Health Canada Approves TWYNSTA™, the First and Only ARB / CCB Single Pill Combination Therapy of its Kind for Effective Hypertension Control

BURLINGTON, ON, Sept. 29, 2011 /CNW/ - TWYNSTA™ (telmisartan and amlodipine) has received Health Canada approval for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.i   TWYNSTA™, the first and only therapy of its kind, combines two blood pressure medications, telmisartan (an angiotensin II receptor antagonist or ARB) and amlodipine (a dihydropyridinic calcium channel blocker, or long-acting CCB) in a single pill for effective blood pressure control.

More than one in five adult Canadians have hypertension.ii In clinical studies, two-thirds of patients with hypertension required two or more antihypertensives to achieve their blood pressure targets,vi and in fact, two-thirds of hypertensive patients have been prescribed at least two medications.iv Even with medication, one-third of hypertensive patients remain uncontrolled.v

Uncontrolled hypertension is an important risk factor for death, stroke, cardiovascular disease and renal disease in Canada.vi Addressing this issue, the 2011 Canadian Hypertension Education Program (CHEP) guidelines recommend that additional antihypertensive drugs should be used if target blood pressure levels are not achieved with monotherapy.vii 

Studies show that TWYNSTA™ provides 24-hour blood pressure controlviii with the majority of antihypertensive effects being attained within two weeks of therapy initiation.ix  Both telmisartan and amlodipine lower blood pressure by reducing peripheral resistance, but do so through different mechanisms. The combination of telmisartan and amlodipine has an additive antihypertensive effect, reducing blood pressure to a greater degree than either monotherapy alone.x,xi,xii

"I'm very excited about the availability of TWYNSTA™ as a new tool to help better manage my patients with hypertension," says Dr. George Honos, Head, Division of Cardiology and Professor at the University of Montreal. "I believe it will provide Canadian physicians with an optimal combination of a proven ARB, telmisartan, and a world‐leading antihypertensive, amlodipine, addressing some important barriers that we have in the management of hypertension, including lowering the blood pressure to target, and encouraging patient adherence."

According to Dr. Honos, non‐adherence to hypertensive therapy is one of the biggest challenges to achieving blood pressure control.xiii

"The CHEP recommendations state that fixed dose combination medications should be prescribed, whenever possible, in order to improve patient adherence.  Moreover, clinical trials have shown that it matters how we lower blood pressure, beyond getting the numbers down to target values. TWYNSTA™ will allow physicians to cut down on the number of pills a hypertensive patient needs to take, while improving blood pressure control," says Dr. Honos.

About Hypertension in Canada
Hypertension is an important risk factor for death, stroke, cardiovascular disease and renal disease in Canadaxiv and over 60 per cent of Canadians over age 60 have hypertension.xv Researchers have predicted that there will be a relative increase of 24 per cent in the prevalence of hypertension in developed countries from 2000 to 2025.xvi

About TWYNSTA™
TWYNSTA™ is a combination of two blood pressure medications, telmisartan (an angiotensin II receptor antagonist or ARB) and amlodipine (a dihydropyridinic calcium channel blocker, or long‐acting CCB) in a single pill for effective blood pressure control.

TWYNSTA™ was studied as part of a randomized, double‐blind, placebo‐controlled, 8 week factorial design trial of hypertensive patients (n=1461) comparing free dose combination telmisartan (including T40 and T80 mg) and amlodipine (including A5 and A10 mg) to monotherapy and placebo.

Results from the study show blood pressure reductions were greater with combination therapy than respective monotherapies.  The greatest overall blood pressure reduction was observed with TWYNSTA™ 80/10mg vs. monotherapy telmisartan or amlodipine (reductions of 26.4 mmHg Systolic Blood Pressure and 20.1 Diastolic Blood Pressure with TWYNSTA™ 80/10 vs. 14.3 mmHg SBP and 14 mmHg DBP with telmisartan alone vs. reductions of 20.7 mmHg SBP and 17.1 mmHg DBP with amlodipine alone).xvii

TWYNSTA™ demonstrated similar efficacy irrespective of age, gender or concomitant diabetesxviii and has an excellent safety and tolerability profile with adverse events occurring with similar frequency across the combination and monotherapy treatment groups.xix

The study concluded that overall, TWYNSTA™ offers a very effective and tolerable option, for patients that require combination therapy.xx

TWYNSTA™ will be available in Canada in a flexible range of dosing regimens of telmisartan / amolodipine (80/5mg, 80/10mg, 40/5mg, 40/10mg).

About Boehringer Ingelheim (Canada) Ltd.
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.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors. In 2010, Boehringer Ingelheim posted net sales of 11.7 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 and the Research and Development Centre located in Laval, Québec, Canada since 1988. Boehringer Ingelheim (Canada) Ltd. is home to more than 700 employees including 160 scientists across the country.

For more information please visit www.boehringer-ingelheim.ca

__________________________________

i TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
ii Hypertension Canada: 2011 One Page Summary.  Available on-line at: http://hypertension.ca/chep/wp-content/uploads/2011/01/OnePage_CHEP2011_EN.pdf
iii Hypertension Canada. 2011 CHEP Recommendations: Part 2 - Recommendations for Hypertension Treatment. Available at: http://hypertension.ca/chep/wpcontent/uploads/2011/04/TreatmentEN_2011_final.ppt. Accessed May, 2011
iv Hypertension Canada: 2010 CHEP Annual Updates ‐Booklet. Available on‐line at: http://hypertension.ca/chep/wpcontent/uploads/2010/03/CHEPbooklet_2010.pdf
v Statistics Canada; Blood pressure in Canadian adults. Cat. No 82‐003‐XPE. Health Reports 21(1), March 2010: 9
vi TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
vii Hypertension Canada. 2011 CHEP Recommendations: Part 2 - Recommendations for Hypertension Treatment. Available at: http://hypertension.ca/chep/wpcontent/uploads/2011/04/TreatmentEN_2011_final.ppt. Accessed May, 2011
viii TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
ix TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
x TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
xi Neutel JM. Complementary Mechanisms of Angiotensin Receptor Blockers and Calcium Channel Blockers in Managing Hypertension. Postgrad Med 2009;121:40‐48.
xii TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
xiii N. Campbell. 2008 Canadian Hypertension Education Program recommendations. Canadian Family Physician 2009: 54. Available on‐line at: http://www.cfp.ca/content/54/11/1539.full.pdf
xiv Tu MD MSc, Karen; Prevalence and incidence of hypertension from 1995 to 2005: a population‐based study CMAJ May 20, 2008:1429
xv Kearney et al. Lancet. 2005;365:217−223
xvi Tu MD MSc, Karen; Prevalence and incidence of hypertension from 1995 to 2005: a population‐based study CMAJ May 20, 2008:1429
xvii TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
xviii TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
xix TWYNSTA™ Product Monograph. Boehringer Ingelheim (Canada) Ltd. July 2011
xx Littlejohn MD, Thomas, et al. Results of Treatment with Telmisartan‐Amlodipine in Hypertensive Patients. Journal of Clinical Hypertension (Greenwich) 2009, 11:4


SOURCE Boehringer Ingelheim

For further information:

Sara McClelland
Boehringer Ingelheim Canada Ltd.
(905) 631‐4713
sara.mcclelland@boehringer-ingelheim.com  
Morgan Cates
Environics Communications
(416) 969‐2789
mcates@environicspr.com

 

Organization Profile

Boehringer Ingelheim

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890