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Comparison of electrocardiogram and blood pressure recording methods in non-rodent toxicology studies: A
Emma Pawluk1, Annie Delaunois1, Bastien Gamboa1
1UCB Biopharma SRL, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Insights
Telemetry methods significantly improve cardiovascular assessments in toxicology studies by reducing animal stress and enabling smaller sample sizes. This shift enhances data accuracy and ethical practices in non-rodent research.
Area of Science:
- Pharmacology and Toxicology
- Veterinary Medicine
- Biomedical Engineering
Background:
- Cardiovascular (CV) parameter recording methodologies influence baseline data and statistical sensitivity in toxicology studies.
- Previous methods relied on restraint-based techniques, potentially introducing stress-related variability in CV parameters.
Purpose of the Study:
- To evaluate the impact of recording methodologies on CV parameters and statistical sensitivity in non-rodent toxicology studies.
- To assess variability in heart rate (HR), blood pressure (BP), and QTc interval based on measurement techniques.
- To determine optimal sample sizes for detecting meaningful CV changes in non-human primate (NHP) studies.
Main Methods:
- Retrospective analysis of 51 non-rodent general toxicology studies from the past 8 years.
- Categorization of CV parameter recording frequency by therapeutic modality and study type.
- Comparison of baseline CV values and sample size requirements between restraint-based and telemetry (Jacketed External Telemetry - JET) methods.
Main Results:
- Electrocardiogram (ECG) and BP were recorded in 63% and 18% of studies, respectively; BP was never recorded alone.
- A decline in restraint-based ECG methods and an increase in telemetry (especially JET) post-2017 were observed.
- Restraint methods yielded higher HR and QTc values compared to JET, indicating stress-related differences. JET requires significantly smaller sample sizes for NHP studies.
Conclusions:
- A notable industry shift towards telemetry-based approaches for CV assessments in toxicology studies is evident.
- Telemetry methods offer more accurate baseline CV data and reduce the need for large, potentially unethical sample sizes.
- This transition supports the development of industry consensus for optimal CV assessment practices in toxicology.
Abstract:
Our study retrospectively examines 51 non-rodent general toxicology studies conducted over the past 8 years to ascertain the influence of recording methodologies on baseline cardiovascular (CV) parameters and statistical sensitivity. Specifically, our work aims to evaluate the frequency of cardiovascular parameter recording categorized by therapeutic modality and study type, to assess the variability in these parameters based on measurement techniques, and to determine the sample sizes needed for detecting relevant changes in heart rate (HR), blood pressure (BP), and QTc interval in non-human primate (NHP) studies. Results indicate that electrocardiogram (ECG) measurements in dogs and NHP were recorded in 63% of studies, combined with BP recording in 18% of studies, while BP was never recorded alone. Trend analysis reveals a decline in the utilisation of restraint-based methods for ECG measurements post-2017, to the benefit of telemetry-based recordings, particularly Jacketed External Telemetry (JET). There was a marked difference in baseline values, with restraint-based methods showing significantly higher HR and QTc values compared to JET, likely linked to animal stress. Further analysis suggests an unrealistic and unethical sample size requirement in NHP studies for detecting biologically meaningful CV parameter changes using restraint-based methods, while JET methods necessitate significantly smaller sample sizes. This retrospective study indicates a notable shift from snapshots short-duration, restraint-based methods towards telemetry approaches over the recent years, especially with an increased usage of implanted telemetry. The transition contributes to potential consensus within industry or regulatory frameworks for optimal practices in assessing ECG, HR, and BP in general toxicology studies.
