Micardis® crosses 50 million patient-years of experience on 15th anniversary
For NON-US and NON-UK Healthcare Media Only
Ingelheim, Germany, 10th November 2013 – On the 15th anniversary of the approval of Micardis (telmisartan) by the Food and Drug Administration (FDA) for the treatment of hypertension, Boehringer Ingelheim announces clinical experience with its angiotensin II receptor blocker (ARB) has reached 50 million patient-years of real world experience.
The announcement of this significant milestone reflects the global value of Micardis as a medicine that provides effective and well-tolerated 24-hour blood pressure (BP) control to patients with hypertension.
UK General
Practitioner
"Achieving 50 million patient-years of experience in a clinical setting is testimony to the patient benefit afforded by Micardis" said Dr. Sarah Jarvis, UK General Practitioner. "Significant real-life experience can offer physicians valuable reassurance, beyond the available clinical trial data, that a treatment is not only effective but well-tolerated by the patients they see every day."
Hypertension is a primary risk factor for cardiovascular events, such as a heart attack or stroke. Five years after the landmark ONTARGET trial was published, Micardis remains the only ARB proven to achieve cardiovascular prevention beyond blood pressure lowering, in a broad range of cardiovascular high-risk patients.
Guidelines for the treatment of hypertension recognise that the majority of patients need two or more anti-hypertensive agents to effectively control blood pressure, especially those with co-morbidities, such as obesity, diabetes or metabolic syndrome. Subsequent approvals of the Micardis-based combinations MicardisPlus (telmisartan/ hydrochlorothiazide) and Twynsta (telmisartan/ amlodipine) gave a broad range of difficult-to-treat patients access to powerful and sustained blood pressure control. Specifically, Twynsta provides effective 24-hour blood pressure reductions & control in high risk hypertensive patients, including those with type 2 diabetes, metabolic syndrome or obesity, and provides mean systolic blood pressure reductions of up to 50 mmHg according to the patient’s needs.
Dugi, Corporate
Senior Vice President
Medicine at
Boehringer Ingelheim
"Boehringer Ingelheim is committed to bringing cardiovascular protection to hypertensive patients worldwide." said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "Micardis has made a significant contribution to the treatment of hypertension since its approval 15 years ago and we are proud to have established a valued and widely prescribed portfolio of treatments that effectively treat a broad range of patients with such a prevalent condition."
NOTES TO EDITORS
Related links:
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.newshome.com/hypertension). Telmisartan is one of the most studied anti-hypertensives in clinical trials and is widely used with a total of more than 50 million (included MicardisPlus & Twynsta) patient years since approval.
Telmisartan was discovered and developed by Boehringer Ingelheim. Telmisartan is currently registered in more than 100 countries worldwide under the trade names 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), Pritor, and PritorPlus (combination with hydrochlorothiazide) in markets across Europe. Pritor and PritorPlus are also marketed by GlaxoSmithKline in selected markets.
About Twynsta
Twynsta is a once daily, single-pill combination of angiotensin II receptor (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine, for the treatment of hypertension.
In October 2009, the US Food and Drug Administration (FDA) approved Twynsta (telmisartan plus amlodipine) for use in the treatment of hypertension alone, or with other antihypertensive agents, and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
The single pill combination of telmisartan and amlodipine is also approved as MICAMLO in Japan.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
Referências
- Micardis (telmisartan) Drug Approval Package http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20850_Micardis.cfm. [Last accessed August 2013]
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- World Heart Federation. Hypertension and cardiovascular disease. http://www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/hypertension [Last accessed August 2013]
- EMA Summary of Product Characteristics for Micardis http://www.medicines.org.uk/emc/medicine/2418/SPC/ [Last accessed August 2013]
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- Neldam, Edwards. ESH 2009 poster presentation (P911); TEAMSTA-10 (data on file; Boehringer Ingelheim).