Efficacy, safety and cost of new cardiovascular drugs: a survey

Eur J Clin Pharmacol. 2003 Nov;59(8-9):701-6. doi: 10.1007/s00228-003-0634-y. Epub 2003 Sep 5.

Abstract

To assess the type and degree of innovation of the cardiovascular drugs centrally approved in the European Union between 1995 and 2002. Sources of information were the European Public Assessment Reports and the Summaries of Product Characteristics published by the European Medicines Evaluation Agency. The Agency approved 11 active substances belonging to 5 therapeutic classes: anti-hypertensives, anti-arrhythmics, anti-platelets, anti-coagulants and fibrinolytics. Analysis of the documentation on which the marketing authorization was based shows few elements of innovation. Moreover, the new drugs usually cost more than similar drugs already available. Cardiovascular drugs approved in Europe in the last few years have contributed little to progress in this area. These approvals provide no real advantage to patients and lay an economic burden on society.

MeSH terms

  • Cardiovascular Agents* / adverse effects
  • Cardiovascular Agents* / economics
  • Cardiovascular Agents* / therapeutic use
  • Drug Approval*
  • Drug Industry / trends
  • European Union

Substances

  • Cardiovascular Agents