Effects of the angiotensin II receptor blockers telmisartan versus valsartan in
combination with hydrochlorothiazide: a large, confirmatory trial.
Author(s): White WB(1), Murwin D, Chrysant SG, Koval SE, Davidai G, Guthrie R.
Affiliation(s): Author information:
(1)Division of Hypertension and Clinical Pharmacology, Pat and Jim Calhoun
Cardiology Center, University of Connecticut School of Medicine, Farmington,
Connecticut, USA. wwhite@nso1.uchc.edu
Publication date & source: 2008, Blood Press Monit. , 13(1):21-7
In 2004-2005, the antihypertensive effects of telmisartan 80 mg versus valsartan
160 mg combined with hydrochlorothiazide 25 mg were assessed in a large
placebo-controlled trial in patients with stages 1 and 2 hypertension and
demonstrated that both agents were highly effective in lowering blood pressure
(BP) compared with placebo and that telmisartan lowered BP significantly greater
than valsartan. To confirm this finding according to Food and Drug Administration
guidelines, we performed a second large trial using the same design in an
entirely separate patient population. The trial was double-blind with a 4 : 4 : 1
randomization scheme to compare once daily telmisartan 80 mg plus
hydrochlorothiazide 25 mg versus once daily valsartan 160 mg plus
hydrochlorothiazide 25 mg versus once daily placebo on reductions in seated
clinic BP in patients with stages 1 and 2 hypertension. The primary endpoints
were the changes from baseline in seated diastolic and systolic BP at the end of
the 8-week treatment period. Safety endpoints included adverse events, changes in
laboratory parameters and pulse rate. In total, 1185 patients were randomized (of
which 1181 were treated and included in the primary analysis: 528 in the
telmisartan-hydrochlorothiazide group, 523 in the valsartan-hydrochlorothiazide
group, and 130 in the placebo group), changes from baseline in BP following
telmisartan-hydrochlorothiazide (-24.6/-18.2 mmHg) were significantly greater
than both placebo (-4.1/-6.1 mmHg) and valsartan-hydrochlorothiazide (-22.5/-17.0
mmHg) (versus placebo, P<0.0001 for systolic and diastolic BP; versus
valsartan-hydrochlorothiazide, P=0.017 for systolic BP and P=0.025 for diastolic
BP). The total number of patients with at least one adverse event reported was
similar among the three treatment groups (placebo, 42%,
telmisartan-hydrochlorothiazide, 36%, and valsartan-hydrochlorothiazide, 37%).
Thus, this large, second trial confirms that telmisartan-hydrochlorothiazide at
doses of 80/25 mg lowered both systolic and diastolic BP to a greater extent than
valsartan-hydrochlorothiazide at doses of 160/25 mg in stages 1-2 hypertension.
Although these are not the highest doses of these agents at present, at the time
that the studies were conducted, they were the maximally approved dosages. Both
studies support the strategy of using angiotensin receptor blockers with a higher
dose of a thazide diuretic (25 mg) for enhancing the control of hypertension.
Erratum in
Blood Press Monit. 2008 Aug;13(4):241.
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