Guidelines for assessing outcomes of antihypertensive treatment.

Because of the changing nature of medical practice and the need to more accurately monitor and quantify the clinical benefits and cost-effectiveness of treatment, the Sixth Report of the Joint National Committee (JNC VI) recommends that the outcomes of antihypertensive therapy be classified as short, intermediate, and long term. Short-term outcomes are most relevant to the practitioner and include such measures as blood pressure control, laboratory changes, and quality of life. In contrast, long-term outcomes, typically measured in randomized clinical trials, are of particular interest to policy makers and guidelines writers, and focus on whether treatments affect survival and the incidence of major cardiovascular events. Intermediate-term outcomes, usually measurable within months of starting treatment, deal with such clinical surrogates as treatment-induced changes in left ventricular structure, arterial compliance, and renal function. No longer are the traditional short-term outcomes adequate to describe a new drug; hypertension specialists, formulary committees, healthcare economists, and even regulatory agencies now expect sponsors to plan studies that define a drug's full range of outcomes. This article briefly discusses some of the criteria for these outcome measures.