Telmisartan/hydrochlorothiazide: A review of its use as fixed-dose combinations in essential hypertension

Drugs

Volumn 68, Issue 13, 2008, Pages 1877-1899

  Plosker, Greg L ^a,b   White, William B ^c  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

^b WOLTERS KLUWER HEALTH   (United States)

^c UNIVERSITY OF CONNECTICUT SCHOOL OF MEDICINE   (United States)

Author keywords

Adis Drug Evaluations; Hypertension; Telmisartan hydrochlorothiazide, general

Indexed keywords

AMLODIPINE; ANGIOTENSIN 1 RECEPTOR; ANGIOTENSIN RECEPTOR ANTAGONIST; DIGOXIN; DIURETIC AGENT; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE PLUS LISINOPRIL; HYDROCHLOROTHIAZIDE PLUS TELMISARTAN; HYDROCHLOROTHIAZIDE PLUS VALSARTAN; LISINOPRIL; LITHIUM; MICARDIS HCT; MICARDIS PLUS; NIFEDIPINE; OLMESARTAN; PLACEBO; RAMIPRIL; TELMISARTAN; THIAZIDE DIURETIC AGENT; UNCLASSIFIED DRUG; VALSARTAN;

ABDOMINAL PAIN; ANTIHYPERTENSIVE ACTIVITY; ANXIETY DISORDER; AREA UNDER THE CURVE; ARTHRALGIA; BACKACHE; BLOOD PRESSURE REGULATION; BRONCHITIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONNECTIVE TISSUE DISEASE; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG PROTEIN BINDING; DRUG TOLERABILITY; DYSPEPSIA; ECZEMA; ERECTILE DYSFUNCTION; ESSENTIAL HYPERTENSION; FATIGUE; FLU LIKE SYNDROME; GASTROINTESTINAL DISEASE; HUMAN; HYPERCHOLESTEROLEMIA; HYPOKALEMIA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MUSCULOSKELETAL DISEASE; NAUSEA; ORTHOSTATIC HYPOTENSION; PAIN; PERIPHERAL EDEMA; PHARYNGITIS; REVIEW; SINUSITIS; TACHYCARDIA; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER RESPIRATORY TRACT INFECTION; VERTIGO; VOMITING;

ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; BENZIMIDAZOLES; BENZOATES; DRUG COMBINATIONS; HALF-LIFE; HUMANS; HYDROCHLOROTHIAZIDE; HYPERTENSION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, ANGIOTENSIN, TYPE 2; TREATMENT OUTCOME;

EID: 50249121614     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200868130-00010     Document Type: Review

References (68)

1. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003 May 21; 289 (19): 2560-72
2. Fields LE, Burt VL, Cutler JA, et al. The burden of adult hypertension in the United States 1999 to 2000: a rising tide. Hypertension 2004; 44 (4): 398-404
3. Wolf-Maier K, Cooper RS, Banegas JR, et al. Hypertension prevalence and blood pressure levels in 6 European countries, Canada, and the United States. JAMA 2003 May 14; 289 (18): 2363-9
4. Wang TJ, Vasan RS. Epidemiology of uncontrolled hypertension in the United States. Circulation 2005 Sep 13; 112 (11): 1651-62
5. Wolf-Maier K, Cooper RS, Kramer H, et al. Hypertension treatment and control in five European countries, Canada, and the United States. Hypertension 2004 Jan; 43 (1): 10-7
6. Mancia G, De Backer G, Dominiczak A, et al. 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 2007 Jun; 28 (12): 1462-536
7. Lewington S, Clarke R, Qizilbash N, et al. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360: 1903-13
8. Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the hypertension Optimal Treatment (HOT) randomized trial. Lancet 1998; 351: 1755-62
9. Ogden LG, He J, Lydick E, et al. Long-term absolute benefit of lowering blood pressure in hypertensive patients according to the JNC VI risk stratification. Hypertension 2000; 35: 539-43
10. Neal B, MacMahon S, Chapman N. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Lancet 2000; 356: 1955-64
11. Meredith PA. Angiotensin II receptor antagonists alone and combined with hydrochlorothiazide: potential benefits beyond the antihypertensive effect. Am J Cardiovasc Drugs 2005; 5 (3): 171-83
12. Ram CVS. Angiotensin receptor blockers and diuretics as combination therapy: clinical implications. Am J Hypertens 2004; 17 (3): 277-80
13. Ram CV. Antihypertensive efficacy of angiotensin receptor blockers in combination with hydrochlorothiazide: a review of the factorial-design studies. J Clin Hypertens (Greenwich) 2004 Oct; 6 (10): 569-77
14. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Anti-hypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002 Dec 18; 288 (23): 2981-97
15. Dahlöf B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the losartan intervention for endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002 Mar 23; 359 (9311): 995-1003
16. Weber MA, Julius S, Kjeldsen SE, et al. Blood pressure dependent and independent effects of antihypertensive treatment on clinical events in the VALUE trial. Lancet 2004 Jun 19; 363 (9426): 2049-51
17. Boehringer Ingelheim. Micardis® HCT (telmisartan and hydrochlorothiazide): prescribing information [online]. Available from URL: http://www.fda.gov [Accessed 2007 Nov 15]
18. Boehringer Ingelheim. Summary of product characteristics: MicardisPlus [online]. Available from URL: http://www.emea.europa.eu [Accessed 2007 Nov 15]
19. Fenton C, Keating GM, Scott LJ. Telmisartan/hydrochlorothiazide: in the treatment of essential hypertension. Drugs 2003; 63 (19): 2013-26; discussion 2027-8
20. Battershill AJ, Scott LJ. Telmisartan: a review of its use in the management of hypertension. Drugs 2006; 66 (1): 51-83
21. Wienen W, Schierok HJ. Effects of telmisartan, hydrochlorothiazide and their combination on blood pressure and renal excretory parameters in spontaneously hypertensive rats. J Renin Angiotensin Aldosterone Syst 2001 Jun; 2 (2): 123-8
22. Fogari R, Preti P, Zoppi A, et al. Effect of telmisartan/ hydrochlorothiazide combination versus nifedipine GITS on ambulatory blood pressure and sympathetic activation. Am J Hypertens 2005 May; 18 (5 Pt 1): 577-83
23. Fogari R, Mugellini A, Zoppi A, et al. Effect of telmisartan/ hydrochlorothiazide vs lisinopril/hydrochlorothiazide combination on ambulatory blood pressure and cognitive function in elderly hypertensive patients. J Hum Hypertens 2006 Mar; 20 (3): 177-85
24. Yong CL, Dias VC, Stangier J. Multiple-dose pharmacokinetics of telmisartan and of hydrochlorothiazide following concurrent administration in healthy subjects. J Clin Pharmacol 2000 Dec; 40 (12 Pt 1): 1323-30
25. Burnier M. Angiotensin II type 1 receptor blockers. Circulation 2001; 103: 904-12
26. Israili ZH. Clinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertension. J Hum Hypertens 2000; 14 Suppl. 1: S73-86
27. U.S. Pharmacopeia. 2008 USP Dictionary of USAN and International Drug Names. Rockville (MD): U.S. Pharmacopeia, 2008
28. 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 2000; 28 (4): 149-67
29. Patel RB, Patel UR, Rogge MC, et al. Bioavailability of hydrochlorothiazide from tablets and suspensions. J Pharm Sci 1984 Mar; 73 (3): 359-61
30. Beermann B, Groschinsky-Grind M. Pharmacokinetics of hydrochlorothiazide in man. Eur J Clin Pharmacol 1977 Dec 2; 12 (4): 297-303
31. Stangier J, Schmid J, Turck D, et al. Absorption, metabolism, and excretion of intravenously and orally administered [14C]telmisartan in healthy volunteers. J Clin Pharmacol 2000 Dec; 40 (12 Pt 1): 1312-22
32. Niemeyer C, Hasenfuss G, Wais U, et al. Pharmacokinetics of hydrochlorothiazide in relation to renal function. Eur J Clin Pharmacol 1983; 24 (5): 661-5
33. Stangier J, Su CA, Schöndorfer G, et al. Pharmacokinetics and safety of intravenous and oral telmisartan 20 mg and 120 mg in subjects with hepatic impairment compared with healthy volunteers. J Clin Pharmacol 2000 Dec; 40 (12 Pt 1): 1355-64
34. Lacourcière Y, Tytus R, O'Keefe D, et al. Efficacy and tolerability of a fixed-dose combination of telmisartan plus hydrochlorothiazide in patients uncontrolled with telmisartan mono-therapy. J Hum Hypertens 2001 Nov; 15 (11): 763-70
35. Lacourcière Y, Martin K. Comparison of a fixed-dose combination of 40 mg telmisartan plus 12.5 mg hydrochlorothiazide with 40 mg telmisartan in the control of mild to moderate hypertension. Am J Ther 2002; 9 (2): 111-7
36. 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. Clin Ther 2001 Jun; 23 (6): 833-50
37. McGill JB, Reilly PA. Combination treatment with telmisartan and hydrochlorothiazide in black patients with mild to moderate hypertension. Clin Cardiol 2001 Jan; 24 (1): 66-72
38. Neutel JM, Klein C, Meinicke TW, et al. Long-term efficacy and tolerability of telmisartan as monotherapy and in combination with other antihypertensive medications. Blood Press 2002; 11 (5): 302-9
39. Freytag F, Holwerda NJ, Karlberg BE, et al. Long-term exposure to telmisartan as monotherapy or combination therapy: efficacy and safety. Blood Press 2002; 11 (3): 173-81
40. Bakris GL, Smith DH, Giles TD, et al. Comparative antihypertensive efficacy of angiotensin receptor blocker-based treatment in African-American and white patients. J Clin Hypertens (Greenwich) 2005 Oct; 7 (10): 587-95; quiz 596-7
41. White WB, Giles T, Bakris GL, et al. Measuring the efficacy of antihypertensive therapy by ambulatory blood pressure monitoring in the primary care setting. Am Heart J 2006 Jan; 151 (1): 176-84
42. Weber MA, White WB, Giles TD, et al. An effectiveness study comparing algorithm-based antihypertensive therapy with previous treatments using conventional and ambulatory blood pressure measurements. J Clin Hypertens 2006 Apr; 8 (4): 241-50; quiz 251-2
43. Redon J, Bilo G, Parati G. Telmisartan improves home blood pressure control during the critical morning hours: results from a post-marketing study (SURGE-2) [abstract no. P-426]. J Clin Hypertens 2007 May; 9 (5 Suppl. A): A177-8
44. Parati G, Bilo G, Redon J. Telmisartan improves ambulatory blood pressure control over 24 hours and in the morning: results from a practice-based study (SURGE-2) [abstract no. P-420]. J Clin Hypertens 2007 May; 9 (5 Suppl. A): A175
45. White WB, Punzi HA, Murwin D, et al. Effects of the angiotensin II receptor blockers telmisartan vs valsartan in combination with hydrochlorothiazide 25 mg once daily for the treatment of hypertension. J Clin Hypertens (Greenwich) 2006 Sep; 8 (9): 626-33
46. White WB, Murwin D, Chrysant SG, et al. Effects of the angiotensin II receptor blockers telmisartan vs valsartan in combination with hydrochlorothiazide: a large, confirmatory trial. Blood Press Monit 2008 Feb; 13 (1): 21-7
47. Sharma AM, Davidson J, Koval S, et al. Telmisartan/ hydrochlorothiazide versus valsartan/hydrochlorothiazide in obese hypertensive patients with type 2 diabetes: the SMOOTH study. Cardiovasc Diabetol. Epub 2007 Oct 2
48. Neutel JM, Littlejohn TW, Chrysant SG, et al. Telmisartan/ hydrochlorothiazide in comparison with losartan/hydrochlorothiazide in managing patients with mild-to-moderate hypertension. Hypertens Res 2005 Jul; 28 (7): 555-63
49. Lacourcière Y, Gil-Extremera B, Mueller O, et al. Efficacy and tolerability of fixed-dose combinations of telmisartan plus HCTZ compared with losartan plus HCTZ in patients with essential hypertension. Int J Clin Pract 2003 May; 57 (4): 237-79
50. Lacourcière Y, Neutel JM, Schumacher H. Comparison of fixed-dose combinations of telmisartan/hydrochlorothiazide 40/12.5 mg and 80/12.5 mg and a fixed-dose combination of losartan/hydrochlorothiazide 50/12.5 mg in mild to moderate essential hypertension: pooled analysis of two multicenter, prospective, randomized, open-label, blinded-end point (PROBE) trials. Clin Ther 2005 Nov; 27 (11): 1795-805
51. Fogari R, Zoppi A, Mugellini A, et al. Effectiveness of hydrochlorothiazide in combination with telmisartan and olmesartan in adults with moderate hypertension not controlled with monotherapy: a prospective, randomized, open-label, blinded end point (PROBE), parallel-arm study. Curr Ther Res Clin Exp 2008 Feb; 69 (1): 1-15
52. Neldam S, Edwards C. Telmisartan plus HCTZ vs. amlodipine plus HCTZ in older patients with systolic hypertension: results from a large ambulatory blood pressure monitoring study. Am J Geriatr Cardiol 2006; 15 (3): 151-60
53. Neldam S, Edwards C. Efficacy and safety of a fixed-dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg in patients with uncontrolled hypertension [abstract no. P12.332]. J Hypertens 2006; 25 Suppl. 2: S114
54. Neldam S, Edwards C. Efficacy and safety of telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) fixed-dose combination (FDC), alone or with other antihypertensive medications, during open-label long-term treatment [abstract no. P-286]. J Clin Hypertens 2008 May; 10 (5 Suppl. A): A123
55. Schumacher H, Mancia G. The safety profile of telmisartan as monotherapy or combined with hydrochlorothiazide: a retrospective analysis of 50 studies. Blood Press 2008; 17 Suppl. 1: 32-40
56. Boehringer Ingelheim GmbH. New powerful antihypertensive MicardisPlus® 80/25 (80mg telmisartan/25mg hydrochlorothiazide) approved by EU Commission [media release]. 2008 Apr 14
57. Cooper WO, Hernandez-Diaz S, Arbogast PG, et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med 2006 Jun 8; 354 (23): 2443-51
58. Sealey JE, Itskovitz-Eldor J. ACE inhibitors and major congenital malformations [letter]. N Engl J Med 2006 Sep 21; 355 (12): 1280-1
59. Dahlöf B, Sever PS, Poulter NR, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 2005 Sep 10; 366: 895-906
60. Poulter NR, Wedel H, Dahlöf B, et al. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA). Lancet 2005 Sep 10; 366 (9489): 907-13
61. Jamerson KA, Weber MA, Bakris GL, et al. Avoiding Cardiovascular Events Through COMbination Therapy in Patients LIving with Systolic Hypertension, the early termination of the ACCOMPLISH trial for efficacy [abstract no. 407-2]. 57th Annual Scientific Session of the American College of Cardiology; 2008 Mar 30-Apr 1; Chicago (IL)
62. O'Riordan M. ACCOMPLISH: ACE inhibitor plus calcium-channel blocker best for reducing clinical events in hypertensive patients [media release; online]. Available from URL: http://www.medscape.com/viewarticle/572304 [Accessed 2008 May 27]
63. The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med 2008 Apr 10; 358 (15): 1547-58
64. Mancia G, Jakobsen A, Heroys J, et al. Cardiac and vascular protection: the potential of ONTARGET. Medscape J Med 2008 Mar 26; 10 Suppl.: S7
65. Bayer Schering Pharma. New antihypertensive PritorPlus® 80/25 and Kinzalkomb® 80/25 approved by EU Commission [online]. Available from URL: http://www.bayerscheringpharma.de [Accessed 2008 May 20]
66. Neutel JM, Saunders E, Bakris GL, et al. The efficacy and safety of low- and high-dose fixed combinations of irbesartan/hydrochlorothiazide in patients with uncontrolled systolic blood pressure on monotherapy: the INCLUSIVE trial. J Clin Hypertens 2005 Oct; 7 (10): 578-86
67. White WB. Relevance of blood pressure variation in the circadian onset of cardiovascular events. J Hypertens 2003; 21 Suppl. 6: S9-15
68. Cook NR, Cohen J, Hebert PR, et al. Implications of small reductions in diastolic blood pressure for primary prevention. Arch Intern Med 1995 Apr 10; 155 (7): 701-9