Relationship between pharmacokinetic parameters and occurrence of adverse events in clinical trials performed in Europe and United States for an angiotensin II receptor antagonist, telmisartan.

Shinji Tatami, Akiko Sarashina, Norio Yamamura, Takashi Igarashi, Yusuke Tanigawara

研究成果: Article

2 引用 (Scopus)

抄録

The objective of this study was to clarify the relationship between the pharmacokinetic parameters of telmisartan and the occurrence of adverse events. In order to perform this study, a total of 1500 adverse events was collected from the eight clinical trials performed in Europe and the United States and the pharmacokinetic parameters (C(max) and AUC) were calculated with the parameters obtained from the population pharmacokinetic model which we have built. Using these data, the pharmacokinetic parameters (C(max) and AUC) were compared between subjects with or without the occurrence of adverse events. The Mann-Whitney test was performed to analyze ten adverse events selected based on the order of frequency. For eight of these ten adverse events, no significant between-group difference was observed in any pharmacokinetic parameter. For two adverse events, pain and sinusitis, the pharmacokinetic parameters, C(max) and AUC, were greater in subjects with adverse events as compared with those without adverse events, but the intersubject variability of pharmacokinetic parameters was large and there were many subjects in whom C(max) and AUC were high without any adverse event. These results suggest that there is no clear relationship between pharmacokinetic parameters of telmisartan and the occurrence of adverse events.

元の言語English
ページ(範囲)24-32
ページ数9
ジャーナルDrug Metabolism and Pharmacokinetics
19
発行部数1
出版物ステータスPublished - 2004
外部発表Yes

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Angiotensin Receptor Antagonists
Pharmacokinetics
Clinical Trials
Area Under Curve
telmisartan
Sinusitis
Pain
Population

これを引用

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AU - Tatami, Shinji

AU - Sarashina, Akiko

AU - Yamamura, Norio

AU - Igarashi, Takashi

AU - Tanigawara, Yusuke

PY - 2004

Y1 - 2004

N2 - The objective of this study was to clarify the relationship between the pharmacokinetic parameters of telmisartan and the occurrence of adverse events. In order to perform this study, a total of 1500 adverse events was collected from the eight clinical trials performed in Europe and the United States and the pharmacokinetic parameters (C(max) and AUC) were calculated with the parameters obtained from the population pharmacokinetic model which we have built. Using these data, the pharmacokinetic parameters (C(max) and AUC) were compared between subjects with or without the occurrence of adverse events. The Mann-Whitney test was performed to analyze ten adverse events selected based on the order of frequency. For eight of these ten adverse events, no significant between-group difference was observed in any pharmacokinetic parameter. For two adverse events, pain and sinusitis, the pharmacokinetic parameters, C(max) and AUC, were greater in subjects with adverse events as compared with those without adverse events, but the intersubject variability of pharmacokinetic parameters was large and there were many subjects in whom C(max) and AUC were high without any adverse event. These results suggest that there is no clear relationship between pharmacokinetic parameters of telmisartan and the occurrence of adverse events.

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