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.

Modern drugs are invented according to medical needs, making use of the latest innovations in technology. They are sophisticated, efficacious, and costly, but are they effective? Are they superior to existing - and cheaper - alternatives, and is this superiority reflected in increased cost-effectiveness? Are they socially more beneficial? These questions, and those related to the intriguing search for better quality of life, are addressed in this book by experts from the fields of medicine, epidemiology, economics, sociology and the pharmaceutical industry. The book describes the environmental situation in the United States and Europe in which pharmaceutical development takes place; it also explores the grounds for agreement as well as disagreement between the social and the economic evaluations of progress. It tackles the problem of outcome measurements, patients' behavior, quality of life, and individual value judgments and describes methodological boundaries in the socioeconomic evaluation of drugs.

Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

An integrated mini review of Angina pectoris and its drug therapy, illustratedwith visually appealing tables and diagrams. A quick visual aide for the coursestudy and board review

The· first meeting of the cardiovascular drug therapy forum took place on April 13-15, 1988 in Montreux, Switzerland. In this meeting, which was closed to the public, approximately 150 leading investigators in the field of cardiovascular drug therapy, both academics and from the pharmaceutical industry, discussed the state of the art and future trends of this rapidly expanding field. The discussions concentrated on four major topics: (1) ischemic heart disease; (2) heart failure; (3) hyper tension; (4) arrhythmias. These topics were discussed by four committees in parallel, and thereafter the main points were reviewed by the whole forum. This framework allowed both intensive and interdisciplinary discussions. This book, the first publication of selected topics from the meeting, focuses mainly on nitrate therapy in ischemic heart disease and heart failure. Adam Schneeweiss, MD Chairman v Contents Opening Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Presentation of the Sir Thomas Lauder Brunton Award for Outstanding Nitrate Research . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Origins of Symptoms in Heart Failure - Relevance in Evaluation of New Drugs . . . . . . . . . . . . . . . . . . . . 5 Mononitrates in Congestive Heart Failure . . . . . . . . . . . . . . . . . 9 Are There Differences Between the Various Formulations of Nitrates in Heart Failure? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Long-Term Nitrate Therapy - A Decade of Changing Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Nitrate Therapy in Angina Pectoris . . . . . . . . . . . . . . . . . . . . . . . . 23 Mononitrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Transdermal Administration of Nitrates . . . . . . . . . . . . . . . . . . . 53 Nitrates in Angina Pectoris - Rationale of Use and Avoidance of Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Treatment of Congestive Heart Failure - Summary . . . . . . . .

With the beginning of the 1980's it was becoming increasingly evident that the lack of approval of new cardiovascular agents for use by clinicians in the United States for the treatment of cardiovascular disorders was becoming a problem. Patients requiring medical therapy for hypertension, angina pectoris, arrhythmias, congestive heart failure, and vasospastic disorders of the coronary arteries could receive in the United States only a small number of the drugs available to physicians in the rest of the world. In fact, as the 1980's began, there was only one available beta blocking agent released by The Food and Drug Administration; and even as of this writing, no oral calcium antagonist agent. This lag, in part, has been due to the confusion of proper and expeditious methods to define safety and efficacy of such agents so that the United States regulatory agency (Food and Drug Administration) could approve the use of such agents by clinicians. The vast number of new beta blocker and calcium antagonist agents being developed, as well as the long-term use abroad of many new drugs, has raised important questions as to how relative safety and efficacy of such agents can be determined to facilitate availability in the United States.