Novartis Diovan associated with 2.6% rate of cough, compared to 8% for ACE inhibitors -- labeling.
Executive Summary
NOVARTIS DIOVAN ASSOCIATED WITH COUGH IN 2.6% OF PATIENTS receiving the newly approved angiotensin II inhibitor compared to 8% of patients receiving ACE inhibitors in trials comparing the two agents with or without placebo, labeling states. The incidence of cough for placebo patients in clinical trials was 1.5%, labeling notes. Diovan (valsartan) was approved by FDA on December 23, joining Merck's Cozaar (losartan) as the second angiotensin II antagonist antihypertensive on the market. (EDITORS' NOTE: "The Pink Sheet" (Jan. 6, p. 12) incorrectly reported that Diovan labeling does not include comparative cough incidence data.)