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Micardis crosses 50 million patient-years of experience on 15th anniversary

Posted: 11 November 2013 | | No comments yet

Boehringer Ingelheim announces clinical experience with its angiotensin II receptor blocker (ARB) has reached 50 million patient-years of real world experience…

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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.1

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.2-5

“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.6,7

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.8 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.9,10 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.11-16

“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.”

References

  1. Micardis (telmisartan) Drug Approval Package http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20850_Micardis.cfm. [Last accessed August 2013]
  2. Costa FV. Telmisartan: standing out in a crowded contest? High Blood Pressure & Cardiovascular Prevention 2006; 13(3):85-94.
  3. Burnier M, et al. The comparative pharmacology of angiotensin II receptor antagonists. Blood Pressure 2001; 10(1):6–11.
  4. McClellan KJ, et al. Telmisartan. Drugs 1998; 56:1039-44.
  5. The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. New England Journal of Medicine 2008; 358(15):1547-59.
  6. World Heart Federation. Hypertension and cardiovascular disease. http://www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/hypertension [Last accessed August 2013]
  7. EMA Summary of Product Characteristics for Micardis http://www.medicines.org.uk/emc/medicine/2418/SPC/ [Last accessed August 2013]
  8. Mancia G, et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension. Blood Press. 2013 Aug;22(4):193-278.
  9. Fenton C, Keating GM, Scott LJ. Telmisartan/hydrochlorothiazide: in the treatment of essential hypertension. Drugs 2003; 63 :2013-26.
  10. McGill JB, Reilly PA. Telmisartan plus hydrochlorothiazide versus telmisartan or hydrochlorothiazide monotherapy in patients with mild to moderate hypertension: a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Clinical Therapeutics 2001; 23: 833-50.
  11. Neutel J 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. J Clin Hypertens. 2010;12(7):537
  12. White 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
  13. Littlejohn et al. Results of Treatment With Telmisartan-Amlodipine in Hypertensive Patients J Clin Hypertens. 2009;11:207–213
  14. Littlejohn et al. Telmisartan plus amlodipine in patients with moderate or severe hypertension: results from a subgroup analysis of a randomized, placebo-controlled, parallel-group, 4 x 4 factorial study. Postgrad Med 2009;121:5–14
  15. Neldam, Lang. J Clin Hypertens. 2009;11 (Suppl s1):114 (P279).
  16. Neldam, Edwards. ESH 2009 poster presentation (P911); TEAMSTA-10 (data on file; Boehringer Ingelheim).