Telmisartan for the reduction of cardiovascular morbidity and mortality

Expert Review of Clinical Pharmacology

Volumn 4, Issue 2, 2011, Pages 151-161

  Verdecchia, Paolo ^a   Angeli, Fabio ^b   Gentile, Giorgio ^c   Mazzotta, Giovanni ^b   Reboldi, Gianpaolo ^c  

^a Ospedale di Assisi   (Italy)

^b SANTA MARIA DELLA MISERICORDIA HOSPITAL   (Italy)

^c UNIVERSITY OF PERUGIA   (Italy)

Author keywords

angiotensin II receptor blocker; ARB; cardiovascular disease; cardiovascular protection; cardiovascular risk; ONTARGET ; telmisartan; TRANSCEND

Indexed keywords

AMLODIPINE; AMLODIPINE BESYLATE PLUS TELMISARTAN; ANTIHYPERTENSIVE AGENT; CALCIUM CHANNEL BLOCKING AGENT; CANDESARTAN HEXETIL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; ENALAPRIL; EPROSARTAN; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE PLUS TELMISARTAN; IRBESARTAN; LISINOPRIL; LOSARTAN; OLMESARTAN; PERINDOPRIL; PLACEBO; RAMIPRIL; TASOSARTAN; TELMISARTAN; THIAZIDE DIURETIC AGENT; VALSARTAN;

ABNORMAL LABORATORY RESULT; ANTIHYPERTENSIVE THERAPY; BEDTIME DOSAGE; BLOOD PRESSURE REGULATION; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; COUGHING; DIURETIC THERAPY; DIZZINESS; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ELIMINATION; DRUG INDUCED HEADACHE; DRUG RECEPTOR BINDING; DRUG SELECTIVITY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; ESSENTIAL HYPERTENSION; FATIGUE; FOOD DRUG INTERACTION; GASTROINTESTINAL ABSORPTION; HEART FAILURE; HEART INFARCTION; HUMAN; HYPERTENSION; HYPERURICEMIA; HYPOKALEMIA; MORTALITY; NAUSEA; PATIENT COMPLIANCE; PERIPHERAL EDEMA; REVIEW; RISK REDUCTION; STROKE; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT;

ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; ANIMALS; BENZIMIDAZOLES; BENZOATES; CARDIOVASCULAR DISEASES; HUMANS; MORBIDITY; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 79952774277     PISSN: 17512433     EISSN: None     Source Type: Journal    
DOI: 10.1586/ecp.10.141     Document Type: Review

References (56)

1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 3, e442 (2006).
2. Leal J, Luengo-Fernández R, Gray A et al. Economic burden of cardiovascular diseases in the enlarged EU. Eur. Heart J. 27, 1610-1619 (2006).
3. Lloyd-Jones D, Adams RJ, Brown TM et al. Heart Disease and Stroke Statistics - 2010 Update. A report from the American Heart Association. Circulation 121, e46-e215 (2009).
4. Unger T. The role of the renin-angiotensin system in the development of cardiovascular disease. Am. J. Cardiol. 89(Suppl.), 3A-10A (2002).
5. Schmieder RE, Hilgers KF, Schlaich MP, Schmidt BM. Renin-angiotensin system and cardiovascular risk. Lancet 369, 1208-1219 (2007).
6. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. The HOPE Study Investigators. N. Engl. J. Med. 342, 145-153 (2000). Seminal study demonstrating the cardioprotective benefit of renin-angiotensin system blockade.
7. Dicpinigaitis PV. Angiotensin-converting enzyme inhibitor-induced cough: ACCP evidence-based clinical practice guidelines. Chest 129(Suppl. 1), 1695-1735 (2006).
8. Miller DR, Oliveria SA, Berlowitz DR, Fincke BG, Stang P, Lillenfeld DE. Angioedema incidence in US veterans initiating angiotensin-converting enzyme inhibitors. Hypertension 51, 1624-1630 (2008).
9. Weber MA, Messerli FH. Angiotensin-converting enzyme inhibitors and angioedema: estimating the risk. Hypertension 51, 1465-1367 (2008).
10. Crowley SD, Gurley SB, Coffman TM. AT(1) receptors and control of blood pressure: the kidney and more. Trends Cardiovasc. Med. 1, 30-34 (2007).
11. Dahlöf B, Devereux RB, Kjeldsen SE et al; LIFE Study Group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 359, 995-1003 (2002).
12. Julius S, Kjeldsen SE, Weber M et al.; VALUE Trial Group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 363, 2022-2031 (2004).
13. Pfeffer MA, McMurray JJ, Velazquez EJ et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N. Engl. J. Med. 349, 1893-1906 (2003).
14. Dickstein K, Kjekshus J; OPTIMAAL Steering Committee. Effects of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction: the OPTIMAAL randomised trial. Lancet 360, 752-760 (2002).
15. Pfeffer MA, Swedberg K, Granger CP et al.; CHARM Investigators and Committees. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programme. Lancet 362, 759-766 (2003).
16. Pitt B, Poole-Wilson P, Segal R et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial - the Losartan Heart Failure Survival Study ELITE II. Lancet 355, 1582-1587 (2000).
17. Cohn JN, Tognoni G; for the Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensinreceptor blocker valsartan in chronic heart failure. N. Engl. J. Med. 345, 1667-1675 (2001).
18. Yusuf S, Teo KK, Pogue J et al.; ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N. Engl. J. Med. 358, 1547-1559 (2008). Landmark study showing that cardiovascular protection with an angiotensin II receptor blocker, telmisartan, is as effective as with the angiotensin-converting enzyme inhibitor ramipril.
19. Kurtz TW, Pravenec M. Molecule-specific effects of angiotensin II-receptor blockers independent of the renin-angiotensin system. Am. J. Hypertens. 21, 852-859 (2008).
20. Burnier M. Telmisartan: a different angiotensin II receptor blocker protecting a different population? J. Int. Med. Res. 37, 1662-1679 (2009).
21. Wienen W, Entzeroth M, van Meel JCA et al. A review on telmisartan: a novel, long-acting angiotensin II-receptor antagonist. Cardiovasc. Drug Rev. 18, 127-154 (2000).
22. Maillard MP, Perregaux C, Centeno C et al. In vitro and in vivo characterization of the activity of telmisartan: an insurmountable angiotensin II receptor antagonist. J. Pharmacol. Exp. Ther. 302, 1089-1095 (2002).
23. Kakuta H, Sudoh K, Sasamata M, Yamagishi S. Telmisartan has the strongest binding affinity to angiotensin II type 1 receptor: comparison with other angiotensin II type 1 receptor blockers. Int. J. Clin. Pharmacol. Res. 25, 41-46 (2005).
24. Benson SC, Pershadsingh HA, Ho CI et al. Identification of telmisartan as a unique angiotensin II receptor antagonist with selective PPARγ -modulating activity. Hypertension 43, 993-1002 (2004).
25. Stangier J, Su CA, Roth W. Pharmacokinetics of orally and intravenously administered telmisartan in healthy young and elderly volunteers and in hypertensive patients. J. Int. Med. Res. 28, 149-167 (2000).
26. Williams B, Lacourcière Y, Schumacher H, Gosse P, Neutel JM. Antihypertensive efficacy of telmisartan vs ramipril over the 24-h dosing period, including the critical early morning hours: a pooled ana lysis of the PRISMA I and II randomized trials. J. Hum. Hypertens. 23, 610-619 (2009).
27. Stangier J, Schmid J, Türck D et al. Absorption, metabolism, and excretion of intravenously and orally administered [14C]telmisartan in healthy volunteers. J. Clin. Pharmacol. 40, 1312-1322 (2000).
28. Israili ZH. Clinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertension. J. Hum. Hypertens. 14(Suppl. 1), S73-S86 (2000).
29. Ebner T, Heinzel G, Prox A, Beschke K, Wachsmuth H. Disposition and chemical stability of telmisartan 1-O-acylglucuronide. Drug Metab. Dispos. 27, 1143-1149 (1999).
30. Teo K, Yusuf S, Anderson C et al. Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease. (ONTARGET/TRANSCEND) trials. Am. Heart J. 148, 52-61 (2004).
31. Yusuf S, Teo K, Anderson C et al.; Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (TRANSCEND) Investigators. Effects of the angiotensinreceptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet 372, 1174-1183 (2008). The sister trial to Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET® ), demonstrating the efficacy of telmisartan in an angiotensin-converting enzymeintolerant population.
32. Yusuf S, Diener HC, Sacco RL et al.; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N. Engl. J. Med. 359, 1225-1237 (2008).
33. Verdecchia P, Sleight P, Mancia G et al; ONTARGET/TRANSCEND Investigators. Effects of telmisartan, ramipril, and their combination on left ventricular hypertrophy in individuals at high vascular risk in the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial and the Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease. Circulation 120, 1380-1389 (2009). Evidence of the regression of cardiac damage with telmisartan treatment.
34. Bakris G, Burgess E, Weir M, Davidai G, Koval S; AMADEO Study Investigators. Telmisartan is more effective than losartan in reducing proteinuria in patients with diabetic nephropathy. Kidney Int. 74, 364-369 (2008).
35. Galle J, Schwedhelm E, Pinnetti S, Böger RH, Wanner C; VIVALDI investigators. Antiproteinuric effects of angiotensin receptor blockers: telmisartan versus valsartan in hypertensive patients with Type 2 diabetes mellitus and overt nephropathy. Nephrol. Dial. Transplant. 23, 3174-3183 (2008).
36. Barnett AH, Bain SC, Bouter P et al; Diabetics Exposed to Telmisartan and Enalapril Study Group. Angiotensinreceptor blockade versus convertingenzyme inhibition in Type 2 diabetes and nephropathy. N. Engl. J. Med. 351, 1952-1961 (2004).
37. Mann JF, Schmieder RE, McQueen M, Dyal L, Schumacher H, Pogue J; ONTARGET Investigators. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. Lancet 372, 547-553 (2008). Evidence for additional renal protection from renin-angiotensin system blockade.
38. Lacourcière Y, Krzesinski J-M, White WB, Davidai G, Schumacher H. Sustained antihypertensive activity of telmisartan compared with valsartan. Blood Press. Monit. 9, 203-210 (2004).
39. Littlejohn T, Mroczek W, Marbury T, VanderMaelen CP, Dubiel RF. A prospective, randomized, open-label trial comparing telmisartan 80 mg with valsartan 80 mg in patients with mild to moderate hypertension using ambulatory blood pressure monitoring. Can. J. Cardiol. 16, 1123-1132 (2000).
40. Calvo C, Hermida RC, Ayala DE, Ruilope LM. Effects of telmisartan 80 mg and valsartan 160 mg on ambulatory blood pressure in patients with essential hypertension. J. Hypertens. 22, 837-846 (2004).
41. Xi GL, Cheng JW, Lu GC Meta-analysis of randomized controlled trials comparing telmisartan with losartan in the treatment of patients with hypertension. Am. J. Hypertens. 21, 546-552 (2008).
42. Schumacher H, Mancia G. The safety profile of telmisartan as monotherapy or combined with hydrochlorothiazide: a retrospective analysis of 50 studies. Blood Press. 17(Suppl. 1), 32-40 (2008). Comprehensive tolerability and safety ana lysis of telmisartan and telmisartan plus hydrochlorothiazide. A retrospective ana lysis of data from 50 trials.
43. Michel MC, Bohner H, Koster J, Schafers R, Heemann U. Safety of telmisartan in patients with arterial hypertension. An open-label observational study. Drug Saf. 27, 335-344 (2004).
44. Zou Z, Xi G-l, Yuan H-B, Zhu Q-F, Shi X-Y. Telmisartan versus angiotensin-converting enzyme inhibitors in the treatment of hypertension: a meta-ana lysis of randomised controlled trials. J. Hum. Hypertens. 2395, 339-349 (2009).
45. Littlejohn TW 3rd, Majul CR, Olvera R et al.; Study Investigators. Results of treatment with telmisartan-amlodipine in hypertensive patients. J. Clin. Hypertens. (Greenwich) 11, 207-213 (2009).
46. Corrao G, Zambon A, Parodi A et al. Discontinuation of and changes in drug therapy for hypertension among newly-treated patients: a population-based study in Italy. J. Hypertens. 26, 819-824 (2008).
47. Costa FV, Esposti LD, Cerra C, Veronesi C, Buda S. Trends in prescription and determinants of persistence to antihypertensive therapy. High Blood Press. Cardiovasc. Prev. 16, 1-10 (2009).
48. ESC/ESH. Mancia G, De Backer G, Dominiczak A et al.; Task Force for the Management of Arterial Hypertension of the European Society of Hypertension; Task Force for the Management of Arterial Hypertension of the European Society of Cardiology. 2007 guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur. Heart J. 28, 1462-1536 (2007).
49. Allender S, Scarborough P, Peto V et al. British Heart Foundation European Cardiovascular Disease Statistics, 2008 www.heartstats.org/datapage. asp?id=7683 (Accessed 15 February 2011)
50. International Diabetes Federation. The Diabetes Atlas (3rd Edition) (2006) www.eatlas.idf.org (Accessed 31 January 2010)
51. EMEA. Micardis (telmisartan). Summary of product characteristics, 25 May 2009 www.ema.europa.eu/docs/en-GB/document-library/EPAR---Product-Information/ human/000209/WC500027641.pdf (Accessed 30 January 2010)
52. EMC. MicardisPlus (telmisartan-HCTZ 80/25 mg). Summary of patient characteristics, 29 May 2009 http://emc.medicines.org.uk/medicine/20957/SPC/ MicardisPlus+80+mg+25+mg+Tablets (Accessed 3 February 2010)
53. FDA. Twynsta (telmisartan plus amlodipine) prescribing information, 16 Oct 2009 www.accessdata.fda.gov/drugsatfda-docs/label/2009/022401lbl.pdf (Accessed 3 February 2010)
54. FDA. Micardis (telmisartan) prescribing information, updated 16 Oct 2009 www.accessdata.fda.gov/drugsatfda-docs/label/2009/020850s025lbl.pdf (Accessed 30 January 2010)
55. EMEA. Committee for Medicinal Products for human use post-authorisation summary of positive opinion for Micardis (telmisartan). EMEA/CHMP/676934/2009 www.ema.europa.eu/pdfs/human/opinion/Micardis-67693409en.pdf (Accessed 30 January 2010)
56. Australian Government Department of Health and Ageing/Therapeutic Goods Administration. Australian Public Assessment Report for Telmisartan www.tga.gov.au/pmeds/auspar/ausparmicardis-pritor.pdf (Accessed 15 February 2011)