Abstract
Aim:
The conventional method for analyzing 24-h ambulatory blood pressure monitoring (24-h ABPM) is insufficient to deal with the large amount of data collected. The aim of this study was to develop a novel cyclic fluctuation model for 24-h ABPM in Chinese patients with mild to moderate hypertension.
Methods:
The data were obtained from 4 independent antihypertensive drug clinical trials in Chinese patients with mild to moderate hypertension. The measurements of 24-h ABPM at the end of the placebo run-in period in study 1 were used to develop the cyclic fluctuation model. After evaluated, the structural model was used to analyze the measurements in the other 3 studies. Models were fitted using NONMEM software.
Results:
The cyclic fluctuation model, which consisted of 2 cosine functions with fixed-effect parameters for rhythm-adjusted 24-h mean blood pressure, amplitude and phase shift, successfully described the blood pressure measurements of study 1. Model robustness was validated by the bootstrap method. The measurements in the other 3 studies were well described by the same structural model. Moreover, the parameters from all the 4 studies were very similar. Visual predictive checks demonstrated that the cyclic fluctuation model could predict the blood pressure fluctuations in the 4 studies.
Conclusion:
The cyclic fluctuation model for 24-h ABPM deepens our understanding of blood pressure variability, which will be beneficial for drug development and individual therapy in hypertensive patients.
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Acknowledgements
This study was supported by the National Key Technology R&D Program Project (2008BAI51B03), the National Key Project for IND (No 2012ZX09303-003 and 2012ZX09303009-001), and the Leading Academic Discipline Project of Shanghai Municipal Education Commission (No 085ZY1202, J50303, SZY11059 and ZYSNXD-CC-LCPJ). We also thank Dr Guang-li MA and Dr Jun-jie DING for providing guidance during the modeling process. The authors would like to thank Beijing Chao-Yang Hospital, Beijing Friendship Hospital, Beijing Xuanwu Hospital and Baotou Central Hospital for collecting the 24-h ABPM data.
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Sheng, Yc., Wang, K., Xu, L. et al. A cyclic fluctuation model for 24-h ambulatory blood pressure monitoring in Chinese patients with mild to moderate hypertension. Acta Pharmacol Sin 34, 1043–1051 (2013). https://doi.org/10.1038/aps.2013.45
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DOI: https://doi.org/10.1038/aps.2013.45
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