Value through Innovation02 September 2014
17 June 2011

New data confirm superior blood pressure reductions in diabetic patients treated with TWYNSTA® compared to amlodipine alone

Results show that in hypertensive patients with diabetes, who are at added risk of cardiovascular (CV) events, TWYNSTA®, 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 goal1

• demonstrates greater blood pressure reduction for a full 24-hrs, with a higher proportion of patients reaching their target blood pressure1

• provides a prompt onset of action, with superior blood pressure reductions already seen after one week of treatment1

Ingelheim, Germany, 17 June 2011 - New data show that TWYNSTA® , a 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 hypertension7 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

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.

 

NOTES TO EDITORS

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 the study
These results originate from an 8-week, double-blind, parallel group study called TEAMSTA Diabetes, which forms part of the Telmisartan Plus Amlodipine Phase III/IV Clinical Trials Programme.

TEAMSTA Diabetes involved 706 patients aged ≥18 years with type 2 diabetes and stage 1 or 2 hypertension (defined as systolic blood pressure [SBP] >150 mmHg) randomised to T80/A10 (n=352) or A10 (n=354); patients received T80/A5 or A5 for the first 2 weeks. The primary end point was changed from baseline in mean systolic blood pressure.

About TWYNSTA®

TWYNSTA® is a once daily, single pill combination of the angiotensin II receptor blocker (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine, for the treatment of hypertension.

In September 2010, the Europe Medicines Agency (EMA) approved TWYNSTA® (telmisartan plus amlodipine) 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.

In the US, TWYNSTA® is approved by the FDA for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

The single pill combination of telmisartan and amlodipine is indicated for the treatment of hypertension in Japan in patients not controlled on either monotherapy and is marketed as MICAMLO®.

About telmisartan (Micardis®/Kinzal®/Pritor®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and has been 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 efficacy and cardiovascular protective effects of telmisartan (for more information please visit www.news-landmarktrials.com). Telmisartan is one of the most studied antihypertensives in clinical trials and is widely used with a total of more than 34 million (included MicardisPlus®) patient years since approval.

Telmisartan was discovered and developed by Boehringer Ingelheim. Telmisartan is currently registered in 112 countries and marketed in 104 countries worldwide under the tradenames Micardis®, Pritor®, and Kinzalmono®. 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 145 affiliates and more than 42,000 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.

For Boehringer Ingelheim - and its employees - carrying a good share of social responsibility is an important component in its business culture. Both global commitments in social projects and properly caring for all its employees are included. Respect, equal opportunity, and the balance of career and family life form the basis for mutual cooperation. And, environmental protection and sustainability are always the main focus during any of Boehringer Ingelheim’s undertakings.

In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

References
1Sharma 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
2Sharma 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
3Dickerson JE. et al. Optimisation of antihypertensive treatment by crossover rotation of four major classes. Lancet 1999; 353: 2008–2013
4Littlejohn 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
5Littlejohn 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
6Oigman 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
7Neutel 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 25th Annual Scientific Meeting of the American Society of Hypertension (ASH), New York, USA, 2010.
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