Switching to TWYNSTA® allows patients with uncontrolled hypertension on monotherapy to rapidly reach their blood pressure goals

Results show that for patients with uncontrolled blood pressure (BP) on renin angiotensin system (RAS) inhibitor monotherapy, switching to TWNYSTA^® may:¹

• deliver the blood pressure reductions needed to get them to BP goal
• demonstrate a rapid benefit, with over half of patients reaching office BP goal within 4 weeks and nearly 70% of patients within 12 weeks
• provide a safe and well-tolerated treatment option in this patient population

For Non-US and Non-UK Healthcare Media Only

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 rapid and sustained blood pressure (BP) reductions that can bring most patients with previously uncontrolled hypertension on RAS inhibitor monotherapy to BP goal effectively within 4 weeks.¹

The results from the TEAMSTA Switch study, presented at the 22^nd Annual Scientific Meeting of the European Society of Hypertension (ESH) in London, show that TWYNSTA^® delivers prompt BP control in the majority of patients with uncontrolled hypertension on RAS blocker monotherapy (i.e. angiotensin II receptor blockers, angiotensin-converting-enzyme inhibitors or direct renin inhibitors) and provides further confirmation of its excellent efficacy in controlling high blood pressure.¹

Despite decades of persistent efforts, in Europe the BP control of patients who suffer from hypertension is only approximately 30%.² “This study clearly shows that the combination of an ARB with a CCB is a highly effective way of optimising blood pressure control in the majority of people” said the lead author of TEAMSTA Switch, Professor Bryan Williams, Professor of Medicine at the University of Leicester, UK.

Summary of the data: ^1,3,4

• Overall 53% patients reached office BP goal within 4 weeks and 67.6% within 12 weeks
• After 12 weeks, BP control rates ranged from 74.7-88% (depending on original monotherapy treatment) in patients receiving telmisartan 80mg/amlodipine 5mg and from 44.9-60.8% in patients who required uptitration to telmisartan 80mg/amlodipine 10mg at either week 4 or 6
• Uptitrated patients had a longer history of hypertension, a higher systolic blood pressure (SBP) at baseline and twice as often suffered from concomitant diabetes
• Using Home Blood Pressure Monitoring, 73.4% and 78.5% of patients reached the BP goal (<140/90 mmHg) after 4 and 12 weeks, respectively
• At baseline, 69% of patients had mild hypertension (140-159/90-99 mmHg) which decreased to 27.1% after 12 weeks of treatment
• At baseline, 26.5% of patients had moderate (160-179/100-109 mmHg) or severe hypertension (≥180/ 110mmHg) which decreased to 4.3% after 12 weeks of treatment
• TWYNSTA^® showed a good safety profile and was well-tolerated in this patient population
• The most common adverse event was peripheral oedema which was experienced by 13.2% of patients, with 5.2% being considered clinically relevant by the treating physician

Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim, commented: “These latest findings add to a robust evidence base, confirming that TWYNSTA^® is a valuable treatment option for patients with hypertension and is highly effective in helping patients who are uncontrolled to reach their BP goals.”

Previous data confirm TWYNSTA^® delivers very effective BP reductions and high BP control rates in patients not controlled by amlodipine alone, as well as in those patients at greater risk of CV events, including patients with severe hypertension, Type 2 diabetes, and obesity and is safe and well tolerated.^5-9

TWYNSTA^® contains telmisartan, the only ARB with a broad indication for CV prevention independent of blood pressure.¹⁰

~ENDS~

NOTES TO EDITORS

Please note:

This press release contains information on work which is being presented at the European Society of Hypertension (ESH) conference in London, 26-29 April, 2012. Please note that the ESH has not been asked to approve this statement, therefore the content of this statement does not necessarily reflect the view of the ESH.

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 12-week, open-label, multicentre study called TEAMSTA Switch, which forms part of the Telmisartan Plus Amlodipine Phase III/IV Clinical Trials Programme.¹

TEAMSTA Switch involved 501 patients aged ≥18 years with uncontrolled hypertension (defined as systolic blood pressure [SBP] ≥140 mmHg or Diastolic blood pressure [DBP] ≥90mmHg), after at least 6 weeks’ stable treatment with RAS blocker monotherapy (ACEi, ARB or direct renin inhibitor [DRI]). Patients were switched to a starting dose of T80/A5 (telmisartan 80mg/ amlodipine 5mg). Patients were uptitrated to T80/A10 after 4/8 weeks if in-clinic BP remained uncontrolled. Home blood pressure monitoring was performed twice daily every other day throughout the total duration of the study (averaging approx 200 readings per patient). The primary endpoint was the percentage of patients reaching a clinic BP goal (<140/90 mmHg) after 12 weeks.¹

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.

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References

1. Williams B. et al . Efficacy of single-pill combination of telmisartan/amlodipine on blood pressure goal attainment in patients uncontrolled by RAS blocker monotherapy. TEAMSTA Switch Study. Abstract presented at European Society of Hypertension (ESH), April 2012

2. Pessina, AC, Ross, GP. Uncontrolled hypertension: highlights and perspectives from the European Society of Hypertension Satellite Symposium. Expert Rev. Cardiovasc. Ther 2011;9(12), 1515–1518

3. Data on file. Boehringer Ingelheim 2012

4. Williams B. et al. Efficacy of single-pill combination of telmisartan/amlodipine on Home Blood Pressure Measurement in patients uncontrolled by RAS blocker monotherapy. TEAMSTA Switch Study. Abstract presented at European Society of Hypertension (ESH), April 2012

5. White B et al. Effects of telmisartan and amlodipine in combination on ambulatory blood pressure in stages 1 -2 hypertension. Blood Press Monit 2010 Aug;15(4):205-12

6. Littlejohn J, et al. Results of treatment with telmisartan-amlodipine in Hypertensive Patients. J Clinl Hypertens 2009;11:4:207-213

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. 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

9. 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

10. Micardis SmPC

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