Long-acting, marked antiischemic effect maintained unattenuated during long-term interval treatment with once-daily isosorbide-5-mononitrate in sustained-release form

Am J Cardiol. 1990 Jun 15;65(22):1434-7. doi: 10.1016/0002-9149(90)91350-f.

Abstract

In 18 patients with documented coronary artery disease, the antiischemic effect of 50 and 100 mg isosorbide-5-mononitrate (IS-5-MN) in sustained-release (SR) form was investigated using a randomized, double-blind, crossover, placebo-controlled protocol. After the initial administration of both dosages, compared to placebo there were significant reductions in exercise-induced ST-segment depression and significant increases in ischemia-free exercise time at all times of testing. At 12 hours, the 100-mg dosage still amounted to greater than 50% of its maximum and was significantly more marked than the 50 mg dose. Accordingly, the 100-mg dosage can be assumed to confer a longer duration of action. At the end of 3 weeks of long-term treatment, the significant antiischemic effects were not diminished versus those observed after initial administration. There was no evidence of tolerance development with either dosage. The IS-5-MN plasma concentration during long-term administration displayed, within the 24-hour treatment cycle, a clear decrease to low baseline values and a marked 5- to 7-fold increase after the daily dose in accordance with the response known to be prerequisite to successful interval treatment. Thus, the once-daily administration of IS-5-MN SR with dosages of 50 mg and, more markedly, 100 mg, provides effective antiischemic protection throughout the daily period of most physical activities in patients with stable angina pectoris.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Blood Pressure / drug effects
  • Coronary Disease / drug therapy*
  • Coronary Disease / physiopathology
  • Delayed-Action Preparations
  • Double-Blind Method
  • Electrocardiography / drug effects
  • Heart Rate / drug effects
  • Humans
  • Isosorbide Dinitrate / administration & dosage
  • Isosorbide Dinitrate / analogs & derivatives*
  • Isosorbide Dinitrate / pharmacokinetics
  • Isosorbide Dinitrate / therapeutic use
  • Physical Exertion
  • Randomized Controlled Trials as Topic
  • Time Factors

Substances

  • Delayed-Action Preparations
  • Isosorbide Dinitrate
  • isosorbide-5-mononitrate