Isosorbide mononitrate clinical studies

Isosorbide mononitrate
ISOSORBIDE MONONITRATE tablet® FDA Package Insert
Indications and Usage
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Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

Controlled trials with Isosorbide mononitrate extended-release tablets have demonstrated antianginal activity following acute and chronic dosing. Administration of Isosorbide mononitrate extended-release tablets once daily, taken early in the morning on arising, provided at least 12 hours of antianginal activity.

In a placebo control parallel study, 30 mg, 60 mg,120 mg, and 240 mg of Isosorbide mononitrate extended-release tablets were administered once daily for up to 6 weeks. Prior to randomization, all patients completed a 1- to 3-week single-blind placebo phase to demonstrate nitrate responsiveness and total exercise treadmill time reproducibility. Exercise tolerance tests using the Bruce Protocol were conducted prior to and at 4 and 12 hours after the morning dose on days 1, 7, 14, 28, and 42 of the double-blind period. Isosorbide mononitrate extended- release tablets 30 and 60 mg (only doses evaluated acutely) demonstrated a significant increase from baseline in total treadmill time relative to placebo at 4 and 12 hours after the administration of the first dose. At day 42, the 120 mg and 240 mg dose of Isosorbide mononitrate extended-release tablets demonstrated a significant increase in total treadmill time at 4 and 12 hours post dosing, but by day 42 the 30 mg and 60 mg doses no longer were differentiable from placebo. Throughout chronic dosing rebound was not observed in any Isosorbide mononitrate extended-release treatment group.

Pooled data from two other trials, comparing Isosorbide mononitrate extended-release tablets 60 mg once daily, Isosorbide dinitrate 30 mg QID, and placebo QID in patients with chronic stable angina using a randomized, double-blind, three-way crossover design found statistically significant increases in exercise tolerance times for Isosorbide mononitrate extended-release tablets compared to placebo at hours 4, 8 and 12 and to Isosorbide dinitrate at hour 4. The increases in exercise tolerance on day 14, although statistically significant compared to placebo, were about half of that seen on day 1 of the trial.