Clinical Pharmacology in the Elderly: Reference Ranges and Biological Variations After Repeated Measurements / Edition 1

by Hans-Peter Breuel, J. Kuhlmann

Overview

The vast majority of pharmaceutical prescriptions are for patients aged 55 years and above. As a consequence, the clinical pharmacological development of a new substance must evaluate its safety in the elderly population. Such safety studies focus on a special subgroup of elderly volunteers who have practically no pathological history and are receiving no medication - the healthy elderly subjects. In order to assess any chances from the norm under medication, it is vital to have hard data on what actually constitutes the norm. This volume is the first reference book to provide data on norm values and biological variations for various clinical and laboratory parameters.

Product Details

ISBN-13:	9783540594956
Publisher:	Springer Berlin Heidelberg
Publication date:	12/13/1995
Edition description:	Softcover reprint of the original 1st ed. 1996
Pages:	182
Product dimensions:	6.10(w) x 9.25(h) x 0.02(d)

About the Author

Breuel, Hans Peter

Table of Contents

1 Introduction.- 2 Theories of Aging.- 3 Changes in Body Functions, Pharmacokinetics, and Receptor Sensitivity with Age.- 3.1 Changes in Central Nervous System.- 3.1.1 Brain Structure and Function.- 3.1.2 Electroencephalogram.- 3.1.2 Cognitive Performance and Behavior.- 3.2 Cardiovascular and Pulmonary Changes.- 3.2.1 Heart.- 3.2.2 Blood Pressure.- 3.2.3 Arrhythmias.- 3.2.4 Lung.- 3.3 Changes in Clinical Chemistry and Hematology.- 3.3.1 Clinical Chemistry.- 3.3.2 Hematology.- 3.3.3 Repeated Measurements of Clinical Chemistry and Hematological Variables.- 3.3.4 Biological Rhythms.- 3.4 Changes in Pharmacokinetics.- 3.4.1 Absorption.- 3.4.2 Distribution.- 3.4.3 Protein Binding.- 3.4.4 Metabolism.- 3.4.5 Excretion.- 3.5 Changes in Receptor Sensitivity.- 4 Practical Aspects in Performing Clinical Trials in Elderly Subjects.- 4.1 Recruitment of Subjects.- 4.2 Performance of the Study.- 4.3 Safety Aspects.- 4.4 Sample Size.- 4.5 Compliance of Subjects with Medication and Study Regulations.- 5 Experimental Findings in Elderly Subjects.- 5.1 Method.- 5.1.1 Inclusion Criteria.- 5.1.2 Exclusion Criteria.- 5.1.3 Technical Methods.- 5.1.4 Data Management and Statistics.- 5.2 Experimental Data.- 5.2.1 Blood Pressure and Pulse Rate.- 5.2.2 Ambulatory Blood Pressure Monitoring.- 5.2.3 ECG Times.- 5.2.4 Ambulatory ECG Monitoring.- 5.2.5 Spirometry (FEV1).- 5.2.6 Clinical Chemistry.- 5.2.7 Hematology.- 5.2.8 Adverse Events.- 5.3 Consequences from Experimental Data in Healthy Subjects.- 6 Statistical Details.- 6.1 Blood Pressure.- 6.1.1 Baseline Values.- 6.1.2 Changes During Study Day.- 6.1.3 Changes After Repeated Measurements.- 6.2 Ambulatory Blood Pressure Monitoring.- 6.2.1 Baseline Values.- 6.2.2 Changes After 2 Weeks.- 6.3 ECG Times.- 6.3.1 Baseline Values.- 6.3.2 Changes During Study Day.- 6.3.3 Changes After Repeated Measurements.- 6.4 Ambulatory ECG Monitoring.- 6.4.1 Baseline Values.- 6.4.2 Changes After 2—3 Weeks.- 6.5 Spirometry (FEV1).- 6.5.1 Baseline Values.- 6.5.2 Changes During Study Day and After 1 Week.- 6.6 Clinical Chemistry.- 6.6.1 Baseline Values.- 6.6.2 Changes After Repeated Measurements.- 6.7 Hematology.- 6.7.1 Baseline Values.- 6.7.2 Changes After Repeated Measurements.- References.

Editorial Reviews

Reviewer: David O. Staats, MD (University of Oklahoma Health Sciences Center)
Description: This book discusses how clinical pharmacology studies are different in older populations than in younger ones and gives tables that describe reference values and distributions of laboratory tests and findings for an older group of persons that are commonly used in clinical pharmacology studies.
Purpose: The purpose is to provide clinical pharmacologists tables of reference ranges of laboratory tests and clinical findings in older age groups and to discuss how clinical pharmacology studies vary from younger to older age groups.
Audience: This book is primarily for clinical pharmacologists. Pharmacists, gerontologists, and geriatricians will find some of the data interesting.
Features: This book features extensive tables of reference values of laboratory tests and clinical findings in older persons that show the range and distribution of the data as well.
Assessment: As more drug trials feature segments of the older population, the discussion of the challenges of performing clinical trials in this age group is quite germane. The numerous tables of reference values give a look at not only how aging influences the trends of these values but also how aging increases the spread and range of values, emphasizing the heterogeneity of older persons. One realizes the limitations of these cross-sectional versus longitudinal data. Clinical pharmacologists will find this book a useful reference.

Doody's Review Service

Reviewer: David O. Staats, MD (University of Oklahoma Health Sciences Center)
Description: This book discusses how clinical pharmacology studies are different in older populations than in younger ones and gives tables that describe reference values and distributions of laboratory tests and findings for an older group of persons that are commonly used in clinical pharmacology studies.
Purpose: The purpose is to provide clinical pharmacologists tables of reference ranges of laboratory tests and clinical findings in older age groups and to discuss how clinical pharmacology studies vary from younger to older age groups.
Audience: This book is primarily for clinical pharmacologists. Pharmacists, gerontologists, and geriatricians will find some of the data interesting.
Features: This book features extensive tables of reference values of laboratory tests and clinical findings in older persons that show the range and distribution of the data as well.
Assessment: As more drug trials feature segments of the older population, the discussion of the challenges of performing clinical trials in this age group is quite germane. The numerous tables of reference values give a look at not only how aging influences the trends of these values but also how aging increases the spread and range of values, emphasizing the heterogeneity of older persons. One realizes the limitations of these cross-sectional versus longitudinal data. Clinical pharmacologists will find this book a useful reference.

This book discusses how clinical pharmacology studies are different in older populations than in younger ones and gives tables that describe reference values and distributions of laboratory tests and findings for an older group of persons that are commonly used in clinical pharmacology studies. The purpose is to provide clinical pharmacologists tables of reference ranges of laboratory tests and clinical findings in older age groups and to discuss how clinical pharmacology studies vary from younger to older age groups. This book is primarily for clinical pharmacologists. Pharmacists, gerontologists, and geriatricians will find some of the data interesting. This book features extensive tables of reference values of laboratory tests and clinical findings in older persons that show the range and distribution of the data as well. As more drug trials feature segments of the older population, the discussion of the challenges of performing clinical trials in this age group is quite germane. The numerous tables of reference values give a look at not only how aging influences the trends of these values but also how aging increases the spread and range of values, emphasizing the heterogeneity of older persons. One realizes the limitations of these cross-sectional versus longitudinal data. Clinical pharmacologists will find this book a useful reference.

David O. Staats