Drug Evaluation in Angina Pectoris

ISBN-13: 9780792328971 / Angielski / Twarda / 1994 / 262 str.

Diego Ardissino; Diego Ed. Ardissino; Gianluigi Ardissino

Opis

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.

Spis treści

Part I: Pathophysiology, Clinical Presentation and Prognosis of Angina Pectoris; G. Specchia, S. Ghio. Part II: Evaluation of the Patient with Angina Pectoris. 1. Clinical value of anginal symptoms and their assessment in drug trials; S. Savonitto, P.A. Merlini. 2. Quality of life assessments in clinical trials of angina pectoris; I. Wilund. 3. Optimizing the exercise test for pharmacologic studies in patients with angina pectoris; J. Myers, V.F. Froelicher. 4. Evaluation of transient myocardial ischemia by Holter monitoring; A.A. Quyyumi. 5. Radionuclide methods for the evaluation of ventricular function and thrombolytic therapy; P. Marzullo, A. Gimelli, A. L'Abbate. 6. Provocative testing of coronary vasoconstriction; M. Previtali, P. Barberis, D. Ardissino. 7. Pharmacological investigations with invasive methods; E. Bramucci. Part III: Planning, Conducting and Evaluating Clinical Trials in Angina Pectoris. 1. Patient selection and definition of study endpoints; P. Schulman, D. Waters. 2. Controlling potential sources of bias in clinical trials of antianginal agents; M. Motolese. 3. Parallel group and crossover designs for drug evaluations in the various forms of angina pectoris; S. Savonitto. 4. Dose response relationships and combination studies with antianginal agents; U. Thadani. 5. Sample size and power of clinical trials; E. Eleuteri, D. Ardissino. 6. Multicenter trials: design and conduct; A. McNeill, J. Lubsen. Part IV: Critical Issues related toSpecific Antianginal Agents. 1. Experimental evaluation and the clinical relevance of tolerance to nitrates; J.O. Parker, J.D. Parker. 2. Clinical evaluation of betablockers in the various forms of angina pectoris; N. Rehnqvist. 3. Efficacy and safety of calcium antagonists as antianginal agents; L.H. Opie. 4. Effects of antithrombotic agents on mortality and nonfatal cardiac events; P. Theroux, R.M. Lidon. 5. The challenge of thrombolytic therapy in unstable angina pectoris; J.A. Venditto, J.A. Ambrose. Part V: Regulatory Aspects related to the Evaluation of New Antianginal Agents. 1. Comments on the Food and Drug Administration (FDA) Advisory Panel Recommended Guidelines for the Conduct of Antianginal Drug Trials; U. Thadani. 2. EEC Guidelines for the evaluation of antianginal agents; B. Dupuis. Index.