Full Description
Recent years have seen an increasing number of supposedly active drugs for the treatment of chronic liver diseases, e.g. ursodeoxycholate for treatment of cholestatic conditions and alpha-interferon for the treatment of chronic viral hepatitis. However, in all controlled studies, hard end-points such as survival or need for transplantation often cannot be obtained, owing to the prolonged course of chronic liver diseases up to the time of hepatic decompensation and death. Therefore, surrogate markers for the different conditions are sorely needed in order to assess the value of these novel treatment modalities. This book, the proceedings of an International Falk Workshop held in Basel, Switzerland, October 23-24, 1995, aims to define surrogate markers and to evaluate critically those frequently used in randomized clinical trials. Surrogate markers considered include different old and new serum markers of chronic liver disease, scores, liver biopsy and quantitative liver function tests. Thus, the book will be of interest to clinicians concerned with prognostication and/or involved in clinical trials, clinical epidemiologists, members of governmental drug licensing agencies, and clinical research directors and their collaborators in the pharmaceutical industry.
Contents
Introduction; R.E. Poupon. Section ISurrogate Markers. 1. Surrogate Markers in AIDS Clinical Trials; J.-P. Aboulker. 2. Surrogate Markers and Prediction of Cardiovascular Disease; P.W.F. Wilson. 3. Requirements for Surrogate Markers as Seen by Regulatory Agencies; C. Peck. Section II: Scores and Quantitative Tests. 4. Quantitative Liver Function Tests; N. Tygstrup. 5. The Threshold Hypothesis of Sodium Retention in the Presence of Liver Disease Provides a Surrogate Marker for the Onset of Ascites; R.A. Branch. 6. Scores in Different Diseases. A Critical Review and Evaluation of Different Surrogate Markers for Assessing Treatments in Chronic Liver Disease; E. Christensen, M.R. Schunk. 7. Validation of Surrogate Markers for Death in Cirrhosis: an Example Using Decrease in Galactose Elimination Capacity; C. Merkel, et al. 8. Quantitative Liver Function Tests as Surrogate Markers for End Points in Controlled Clinical Trials; E. Lotterer, et al. Section III: Cirrhosis and Portal Hypertension. 9. The Child-Turcotte and Chilf-Pugh Classifications; N. McIntyre. 10. Portal Hypertension and Survival; J. Bosch, et al. 11. Impact of Ascites on Survival of Patients with Liver Cirrhosis; M. Bernardi, et al. Section IV: New and Old Markers. 12. Serum Markers for Liver Fibrosis - Current and Future Developments; D. Schuppan, et al. 13. Surrogate Markers to Assess Efficiency of Treatment in Chronic Liver Diseases: New Biochemical Indices; G. Ramadori, F. Polzien. 14. Liver Biopsy as a Surrogate Marker in Chronic Liver Disease; B. Portmann. 15. Measurement of Quality of Life; A.J. Chwalow. 16. Surrogate Markers: Quality of Life in Liver Disease; H.U. Fisch, et al. Section V: Chronic Liver Disease. 17. Assessment of Treatment in Cholestasis; U. Beuers, G. Paumgartner. 18. Hepatic Uptake and Excretion of Bile Acids: Quantitative Tests of Liver Function in Chronic Cholestatic Liver Diseases; R.P. Jazrawi, et al. 19. Surrogate Markers to Assess Efficacy of Treatment in Chronic Liver Diseases: Viral Hepatitis; L. Pagliario, et al. 20. Surrogate Markers in Chronic Liver Diseases &endash; Essence from the Poster Session; J. Scholmerich. Concluding Remarks; J. Reichen. Index.
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