gov/pubmed/29953477 http://dx.doi.org/10.1371/journal.pone.0199299 |
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author | Santi, Daniele Locaso, Michela Granata, Antonio R. Trenti, Tommaso Roli, Laura Pacchioni, Chiara Rochira, Vincenzo Carani, Cesare Simoni, Manuela |
author_facet | Santi, Daniele Locaso, Michela Granata, Antonio R. Trenti, Tommaso Roli, Laura Pacchioni, Chiara Rochira, Vincenzo Carani, Cesare Simoni, Manuela |
author_sort | Santi, Daniele |
collection | PubMed |
description | INTRODUCTION: Appropriate algorithms for the prediction of cardiovascular risk are strongly suggested in clinical practice, although still controversial. In type 2 diabetes mellitus (T2DM), the beneficial effect of phosphodiesterase (PDE)-5 inhibitors is demonstrated on endothelial function but not on the estimation of cardiovascular risk. AIM: To study whether the chronic Vardenafil administration to men with T2DM influences variables correlated with the predicted long-term cardiovascular risk calculated by different validated algorithms. METHODS: Per-protocol analysis of a longitudinal, prospective, randomized, placebo-controlled, double-blind, investigator-started, clinical trial. 54 male patients affected by T2DM were assigned to study (26patients) and control-group (28patients), respectively. The study included a treatment phase (24weeks) (Vardenafil/placebo 10mg twice-daily) and a follow-up phase (24weeks). Three time points were considered: baseline(V0), end of treatment(V1) and end of the study(V2). Parameters evaluated: endothelial health-related parameters and cardiovascular risk, assessed by calculating the Framingham (coronary hart disease [CHD], myocardial infarction [MI], stroke and cardiovascular disease [CVD]), ASSIGN and CUORE equations. RESULTS: Predicted cardiovascular risk at ten years resulted different using the three algorithms chosen, without differences between study and control groups and among visits. IL-6 was directly related to CHD, CVD and CUORE scores at V1 and with MI and STROKE at V2. Similarly, hs-CRP was directly related to CHD, MI, STROKE and CUORE only at V1 in the study group. Testosterone serum levels were inversely related to CHD and MI at V1 in study group. DISCUSSION: The predicted cardiovascular risk is different depending on the algorithm chosen. Despite no predictive risk reduction after six months of treatment, a possible effect of Vardenafil could be hypothesized through its action on inflammation markers reduction and through restoration of normal testosterone levels. |
format | Online Article Text |
id | pubmed-6023114 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-60231142018-07-07 Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? Santi, Daniele Locaso, Michela Granata, Antonio R. Trenti, Tommaso Roli, Laura Pacchioni, Chiara Rochira, Vincenzo Carani, Cesare Simoni, Manuela PLoS One Research Article INTRODUCTION: Appropriate algorithms for the prediction of cardiovascular risk are strongly suggested in clinical practice, although still controversial. In type 2 diabetes mellitus (T2DM), the beneficial effect of phosphodiesterase (PDE)-5 inhibitors is demonstrated on endothelial function but not on the estimation of cardiovascular risk. AIM: To study whether the chronic Vardenafil administration to men with T2DM influences variables correlated with the predicted long-term cardiovascular risk calculated by different validated algorithms. METHODS: Per-protocol analysis of a longitudinal, prospective, randomized, placebo-controlled, double-blind, investigator-started, clinical trial. 54 male patients affected by T2DM were assigned to study (26patients) and control-group (28patients), respectively. The study included a treatment phase (24weeks) (Vardenafil/placebo 10mg twice-daily) and a follow-up phase (24weeks). Three time points were considered: baseline(V0), end of treatment(V1) and end of the study(V2). Parameters evaluated: endothelial health-related parameters and cardiovascular risk, assessed by calculating the Framingham (coronary hart disease [CHD], myocardial infarction [MI], stroke and cardiovascular disease [CVD]), ASSIGN and CUORE equations. RESULTS: Predicted cardiovascular risk at ten years resulted different using the three algorithms chosen, without differences between study and control groups and among visits. IL-6 was directly related to CHD, CVD and CUORE scores at V1 and with MI and STROKE at V2. Similarly, hs-CRP was directly related to CHD, MI, STROKE and CUORE only at V1 in the study group. Testosterone serum levels were inversely related to CHD and MI at V1 in study group. DISCUSSION: The predicted cardiovascular risk is different depending on the algorithm chosen. Despite no predictive risk reduction after six months of treatment, a possible effect of Vardenafil could be hypothesized through its action on inflammation markers reduction and through restoration of normal testosterone levels. Public Library of Science 2018-06-28 /pmc/articles/PMC6023114/ /pubmed/29953477 http://dx.doi.org/10.1371/journal.pone.0199299 Text en © 2018 Santi et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Santi, Daniele Locaso, Michela Granata, Antonio R. Trenti, Tommaso Roli, Laura Pacchioni, Chiara Rochira, Vincenzo Carani, Cesare Simoni, Manuela Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? |
title | Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? |
title_full | Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? |
title_fullStr | Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? |
title_full_unstemmed | Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? |
title_short | Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? |
title_sort | could chronic vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus? |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023114/ https://www.ncbi.nlm.nih.gov/pubmed/29953477 http://dx.doi.org/10.1371/journal.pone.0199299 |
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