Efficacy and safety of fixed combinations of irbesartan/hydrochlorothiazide in hypertensive women: The inclusive trial

Journal of Women's Health

Volumn 17, Issue 6, 2008, Pages 931-938

  Ofili, Elizabeth O ^a   Cable, Greg ^b   Neutel, Joel M ^c   Saunders, Elijah ^d  

^a MOREHOUSE SCHOOL OF MEDICINE   (United States)

^b SANOFI   (France)

^c Orange County Research Center   (United States)

^d UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE PLUS IRBESARTAN; PLACEBO;

ADULT; AFRICAN AMERICAN; ARTICLE; CAUCASIAN; CLINICAL TRIAL; COMORBIDITY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; GROUPS BY AGE; HEADACHE; HISPANIC; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; METABOLIC SYNDROME X; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SINGLE BLIND PROCEDURE; SINUSITIS; STATISTICAL SIGNIFICANCE; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; URINARY TRACT INFECTION;

ADULT; AGED; ANTIHYPERTENSIVE AGENTS; BIPHENYL COMPOUNDS; BLOOD PRESSURE; DIABETES MELLITUS, TYPE 2; DRUG COMBINATIONS; FEMALE; HUMANS; HYDROCHLOROTHIAZIDE; HYPERTENSION; MIDDLE AGED; PROSPECTIVE STUDIES; TETRAZOLES;

EID: 49149115955     PISSN: 15409996     EISSN: None     Source Type: Journal    
DOI: 10.1089/jwh.2008.0499     Document Type: Article

References (51)

1. Ong KL, Cheung BMY, Man YB, Lau CP, Lam KSL. Prevalence, awareness, treatment, and control of hypertension among United States adults, 1999-2004. Hypertension 2007;49:69-75.
2. Rosamond W, Flegal K, Friday G, et al. Heart disease and stroke statistics - 2007 update: A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2007;115:e69-171.
3. Lund LH, Mancini D. Heart failure in women. Med Clin North Am 2004;88:1321-1345.
4. Agabiti-Rosei E, Muiesan ML. Left ventricular hypertrophy and heart failure in women. J Hypertens (Suppl) 2002;20:S34-S38.
5. Regitz-Zagrosek V, Lehmkuhl E. Heart failure and its treatment in women. Role of hypertension, diabetes, and estrogen. Herz 2005;30:356-367.
6. Gudmundsson LS, Johannsson M, Thorgeirsson G, Sigfusson N, Sigvaldason H, Witteman JC. Hypertension control as predictor of mortality in treated men and women, followed for up to 30 years. Cardiovasc Drugs Ther 2005;19:227-235.
7. Welty FK. Women and cardiovascular risk. Am J Cardiol 2001;88:48J-52J.
8. McBride SM, Flynn FW, Ren J. Cardiovascular alteration and treatment of hypertension: Do men and women differ? Endocrine 2005;28:199-207.
9. 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;289:2560-2572.
10. 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). J Hypertens 2007;25:1105-1187.
11. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2004;27:S15-S35.
12. 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 Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002;288:2981-2997.
13. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: The VALUE randomised trial. Lancet 2004;363:2022-2031.
14. MacMahon S, Peto R, Cutler J, et al. Blood pressure, stroke, and coronary heart disease. Part 1, Prolonged differences in blood pressure: Prospective observational studies corrected for the regression dilution bias. Lancet 1990;335:765-774.
15. Kochar M, Guthrie R, Triscari J, Kassler-Taub K, Reeves RA. Matrix study of irbesartan with hydrochlorothiazide in mild-to-moderate hypertension. Am J Hypertens 1999;12:797-805.
16. Rosenstock J, Rossi L, Lin CS, MacNeil D, Osbakken M. The effects of irbesartan added to hydrochlorothiazide for the treatment of hypertension in patients non-responsive to hydrochlorothiazide alone. J Clin Pharm Ther 1998;23:433-440.
17. Howe P, Phillips P, Saini R, Kassler-Taub K. The antihypertensive efficacy of the combination of irbesartan and hydrochlorothiazide assessed by 24-hour ambulatory blood pressure monitoring. Irbesartan Multicenter Study Group. Clin Exp Hypertens 1999;21:1373-1396.
18. Raskin P, Guthrie R, Flack J, Reeves R, Saini R. The long-term antihypertensive activity and tolerability of irbesartan with hydrochlorothiazide. J Hum Hypertens 1999;13:683-687.
19. Coca A, Calvo C, Sobrino J, et al. Once-daily fixed-combination irbesartan 300 mg/ hydrochlorothiazide 25 mg and circadian blood pressure profile in patients with essential hypertension. Clin Ther 2003;25:2849-2864.
20. 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 (Greenwich) 2005;7:578-586.
21. Sowers JR, Neutel JM, Saunders E, et al. Antihypertensive efficacy of Irbesartan/HCTZ in men and women with the metabolic syndrome and type 2 diabetes. J Clin Hypertens (Greenwich) 2006;8:470-480.
22. Ofili EO, Ferdinand KC, Saunders E, et al. Irbesartan/HCTZ fixed combinations in patients of different racial/ethnic groups with uncontrolled systolic blood pressure on monotherapy. J Natl Med Assoc 2006;98:618-626.
23. Neutel JM, Franklin SS, Oparil S, Bhaumik A, Ptaszynska A, Lapuerta P. Efficacy and safety of irbesartan/HCTZ combination therapy as initial treatment for rapid control of severe hypertension. J Clin Hypertens (Greenwich) 2006;8:850-857.
24. Neutel JM, Franklin SS, Lapuerta P, Bhaumik A, Ptaszynska A. A comparison of the efficacy and safety of irbesartan/HCTZ combination therapy with irbesartan and HCTZ monotherapy in the treatment of moderate hypertension. J Hum Hypertens 2007, October 11 e-pub ahead of print.
25. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002;106:3143-3421.
26. O'Brien E, Mee F, Atkins N, Thomas M. Evaluation of three devices for self-measurement of blood pressure according to the revised British Hypertension Society Protocol: The Omron HEM-705CP, Philips HP5332, and Nissei DS-175. Blood Press Monit 1996;1:55-61.
27. Fleiss JL. Statistical methods for rates and proportions, 2nd ed. New York: John Wiley & Sons, 1981.
28. Kjeldsen SE, Os I, Hoieggen A, Beckey K, Gleim GW, Oparil S. Fixed-dose combinations in the management of hypertension: Defining the place of angiotensin receptor antagonists and hydrochlorothiazide. Am J Cardiovasc Drugs 2005;5:17-22.
29. Dahlof B, Gosse P, Gueret P, et al. Perindopril/indapamide combination more effective than enalapril in reducing blood pressure and left ventricular mass: The PICXEL study. J Hypertens 2005;23:2063-2070.
30. Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: Analysis of 354 randomised trials. BMJ 2003;326:1427.
31. Fox KM. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: Randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet 2003;362:782-788.
32. Salerno CM, Demopoulos L, Mukherjee R, Gradman AH. Combination angiotensin receptor blocker/hydrochlorothiazide as initial therapy in the treatment of patients with severe hypertension. J Clin Hypertens (Greenwich) 2004;6:614-620.
33. Lacourciere Y, Poirier L, Hebert D, et al. Antihypertensive efficacy and tolerability of two fixed-dose combinations of valsartan and hydrochlorothiazide compared with valsartan monotherapy in patients with stage 2 or 3 systolic hypertension: An 8-week, randomized, double-blind, parallel-group trial. Clin Ther 2005;27:1013-1021.
34. Flack JM, Hamaty M. Difficult-to-treat hypertensive populations: Focus on African-Americans and people with type 2 diabetes. J Hypertens (Suppl) 1999;17:S19-S24.
35. Douglas JG. Clinical guidelines for the treatment of hypertension in African Americans. Am J Cardiovasc Drugs 2005;5:1-6.
36. Lindholm LH, Ibsen H, Dahlof B, et al. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A randomised trial against atenolol. Lancet 2002;359:1004-1010.
37. 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) randomised trial. HOT Study Group. Lancet 1998;351:1755-1762.
38. McFarlane SI, Castro J, Kaur J, et al. Control of blood pressure and other cardiovascular risk factors at different practice settings: Outcomes of care provided to diabetic women compared to men. J Clin Hypertens (Greenwich) 2005;7:73-80.
39. Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001;345:851-860.
40. Bakris GL, Williams M, Dworkin L, et al. Preserving renal function in adults with hypertension and diabetes: A consensus approach. National Kidney Foundation Hypertension and Diabetes Executive Committees Working Group. Am J Kidney Dis 2000;36:646-661.
41. Nakao N, Yoshimura A, Morita H, Takada M, Kayano T, Ideura T. Combination treatment of angiotensin-II receptor blocker and angiotensin-converting-enzyme inhibitor in non-diabetic renal disease (COOPERATE): A randomised controlled trial. Lancet 2003;361:117-124.
42. Randomised placebo-controlled trial of effect of ramipril on decline in glomerular filtration rate and risk of terminal renal failure in proteinuric, non-diabetic nephropathy. The GISEN Group (Gruppo Italiano di Studi Epidemiologici in Nefrologia). Lancet 1997;349:1857-1863.
43. Ruggenenti P, Perna A, Loriga G, et al. Blood-pressure control for renoprotection in patients with non-diabetic chronic renal disease (REIN-2): Multicentre, randomised controlled trial. Lancet 2005;365:939-946.
44. Meredith PA. Angiotensin II receptor antagonists alone and combined with hydrochlorothiazide: Potential benefits beyond the antihypertensive effect. Am J Cardiovasc Drugs 2005;5:171-183.
45. Scheen AJ. Prevention of type 2 diabetes mellitus through inhibition of the renin-angiotensin system. Drugs 2004;64:2537-2565.
46. Sarafidis PA, Bakris GL. Antihypertensive therapy and the risk of new-onset diabetes. Diabetes Care 2006;29:1167-1169.
47. Zillich AJ, Garg J, Basu S, Bakris GL, Carter BL. Thiazide diuretics, potassium, and the development of diabetes: A quantitative review. Hypertension 2006;48:219-224.
48. Benedict CR. Safe and effective management of hypertension with fixed-dose combination therapy: Focus on losartan plus hydrochlorothiazide. Int J Clin Pract 2000;54:48-54.
49. Chrysant SG. Fixed combination therapy of hypertension: Focus on valsartan/hydrochlorothiazide combination (Diovan/HCT). Expert Rev Cardiovasc Ther 2003;1:335-343.
50. Croom KF, Curran MP, Goa KL, Perry CM. Irbesartan: A review of its use in hypertension and in the management of diabetic nephropathy. Drugs 2004;64:999-1028.
51. Chrysant SG, Chrysant GS. Antihypertensive efficacy of olmesartan medoxomil alone and in combination with hydrochlorothiazide. Expert Opin Pharmacother 2004;5:657-667.