Titlebook: Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affect; Proceedings of the T Joel Morganroth,

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Do We Need Any More Antihypertensive Drugs: The Validity of a Change in Blood Pressure as the Only Ethere is a hierarchy of possible and potential endpoints beyond simple antihypertensive efficacy than can be considered as criteria for approvability (Table). Brief consideration will be given to each of these, starting from the bottom and proceeding upward.

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The Cost and Time to Develop a New Antihypertensive Drug Depending upon the Endpointy differ among companies due to unique perspectives and practices within the company; however, most often, the plans follow guidelines for drug development that are issued by the Food and Drug Administration.

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Is Ambulatory Blood Pressure Monitoring Required to Define the Hypertensive Patient and to Detect EfBP measurements outside of the medical care environment. During the past 20 years, automatic portable recorders have been developed which have greatly aided in assessing blood pressure during the day and night (1–3). There are a number of advantages of automatic ambulatory blood pressure monitoring

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Is It Necessary to Demonstrate Changes in Left Ventricular Hypertrophy in the Evaluation of Antihypectice, this is unlikely to be achieved. The large scale clinical studies of the benefits of treating hypertension have produced findings that are both confusing and disappointing (1). While there is general consensus that any effective antihypertensive drug is likely to lower the prevalence of strok

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How Does One Define Dose-Duration of an Antihypertensive Drug? What is the Role of Non-Mem and the Plled trials that demonstrate an antihypertensive effect in a general population of patients with essential hypertension, and that the dosing interval for the antihypertensive effect be clear. The antihypertensive effect is taken simply as a reflection of a change in blood pressure in comparison to p

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What Have We Learned from Prior Clinical Trials of Antihypertensive Drug Therapy?lopment of cardiovascular complications. The data differ somewhat according to the degree of severity of hypertension, and the findings in patients with moderate and severe hypertension (diastolic blood pressures 105–114 mmHg and ≥ 115 mmHg, respectively) should best be considered separately from th

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