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Clinical Drug Investigation

, Volume 14, Issue 2, pp 117–124 | Cite as

Sustained-Release Isosorbide-5-Mononitrate Improves Exercise Capacity 30 Minutes after Oral Application

  • J. Guzik
  • M. Kanopka
  • J. Maciejewicz
  • A. Maziarz
  • J. Stepien
Clinical Pharmacodynamics

Summary

The short-term antianginal efficacy of a slow-release 50mg isosorbide-5-mononitrate (IS-5-MN) capsule preparation was assessed in a randomised, double-blind, placebo-controlled, crossover study in 20 patients. The primary target parameter was the time to moderate angina (time to P2) occurring during ergometric exercise testing commencing 30 minutes after intake of the drug. The 50mg IS-5-MN sustained-release preparation increased the time until moderate angina occurred by 75.9 seconds compared with placebo. Mean time to moderate angina was 703.3 seconds in sequence group 1, 30 minutes after intake of IS-5-MN on the first day, while mean duration of exercise was 641.6 seconds on the second day, when placebo medication was applied. Patients of sequence group 2 stopped exercising after an average 590.6 seconds the first day (placebo) and after 680.7 seconds the second day (IS-5-MN). These findings indicate that the antianginal activity of slow-release IS-5-MN is present 30 minutes after intake of the drug.

Keywords

Placebo Adis International Limited Drug Invest Sequence Group Mononitrate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Bonn R. Sustained release isosorbide mononitrate (50 mg): optimisation of a once-daily dosage form for long-term treatment of angina pectoris. Am J Cardiol 1988; 61: 12E–14EPubMedCrossRefGoogle Scholar
  2. 2.
    Ahmadinejad M, Eghbal B, Sorgenicht W, et al. Slow-release isosorbide-5-mononitrate — a new once-daily therapeutic modality for angina pectoris. Eur Heart J 1988; 9Suppl. A: 135–9PubMedGoogle Scholar
  3. 3.
    Beyerle A, Reiniger G, Rudolph W. Long-acting, marked anti-ischemic effect maintained unattenuated during long-term interval treatment with once-daily isosorbide-5-mononitrate in sustained-release form. Am J Cardiol 1990; 65: 1434–7PubMedCrossRefGoogle Scholar
  4. 4.
    Jansen W, Prenzel R, Kümper H, et al. Interval treatment of coronary artery disease with sustained-release isosorbide-5-mononitrate. Am J Cardiol 1990; 65: 16J–22JPubMedCrossRefGoogle Scholar
  5. 5.
    Heepe W, Gathmann-Lewik U. Antianginal efficacy and toler-ability of 50mg sustained-release isosorbide-5-mononitrate in an open twelve-months observation study. Cardiology 1987; 74Suppl. 1: 34–9PubMedCrossRefGoogle Scholar
  6. 6.
    Kenedi P, Gathmann-Lewik U. Dose-effect relationship amongst three different sustained-release forms of isosorbide 5-mononitrate in patients with coronary artery disease. Cardiology 1987; 74Suppl. 1: 29–33PubMedCrossRefGoogle Scholar
  7. 7.
    Ingendaay A, Klein G, Rehm D, et al. A comparison of the pharmacokinetics of different sustained-release mononitrate presentations. Munch Med Wochenschr 1987; 3: 34–6Google Scholar
  8. 8.
    Bussmann WD. Comparison of the nitrate patch Biophase 10 with placebo and 20mg isosorbide-5-nitrate (Elantan® 20) in aspect of anti-ischaemic efficacy and onset of action in a short-term study. Study report F 8328, 1991, Schwarz Pharma AGGoogle Scholar
  9. 9.
    Eggeling TH, Jansen W, Osterspey A, et al. Einflu\ von 50 mg Isosorbid-5-Nitrat retard auf die Belastbarkeit von Patienten mit koronarer Herzkrankheit. Med Klin 1986; 81(8): 275–80Google Scholar
  10. 10.
    Grizzle JE. The two period change-over design and its use in clinical trials. Biometrics 1965; 5: 467–80CrossRefGoogle Scholar
  11. 11.
    Jones B, Kenward MG. Design and analysis of cross-over trials. London: Chapman and Hall, 1989Google Scholar
  12. 12.
    Abrams J. Tolerance to organic nitrates. Circulation 1986; 74(6): 1181–5PubMedCrossRefGoogle Scholar
  13. 13.
    Luke R, Sharpe N, Coxon R. Transdermal nitroglycerin in angina pectoris: efficacy of intermittent application. J Am Coll Cardiol 1987; 10(3): 642–6PubMedCrossRefGoogle Scholar
  14. 14.
    Goldberg R, Brady P, James EM, et al. Time of onset of symptoms of acute myocardial infarction. Am J Cardiol 1990; 66: 140–4PubMedCrossRefGoogle Scholar
  15. 15.
    Rocco MB, Barry J, Campbell S, et al. Circadian variation of transient myocardial ischemia in patients with coronary artery disease. Circulation 1987; 75: 395–400PubMedCrossRefGoogle Scholar
  16. 16.
    Willich SN, Loewel H, Lewis M, et al. Association of wake time and the onset of myocardial infarction. Circulation 1991; 80Suppl. VI: VI62–VI–7Google Scholar

Copyright information

© Adis International Limited 1997

Authors and Affiliations

  • J. Guzik
    • 1
  • M. Kanopka
    • 1
  • J. Maciejewicz
    • 1
  • A. Maziarz
    • 1
  • J. Stepien
    • 1
  1. 1.Department of CardiologyDietl’s HospitalCracowPoland

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