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Title: Canada Approves Cozaar (Losartan Potassium), Treatment For Diabetics With Kidney Disease, Hypertension

"Canada Approves Cozaar (Losartan Potassium), Treatment For Diabetics With Kidney Disease, Hypertension"

MONTREAL, QC -- May 7, 2003 -- Health Canada has approved the drug CozaarŽ (losartan potassium) to delay the progression of kidney disease in people with type 2 diabetes, kidney disease and high blood pressure. Losartan continues to be indicated for the treatment of high blood pressure. The new indication is based on the results of the landmark RENAAL study, published in the New England Journal of Medicine, in September 2001. The study demonstrated that treatment with losartan, an angiotensin II receptor antagonist (AIIA), significantly delayed the progression of kidney disease as measured by the incidence of doubling of serum creatinine (a marker indicating more than 50 per cent loss of kidney function), end-stage renal disease (the need for long-term dialysis or kidney transplantation for survival), or death. In RENAAL, losartan also demonstrated a significant reduction in proteinuria and a cardio-protective benefit by significantly reducing the rate of first hospitalization for heart failure in this patient population. "With no proven treatments for delaying end-stage renal disease available on the market, we are very pleased to now have losartan as a new tool to combat this debilitating and potentially fatal disease in people with type 2 diabetes, kidney disease and high blood pressure," said Dr. Scholey, staff nephrologist at the Toronto General Hospital, as well as professor of medicine in the Department of Medicine at the University of Toronto. "End-stage renal disease, the point at which the kidney ceases to function, is costly both in terms of quality of life and health care dollars." Diabetes and kidney disease in Canada More than 1.3 million Canadians have been diagnosed with diabetes. It is estimated that an additional half a million Canadians remain undiagnosed. Among those diagnosed with diabetes, 800,000 are also affected by high blood pressure. According to Health Canada, there are approximately 60,000 Canadians newly diagnosed with diabetes each year. Ninety to ninety-five per cent of diabetics have type 2 diabetes, which usually occurs after age 40. Diabetes and high blood pressure damage the tiny blood vessels in the kidney that act as filters to remove wastes from the blood. Individually, diabetes and high blood pressure increase the risk of kidney disease; together, the risk rises dramatically, accounting for 57 per cent of all cases of end-stage renal disease (ESRD). "Kidney disease is a serious complication of diabetes," said Donna Lillie, National Director of Research and Professional Education at the Canadian Diabetes Association. "The Canadian Diabetes Association welcomes all new treatment options that may help people with type 2 diabetes reduce the risk of developing end-stage renal disease." RENAAL study demonstrates effectiveness of losartan RENAAL is the first and only study to report the effectiveness of a drug in reducing ESRD in people with type 2 diabetes and kidney disease. The primary endpoint of the study was the time to the first occurrence of either doubling of serum creatinine, end-stage renal disease or death. Patients taking losartan once daily plus conventional blood pressure therapy had a significant reduction in the primary endpoint by 16 percent (p=0.024) compared to the placebo group. This renal protective effect of losartan was found to be beyond its blood pressure lowering ability. Losartan significantly reduced the risk of: - The progression to ESRD by 28 per cent, (p=0.002); - The doubling of serum creatinine concentration by 25 per cent (p=0.006); - The combined end point of ESRD or death by 20 per cent (p=0.010). The risk of death was not significantly different between study groups. The study also examined the effects of treatment on cardiovascular events and changes in proteinuria (the presence of protein in the urine, which acts as a marker of kidney damage). - Proteinuria was significantly reduced by 35 per cent in the patient group treated with losartan plus conventional blood pressure therapy (p less than 0.001). - Losartan also demonstrated cardio-protective benefits by significantly reducing the rate of first hospitalization for heart failure by 32 per cent (p=0.005). Losartan also provided excellent tolerability in this population. Incidences of reported adverse experiences were similar between groups treated with losartan and placebo. In RENAAL, losartan led to significant improvements in renal outcome beyond its effects on blood pressure control in patients with type 2 diabetes and kidney disease. Cozaar (losartan potassium) Cozaar (losartan potassium) launched in Canada in 1995 is indicated for the treatment and control of high blood pressure, and now also indicated to delay the progression of renal disease in people with type 2 diabetes, kidney disease and high blood pressure. It is the only medicine to demonstrate a significant reduction in the risk of ESRD in this patient population. Losartan was the first in a new type of hypertension medications called either angiotensin II receptor antagonists (AIIAs) or angiotensin II receptor blockers (ARBs). This class is recommended as a first line therapy for patients with high blood pressure by the Quebec Hypertension Society in its Hypertension Therapeutic Guide 2002. (t)Ž Registered Trademark Merck & Co., Inc. Used under license. Ž Registered trademark of E.I. Du Pont de Nemours and Company, Wilmington, Delaware, USA. Used under licence. SOURCE: Merck Frosst Canada Ltd

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