New Investigational Combination Telmisartan And Amlodipine Shows Effective And Well-tolerated 24-hour Blood Pressure Control In Hypertensive Patients

Main Category: Hypertension
Article Date: 16 Jun 2009 - 0:00 PDT

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Data presented today at the 19th Scientific Meeting of the European Society of Hypertension, Milan, Italy has demonstrated that treatment with an investigational combination of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]) shows substantial and sustained 24-hour blood pressure (BP) lowering and is well-tolerated in a range of patients with hypertension at risk of cardiovascular (CV) events. This includes patients with Type 2 diabetes, obese patients, the elderly, black patients and those not controlled by amlodipine alone.1-8

Suboptimal treatment of hypertension has recently been highlighted by the World Health Organization as the number-one risk of death globally;9 the majority of patients do not achieve BP control on one therapeutic agent alone,10 with treatment intolerance and non-compliance being common problems.11 The unmet need for a convenient and tolerable treatment that helps the majority of patients control their BP clearly persists.

Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine, Prevention and Applied Biotechnologies of the University of Milan, Bicocca commented, "Recent data from a large population-based study in Italy shows a lack of blood pressure control with monotherapy, which is frequently abandoned after just a few months - a trend that continues over time. Interestingly, however, the study also highlighted differences in discontinuation rates between treatment classes, with ARBs, such as telmisartan resulting in the best treatment compliance rates. The new telmisartan and amlodipine combination data show that this combination is effective and well-tolerated in difficult-to-treat patients at cardiovascular risk and in patients not controlled by amlodipine alone, which may aid patient compliance and help to improve cardiovascular disease management."

Study results

The telmisartan and amlodipine combination was investigated in a double-blind trial involving 1,461 patients with hypertension who were randomised to one of 16 treatment arms involving telmisartan 0, 20, 40 or 80mg plus amlodipine 0, 2.5, 5 or 10mg for eight weeks.12

New results presented at ESH show that in a broad range of hypertensive at-risk patients (Type 2 diabetes, obese patients, the elderly), combination treatment with telmisartan 40-80mg and amlodipine 5-10mg1-8:

- provides effective 24-hour BP control, including the last six hours of the dosing interval and early morning hours when the risk of CV events is highest
- is well-tolerated with less peripheral oedema (telmisartan 40-80mg and amlodipine 5-10mg 5.2%/amlodipine 10mg 17.8%) compared with amlodipine 10mg alone
- provides effective BP reductions and control (<140/90mmHg) in patients whose BP is not controlled with amlodipine 5-10mg alone.

In patients receiving telmisartan 80mg plus amlodipine 10mg:

- Type 2 diabetes: 87.0% (n=20) of patients achieved BP control, with a third (30.4%) reaching the more stringent BP goal of <130/80mmHg (n=7, subgroup n=23, all treatment groups n=231). BP reductions in non-diabetics and diabetics were -25.1/-19.4mmHg and -29.1/-20.2 mmHg, respectively 2,5

- Obesity: 81.7% (n=71) and 83.1% (n=65) of obese and non-obese patients achieved BP control with BP reductions of -24.6/-19.9 mmHg and -27.1/-19.2 mmHg, respectively (clinically obese at baseline, BMI ≥30 kg/m2, subgroup n=87, all treatment groups n=783)3,5

- Elderly: 77% (n=22) of patients ≥ 65 years of age achieved BP control with BP reduction in patients ≥ 65 and < 65 years of age -27.2/-22.8 mmHg and -25.5/-18.9 mmHg, respectively (subgroup n=29, all treatment groups n=202)1,6

In patients not controlled with amlodipine 5-10mg:7,8

- 66% of patients (n=277) achieved BP control with telmisartan 80mg plus amlodipine 5mg when previously not controlled with amlodipine 5mg
- 60% of patients (n=310) achieved BP control with telmisartan 80mg plus amlodipine 10mg when previously not controlled with amlodipine 10mg
- the oedema rate with telmisartan 80mg plus amlodipine 5mg (3.6%) was significantly lower, than with amlodipine 10mg alone (27.2%), which may make the combination a better solution than up titrating amlodipine.7

Dr. Sarah Jarvis, Richford Gate Medical Practice, London,"Patients who are at higher risk of cardiovascular events often need more than one treatment to control their blood pressure, but a treatment that works is only half the story. Tolerability is essential to ensure patients keep taking their treatment and are protected. Regardless of Type 2 diabetes, obesity or age, the telmisartan and amlodipine combination shows excellent blood pressure control and a good tolerability profile, which could make it a good option for patients and physicians alike."

Proven 24-hour blood pressure reductions and cardiovascular protection

Unlike many anti-hypertensive treatments, telmisartan and amlodipine are once-daily treatments that provide both substantial and sustained 24-hour BP reductions13-15 and have an evidence base in CV outcomes demonstrating protective benefits16,17. As demonstrated in The ONTARGET™ Trial Programme, telmisartan is the only ARB proven to achieve CV protective benefits in a broad range of high CV risk patients, reducing the risk of CV death, myocardial infarction, stroke and hospitalisation for congestive heart failure16.

Notes

Please be advised

This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

About telmisartan (Micardis®/Kinzal®/Pritor®)

Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and is being investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the clinical trial programmes ONTARGET™, PROTECTION™ and PRoFESS®, over 58,000 patients were enrolled to investigate the cardiovascular protective effects of telmisartan

Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis® and Micardisplus® (combination with hydrochlorothiazide) the company markets telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis®, Bayer HealthCare promotes telmisartan under the brand names Kinzalmono®, Kinzalkomb® (combination with hydrochlorothiazide), and Pritor® and PritorPlus® (combination with hydrochlorothiazide) in markets across Europe. Pritor® and PritorPlus® is also marketed by GlaxoSmithKline in selected markets.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

References:

1 Littlejohn T, et al. Combination of telmisartan with amlodipine provides an effective treatment option for elderly patients: sub-analysis from a factorial design study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

2 Littlejohn T, et al. Telmisartan in combination with amlodipine provides highly effective and well tolerated treatment option for hypertensive patients with diabetes: sub-analysis from a factorial design study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

3 Littlejohn T, et al. Efficacy of telmisartan in combination with amlodipine in obese hypertensive patients: sub-analysis from a factorial design study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

4 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in Black and Latin American hypertensive patients: finding of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

5 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in diabetic and obese hypertensive patients: findings of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

6 Littlejohn T, et al. Telmisartan and amlodipine in combination are effective at lowering 24-hour BP in elderly hypertensive patients and those with elevated SBP: findings of an ABPM sub-study. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

7 Neldem S, et al. Fixed-dose combination therapy with telmisartan and amlodipine 5 mg in non-responders to amlodipine 5 mg provides superior blood pressure reductions to, and is better tolerated than, amlodipine 10 mg. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

8 Neldam S, et al. Switch to a fixed-dose combination therapy with telmisartan and amlodipine provides significant blood pressure reduction and control in patients not adequately controlled with amlodipine 10 mg. Presented at the Annual Meeting of the European Society of Hypertension. June 2009, Milan, Italy.

9 Helms RA, et al. Textbook of therapeutics: drug and disease management. Edition 8. Published by Lippincott Williams & Wilkins, 2006.

10 Mancia G, et al. 2007 Guidelines for the management of arterial hypertension. The task force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Journal of Hypertension 2007, 25:1105-1187.

11 Stephenson J. Noncompliance may cause half of antihypertensive drug `failures.` Journal of the American Medical Association 1999; 282:313-314.

12 Littlejohn TW III, et al. Results of Treatment With Telmisartan-Amlodipine in Hypertensive Patients. Journal of Clinical Hypertension 2009; 11:207-213.

13 Costa FV. Telmisartan: Standing Out in a Crowded Contest? High Blood Pressure & Cardiovascular Prevention 2006; 13(3):85-94.

14 Burnier M, et al. The Comparative Pharmacology of Angiotensin II Receptor Antagonists. Blood Pressure 2001; 10 (1):6-11.

15 Abernethy DR. Pharmacokinetics and pharmacodynamics of amlodipine. Cardiology 1992; 80(1):31-36.

16 The ONTARGETTM Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. New England Journal of Medicine 2008; 358(15):1547-59.

17 Nissen SE, et al. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure. The CAMELOT Study: a randomized controlled trial. Journal of the American Medical Association 2004; 292(18):2217-2225.

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Boehringer Ingelheim