Related Experiment Video
Updated: Feb 8, 2026
A Zebrafish Model of Diabetes Mellitus and Metabolic Memory
Published on: February 28, 2013
Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus?
Daniele Santi1,2, Michela Locaso1,2, Antonio R Granata2
1Unit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Insights
Vardenafil did not reduce cardiovascular risk in men with type 2 diabetes mellitus (T2DM) over six months. However, it may positively influence inflammation markers and testosterone levels, suggesting potential long-term benefits.
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Cardiovascular risk prediction algorithms are crucial in clinical practice but remain debated.
- Phosphodiesterase (PDE)-5 inhibitors show benefits for endothelial function in type 2 diabetes mellitus (T2DM), but their impact on cardiovascular risk estimation is unclear.
Purpose of the Study:
- To investigate if chronic Vardenafil administration affects cardiovascular risk factors in men with T2DM.
- To assess changes in endothelial function and cardiovascular risk using validated algorithms.
Main Methods:
- A 24-week randomized, double-blind, placebo-controlled trial involving 54 male T2DM patients.
- Vardenafil (10mg twice-daily) or placebo was administered, with assessments at baseline, end of treatment, and end of study.
- Cardiovascular risk was calculated using Framingham, ASSIGN, and CUORE equations; inflammatory markers and testosterone levels were also measured.
Main Results:
- No significant differences in predicted cardiovascular risk were observed between Vardenafil and placebo groups across different algorithms and time points.
- Interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) levels correlated with cardiovascular risk scores.
- Testosterone levels showed an inverse relationship with coronary heart disease (CHD) and myocardial infarction (MI) risk in the Vardenafil group.
Conclusions:
- The choice of cardiovascular risk algorithm impacts predictions.
- While Vardenafil did not reduce predicted risk in six months, its potential to reduce inflammation and restore testosterone levels warrants further investigation for long-term cardiovascular benefits in T2DM.
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.
Related Concept Videos
01:22Diabetes Mellitus: Type 2 and Gestational
01:22Diabetes Mellitus: Overview and Type I Subtype
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
01:18Types of Records II: Educational and Administrative Records
01:12Relative Risk
01:14Overview of the Cardiovascular System
Heart
The heart is the central pump of the cardiovascular system that circulates blood throughout the body. It comprises two atria receiving the blood and two ventricles pumping blood out of the heart. Their rhythmic contractions, called heartbeats, ensure that blood flow remains continuous.
Blood Vessels
Blood...
01:20Pathophysiology of Diabetes
Type 1 diabetes is characterized by autoimmune-mediated destruction of pancreatic β cells, with environmental factors potentially triggering this process in genetically susceptible individuals. Despite many not having a family history, certain genes increase susceptibility,...