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Pharmacy World and Science

, Volume 23, Issue 1, pp 28–30 | Cite as

Comparative trials in registration files of cardiovascular drugs: Comparator drugs and dosing schemes.

  • N.F. Wieringa
  • R. Vos
  • P.A. de Graeff
Article

Abstract

Registration files of 13 cardiovascular drugs were analysed with respect to the number of double‐blind phase‐III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double‐blind trials used active comparator drugs. The majority of files included first‐choice reference drugs, but we also found trials in three files with lower dosing schemes of comparator drugs and four files which included only placebo or active controlled double‐blind trials. To allow a better interpretation of the information provided in European Public Assessment Reports, which are published for every product approved for marketing in the European Union, uniform reporting is recommended on basic details of trial design, such as comparator drugs used and dosing schemes.

Cardiovascular drugs Dosing schemes therapy 

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References

  1. 1.
    Garattini S. The drug market in four European countries. Pharmacoeconomics, 1998:14,suppl.1:69-79Google Scholar
  2. 2.
    International Society of Drug Bulletins. ISDB assessment of 9 European Public Assessment Reports published by the EMEA, http://prn.usm.mu/isdb/2epars.htmlGoogle Scholar
  3. 3.
    Wieringa NF, de Graeff PA, van der Werf GT, Vos R. Cardiovascular drugs: discrepancies in demographics between pre-and postregistration use. Eur J Clin Pharmacol, 1999:55;537-44Google Scholar
  4. 4.
    Dutch College of General Practitioners. Guidelines for Hypertension 1991, Angina pectoris 1994 and Hypercholesterolemia 1991.Google Scholar
  5. 5.
    Dutch Health Care Insurance Board. Pharmacotherapeutical Compass, Eds. 1985, 1988, 1990/91, 1995.Google Scholar
  6. 6.
    FDA. International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials. Federal Register. 1998, Vol. 63, No. 179, p. 49583-98.Google Scholar
  7. 7.
    Fleming TR. Design and interpretation of equivalence trials. Am Heart J, 2000:139:S171-6.Google Scholar
  8. 8.
    Abbasi K, Herxheimer A. The European Medicines Evaluation Agency: open to criticism. Transparancy must be coupled with greater rigour. BMJ, 1998:317;898.Google Scholar

Copyright information

© Kluwer Academic Publishers 2001

Authors and Affiliations

  • N.F. Wieringa
    • 1
  • R. Vos
    • 2
  • P.A. de Graeff
    • 3
  1. 1.Dept. of Social Pharmacy & PharmacoepidemiologyUniversity of GroningenGroningenthe Netherlands
  2. 2.Dept. of Health Ethics and PhilosophyMaastricht UniversityMaastrichtthe Netherlands
  3. 3.Dept. of Clinical PharmacologyUniversity of Groningen, the Netherlands and Dutch Medicines Evaluation BoardThe Haguethe Netherlands

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