The angiotensin receptor blocker (ARB) telmisartanb (Micardis™/Pritor™) slows the progression of nephropathy in
hypertensive patients with type 2 diabetes, according to pivotal study results published today in the New England Journal of
Medicine.1 Telmisartan is the first ARB to demonstrate stabilization of glomerular filtration rate (GFR)c decline over 5
years, indicating long-term renoprotection in diabetic patients.
The five year DETAILTM (Diabetics Exposed to Telmisartan And enalaprIL) study randomised 250 patients with type 2 diabetes, hypertension and early stage nephropathy to once daily telmisartan 80mg or the ACE-inhibitor enalapril 20mg. The primary endpoint of the study was the change from baseline in glomerular filtration rate (GFR) - widely accepted as the best measure of overall kidney function in health and disease2 - after five years. The decline in GFR was similar with telmisartan and enalapril.1 The study demonstrated that telmisartan was as effective as enalapril in protecting against the progression of diabetic nephropathy.
DETAIL study published in The New England Journal of Medicine
"DETAIL is highly clinically relevant. We believe it is the only long-term, hard end-point comparison of an ARB and an ACE-inhibitor in early nephropathy. The results provide long-term data which support the renoprotective benefits of the ARB class suggested by previous studies. This study confirms that telmisartan is a valid choice for first-line treatment of hypertensive patients with diabetic nephropathy. The fact that telmisartan is equally effective as enalapril is particularly encouraging in view of the superior tolerability profile of ARBs compared with ACE-inhibitors." commented lead investigator Professor Anthony Barnett, Consultant Physician, Clinical Director of Diabetes and Endocrinology, Birmingham Heartlands and Solihull Hospitals and Professor of Medicine, University of Birmingham, United Kingdom.
Despite all DETAIL patients having type 2 diabetes, hypertension and nephropathy, cardiovascular mortality was only 5% in both groups over five years - much lower than would be expected in this high-risk group, half of whom had a history of cardiovascular disease at baseline.1 Blood pressure was lowered in both groups to a comparable degree over the course of the trial.1
The study inclusion criteria required all patients to be tolerant of ACE-inhibitors. There were therefore no major differences in adverse events between the two drugs.1 However, ACE-inhibitors can be poorly tolerated, with cough a common side effect that can impact on patient compliance.3 It is therefore worthy to note, that in two comparative studies of telmisartan and enalapril in patients who were not pre-selected for ACE-intolerance, telmisartan was better tolerated.4,5
Professor Eberhard Ritz, Vice President of the International Society of Nephrology, at the Ruperto Carola University of Heidelberg, Germany, commented, "DETAIL is a much needed study that adds weight to the body of evidence for ARBs, and in particular, telmisartan. The DETAIL study undoubtedly represents a breakthrough in our understanding of the management of diabetic nephropathy. DETAIL shows that treatment in the earliest stages of diabetic nephropathy yield results which are far better than what have been achieved previously with ARBs in advanced diabetic nephropathy (IDNT,RENAAL). After 5 years the loss of renal function (GFR) was comparable to what is expected with advancing age. This is most encouraging and implies that loss of renal function has been halted."
Current US and European hypertension guidelines advocate first line use of ARBs and ACE inhibitors for hypertensive patients with type 2 diabetic nephropathy.6,7 Various studies have shown that effective blockade of the renin-angiotensin-aldosterone system (RAAS) can reduce renal damage by mechanisms beyond those of blood pressure control alone. For ACE-inhibitors, the evidence for renoprotection independent of blood pressure control derives mainly from observations in patients with type 1 diabetes.2 In type 2 diabetes, trial evidence for renoprotection is now stronger with ARBs which have proved to be more effective than other classes of antihypertensives in slowing the progression of kidney disease in patients with microalbuminuria or proteinuria.8-11
A number of studies of telmisartan (Micardis�/Pritor�) in microalbuminuria and proteinuria have already delivered encouraging results.12-17 DETAIL is the first of five major trials investigating the renoprotective benefits of telmisartan which form part of the ongoing PROTECTIONTM (Programme of Research tO show Telmisartan End-organ proteCTION) study programme.18 PROTECTION involves more than 6,500 patients from 32 countries worldwide.
Notes to Editor
a) The DETAIL study is an independent, investigator-led study supported by a grant from Boehringer Ingelheim.
b) Telmisartan (Micardis™/ Pritor™) was discovered and developed by Boehringer Ingelheim, Germany. Boehringer Ingelheim markets telmisartan under the trademark Micardis™ in 84 countries around the world, including the USA, Japan and major European countries. In Canada and Australia GlaxoSmithKline (GSK) and Boehringer Ingelheim co-promote telmisartan under the Micardis™ trademark. GSK currently promotes telmisartan as Pritor™ under a co-marketing agreement with Boehringer Ingelheim in 30 countries excluding the USA.
Telmisartan was licensed to GSK from Boehringer Ingelheim in March 1998. The European, centralised marketing authorisation for telmisartan 40 mg & 80 mg tablets was granted to Boehringer Ingelheim on 11th December 1998.
Furthermore, Boehringer Ingelheim markets telmisartan in cooperation with Bayer AG in some European countries, Yamanouchi in Japan and Abbott Laboratories in the USA.
c) Although GFR declines naturally with age, in individuals with diabetes, GFR declines at a faster rate indicating the progression of kidney disease. The objective of prescribing an ARB or an ACE inhibitor is to reduce the progression of kidney disease, demonstrated by a reduction in the speed at which GFR declines.
The five year DETAILTM (Diabetics Exposed to Telmisartan And enalaprIL) study randomised 250 patients with type 2 diabetes, hypertension and early stage nephropathy to once daily telmisartan 80mg or the ACE-inhibitor enalapril 20mg. The primary endpoint of the study was the change from baseline in glomerular filtration rate (GFR) - widely accepted as the best measure of overall kidney function in health and disease2 - after five years. The decline in GFR was similar with telmisartan and enalapril.1 The study demonstrated that telmisartan was as effective as enalapril in protecting against the progression of diabetic nephropathy.
DETAIL study published in The New England Journal of Medicine
"DETAIL is highly clinically relevant. We believe it is the only long-term, hard end-point comparison of an ARB and an ACE-inhibitor in early nephropathy. The results provide long-term data which support the renoprotective benefits of the ARB class suggested by previous studies. This study confirms that telmisartan is a valid choice for first-line treatment of hypertensive patients with diabetic nephropathy. The fact that telmisartan is equally effective as enalapril is particularly encouraging in view of the superior tolerability profile of ARBs compared with ACE-inhibitors." commented lead investigator Professor Anthony Barnett, Consultant Physician, Clinical Director of Diabetes and Endocrinology, Birmingham Heartlands and Solihull Hospitals and Professor of Medicine, University of Birmingham, United Kingdom.
Despite all DETAIL patients having type 2 diabetes, hypertension and nephropathy, cardiovascular mortality was only 5% in both groups over five years - much lower than would be expected in this high-risk group, half of whom had a history of cardiovascular disease at baseline.1 Blood pressure was lowered in both groups to a comparable degree over the course of the trial.1
The study inclusion criteria required all patients to be tolerant of ACE-inhibitors. There were therefore no major differences in adverse events between the two drugs.1 However, ACE-inhibitors can be poorly tolerated, with cough a common side effect that can impact on patient compliance.3 It is therefore worthy to note, that in two comparative studies of telmisartan and enalapril in patients who were not pre-selected for ACE-intolerance, telmisartan was better tolerated.4,5
Professor Eberhard Ritz, Vice President of the International Society of Nephrology, at the Ruperto Carola University of Heidelberg, Germany, commented, "DETAIL is a much needed study that adds weight to the body of evidence for ARBs, and in particular, telmisartan. The DETAIL study undoubtedly represents a breakthrough in our understanding of the management of diabetic nephropathy. DETAIL shows that treatment in the earliest stages of diabetic nephropathy yield results which are far better than what have been achieved previously with ARBs in advanced diabetic nephropathy (IDNT,RENAAL). After 5 years the loss of renal function (GFR) was comparable to what is expected with advancing age. This is most encouraging and implies that loss of renal function has been halted."
Current US and European hypertension guidelines advocate first line use of ARBs and ACE inhibitors for hypertensive patients with type 2 diabetic nephropathy.6,7 Various studies have shown that effective blockade of the renin-angiotensin-aldosterone system (RAAS) can reduce renal damage by mechanisms beyond those of blood pressure control alone. For ACE-inhibitors, the evidence for renoprotection independent of blood pressure control derives mainly from observations in patients with type 1 diabetes.2 In type 2 diabetes, trial evidence for renoprotection is now stronger with ARBs which have proved to be more effective than other classes of antihypertensives in slowing the progression of kidney disease in patients with microalbuminuria or proteinuria.8-11
A number of studies of telmisartan (Micardis�/Pritor�) in microalbuminuria and proteinuria have already delivered encouraging results.12-17 DETAIL is the first of five major trials investigating the renoprotective benefits of telmisartan which form part of the ongoing PROTECTIONTM (Programme of Research tO show Telmisartan End-organ proteCTION) study programme.18 PROTECTION involves more than 6,500 patients from 32 countries worldwide.
Notes to Editor
a) The DETAIL study is an independent, investigator-led study supported by a grant from Boehringer Ingelheim.
b) Telmisartan (Micardis™/ Pritor™) was discovered and developed by Boehringer Ingelheim, Germany. Boehringer Ingelheim markets telmisartan under the trademark Micardis™ in 84 countries around the world, including the USA, Japan and major European countries. In Canada and Australia GlaxoSmithKline (GSK) and Boehringer Ingelheim co-promote telmisartan under the Micardis™ trademark. GSK currently promotes telmisartan as Pritor™ under a co-marketing agreement with Boehringer Ingelheim in 30 countries excluding the USA.
Telmisartan was licensed to GSK from Boehringer Ingelheim in March 1998. The European, centralised marketing authorisation for telmisartan 40 mg & 80 mg tablets was granted to Boehringer Ingelheim on 11th December 1998.
Furthermore, Boehringer Ingelheim markets telmisartan in cooperation with Bayer AG in some European countries, Yamanouchi in Japan and Abbott Laboratories in the USA.
c) Although GFR declines naturally with age, in individuals with diabetes, GFR declines at a faster rate indicating the progression of kidney disease. The objective of prescribing an ARB or an ACE inhibitor is to reduce the progression of kidney disease, demonstrated by a reduction in the speed at which GFR declines.
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