VALSARTAN, A NEW ANGIOTENSIN-II RECEPTOR ANTAGONIST - A DOUBLE-BLIND-STUDY COMPARING THE INCIDENCE OF COUGH WITH LISINOPRIL AND HYDROCHLOROTHIAZIDE

The present study compares the occurrence of a dry, persistent cough w ith doses of 80 mg of valsartan, 10 mg of lisinopril, or 25 mg of hydr ochlorothiazide in patients with a history of angiotensin-converting e nzyme inhibitor-induced cough. This was a randomized, double-blind, ac tive-controlled, parallel group, multicenter trial involving 129 adult outpatients with essential hypertension. After confirmation of angiot ensin-converting enzyme inhibitor-induced cough during a 2 to 4 week c hallenge with lisinopril (followed by a washout period of 2 weeks), pa tients were randomized to receive 6 weeks of double-blind treatment on ce daily with 80 mg valsartan, 10 mg lisinopril, or 25 mg hydrochlorot hiazide. Assessments were made at baseline and after 3 and 6 weeks of treatment. Comparability of response to treatment was assessed by mean sitting diastolic and systolic blood pressure at the end of treatment . The occurrence of a dry, persistent cough was significantly less (P < 0.001) at 3 and 6 weeks with valsartan (19.5%) than with lisinopril (68.9%), with no significant difference between valsartan and hydrochl orothiazide (19.0%). There were no statistically significant differenc es in reduction of blood pressure among the three treatment groups. Th e overall incidence of adverse experiences, whether or not treatment-r elated, was highest for lisinopril (86.7%) compared with valsartan (57 .1%), and hydrochlorothiazide (61.9%). A dry cough in the lisinopril g roup accounted for this difference. There were no clinically significa nt changes in physical signs or in results of clinical laboratory eval uations during double-blind treatment, except for from metabolic chang es in 3 patients receiving hydrochlorothiazide. in hypertensive patien ts with a history of angiotensin-converting enzyme inhibitor-induced c ough, a single daily dose of 80 mg of valsartan produced therapeutic e fficacy comparable to lisinopril but with significantly less cough.