New investigational combination telmisartan and amlodipine shows effective and well-tolerated 24-hour blood pressure control in hypertensive patients at risk of cardiovascular events

MILAN--(BUSINESS WIRE)--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 5-10mg^1-8:

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 reductions^13-15 andhave an evidence base in CV outcomes demonstrating protective benefits^16,17. 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 to editors/References

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