Telmisartan May Significantly Slow The Progression Of Diabetic Kidney Disease In Hypertensive Patients With Type 2 Diabetes

Main Category: Diabetes
Article Date: 19 Jun 2007 - 1:00 PDT

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New data presented today at the Annual European Society of Hypertension meeting in Milan reveals that the long-acting angiotensin receptor blocker (ARB) telmisartan (MICARDIS®) may slow the progression of diabetic nephropathy in hypertensive type 2 diabetic patients with overt nephropathy.1 In the AMADEO study - one of the first studies to compare the protective potential of two ARBs in hypertensive patients with diabetic nephropathy - telmisartan 80mg was superior to losartan 100mg after one year's treatment in reducing proteinuria (29% vs. 20%; p= 0.0284)1, despite similar blood pressure control.1 Telmisartan is licensed for the treatment of essential hypertension.

Commenting on the results, Professor Stephen Bain, Professor of Medicine, Swansea said, "The AMADEO results are encouraging for an increasing number of patients with type 2 diabetes because they suggest that telmisartan may provide greater renoprotection than losartan. It is particularly interesting that the observed effect could mainly be attributed to reasons other than blood pressure reduction, as all patients had similar blood pressure at study start, and the difference in final blood pressure was not significantly different. This finding is consistent with additional properties beyond the blood pressure lowering effect."

Proteinuria (high levels of protein in the urine) is a very important signal for disease severity in diabetic nephropathy and is also considered a relevant cardiovascular risk factor - reductions of proteinuria are associated with slowed progression to end-stage kidney disease and reduced cardiovascular events.2

AMADEO is the last in the series of PROTECTION studies which are part of an extensive ongoing trial programme, including observational and clinical studies, investigating the effects of telmisartan compared with other treatments for hypertension, including other available ARBs. The trials investigate the effects of telmisartan in providing 24 hour reduction of BP as well as potential organ-protective effects.

About AMADEO

AMADEO, a randomized, double-blind, forced-titration, parallel-group, multicentre study, included 860 hypertensive patients (>130/80mmHg) with type 2 diabetes and overt nephropathy from 124 centres in 10 countries. Patients were randomized to receive treatment with either telmisartan 80mg or losartan 100mg. Other non-ARB treatments (hydrochlorothiazide or calcium channel blocker) were added, if needed, to ensure that blood pressure control was comparable between the two patient groups.

-- After one year's treatment, telmisartan was significantly more effective than losartan. Proteinuria was reduced by 29% with telmisartan vs. 20% with losartan; p<0.03.1

-- Telmisartan was superior to losartan on the primary endpoint, a change from baseline after 12 months (log transformed Urinary Protein creatinine ratio) of 0.71 (95% CI; 0.66, 0.77) vs. 0.80 (95% CI; 0.74,0.87) for losartan; p<0.03.1

-- No significant difference in blood pressure control or number of adverse events was observed between the two treatments groups.1

About diabetic nephropathy

Diabetic nephropathy is a kidney disease that occurs approximately in one third of patients with diabetes.3 The prevalence of diabetes is projected to increase at an alarming rate from 171 million in 2000 to 366 million by 2030,4 with the upsurge in obesity closely linked to increased type 2 diabetes. Over time, diabetic nephropathy can lead to end-stage renal disease, a serious condition that needs dialysis and increased medical care and resources. Treatment with dialysis or kidney transplantation is very expensive; over 2% of the total NHS budget is spent on renal replacement therapy (dialysis and/or a kidney transplant).5

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and almost 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

For more information please visit www.boehringer-ingelheim.com

Micardis® (telmisartan) prescribing information (UK)

Tablets containing 20, 40 or 80mg telmisartan, a specific angiotensin II receptor (type AT1) antagonist. Indication: essential hypertension. Dose: adults only: usually 40mg once daily, range 20-80mg. Can be used together with thiazide-type diuretics. Maximum antihypertensive effect takes 4-8 weeks to develop. Maximum dose in mild to moderate hepatic impairment 40mg. A starting dose of 20mg is recommended in severe renal impairment or haemodialysis. Contra-indications: hypersensitivity to any of the ingredients; pregnancy and lactation; biliary obstructive disorders; severe hepatic impairment. Precautions: hepatic impairment; renovascular hypertension; renal impairment & kidney transplant; intravascular hypovolaemia; renin-angiotensin-aldosterone system stimulation; primary aldosteronism; aortic or mitral valve stenosis; obstructive hypertrophic cardiomyopathy; hyperkalaemia; fructose intolerance; ischaemic cardiopathy or ischaemic cardiovascular disease. Apparently less effective in black patients than in other racial groups. Interactions: lithium; medicinal products that may increase potassium levels or induce hyperkalaemia; NSAIDs; diuretics; other antihypertensive agents; baclofen; amifostine; alcohol; barbiturates; narcotics; antidepressants; systemic corticosteroids. Side-effects: In clinical trials the following effects have been reported commonly (≥ 1/100, < 1/10),: urinary tract infections; upper respiratory tract infections including pharyngitis & sinusitis; abdominal pain; diarrhoea; dyspepsia; eczema; arthralgia; back pain; muscle spasms or pain in extremities; myalgia; chest pain; influenza-like illness. Uncommonly (≥ 1/1000, < 1/100), anxiety; visual disturbances; vertigo; dry mouth, flatulence; hyperhydrosis; tendonitis have been reported. Rarely (≥ 1/10,000, < 1/1,000), stomach discomfort has been reported. Since the introduction of telmisartan to the market, reported side-effects have included: erythema; pruritis; syncope; insomnia; depression; vomiting; hypotension; bradycardia; tachycardia; abnormal hepatic function; liver disorder; renal impairment; hyperkalaemia; dyspnoea; anaemia; eosinophilia; thrombocytopenia; asthenia; lack of efficacy. Isolated cases of angioneurotic oedema and urticaria have also been reported. Infrequently, a decrease in haemoglobin or an increase in uric acid have been observed. Cases of increased blood CPK have also been reported. Prescribers should consult the Summary of Product Characteristics in relation to other side-effects. Presentations and NHS price: blister packs of 28 tablets, 20mg £11.34 EU/1/98/090/010; 40mg £11.34 EU/1/98/090/002; 80mg £14.18 EU/1/98/090/006 Prescription only. Marketing authorisation holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. Prepared May 2007.

For full prescribing information please see Summary of Product Characteristics.

Micardis® is a registered trademark.

Adverse events should be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone). Information about adverse event reporting can be found at http://www.yellowcard.gov.uk

References

1. Burgess E et al. Efficacy of telmisartan compared with losartan in reducing proteinuria in hypertensive type 2 diabetic patients with overt nephropathy. Presented at the Annual Meeting of the European Society of Hypertension. June 2007, Milan, Italy.

2. Bakris G et al. Comparative long term effects of two AT1 receptor blockers on proteinuria in patients with type-2 diabetes and overt nephropathy and hypertension: results of the AMADEO trial. Presented at the Annual Meeting of the American Society of Hypertension.May 2007, Chicago, USA

3. Hossain P et al. Obesity and Diabetes in the Developing World - a Growing Challenge. NEJM 2007; 356(3):213-215.

4. Wild S et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27:1047-53.

5. Institute for Health and Clinical Excellence. National Institute for Health and Clinical Excellence. SCOPE. Chronic Kidney Disease: Early identification and management of chronic kidney disease in adults in primary and secondary care. January 2007.

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