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Eprosartan Mesylate Shows Benefits in Elderly With Isolated Systolic Hypertension: Presented at ASH(HYP)

By Jill Stein

NEW YORK, NY -- May 20, 2003 -- The antihypertensive effect of the angiotensin receptor blocker eprosartan mesylate remains constant throughout a 24-hour dosing period in older patients with isolated systolic hypertension, researchers reported here on May 16^th at the 18^th Annual Scientific Meeting of the American Society of Hypertension.
Henry A. Punzi, MD, of the Trinity Hypertension Research Institute, Carrollton, Tex, presented results from a randomized, double-blind, placebo controlled study involving patients who did not respond to initial monotherapy. His research team randomized 283 patients to treatment with placebo alone, or in combination with hydrochlorothiazide.

"Isolated systolic pressure occurs in about 20% of persons 80 years of age or older, and effective treatment of isolated systolic hypertension in this population can decrease the risk of stroke and major cardiovascular events," Dr. Punzi pointed out.

The study included a screening visit, a 3 – 5 week placebo run-in period, and a 13-week double-blind treatment period. The treatment phase included a 6-week titration period with eprosartan 600 mg once daily up to 1200 mg once daily, or placebo; a 3-week monotherapy maintenance period, and a 4-week add-on period of single-blind treatment with 12.5 mg of hydrochlorothiazide in combination with double-blind maintenance treatment.

At enrollment, all participants in the trial had a seated systolic blood pressure greater than 160 mm Hg, and a seated diastolic blood pressure less than 90mm Hg. Mean seated baseline systolic blood pressures were similar in eprosartan and placebo patients.

At the end of therapy, eprosartan was associated with a statistically significant decrease in trough sitting systolic blood pressure of 16.1 mm Hg versus 8.4 mm Hg with placebo (P<0.0001).

At the end of combination therapy, eprosartan was associated with a statistically significant decrease from baseline in seated systolic blood pressure of 21.7 mm Hg versus 14.4 mm Hg with placebo (P<0.002).

The placebo-corrected trough-to-peak ratios for seated systolic blood pressure at week 9 were 1.05 and 1.02 at 2 and 3 hours post-dose, respectively.

Eprosartan treatment also lowered pulse pressure, which is considered an excellent marker of future left ventricular mass index.

"Treatment with eprosartan was safe and well tolerated," Dr. Punzi said. Overall, 8 serious adverse events occurred, and none was thought to be treatment-related. The most common adverse events were headache, upper respiratory tract infection, and dizziness. There was no marked difference between the groups in incidence of these side effects.

"Overall, the results demonstrate that the blood pressure effect of eprosartan 600 mg to 1200 mg once daily in older patients with isolated systolic hypertension, remains constant throughout the 24-hour dosing period," Dr. Punzi said.


[Study title: A 13-Week, Double-Blind, Placebo-Controlled, Parallel, Multicenter Study of Eprosartan Mesylate Given in Titrated Doses of 600mg or 1200 Mg Once Daily in Patients With Isolated Systolic Hypertension. Abstract P-248]

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