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Nocturnal Dosing of Graded-Release Diltiazem Tops Nocturnal Ramipril for Blood Pressure Control: Presented at ASH(HYP)

By Jill Stein

NEW YORK, NY -- May 20, 2003 -- Nocturnal dosing of graded-release diltiazem is more effective than nocturnal dosing of ramipril in decreasing early morning blood pressure, as well as 24-hour blood pressure in patients with stage I or II hypertension.

Researchers reported the findings here on May 16^th at the 18^th Annual Scientific Meeting of the American Society of Hypertension.

William White, MD, of the University of Connecticut, Farmington, Conn, presented results in 261 patients with stage I or II hypertension. They randomized 130 patients to 10 weeks of treatment with diltiazem extended-release (240 mg to 360 mg to 540 mg QD), and 131 to ramipril (5 mg to 10 mg to 20 mg QD). Both treatments were dosed at bedtime.

Diastolic blood pressure levels during the first 4 hours after awakening were taken in all patients with ambulatory blood pressure monitoring (ABPM), starting at baseline. Titration of the dose occurred when the clinic blood pressure was greater than or equal to 130/85 mm Hg.

In both treatment groups, 76% of patients required titration to the highest dose, 16% only to the intermediate dose, and 8% remained on the lowest dose throughout the 10-week double-blind treatment period.

Graded-release diltiazem was associated with a significantly larger reduction in the diastolic blood pressure during the first 4 hours after awakening, and for the 24-hour mean, compared to ramipril.

The least squares mean difference between diltiazem extended-release and ramipril were 6.7 mm Hg (P<0.0001), 6.3 mm Hg (P<0.0001), and 2.9 mm Hg (P<0.0001), during the first 4 hours after awakening, and for the 24-hour mean, respectively.

Diltiazem was associated with a significantly larger decrease (4.4 mm Hg, P<0.003; and 3.7 mm Hg, P<0.005) in systolic blood pressure during the first 4 hours after awakening, and for the 24-hour mean, respectively, compared to ramipril.

Mean change from baseline in the 24-hour mean systolic blood pressure was not significantly different in either treatment group. However, qualification for randomization was based on clinic and ABPM of diastolic blood pressure, not on clinic and ABPM systolic blood pressure.

The reductions in systolic blood pressure were larger during the first 4 hours post-awakening in patients treated with diltiazem, rather than ramipril.

Larger reductions in ambulatory heart rate and systolic blood pressure with diltiazem led to a substantially greater change from baseline in the rate-pressure product, compared to ramipril. Rate-pressure product is a strong correlate of myocardial oxygen demand, which is a strong correlate of myocardial ischemia.

"Both treatments were generally well tolerated, and the types and incidence of adverse events were consistent with prior reports for each treatment," Dr. White said.

The study was supported by Biovail Corporation, Chantilly, VA.


[Study title: Comparison of Nocturnal Dosing of Diltiazem ER And Ramipril on Early Morning Blood Pressure, Heart Rate, and the Rate-Pressure Product. Abstract P-265]

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