By Jill Stein
CHICAGO, IL -- May 24, 2007 -- Initial therapy with combination valsartan/hydrochlorothiazide (HCTZ) provides quicker and better blood pressure control than valsartan monotherapy in patients with severe hypertension, according to data announced here at the 22nd Annual Meeting of the American Society of Hypertension (ASH).
Findings of the 6-week, multicentre, randomised, double-blind, parallel group trial were presented by David Calhoun, MD, associate professor, vascular biology and hypertension program, University of Alabama at Birmingham, United States.
His group compared the combination of valsartan/HCTZ 160/12.5 mg force-titrated to 160/25 mg at week 2 and 320/25 mg at week 4 versus monotherapy with valsartan 160 mg force-titrated to valsartan 320 mg at week 2 as initial therapy in patients with severe hypertension.
"The importance of aggressive blood pressure lowering in patients with severe hypertension to prevent significant cardiovascular morbidity and mortality has long been established,' Dr. Calhoun noted. "Current treatment guidelines agree that intensive therapy is required in patients with significantly elevated blood pressure, and such patients often require combination therapy with two or more drugs to meet their blood pressure goals."
Combination therapy with agents having complementary modes of action leads to more prompt blood pressure control, possibly with fewer side effects than high-dose monotherapy, which may enhance patient adherence, he added.
A total of 608 patients were randomised. The baseline demographic characteristics were comparable between treatment groups. Overall, 39.6% of the valsartan/HCTZ group attained blood pressure control at the fourth week versus 21.8% of the valsartan monotherapy group (P <.0001). At the sixth week, blood pressure control rates further increased to 48.2% with combination therapy and 27.2% with valsartan monotherapy
(P <.0001).
Differences in control rates between treatment groups were evident as early as the second week (24.1% and 14.1% for valsartan/HCTZ and valsartan alone, respectively).
Mean decreases from baseline in mean seated systolic blood pressure and mean seated diastolic blood pressure at the fourth week were -29.8/-22.7 mmHg and -20.4/-17.5 mmHg for combination therapy and valsartan monotherapy, respectively (P <.0001). Results were maintained at 6 weeks.
Subgroup analysis showed consistently greater proportions of patients achieving blood pressure control with valsartan /HCTZ versus valsartan alone in both younger and older patients, in racial subgroups, and in those with baseline mean seated systolic blood pressure less than 180 mmHg and mean seated systolic blood pressure greater than or equal to 180 mmHg.
The researchers conclude combination therapy with valsartan/HCTZ for the initial treatment of patients with severe hypertension was safe and well tolerated.
The study was sponsored by Novartis.
[Presentation Title: Control of Severe Hypertension with the Combination of Valsartan/Hydrochlorothiazide as Initial Therapy. Abstract P-67]
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