4-year medical study RENAAL shows permanent kidney damage risks can be reduced
November 8, 2001 | 12:00am
• US Clinical Study shows "losartan" can help avoid
• Kidney Dialysis and Transplantation for millions suffering
• Type 2 Diabetes and Hypertension
According to a New England Journal of Medicine (NEJM) estimate, some 146 million people worldwide are afflicted with Type 2 diabetes, a common form of diabetes affecting 90 to 95 percent of patients with diabetes. The well-known malady usually occurs later in life and is often associated with increased body weight, hypertension and abnormalities of blood lipids.
Hypertension is two to three times more common in patients with Type 2 diabetes than in patients without diabetes. Individually, diabetes and hypertension increase the risk of kidney failure, as well as cardiovascular disease. Together, the risks rise dramatically.
The two ailments – diabetes and hypertension – damage the tiny blood vessels in the kidney that act as filters to remove wastes from the blood. It is estimated that 20 to 30 percent of diabetic patients develop "end-stage renal disease" (ESRD) or permanent kidney damage. In the U.S., diabetes is the leading cause of ESRD as in many other countries worldwide.
The results from a new clinical trial called RENAAL (Reduction of Endpoints in Non-Insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan) showed treatment with the anti-hypertensive losartan protects the kidney and dramatically delays the progression of kidney disease, including reducing the risk of developing end-stage renal disease. ESRD is a condition which requires expensive dialysis or transplantation for patient survival.
In a worldwide teleconference conducted recently by a team led by two internationally prominent practitioners, Dick de Zeeuw, M.D., Ph.D., professor and head of Clinical Pharmacology, University of Groningen, The Netherlands and Hans Parving, M.D. of the Steno Diabetes Center in Copenhagen, Denmark, the results of the RENAAL study or renal protection study for losartan was discussed. The study included 1,513 patients from 28 countries and is the first and only study to report that a drug can reduce ESRD in Type 2 diabetic patients with kidney disease. All previous studies with angiotensin converting enzyme (ACE) Inhibitors have not yielded data on progression to ESRD in this growing sector of world population.
"Delaying the development of end-stage renal disease, which essentially is death of the kidney, is an enormously important goal due to the limited and costly treatment options, such as dialysis or transplant," said Dr. de Zeeuw, RENAAL Steering Committee member. "And for the first time, we found that we could reduce the risk of ESRD when treating these patients with losartan. This certainly is a major advance in our ability to help these patients control the course of their disease."
Losartan found to control course of renal disease
Losartan (Cozaar) is one of the newest class of antihypertensives known as angiotensin II antagonists (AIIA). It is approved by the US Food and Drug Administration (US FDA) for the treatment of high blood pressure, commonly known as hypertension. An advantage of AIIAs is their excellent tolerability, compared to other classes of antihypertensives.
In RENAAL, investigators followed patients for an average of 3.4 yearsiii. 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 (the need for long-term dialysis or kidney transplantation), or death.
Patients taking losartan once daily plus conventional blood pressure therapy had a significant reduction in the primary composite endpoint by 16 percent, p=0.024, compared to the placebo (sugar pill) group plus conventional blood pressure therapy. According to the team co-led by Dr. Hans Parving, the renal protective effect of losartan was beyond its blood pressure lowering ability.
"In RENAAL, losartan led to significant improvements in renal outcomes beyond its effects on blood pressure control in patients with Type 2 diabetes and kidney disease," Dr. de Zeeuw said. "These findings are particularly important because no other blood pressure medicine, including ACE inhibitors, have been shown to slow the progression of end-stage renal disease in this patient population."
• Kidney Dialysis and Transplantation for millions suffering
• Type 2 Diabetes and Hypertension
According to a New England Journal of Medicine (NEJM) estimate, some 146 million people worldwide are afflicted with Type 2 diabetes, a common form of diabetes affecting 90 to 95 percent of patients with diabetes. The well-known malady usually occurs later in life and is often associated with increased body weight, hypertension and abnormalities of blood lipids.
Hypertension is two to three times more common in patients with Type 2 diabetes than in patients without diabetes. Individually, diabetes and hypertension increase the risk of kidney failure, as well as cardiovascular disease. Together, the risks rise dramatically.
The two ailments – diabetes and hypertension – damage the tiny blood vessels in the kidney that act as filters to remove wastes from the blood. It is estimated that 20 to 30 percent of diabetic patients develop "end-stage renal disease" (ESRD) or permanent kidney damage. In the U.S., diabetes is the leading cause of ESRD as in many other countries worldwide.
The results from a new clinical trial called RENAAL (Reduction of Endpoints in Non-Insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan) showed treatment with the anti-hypertensive losartan protects the kidney and dramatically delays the progression of kidney disease, including reducing the risk of developing end-stage renal disease. ESRD is a condition which requires expensive dialysis or transplantation for patient survival.
In a worldwide teleconference conducted recently by a team led by two internationally prominent practitioners, Dick de Zeeuw, M.D., Ph.D., professor and head of Clinical Pharmacology, University of Groningen, The Netherlands and Hans Parving, M.D. of the Steno Diabetes Center in Copenhagen, Denmark, the results of the RENAAL study or renal protection study for losartan was discussed. The study included 1,513 patients from 28 countries and is the first and only study to report that a drug can reduce ESRD in Type 2 diabetic patients with kidney disease. All previous studies with angiotensin converting enzyme (ACE) Inhibitors have not yielded data on progression to ESRD in this growing sector of world population.
"Delaying the development of end-stage renal disease, which essentially is death of the kidney, is an enormously important goal due to the limited and costly treatment options, such as dialysis or transplant," said Dr. de Zeeuw, RENAAL Steering Committee member. "And for the first time, we found that we could reduce the risk of ESRD when treating these patients with losartan. This certainly is a major advance in our ability to help these patients control the course of their disease."
Losartan found to control course of renal disease
Losartan (Cozaar) is one of the newest class of antihypertensives known as angiotensin II antagonists (AIIA). It is approved by the US Food and Drug Administration (US FDA) for the treatment of high blood pressure, commonly known as hypertension. An advantage of AIIAs is their excellent tolerability, compared to other classes of antihypertensives.
In RENAAL, investigators followed patients for an average of 3.4 yearsiii. 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 (the need for long-term dialysis or kidney transplantation), or death.
Patients taking losartan once daily plus conventional blood pressure therapy had a significant reduction in the primary composite endpoint by 16 percent, p=0.024, compared to the placebo (sugar pill) group plus conventional blood pressure therapy. According to the team co-led by Dr. Hans Parving, the renal protective effect of losartan was beyond its blood pressure lowering ability.
"In RENAAL, losartan led to significant improvements in renal outcomes beyond its effects on blood pressure control in patients with Type 2 diabetes and kidney disease," Dr. de Zeeuw said. "These findings are particularly important because no other blood pressure medicine, including ACE inhibitors, have been shown to slow the progression of end-stage renal disease in this patient population."
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