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(Circulation. 2003;107:e9002.)
© 2003 American Heart Association, Inc.

Cardiovascular News

Thomas Fleming, PhD; Jeff Borer, MD; Paul W. Armstrong, MD; Marc Pfeffer, MD, PhD

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Food and Drug Administration: Cardiovascular and Renal Drugs Advisory Committee, 98th Meeting, January 6th-7th, 2003

Cozaar
Cozaar (losartan potassium), an angiotensin AT₁ receptor antagonist presently approved for the management of hypertension and nephropathy in Type II diabetics, was proposed by Merck for a new supplemental indication to reduce cardiovascular morbidity and mortality. The application was based on new data arising from the Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study, a large, multinational, double-blind, parallel, randomized, active controlled study of 9193 patients with a mean follow-up of 4.8 years. Patients aged between 55 and 80 years with ECG-confirmed left ventricular hypertrophy and blood pressures between 160-200 mm Hg systolic and 95-115 mm Hg diastolic who were off antihypertensive medications were eligible. After a withdrawal period from all antihypertensive medications and a 2-week placebo run-in, patients were randomized to either 50 mg of losartan or 50 mg of atenolol (the active comparator). Subsequently, a titration scheme aimed at achieving similar blood pressure reductions in each group with a target <140/90 mm Hg was undertaken. This involved the introduction of hydrochlorothiazide, uptitration of losartan or atenolol, or the addition of other antihypertensive agents (excluding ACE inhibitors and ß-blockers).

At the conclusion of the trial, sitting trough blood pressure measurements were comparable: ie, systolic blood pressure fell by 30.2 mm Hg in the losartan-treated patients and 29.1 mm Hg in the atenolol group, and diastolic pressure fell 16.6 and 16.8 mm Hg, respectively. Pulse pressure was reduced by 13.6 mm Hg with losartan and by 12.4 mm Hg with atenolol (P<0.001).

According to the prespecified analysis, . . . [Full Text of this Article]

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