Some problems with antihypertensive drug studies in the context of the new guidelines.

A dose-response analysis establishes the efficacy of most drugs. The medical literature is replete with so-called "Dose-Responses" to antihypertensive agents. The majority of these have failed. The use of a placebo helps minimize bias, though most studies here simply compared a test drug with the old drug. Short-acting drugs can have their duration of effect prolonged by giving larger doses than necessary. In order to produce more meaningful data, the Food and Drug Administration gathered together a group of experts who collectively proposed a set of Guidelines for studying these drugs. Though the final version has not yet been issued, investigators and clinicians working with this class of drugs are vitally interested in these guidelines, and have already encountered several problems. We identify some of these problems and propose some solutions.