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Title: Amlodipine Plus Valsartan Reduces Blood Pressure Reductions Better Than Monotherapy in Black Patients With Severe Hypertension: Presented at ASH(HYP)

"Amlodipine Plus Valsartan Reduces Blood Pressure Reductions Better Than Monotherapy in Black Patients With Severe Hypertension: Presented at ASH(HYP)"

By Betty S. Riggs NEW ORLEANS -- May 15, 2008 -- In black patients with stage 2 hypertension, combination therapy with amlodipine and valsartan produced a significantly greater antihypertensive effect than therapy with amlodipine alone, but with similar tolerability. John M. Flack, MD, MPH, Professor of Medicine and Physiology, Chairman of Department of Medicine, Chief, Division of Translational Research and Clinical Epidemiology, Wayne State University School of Medicine, Detroit, Michigan, reported the findings here at the 23rd Annual Scientific Meeting of the American Society of Hypertension (ASH[HYP]). The 12-week, double-blind, randomised, parallel-group, multicentre trial that was conducted in 572 black patients with stage 2 hypertension, defined as a mean systolic blood pressure (SBP) of >=160 to <200 mm Hg. After a 3- to 7-day washout period, patients were randomised to treatment with amlodipine 5 mg plus valsartan 160 mg (A/V) or amlodipine 5 mg alone (A). At week 2, patients were titrated to A/V 10/160 mg or A 10 mg. At week 4, patients in the combination group who still had an SBP >=130 mm Hg could be titrated to A/V 10/320 mg in a blinded fashion while patients on A 10 mg remained at that dose, receiving a matching placebo to maintain the blind. At week 8, patients not achieving the goal SBP in either group could also receive hydrochlorothiazide 12.5 mg. The primary endpoint was the reduction in mean sitting SBP from baseline to week 8 (before the addition of hydrochlorothiazide). Secondary outcomes included: reductions from baseline in mean sitting SBP at weeks 2, 4, and 12; reductions from baseline in mean sitting diastolic blood pressure (DBP) at weeks 2, 4, 8, and 12 weeks; and the proportion of patients achieving BP control, defined as mean sitting SBP <140 mm Hg, mean sitting DBP <90 mm Hg. Primary efficacy was assessed using a 2-sided analysis of covariance of least squares mean difference between A/V and A. Last observation carried forward was used to impute missing data. At baseline, the mean age of the cohort was 53.2 years, and 60% of patients were female. Mean BP at baseline was 170/98 mm Hg, and 14.2% of patients had severe hypertension, defined as mean sitting SBP >180 mm Hg. After 8 weeks of treatment, the reduction in mean sitting SBP with A/V was 33.3 mm Hg and with A it was 26.6 mm Hg ([P < .0001). The reduction in mean sitting DBP at this point was 13.6 mm Hg with A/V compared to 10.8 mm Hg with A (P = .0002).

For the patients with severe hypertension at baseline, significantly greater reductions were achieved with A/V at week 12 compared with A (50.5/18.0 mm Hg vs 41.7/13.3 mm Hg, P < .05).

At week 8, 49.8% of patients treated with A/V achieved BP control compared with 30.2% of patients treated with A (P < .05). By week 12, control rates increased to 57.2% of patients treated with A/V and 35.9% of patients treated with A (P < .05).

Most adverse events were mild to moderate in severity and the incidence was similar between groups (44.4% with A/V vs 45.3% with A).

According to Dr. Flack, "The era of [hypertension] monotherapy is dead."

He noted that the combination of a calcium channel blocker (CCB) and an angiotensin receptor blocker (ARB) is of interest because of excellent efficacy and tolerability. The combination of a CCB/ARB has no risk of drug-related angio-oedema as opposed to a combination with an angiotensin-converting enzyme inhibitor (ACEI). This is particularly important in black patients, who are at increased risk of angio-oedema associated with ACEI treatment.

The investigators concluded that in black patients with stage 2 hypertension, treatment with A/V produced significantly greater reductions in mean sitting SBP and mean sitting DBP than treatment with A alone, even in patients with the most severe baseline mean sitting SBP.

More patients receiving combination therapy achieved BP control than did patients treated with monotherapy. The differential BP effects were observed as early as week 2 and were sustained throughout the study, while the tolerability profile was similar between groups.

This study was sponsored by Novartis Pharma AG.

[Presentation title: Efficacy and Safety of Amlodipine/Valsartan Combination Therapy Compared With Amlodipine Monotherapy in Black Patients With Stage 2 Hypertension. Abstract P-33]

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