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Drug Evaluation in Angina Pectoris : DEVELOPMENTS IN CARDIOVASCULAR MEDICINE - Gianluigi Ardissino

Drug Evaluation in Angina Pectoris

DEVELOPMENTS IN CARDIOVASCULAR MEDICINE

By: Gianluigi Ardissino (Editor), Lionel H. Opie (Editor), Stefano Savonitto (Editor)

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Published: 30th November 1994
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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.

Pathophysiology, Clinical Presentation and Prognosis of Angina Pectoris
Evaluation of the Patient with Angina Pectoris
Clinical value of anginal symptoms and their assessment in drug trials
Quality of life assessments in clinical trials of angina pectoris
Optimizing the exercise test for pharmacologic studies in patients with angina pectoris
Evaluation of transient myocardial ischemia by Holter monitoring
Radionuclide methods for the evaluation of ventricular function and thrombolytic therapy
Provocative testing of coronary vasoconstriction
Pharmacological investigations with invasive methods
Planning, Conducting and Evaluating Clinical Trials in Angina Pectoris
Patient selection and definition of study endpoints
Controlling potential sources of bias in clinical trials of antianginal agents
Parallel group and crossover designs for drug evaluations in the various forms of angina pectoris
Dose response relationships and combination studies with antianginal agents
Sample size and power of clinical trials
Multicenter trials: design and conduct
Critical Issues related to Specific Antianginal Agents
Experimental evaluation and the clinical relevance of tolerance to nitrates
Clinical evaluation of betablockers in the various forms of angina pectoris
Efficacy and safety of calcium antagonists as antianginal agents
Effects of antithrombotic agents on mortality and nonfatal cardiac events
The challenge of thrombolytic therapy in unstable angina pectoris
Regulatory Aspects related to the Evaluation of New Antianginal Agents
Comments on the Food and Drug Administration (FDA) Advisory Panel Recommended Guidelines for the Conduct of Antianginal Drug Trials
EEC Guidelines for the evaluation of antianginal agents
Index
Table of Contents provided by Publisher. All Rights Reserved.

ISBN: 9780792328971
ISBN-10: 0792328973
Series: DEVELOPMENTS IN CARDIOVASCULAR MEDICINE
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 262
Published: 30th November 1994
Publisher: Springer
Country of Publication: NL
Dimensions (cm): 25.4 x 17.8  x 1.7
Weight (kg): 1.67