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| |  ASH: Cozaar (Losartan) Significantly Reduces Progression of Kidney Disease in Type 2 Diabetics SAN FRANCISCO, CA -- May 24, 2001 -- In a study of patients with Type 2 diabetes(1) and kidney disease, investigational treatment with Cozaar® (losartan potassium tablets), once daily, significantly reduced the risk of worsening kidney disease, including a reduction in the risk of progressing to end-stage renal disease (ESRD) in which dialysis or transplantation is required for survival. The study achieved its primary objective by significantly reducing the risk of the composite measure of either doubling of serum creatinine (a marker of kidney disease), kidney failure or death. The results of this landmark study, which included 1,513 patients from 29 countries, were presented here today during the 16th Annual Scientific Meeting of the American Society of Hypertension. Cozaar, from Merck & Co., Inc., is approved to treat high blood pressure, or hypertension. This study is the first to investigate the renal protective effect of Cozaar in patients with Type 2 diabetes and kidney disease. Diabetes is the leading cause of kidney failure in the U.S. Currently there is no medication approved to reduce the risk of progression of kidney disease to dialysis or transplantation in patients with Type 2 diabetes and kidney disease. "The prognosis for patients with end-stage renal disease is bleak," said Barry M. Brenner, M.D., director emeritus, Renal Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, and lead investigator of the trial. "Keeping a person's kidneys functioning for as long as possible is an important goal of therapy. In this study we were able to reduce the risk of end-stage renal disease, or kidney failure, by 28 percent. No study has demonstrated this effect before in patients with Type 2 diabetes and kidney disease." This randomized, placebo-controlled study called RENAAL (Reduction of Endpoints in Non-Insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan) followed patients for an average of 3.4 years(2). All patients in the study had Type 2 diabetes, proteinuria (protein in the urine) and elevated serum creatinine, markers which are indicative of kidney disease. Approximately 94 percent of the patients had high blood pressure and were taking blood pressure medication at the start of the study. In the study, 751 patients were randomized to the group treated with Cozaar (50 mg to 100 mg once daily) and 762 to the placebo treatment group. Both treatment groups continued to receive conventional blood pressure medication as appropriate. Conventional blood pressure medications taken by both treatment groups included calcium channel blockers, diuretics, beta- blockers, alpha blockers or centrally-acting agents. Other angiotensin II antagonists (AIIAs) and angiotensin converting enzyme (ACE) inhibitors were excluded from the study. Standard medical care for managing diabetes was continued throughout the study. The patients in the study were ethnically diverse, and included: Caucasians (48.6 percent), Blacks (15.2 percent), Asians (16.7 percent), Hispanics (18.2 percent) and Native Americans (0.2 percent). The primary endpoint of the study was a composite measure consisting of time to the first occurrence of either doubling of serum creatinine (a marker indicating more than 50 percent loss of kidney function), end-stage renal disease, or death. Results showed that patients taking Cozaar once daily plus conventional blood pressure therapy compared to the placebo group plus conventional blood pressure therapy had a significant reduction in the risk of kidney disease progression by 16 percent, p=0.024 (43.5 percent of patients in the group taking Cozaar reached the primary composite endpoint compared to 47.1 percent of patients in the placebo group). This renal protective effect of Cozaar was found to be largely independent of its blood pressure lowering in this study. Researchers also reported the following results: 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. An exception was hospitalization for heart failure, a component of the cardiovascular composite endpoint, which was significantly reduced by 32 percent, p=0.005, in the patient group treated with Cozaar (11.9 percent of the patients in the group taking Cozaar were hospitalized for heart failure compared to 16.7 percent of patients in the placebo group). 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. The study showed that Cozaar plus conventional blood pressure therapy significantly reduced proteinuria by 35 percent compared to the placebo plus conventional blood pressure therapy group, p=0.0001. 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. Cozaar is contraindicated in patients who are hypersensitive to any component of the product. In clinical trials for hypertension, the most common adverse events occurring with Cozaar at a rate of one percent or more than placebo were upper respiratory infection (7.9 percent for Cozaar versus 6.9 percent for placebo), dizziness (3.5 percent versus 2.1 percent for placebo) and leg pain (1.0 percent versus 0.0 percent for placebo). References: Related Link: Merck & Co., Inc.
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