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Isosorbide mononitrate 30% immediate-release 70% sustained-release formulation: a review. DUMQOL (DUtch Mononitrate

T J Cleophas1, M G Niemeyer, A H Zwinderman

  • 1European Interuniversity College of Pharmaceutical Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.

Angiology
|August 26, 2000
PubMed

Insights

Isosorbide mononitrate IR-SR offers rapid action and superior antianginal effects compared to conventional ISMN/ISDN. This formulation improves quality of life and shows no signs of tolerance, with long-term data pending.

Area of Science:

  • Pharmacology
  • Cardiology
  • Clinical Pharmacy

Background:

  • Isosorbide mononitrate 30% immediate-release 70% sustained-release (IR-SR) formulation introduced in 1985.
  • Theoretical advantages over conventional isosorbide mononitrate or dinitrate (ISMN/ISDN) include simpler pharmacokinetics.

Purpose of the Study:

  • Review published data on isosorbide mononitrate IR-SR efficacy and safety.
  • Evaluate if theoretical pharmacokinetic advantages translate to improved clinical effectiveness.

Main Methods:

  • Review of published literature on isosorbide mononitrate IR-SR.
  • Comparison of antianginal effects, quality-of-life indices, and tolerance with placebo, conventional ISMN/ISDN, bupranolol, and sustained-release nifedipine.

Main Results:

  • Isosorbide mononitrate IR-SR demonstrated rapid onset (30 min) and prolonged action (up to 17 hours).
  • Antianginal effects were dose-dependent, superior to placebo and conventional ISMN/ISDN, and comparable to sustained-release nifedipine.
  • Significant improvements in quality-of-life indices (mobility, psychological distress, life satisfaction) were observed with once-daily IR-SR.
  • No tolerance developed after 13 months of once-daily use, and no rebound ischemia occurred upon discontinuation.

Conclusions:

  • Isosorbide mononitrate IR-SR is clinically effective, offering faster onset and greater efficacy than conventional ISMN/ISDN.
  • The formulation enhances patient quality of life without reported nitrate tolerance.
  • Ongoing large studies will assess long-term effects on morbidity and mortality.

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