Anti-anginal Efficacy of a Controlled-Release Formulation of lsosorbide-5-mononitrate Once Daily in Angina Patients on Chronic β-Blockade

The anti-anginal effect of a controlled-release (Durules®) formulation of isosorbide-5-mononitrate (5-ISMN) 60 mg, Imdur®, once daily was evaluated in a randomised double-blind, placebo-controlled, crossover study with a placebo run-in period. Each period lasted for 2 weeks. A total of 70 patients (58 men and 12 women) with stable exertional angina pectoris on β-blockade, mean age 59 years (range 39–71), were included. Exercise testing was performed on a bicycle ergometer 3 hours after the dose at the end of each period. Anginal attacks and intake of sublingual nitroglycerin tablets were noted. Imdurr in combination with a β-blocker significantly increased the total exercise capacity, the time and total work until the onset of chest pain and at 1 mm ST-depression compared with β-blockade alone. The attack rate and the nitroglycerin consumption were significantly decreased. Headache was the only significant side-effect. In conclusion, the addition of Imdur® once daily to β-blockade significantly increased the anti-anginal effect.