Superior BP Reductions in Diabetic Patients Treated with Telmisartan/Amlodipine

Results show that in hypertensive patients with diabetes who are at added risk of cardiovascular (CV) events, TWYNSTA® (Boehringer Ingelheim GmbH), the single pill combination of the angiotensin II receptor blocker (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine, compared to amlodipine alone delivers superior blood pressure (BP) reductions needed to get these added risk patients to BP goal. [1]

The new data show that the once daily, single pill combination of the angiotensin II receptor blocker (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine, leads to prompt and very effective reductions in blood pressure in hypertensive patients with diabetes. The results from the TEAMSTA Diabetes study, presented at the 21st Annual Scientific Meeting of the European Society of Hypertension (ESH) in Milan, are further confirmation that TWYNSTA® provides a significantly greater reduction in blood pressure compared to amlodipine alone in hypertensive patients who are at added risk of serious CV events and are often more difficult to treat.[1]

“Hypertension is extremely common in people with diabetes and these patients are at a much greater risk of serious cardiovascular events such as a stroke or heart attack” said the lead author of TEAMSTA Diabetes, Dr. Arya M. Sharma, Professor of Medicine and Chair in Obesity Research and Management at the University of Alberta, Canada.

“The results of this study show that for these patients, TWYNSTA® significantly lowers blood pressure and helps them better achieve their blood pressure goals over 24-hours. In addition, the single-pill combination of telmisartan and amlodipine may also reduce the pill burden for patients that usually have to take multiple treatments due to co-morbidities such as type-2 diabetes.”

TWYNSTA® is a combination of the longest acting agents in each class and the study results highlight that more than 71% of diabetes patients with hypertension (baseline BP 161/91mmHg) treated with TWYNSTA® achieved the study-defined blood pressure goal (<140/90 mmHg) and over 50% of patients achieved their 24-hr blood pressure goal (<130/80 mmHg) as measured by ABPM, compared to 54% and 39%, respectively, of patients on amlodipine monotherapy.[1] Similar results were seen in obese patients (BMI≥30 kg/m2), which formed the largest subpopulation (approximately 57%) in TEAMSTA Diabetes.[2] Numerous studies have shown that less than 40% of hypertensive patients achieve target BP with monotherapy. [3] This figure is even lower in patients with comorbid obesity or diabetes.[3]

The TEAMSTA data confirm results from a previous sub-analysis of the factorial design study where 87% of the diabetes and 81% of the obese patients treated with TWYNSTA® achieved the study-defined BP goal of <140/90 mmHg.[4,5,6] Results from the TEAMSTA Diabetes study further add to previous TWYNSTA® data showing consistent BP reductions across all hypertension severities (mild to severe). In patients with severe hypertension[7] the systolic BP reductions were up to 50 mmHg. These data demonstrate the effectiveness of TWYNSTA® in patients at additional risk for CV events who often find their BP targets difficult to achieve.

Research shows that in patients with hypertension, TWYNSTA® provides up to 80% of the maximum BP reduction within two weeks after the initiation of treatment, showing prompt onset of action and effective BP lowering.[7]

Study Results
Results showed that combination treatment with telmisartan 80mg and amlodipine 10mg vs amlodipine monotherapy provides: [1]

- significantly greater mean systolic BP reductions at 8 weeks (-29 mmHg vs -22.9 mmHg; p<0.0001)
- significantly greater mean systolic BP reductions already at week 1 (-17.5 mmHg vs -12.6 mmHg; p<0.0001) and maintained throughout the study
- consistently higher office BP (<140/90 mmHg) and systolic BP (<140 mmHg) goal rates of 71.4% and 73.2% vs 53.8% and 56.8%, respectively
- greater 24-hr ambulatory BP reductions (ABPM) (SBP:-16.5 mmHg vs -11.1 mmHg; p=0.0044) and consistently higher 24-hr BP goal rates (<130/80 mmHg; 52.9% vs 39.1%)
- a safe and well tolerated treatment option with fewer treatment-related adverse events and treatment discontinuations

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, commented: “TWYNSTA® combines the robust evidence base with regard to cardiovascular outcomes of telmisartan and amlodipine. These latest findings further support previous TWYNSTA® data that show that this single-pill combination is a valuable treatment option for hypertensive patients, especially those with co-morbidities such as diabetes or obesity.”

TWYNSTA® contains telmisartan, the only ARB with a broad indication for CV prevention independent of blood pressure.[8]

TWYNSTA® was recently approved by the European Medicines Agency for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets containing the same component doses. TWYNSTA® is also approved in the US and Japan.

References:
[1] Sharma AM. et al. Single-pill combination of telmisartan 80mg/amlodipine 10mg provides superior blood pressure reductions to amlodipine in added risk hypertensive patients. TEAMSTA Diabetes Study. Abstract presented at European Society of Hypertension (ESH), June 2011
[2] Sharma AM. et al. Single-pill combination of telmisartan 80mg/amlodipine 10mg provides superior blood pressure reductions to amlodipine in added risk hypertensive patients: sub-analysis of the obese patients in the TEAMSTA Diabetes Study. Abstract presented at European Society of Hypertension (ESH), June 2011
[3] Dickerson JE. et al. Optimisation of antihypertensive treatment by crossover rotation of four major classes. Lancet 1999; 353: 2008–2013
[4] Littlejohn TW. et al. Telmisartan in combination with amlodipine provides a highly effective and well tolerate treatment option for hypertensive patients with diabetes: sub-analysis from a factorial design study. Abstract presented at European Society of Hypertension (ESH), June 2009
[5] Littlejohn TW. et al. Telmisartan in combination with amlodipine in obese patients with hypertension: sub-analysis from a factorial design study. Abstract presented at American Society of Hypertension (ASH), May 2009
[6] Oigman W., Neves MF., Gismondi, R. Combination of telmisartan plus amlodipine in the treatment of hypertension: review of results. Expert Rev Cardiovasc Ther 2010;8(11):1509-1517
[7] Neutel JM. et al. Single-pill combination of telmisartan 80 mg/amlodipine 10 mg provides superior blood pressure reductions in patients with severe hypertension: TEAMSTA Severe HTN Study. Poster presentation at the European Society of Hypertension (ESH), June 2010.
[8] Micardis SmPC

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Tags: Amlodipine, Blood, TEAMSTA, Telmisartan, Twynsta, cardiovascular, diabetes, hypertension, pressure

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Diabetes Mellitus (DM) is a common metabolic disorder associated with abnormally high blood sugar levels. Diabetes is classified as either type 1 (T1DM), which is characterized by severely diminished insulin production, or type 2 (T2DM), which is characterized by moderately diminished insulin production in conjunction with insulin resistance (insensitivity of the tissues of the body to insulin). Insulin is a hormone that regulates blood glucose levels. Diabetes can seriously impair overall quality of life and may lead to multiple complications including heart disease, stroke, and kidney failure. According to the International Diabetes Federation, more than 245 million people have diabetes, with type 2 diabetes being the most prevalent.

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