Off-label use of sildenafil in valvular heart disease should be avoided

A study presented at the European Society of Cardiology Congress reported the effects of sildenafil in patients with valvular heart disease.

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Residual pulmonary hypertension (PH) is a common complication after correction of valvular heart disease (VHD), and is associated with poor outcomes. Sildenafil is sometimes used off-label in these patients but its efficacy has never been explored in a clinical trial.

In a study presented at the European Society of Cardiology Congress in Barcelona, researchers randomly assigned 200 patients with residual PH to daily sildenafil or placebo for six months[1]

They found that, based on a composite score, the clinical status of the patients worsened in twice as many of those receiving sildenafil compared with those on placebo (33% vs 15%). Major clinical events — death or readmission for heart failure — were also twice as likely to occur in the sildenafil group.

The team concluded that treatment with sildenafil in patients with residual PH after successful correction of VHD was associated with unfavourable clinical outcomes compared with placebo, and should be avoided in this group of patients.


[1] Bermejo J, SIOVAC investigators. Effect of sildenafil on clinical outcomes in patients with corrected valvular heart disease and residual pulmonary hypertension. Presented at ESC Congress 2017; 26–30 August; Barcelona, Spain.



Last updated
Clinical Pharmacist, CP, November 2017, Vol 9, No 11;9(11):DOI:10.1211/PJ.2017.20203778

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