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Congestive Heart Failure
About 2. 5 million individuals have congestive heart fai lure in the United States with over 400,000 new cases expected annually. Congestive heart failure also is one of the commonest causes for hospital admissions accounting for over 5 million hospital days per year. Despite the early recognition of this condition and active medical research into both mechanisms and therapy, prognosis continues to remain dismal wi th less than a 50% expected five year survival. In the last decade we have seen many new medical and therapeutic options for patients with congestive heart failure which extend beyond the use of bed rest, sodium restriction, digitalis and diuretics. These include vasodilators of a...
Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents
The Symposium on New Drugs provides a forum for academic investigators, research and development personnel from the pharmaceutical industry and members of the Food and Drug Administration to discuss important clinical research issues. The Ninth Annual symposium on New Drugs addressed the problem of determining the risk versus benefit for use of three important classes of cardiovascular agents: thrombolytic, antiarrhythmic, and hypolipidemic agents. The use of thrombolytic agents has become one of the major advances in clinical intensive cardiologic care in the 1980s. While the lysis of clot(s) obstructing a major coronary artery should reverse or prevent the damage of acute myocardial ischem...
The Evaluation of Beat Blocker and Calcium Antagonist Drugs
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 age...
Proceedings
None
Sudden Cardiac Death and Congestive Heart Failure: Diagnosis and Treatment
In Harch of 1980, we organized the first symposium on how to evaluate new antiarrhythmic agents in which the participants included members of the Cardio-Renal Division of the Food and Drug Administration, academic investigators from the United States and Abroad and directors and imple mentors of pharmacological research representing the pharmaceutical industry. By bringing together all three elements, it was hoped that better communication and under standing would ensue to more rapidly bring new cardiac agents to the American public. This goal was important since a rather limited number of antiarrhythmic agents were and are currently available to treat patients with such disorders in the Uni...
Cardiac Arrhythmias: New Therapeutic Drugs and Devices
In summary, there are many animal models that are useful in selecting new antiarrhythmic drugs. The selection of which model is most idea depends upon precisely what question is being asked. The large number of experimental models used to evaluate antiarrhythmic compounds points out the inability of anyone model to define the probability of antiarrhythmic efficacy in man. It has therefore become standard practice to utilize a batter of animal models for the evaluation of new antiarrhythmic agents. Each model has its own advantages and disadvantages and it is necessary to understand each model fully in oder to evaluate experimental findings and apply them to clinical settings. We believe that...
Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affecting Antiarrhythmic Heart Failure and Hypolipidemia
The Symposium on New Drugs provides for an annual forum for academic investigators, research and development personnel from the pharmaceutical and related health care industries, and members of the Food and Drug Administration to discuss important clinical research issues. The Tenth Annual Symposium on New Drugs addressed the problem of whether it was still appropriate to approve antihypertensive agents soley on the endpoint of lowering cuff blood pressure. The initial discussions at this symposium related to the approaches and methods to studying antihypertensive agents. Dr. William Frishman provided a detailed list of the new approaches to the treatment of hypertension and pointed out the ...
Current Catalog
First multi-year cumulation covers six years: 1965-70.
