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| |  ASH: Useful Role of Chronotherapeutic Verelan PM (Verapamil) Confirmed in Multiple Subgroups By Jill Stein Special to DG News NEW YORK, NY -- May 19, 2002 -- The efficacy and safety of chronotherapeutic Verelan PM (verapamil) in a wide range of hypertensive patients has been documented in a study reported here Friday at the 17th Annual Scientific Meeting of the American Society of Hypertension (ASH). Dr. L. Michael Prisant and associates, from the Medical College of Georgia, in Augusta, Georgia, United States, evaluated early morning blood pressure reduction with Verelan in 2,556 patients with stage I or II essential hypertension that had not been treated or had been treated with one antihypertensive agent. The study, known as Controlling Hypertension in the moRning with a ChrONO Med (CHRONO), was designed as a community-based trial to gather clinical information on the established efficacy of Verelan PM for the control of morning blood pressure following bedtime dosing in patients with essential hypertension. All patients started with 200 mg/day at bedtime and were titrated to a maximum of 400 mg/day at four-week intervals until target morning blood pressure (less than 140/90 mm Hg) was reached. The data showed that Verelan PM was associated with statistically significant decreases in both diastolic blood pressure (DBP, 11.5±10.5 mm Hg) and systolic blood pressure (SBP, 17.9±17.6 mm Hg). A diastolic blood pressure response was achieved in 85.3 percent of patients, and a systolic blood pressure response was achieved in 76.9 percent of patients. Notably, 62.6 percent of patients reached target blood pressure levels recommended by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) -- less than 140/90 mm Hg -- with Verelan PM monotherapy. Dr. Prisant said the study results also underscore the desirability of Verelan PM titration, because higher doses are associated with increases in the cumulative response rate. For example, doubling the dose from 200 mg to 400 mg nearly doubled the blood pressure cumulative response rates (DBP: 45.8-85.3 percent; SBP: 42.2-76.9 percent). Similarly, the percentage of patients who reached target blood pressure increased from 36.8 percent at the 200 mg dose to 62.6 percent at the 400 mg dose. Higher doses were also associated with greater reductions in heart rate. All doses of Verelan were well tolerated, and the most common adverse event was constipation, a well-known side effect of verapamil. Verelan PM delivers verapamil hydrochloride through a controlled-onset, extended-release chronotherapeutic formulation dosed once daily at bedtime. Maximum plasma concentrations of Verelan PM peak in the morning when blood pressure is highest, and trough concentrations occur at night when blood pressure is lowest.
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