| Autor: |
Wieringa, Nicolien F., Vos, Rein, Werf, Ger Th. van der, Graeff, Pieter A. de |
| Zdroj: |
Drug Development Research; November 2000, Vol. 51 Issue: 3 p159-168, 10p |
| Abstrakt: |
Phase III trials from registration files of cardiovascular drugs were analyzed to study the inclusion of patients with concomitant morbidity and medication. For this purpose, 15 drugs were selected which were registered in the Netherlands during the period 19851994 for the indications hypertension, angina pectoris, hypercholesterolemia, or myocardial infarction. The results show that preregistration trials are performed in populations which present with comorbidity and comedication. Cardiovascular, endocrine, and metabolic diseases were the most prevalent coexisting diseases. Large variation was found between registration files in the reporting of data and in patterns of comorbidity. Differences in mean comorbidity and comedication per patient were found between trials performed in different regions. The impact of various definitions of patient selection criteria on the actual inclusion of patients with coexisting morbidity was analyzed. Differences in definitions resulted in different levels of inclusion. Also, trials were found to include patients when this was not allowed and vice versa. The results are discussed in relation to the question of whether the generalizability of preregistration trials can be enhanced by further utilization of data from these heterogeneous populations. The issue to study is variability between safety and efficacy in patient groups with different patterns of comorbidity and comedication. In order to allow registration authorities to consider patterns of comorbidity and comedication during the evaluation of registration files, development of guidelines for uniform reporting of data in preregistration trials is recommended. Drug Dev. Res. 51:159168, 2000. © 2001 Wiley-Liss, Inc. |
| Databáze: |
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