Clinical studies of CS-866, the newest angiotensin II receptor antagonist

Angiotensin II receptor blockers have shown widespread efficacy as antihype rtensive medications. These agents bind selectively to angiotensin II type 1 (AT(1)) receptors, specifically blocking the renin-angiotensin system at the last step in its cascade. CS-866 is the most recently introduced drug i n this class. This article presents integrated safety and efficacy data fro m 7 randomized, double-blind, placebo-controlled, parallel group studies in which once-daily CS-866 monotherapy was used in the treatment of patients with essential hypertension (sitting diastolic blood pressure greater than or equal to 100 mm Hg and less than or equal to 115 mm Hg). Data from a tot al of 2,145 CS-866-treated patients were included in the efficacy analysis. Safety data were available from 2,540 CS-866-treated patients, with a cumu lative exposure of 5,888 patient-months. The antihypertensive efficacy of t he drug was assessed using both cuff bleed pressure measurements and 24-hou r ambulatory blood pressure monitoring. The data show that CS-866 is effect ive and safe for the treatment of hypertension. Dose-dependent reductions i n both diastolic and systolic blood pressures occurred within 1 week of ini tiating treatment, and the response was almost maximal within 2 weeks. Ther e was no difference in efficacy between younger (<65 years) and older (<gre ater than or equal to>65 years) groups of patients. Trough-to-peak ratios s howed that CS-866 retains the majority of its peak effect 24 hours after tr eatment, end is therefore suitable for once-daily dosing. Dizziness was the only treatment-emergent adverse event with which CS-866 was associated. (C ) 2001 by Excerpta Medica, Inc.