William B. White, MD, chief, section of hypertension and clinical pharmacology, University of Connecticut School of Medicine, Farmington, United States, and associates randomized 1,185 patients to telmisartan 80 mg combined with hydrochlrothiazide 25 mg or valsartan 160 mg combined with hydrochlorothiazide 25 mg. Patients had stage 1 to 2 hypertension.

"Highly effective combination therapies are needed for control of blood pressure, particularly in patients with high levels of cardiovascular risk," Dr. White noted. "Angiotensin II receptor blockers combined with a high dose of hydrochlorothiazide, i.e. 25 mg daily, are increasingly recognized as effective antihypertensive therapy."

In 2004-2005, Dr. White's group evaluated the antihypertensive effects of telmisartan 80 mg versus valsartan 160 mg when combined with hydrochlorothiazide 25 mg in a large placebo-controlled trial in patients with stage 1 or 2 hypertension. The study demonstrated that both agents were highly effective in lowering blood pressure compared with placebo and that telmisartan lowered blood pressure significantly more than valsartan.

In order to confirm the findings per FDA guidelines, his team performed a second large trial using virtually the same design in an entirely separate patient population. The primary endpoints were the changes from baseline in seated diastolic and systolic blood pressure at the end of the 8-week treatment period.

As in the earlier trial comparing these two agents which found a -2.8/-1.5 mmHg difference favouring telmisartan-hydrochorothiazide, telmisartan -hydrochlorothiazide was associated with larger reductions in trough systolic and diastolic blood pressure than valsartan-hydrochlorothiazide.

The change in diastolic blood pressure was -18.2 mmHg for the telmisartan-hydrochlorothiazide group and -17.0 mmHg for the valsartan-hydrochlorothiazide group. The change in systolic blood pressure was -24.6 mmHg and -22.5 for the two groups, respectively.

The diastolic blood pressure effect was greater in patients under 65 years of age (P =.004) and in women compared with men (P =.0004). The total number of patients with at least one adverse event reported during active treatment was similar among the three treatment groups.

Dr. White said that the present study confirms the utility of angiotensin II receptor blocks that use a higher dose of hydrochlorothiazide (25 mg) as an important option in clinical practice.

The study was sponsored by Boehringer Ingelheim.


[Presentation Title: A Second Large Trial of Telmisartan and HCTZ (80/25 mg) Shows a Larger Antihypertensive Effect Than Valsartan and HCTZ (160/25 mg). Abstract Number P-94]

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