[Reduction of cardiovascular disorders by preventive perioperative antihistamine administration in general surgery: are the drugs interchangeable?]

Langenbecks Arch Chir Suppl Kongressbd. 1998;115(Suppl I):731-5.
[Article in German]

Abstract

In clinical reality the drugs used for H1/H2-prophylaxis are not restricted to the combination of dimetinden/cimetidine, also only for this combination the effectiveness for preventing severe cardiorespiratory disturbances is proven in a randomised controlled clinical trial. However, it is almost impossible to conduct such an extended clinical trial in order to check all possible combinations. Instead of this, we developed a complex animal model featuring clinical variability and the principles of a well conducted randomised controlled clinical trial (CMRT = clinic modelling randomised trials), to evaluate different H1/H2 combinations. In this CMRT in pigs (four groups of 15 animals), the H1/H2 combination of dimetinden/cimetidine and dimetinden/famotidine showed an effectiveness similar to the randomised clinical trial. With dimetinden/ranitidine no significant prophylactic effect was observed. Two conclusions can be drawn: (1) CMRTs in animals are able to answer relevant clinical and research questions that otherwise only could be solved by clinical studies and may be a successful intermediate between basic research and clinical trials. (2) Drugs, even of the same substance class, may not be simply exchangeable. Hence, before changing a proven medication, trials in an adequate complex animal model (CMRT) should be mandatory.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Animals
  • Cardiovascular Diseases / prevention & control*
  • Cimetidine / administration & dosage
  • Dimethindene / administration & dosage
  • Disease Models, Animal
  • Drug Evaluation, Preclinical
  • Drug Therapy, Combination
  • Famotidine / administration & dosage
  • Female
  • Histamine H1 Antagonists / administration & dosage*
  • Histamine H2 Antagonists / administration & dosage*
  • Humans
  • Male
  • Postoperative Complications / prevention & control*
  • Premedication*
  • Randomized Controlled Trials as Topic
  • Ranitidine / administration & dosage
  • Swine

Substances

  • Histamine H1 Antagonists
  • Histamine H2 Antagonists
  • Famotidine
  • Dimethindene
  • Cimetidine
  • Ranitidine