The Safety After Fifty Evaluation trial: evaluation of the safety and efficacy of antihypertensive therapy with metoprolol in patients 50 to 75 years of age: study design.

Hypertension increases in prevalence with advancing age and is a major risk factor for the development of cardiovascular disease in elderly patients. However, the presence of coexisting illness, altered drug metabolism, enhanced susceptibility to drug side effects, and physiologic changes such as reduced plasma volume and lower plasma renin levels make treatment of hypertension in elderly patients more difficult. Nonetheless, several studies have now demonstrated the beneficial effects of antihypertensive drug therapy in older patients. The Safety After Fifty Evaluation trial was designed to determine the short-term efficacy and tolerability of once-daily therapy with the cardioselective beta-blocker metoprolol alone or in combination with hydrochlorothiazide in the treatment of mild hypertension in patients 50 to 75 years of age. A total of 24,816 patients were enrolled in the trial by 2821 practicing physicians from across the United States. This article describes the details of the Safety After Fifty Evaluation study design. Results of the trial will be reported separately.