Effects of valsartan 160 mg/HCTZ 12.5 mg vs. amlodipine 10 mg in African American patients with stage I and stage II hypertension: results of the aadvance study

Despite increasing evidence to show that drugs that block the renin-angiotensin system (RAS) provide vascular protection beyond their ability to reduce BP, African American (AA) patients are frequently denied the benefits of this protection due to concerns over lack of efficacy of these agents in this population group. It has also been demonstrated that the addition of HCTZ to ACEI or ARBs substantially enhances the efficacy of these agents in AA patients similar to that seen in Caucasian patients. The AADVANCE (African American hypertension: Diovan (Valsaratan) vs. Amlodipine (Norvasc)-Comparing Efficacy) was performed to assess whether adding HCTZ 12.5 mg to Valsartan (Val) 160 mg results in similar efficacy to high dose Amlodipine (Am) 10 mg, the current gold standard for efficacy in AA patients. This study was a double-blind, randomized, parallel group study comparing the efficacy and safety of Valsartan 160 mg/HCTZ 12.5 mg with Amlodipine 10 mg in AA patients with stage I and II hypertension (mean seated systolic BP ≥140 mmHg and ≤180 mmHg and mean seated diastolic BP ≥ 90 mmHg and ≤ 110 mmHg). Following a 2-3 week single-blind placebo run-in period, 380 patients were randomized in a 1:1 fashion to Valsartan 160 mg/HCTZ 12.5 mg or Amlodipine 10 mg. Patients entered a 2-week titration period of blinded drug. Patients in the Valsartan/HCTZ group were started on Valsartan 160 mg and patients in the Amlodipine group were started on Amlodipine 5 mg for 2 weeks. Following this 2-week period, patients were titrated to Valsartan 160 mg/HCTZ 12.5 mg or to Amlodipine 10 mg for a further 10-week period. Twenty-four hour ABPM was measured at the end of the run-in period and repeated at the end of the study. Quality of life assessment (using the SF - 12V2 instrument) and assessment of peripheral edema were performed at the end of the single-blind period and at the end of the study. Recruitment was done in an acceptable planned time with enthusiastic support by the AA patients. The primary results of AADVANCE will be available for presentation. Documentation of efficacy and safety of Valsartan 160 mg/HCTZ 12.5 mg in AA patients will provide evidence to support the use of ARBs/HCTZ as a first line treatment in AA patients offering them the potential of efficacy, safety and the benefits of RAS blockade beyond BP reduction.