Abstract
Purpose: RAAS inhibitors have historically been less effective than other antihypertensive agents in lowering BP in African American (AA) patients (pts). There is relatively little data concerning the efficacy of valsartan in the treatment of hypertension (HTN) in AA pts. The purpose of this study was to compare the efficacy and safety of amlodipine and valsartan in hypertensive AA pts using ABPM. Methods: AA with a history of uncomplicated HTN with a baseline BP >140/90 mmHg were eligible to participate. Patients were randomized in double-blind fashion to receive amlodipine (A) or valsartan (V) for a period of 6 to 16 weeks depending on response. After an intervening washout period where baseline BP was re-established, pts were crossed-over to other treatment. Double-blind therapy was titrated based on office BP measurements with a BP goal of <140/90 mmHg. Doses of A were 5 mg/d, 10 mg/d, and 10 mg/d plus HCTZ 12.5 mg/d. Doses of V were 80 mg/d, 160 mg/d, and 160 mg/d plus HCTZ 12.5 mg/d. After achievement of the optimal dose on each agent, pts underwent 24-hr ABPM. Results: Twenty pts (12 men, 8 women) with mean age of 42±11 years were randomized. Mean baseline BP prior to each ABPM monitoring period was 155±12/100±8 mmHg. Final doses of A were 5 mg/d in 9 pts, 10 mg/d in 5 pts, and 10 mg/d plus HCTZ in 6 pts. Final doses of V were 80 mg/d in 9 pts, 160 mg/d in 4 pts, and 160 mg/d plus HCTZ in 7 pts. Based on office BP measurements, the number of pts achieving goal BP with A was 15 (75%) and with V was 14 (70%). Two pts on V failed to complete ABPM due to side effects (headache and dizziness in 1 pt and hyperkalemia with serum K+ >6.5 mEq/L in 1 pt). One pt on A failed to complete ABPM due to side effects (headache, dizziness). Four (20%) pts in each treatment group had drug-related side effects. ABPM results were not significantly different between A and V. Conclusions: A and V produce similar reductions in BP in AA pts with uncomplicated HTN. Both office BP measurements and ABPM data indicate that AA hypertensive pts respond similarly to to A and V.