Acute Haemodynamic Effects of a New Formulation of Isosorbide Dinitrate Spray in Patients with Heart Failure

Summary

In a randomised double-blind placebo-controlled parallel-group comparison, the haemodynamic effects of a new formulation of isosorbide dinitrate (ISDN) buccal spray in 2 doses (1.25mg and 2.5mg) on pulmonary capillary wedge pressure (PCWP) were investigated in 30 patients with heart failure. Three minutes after administration of either dose of ISDN spray, the onset of a clinically relevant haemodynamic improvement was observed. The maximal reduction from baseline in PCWP was approximately 40% (10mm Hg) 10 minutes after administration of either dose of ISDN spray. This compared with a maximal 14% (3mm Hg) fall in PCWP in placebo-treated patients (p < 0.01). There was a transient 10% fall in systolic blood pressure after ISDN spray at either dose, but no changes in diastolic or mean arterial blood pressure and heart rate compared with placebo-treated patients. There were no significant differences between ISDN spray at 1.25 and 2.5mg in any of the parameters measured. Adverse effects were observed in 2 patients (1 pulmonary oedema with placebo; 1 symptomatic transient hypotension with ISDN 1.25mg). In conclusion, this study clearly shows the rapid beneficial acute haemodynamic effect of ISDN spray in patients with heart failure.