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TitleDrug Evaluation in Angina Pectoris [electronic resource] / edited by Diego Ardissino, Lionel H. Opie, Stefano Savonitto
ImprintBoston, MA : Springer US : Imprint: Springer, 1994
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Descript XVI, 262 p. online resource


Although there are many books on angina, few are devoted to the important problem of how to evaluate drug efficacy in angina pectoris. Drug Evaluation in Angina Pectoris has two fundamental aims: the first is to review the methodological aspects of drug evaluation in stable and unstable angina pectoris; the second is to provide a logical and methodological background for future studies aimed at assessing the ability of medical treatment to improve prognosis. Part I updates the pathophysiology, clinical presentation and prognosis of angina pectoris. Part II aims to ̀put in numbers' the symptoms and signs of myocardial ischemia, starting from a revision of the currently used parameters. It is extremely important to quantify the variability of the disease for the correct design of clinical trial, a subject dealt with in Part III, which also discusses some clinico-pharmacological aspects of therapy. Part IV is a critical review of the drugs currently used for the treatment of stable and unstable angina, and particularly considers some important unresolved issues concerning their use. The current FDA and EC guidelines for the evaluation of antianginal drugs are briefly discussed in Part V, giving clinical investigators insight into how antianginal drugs are evaluated by regulatory agencies and what is considered as proof of a valid efficacy/tolerability ratio. Drug Evaluation in Angina Pectoris will assist discerning cardiologists, pharmacologists, and advanced students of cardiology as well as innovative pharmaceutical companies, all of whom need to understand what angina is, how to evaluate treatment, and how to judge the agents used in its treatment


I. Pathophysiology, Clinical Presentation, and Prognosis of Angina Pectoris -- 1. Pathophysiology, Clinical Presentation, and Prognosis of Angina Pectoris -- II. Evaluation of the Patient with Angina Pectoris -- 2. Clinical Value of Anginal Symptoms and their Assessment in Drug Trials -- 3. Quality of Life Assessments in Clinical Trials of Angina Pectoris -- 4. Optimizing the Exercise Test for Pharmacological Studies in Patients with Angina Pectoris -- 5. Evaluation of Transient Myocardial Ischemia by Holtet Monitoring -- 6. Radionuclide Methods for the Evaluation of Ventricular Function and Thrombolytic Therapy -- 7. Provocative Testing of Coronary Vasoconstriction -- 8. Pharmacological Investigation Using Invasive Methods -- III. Planning, Conducting, and Evaluating Clinical Trials in Angina Pectoris -- 9. Patient Selection and Definition of Study Endpoints -- 10. Controlling Potential Sources of Bias in Clinical Trials of Antianginal Agents -- 11. Parallel-Group and Crossover Designs for Drug Evaluation in the Various Forms of Angina Pectoris -- 12. Dose-Response Relationships and Combination Studies with Antianginal Agents -- 13. Sample Size and Power of Clinical Trials -- 14. Multicenter Trials: Design and Conduct -- IV. Critical Issues Related to Specific Antianginal Agents -- 15. Experimental Evaluation and Clinical Relevance of Tolerance to Nitrates -- 16. Clinical Evaluation of Beta-blockers in Various Forms of Angina Pectoris -- 17. Efficacy and Safety of Calcium Antagonists as Antianginal Agents -- 18. Effects of Antithrombotic Agents on Mortality and Nonfatal Cardiac Events -- 19. The Challenge of Thrombolytic Therapy in Unstable Angina Pectoris -- V. Regulatory Aspects Related to the Evaluation of New Antianginal Agents -- 20. Comments on the Food and Drug Administration (FDA) Cardiac and Renal Drugs Advisory Committee Recommended Guidelines for the Conduct of Antianginal Drug Trials -- 21. European Communitiesโ{128}{153} Committee for Proprietary Medicinal Products (CPMP) Working Party on Efficacy of Medicinal Products

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