International Patterns of Clinical Use and Toxicity of Digitalis Glycosides: Report From the Boston Collaborative Drug Surveillance Program

Abstract

Clinical pharmacokinetic studies of digitalis glycosides have the ultimate objective of providing information on drug absorption, distribution, and elimination which might promote the safe and effective use of these drugs in humans. Although understanding of the pharmacokinetics of digitalis derivatives has advanced impressively in the last decade, the impact of this new knowledge upon the clinical use of digitalis glycosides is largely unknown. This is not surprising, since assessment of a drug’s “safety” and “effectiveness” in clinical practice is exceedingly difficult. Furthermore, pharmacokinetic studies have been performed in many parts of the world. It is not established whether results obtained with one subject population in one nation are applicable to subjects in other nations where genetic heritages are different and where subjects are exposed to entirely different environments. To provide some preliminary insight into these problems, the present report describes a preliminary evaluation of patterns of clinical use and toxicity of digitalis glycosides based upon data collected by the Boston Collaborative Drug Surveillance Program (BCDSP).