Co-morbidity of 'clinical trial' versus 'real-world' patients using cardiovascular drugs

Pharmacoepidemiology and Drug Safety
Nicolien F WieringaPieter A de Graeff

Abstract

To examine discrepancies between co-morbidity of patients included in pre-marketing clinical trials of cardiovascular drugs and patients from daily practice, representing the actual users after marketing, and to investigate the availability of data regarding co-morbidity in registration files. Data were collected from phase III trials of registration files of 16 drugs, registered in the Netherlands in the period 1985 through 1994 for the indications hypertension, angina pectoris or hypercholesterolemia, and from a general practitioners database. Patients were selected who used drugs from the same therapeutic classes for the same indication as the patients in the pre-marketing trials. Prevalences of concomitant cardiovascular, endocrine and metabolic diseases were compared between pre- and postmarketing populations. Discrepancies were defined as more than 10% difference in prevalences. Data regarding co-morbidity were present in 13 out of 16 registration files and differed in format of reporting. For all indications, coexisting cardiovascular, endocrine and metabolic diseases were less prevalent in the pre-marketing populations, except ischemic heart disease, which was more prevalent coexisting with angina pectoris and hyperchol...Continue Reading

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Citations

Jul 16, 2008·European Journal of Clinical Pharmacology·Maurits E L ArbouwToine C G Egberts
May 4, 2010·Journal of Critical Care·Jay S SteingrubUNKNOWN XEUS Investigators
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Feb 7, 2002·Pharmacoepidemiology and Drug Safety
Jul 12, 2018·Stroke; a Journal of Cerebral Circulation·Layton LamsamJohn K Ratliff
Jul 18, 2006·Pharmacoepidemiology and Drug Safety·Karin MartinThierry Schaeverbeke
Mar 23, 2013·Cardiovascular Drugs and Therapy·Aldo P MaggioniUNKNOWN ARNO Cardiovascular Observatory

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