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T2DM: do chronic use of erectile dysfunction drugs worsen CVD risk?

A recent study, published in the journal PLoS One, shows beneficial effects of 6-month administration of vardenafil, a phosphodiesterase-5 (PDE-5) inhibitor, on cardiovascular health in patients with type 2 diabetes mellitus (T2DM). Although no predictive risk reduction was observed, the beneficial effect of vardenafil could be inferred through its action on inflammation markers reduction and restoration of normal testosterone levels.

Researchers conducted a secondary analysis of a randomised, placebo-controlled trial involving 54 men with T2DM and erectile dysfunction, but with no previous use of PDE-5 inhibitors. Patients were allocated to either vardenafil (n=26; 10 mg twice daily) or control (n=28) group. Study included 24 weeks each of treatment and follow-up phases. Cardiovascular risk was calculated using Framingham algorithm (coronary heart disease [CHD], myocardial infarction [MI], stroke and cardiovascular disease (CVD), ASSIGN equation and the CUORE score.

The 3 algorithms differed in assessment of basal cardiovascular risk at 10 years (P=.004) with no difference observed between vardenafil and control groups. However, in vardenafil group, IL-6 was significantly associated with CHD (P=.027), CVD (P=.047) and CUORE score (P=.020) at the end of treatment, and with MI (P=.035) and stroke (P=.030) at the end of study. Similar associations were observed between high sensitivity C-reactive protein and CHD (P=.039), MI (P= .037), stroke (P=.039), CVD (P=.020) and CUORE score (P=.017). At the end of treatment, significant inverse association was observed between testosterone levels and CHD (P=.040) and MI (P=.049) in the vardenafil group.

Authors commented, “Improvement of endothelial health-related parameters resulting from chronic vardenafil administration opens the possibility of a stronger effect of this treatment on the predicted cardiovascular risk.” They suggest for further evaluation of longer duration of chronic PDE-5 inhibitors treatment.


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