Antihypertensive Agents

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Exposure-response information plays an important role in the development of drugs for the treatment of many cardiovascular illnesses, including hypertension. The surrogate markers measured as response for antihypertensive drugs include changes in blood pressure. Exposure-response data are usually collected in Phase II trials that are double-blind, randomized, placebo-controlled, and parallel-group in design. In the development of antihypertensive drugs such as the angiotensin-converting enzyme (ACE) inhibitors or beta blockers, it is important that exposure-response information be obtained across several orders of magnitude of doses in order to be able to determine the optimum dose for patients. In October 2000, the FDA convened an advisory committee meeting to discuss the importance of obtaining appropriate dose-response information during antihypertensive drug development. The committee concluded that elucidating the full range of dose-response relationships for antihypertensive drugs does not constitute an undue burden on investigators, and may help avoid the conduct of trials and experiments that do not contribute to the total knowledge of the appropriate exposure-response relationship.

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