Standard medical care for managing diabetes was continued throughout the study. This renal protective effect of Cozaar was found to be largely independent of its blood pressure lowering in this study. The study also examined the effects of treatment on cardiovascular events, a composite of heart attack, stroke, revascularization, hospitalization for unstable angina, hospitalization for heart failure and cardiovascular death. There were similar effects in both treatment groups for the composite endpoint of cardiovascular disease and death. Changes in proteinuria also were assessed in the study.
Proteinuria is the presence of a protein in the urine and is a marker of kidney damage.
Cozaar was generally well-tolerated in this population. Discontinuations from study therapy due to clinical adverse events, not including deaths, were 17 percent in the group receiving Cozaar plus conventional blood pressure therapy versus 22 percent in the placebo plus conventional blood pressure therapy group. The most common clinical adverse events requiring discontinuation were heart failure, end-stage renal disease, heart attack, stroke and worsening renal insufficiency. When used in pregnancy during the second and third trimesters, drugs such as Cozaar that act directly on the renin-angiotensin system have shown a potential for fetal injury or death. When pregnancy is detected, Cozaar should be discontinued as soon as possible.