Zofenopril plus hydrochlorothiazide fixed combination in the treatment of hypertension and associated clinical conditions

Cardiovascular Therapeutics

Volumn 27, Issue 4, 2009, Pages 275-288

  Omboni, Stefano ^a   Malacco, Ettore ^b   Parati, Gianfranco ^c  

^a ITALIAN INSTITUTE OF TELEMEDICINE   (Italy)

^b UNIVERSITY OF MILAN   (Italy)

^c UNIVERSITY OF MILANO BICOCCA   (Italy)

Author keywords

Chronic kidney disease; Diabetes mellitus; Dyslipidemia; Hypertension; Metabolic syndrome; Zofenopril; Zofenopril plus hydrochlorothiazide

Indexed keywords

AMLODIPINE; ANGIOTENSIN II ANTAGONIST; ANTIHYPERTENSIVE AGENT; ATENOLOL; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM ANTAGONIST; CANDESARTAN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; ENALAPRIL; GLUCOSE; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE PLUS IRBESARTAN; HYDROCHLOROTHIAZIDE PLUS LISINOPRIL; HYDROCHLOROTHIAZIDE PLUS TELMISARTAN; HYDROCHLOROTHIAZIDE PLUS ZOFENOPRIL; INDAPAMIDE; INDAPAMIDE PLUS PERINDOPRIL; IRBESARTAN; LISINOPRIL; LOSARTAN; PERINDOPRIL; PLACEBO; TELMISARTAN; UNCLASSIFIED DRUG; ZOFENOPRIL;

ACUTE HEART INFARCTION; ANTIHYPERTENSIVE ACTIVITY; ANTIOXIDANT ACTIVITY; BLOOD PRESSURE MONITORING; BLOOD PRESSURE REGULATION; CARDIOVASCULAR RISK; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIABETES MELLITUS; DIABETIC NEPHROPATHY; DIZZINESS; DOSE CALCULATION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; ESSENTIAL HYPERTENSION; HEART INFARCTION; HEART PROTECTION; HIGH RISK PATIENT; HUMAN; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPERRENINEMIA; HYPERTENSION; HYPERURICEMIA; IMPAIRED GLUCOSE TOLERANCE; KIDNEY DYSFUNCTION; KIDNEY FAILURE; METABOLIC DISORDER; METABOLIC SYNDROME X; MONOTHERAPY; NONHUMAN; PATIENT COMPLIANCE; POLYURIA; PRACTICE GUIDELINE; PRIORITY JOURNAL; REFLEX TACHYCARDIA; RENIN ANGIOTENSIN ALDOSTERONE SYSTEM; REVIEW; RISK FACTOR; SODIUM DEPLETION; SYSTOLIC HYPERTENSION; TACHYCARDIA;

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CAPTOPRIL; DIURETICS; DRUG THERAPY, COMBINATION; HUMANS; HYDROCHLOROTHIAZIDE; HYPERTENSION; KIDNEY DISEASES; METABOLIC DISEASES;

EID: 70449463153     PISSN: 17555914     EISSN: 17555922     Source Type: Journal    
DOI: 10.1111/j.1755-5922.2009.00102.x     Document Type: Review

References (78)

1. 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.
2. Collins R, Peto R, MacMahon S, et al. Blood pressure, stroke, and coronary heart disease: Part 2. Short-term reductions in blood pressure: Overview of randomised drug trials in their epidemiological context. Lancet 1990 335 : 827 838.
3. Blood Pressure Lowering Treatment Trialists' Collaboration, Turnbull F, Neal B, Ninomiya T, et al. Effects of different regimens to lower blood pressure on major cardiovascular events in older and younger adults: Meta-analysis of randomised trials. BMJ 2008 336 : 1121 1123.
4. Staessen JA, Li Y, Thijs L, Wang JG. Blood pressure reduction and cardiovascular prevention: An update including the 2003-2004 secondary prevention trials. Hypertens Res 2005 28 : 385 407.
5. Staessen JA, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Lancet 1997 350 : 757 764.
6. 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. (Pubitemid 28269185)
7. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998 317 : 703 713.
8. Brown MJ, Palmer CR, Castaigne A, de Leeuw PW, Mancia G, Rosenthal T, Ruilope LM. Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Lancet 2000 356 : 366 372.
9. Hansson L, Hedner T, Lund-Johansen P, et al. Randomised trial of effects of calcium antagonists compared with diuretics and beta-blockers on cardiovascular morbidity and mortality in hypertension: The Nordic Diltiazem (NORDIL) study. Lancet 2000 356 : 359 365.
10. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin versus usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA 2002 288 : 2998 3007.
11. Dahlof 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 2002 359 : 995 1003. (Pubitemid 34286536)
12. Wing LM, Reid CM, Ryan P, et al. Second Australian National Blood Pressure Study Group. A comparison of outcomes with angiotensin-converting- enzyme inhibitors and diuretics for hypertension in the elderly. N Engl J Med 2003 348 : 583 592.
13. Black HR, Elliott WJ, Grandits G, et al. CONVINCE Research Group. Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) Trial. JAMA 2003 289 : 2073 2082.
14. 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 2004 363 : 2022 2031.
15. Beckett NS, Peters R, Fletcher AE, et al. HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008 358 : 1887 1898.
16. 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 published correction appears in J Hypertens 2007 25 : 1749. (Pubitemid 46924065)
17. Chobanian AV, Bakris GL, Black HR, et al. for the National High Blood Pressure Education Program Coordinating Committee. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII Report). JAMA 2003 289 : 2560 2572 published correction appears in JAMA 2003;290:197.
18. Bisognano JD, McLaughlin T, Roberts CS, Tang SS. Calcium channel blockers, angiotensin receptor blockers, and angiotensin-converting enzyme inhibitors: Effectiveness in combination with diuretics or beta-blockers for treating hypertension. Vasc Health Risk Manag 2007 3 : 579 585.
19. Wald DS, Law M, Morris JK, Bestwick JP, Wald NJ. Combination therapy versus monotherapy in reducing blood pressure: Meta-analysis on 11,000 participants from 42 trials. Am J Med 2009 122 : 290 300.
20. Waeber B. Combination therapy with ACE inhibitors/angiotensin II receptor antagonists and diuretics in hypertension. Expert Rev Cardiovasc Ther 2003 1 : 43 50.
21. Sica DA. Rationale for fixed-dose combinations in the treatment of hypertension: The cycle repeats. Drugs 2002 62 : 443 462.
22. Smith DH. Fixed-dose combination antihypertensives and reduction in target organ damage: Are they all the same? Am J Cardiovasc Drugs 2007 7 : 413 422.
23. Lewis EJ, Hunsicker LG, Bain RP, Rohde RD. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. The Collaborative Study Group. N Engl J Med 1993 329 : 1456 1462.
24. Giatras I, Lau J, Levey AS. Effect of angiotensin-converting enzyme inhibitors on the progression of nondiabetic renal disease: A meta-analysis of randomized trials. Angiotensin-Converting Enzyme Inhibition and Progressive Renal Disease Study Group. Ann Intern Med 1997 127 : 337 345.
25. Zofenopril + Hydrochlorothiazide. Summary of product characteristics, 2007. Available on request from the authors.
26. Pasini AF, Garbin U, Nava MC, et al. Effect of sulfhydryl and non-sulfhydryl angiotensin-converting enzyme inhibitors on endothelial function in essential hypertensive patients. Am J Hypertens 2007 20 : 443 450.
27. Evangelista S, Manzini S. Antioxidant and cardioprotective properties of the sulphydryl angiotensin-converting enzyme inhibitor zofenopril. J Int Med Res 2005 33 : 42 54.
28. Napoli C, Sica V, de Nigris F, Pignalosa O, Condorelli M, Ignarro LJ, Liguori A. Sulfhydryl angiotensin-converting enzyme inhibition induces sustained reduction of systemic oxidative stress and improves the nitric oxide pathway in patients with essential hypertension. Am Heart J 2004 148 : e5.
29. Borghi C, Ambrosioni E, Survival of Myocardial Infarction Long-term Evaluation-2 Working Party. Double-blind comparison between zofenopril and lisinopril in patients with acute myocardial infarction: Results of the Survival of Myocardial Infarction Long-term Evaluation-2 (SMILE-2) Study. Am Heart J 2003 145 : 80 87.
30. Borghi C, Bacchelli S, Esposti DD, Bignamini A, Magnani B, Ambrosioni E. Effects of the administration of an angiotensin-converting enzyme inhibitor during the acute phase of myocardial infarction in patients with arterial hypertension. SMILE Study Investigators. Survival of myocardial infarction long-term evaluation. Am J Hypertens 1999 12 : 665 672.
31. Borghi C, Bacchelli S, Esposti DD, Ambrosioni E, SMILE Study. Effects of the early ACE inhibition in diabetic nonthrombolyzed patients with anterior acute myocardial infarction. Diabetes Care 2003 26 : 1862 1868.
32. Kelbaek H, Agner E, Wroblewski H, Vasehus Madsen P, Marving J. Angiotensin converting enzyme inhibition at rest and during exercise in congestive heart failure. Eur Heart J 1993 14 : 692 695.
33. Binkley PF, Haas GJ, Starling RC, Nunziata E, Hatton PA, Leier CV, Cody RJ. Sustained augmentation of parasympathetic tone with angiotensin-converting enzyme inhibition in patients with congestive heart failure. J Am Coll Cardiol 1993 21 : 655 661.
34. Nilsson P. Antihypertensive efficacy of zofenopril compared with atenolol in patients with mild to moderate hypertension. Blood Press 2007 2 (suppl 25 30.
35. Farsang C. Blood pressure control and response rates with zofenopril compared with amlodipine in hypertensive patients. Blood Press 2007 2 (suppl 19 24.
36. Lacourciere Y, Provencher P. Comparative effects of zofenopril and hydrochlorothiazide on office and ambulatory blood pressures in mild to moderate essential hypertension. Br J Clin Pharmacol 1989 27 : 371 376.
37. Mallion JM. An evaluation of the initial and long-term antihypertensive efficacy of zofenopril compared with enalapril in mild to moderate hypertension. Blood Press 2007 2 (suppl. 13 18.
38. Malacco E, Piazza S, Omboni S. Zofenopril versus lisinopril in the treatment of essential hypertension in elderly patients. A randomised, double-blind, multicentre study. Clin Drug Invest 2005 25 : 175 182.
39. Narkiewicz K. Comparison of home and office blood pressure in hypertensive patients treated with zofenopril or losartan. Blood Press 2007 2 (suppl 7 12.
40. Leonetti G, Rappelli A, Omboni S, on behalf of the Study Group. A similar 24-h blood pressure control is obtained by zofenopril and candesartan in primary hypertensive patients. Blood Press 2006 15 (suppl 1 18 26.
41. Zofenopril Calcium + Hydrochlorothiazide Investigator's Brochure. Version 5.0. Release Date: April 18, 2008. Available on request from the authors.
42. Westendorp B, Schoemaker RG, van Gilst WH, van Veldhuisen DJ, Buikema H. Hydrochlorothiazide increases plasma or tissue angiotensin-converting enzyme-inhibitor drug levels in rats with myocardial infarction: Differential effects on lisinopril and zofenopril. Eur J Pharmacol 2005 527 : 141 149.
43. García-Estañ J, Ortiz MC, O'Valle F, et al. Effects of angiotensin-converting-enzyme inhibitors in combination with diuretics on blood pressure and renal injury in nitric oxide-deficiency-induced hypertension in rats. Clin Sci (Lond) 2006 110 : 227 233.
44. Parati G, Omboni S, Malacco E, on behalf of the Study Group. Antihypertensive efficacy of zofenopril and hydrochlorothiazide combination on ambulatory blood pressure. Blood Press 2006 15 (suppl.1 7 17. (Pubitemid 43347948)
45. Malacco E, Omboni S. Antihypertensive efficacy of zofenopril plus hydrochlorothiazide fixed combination is superior to that of single components. Eur Heart J 2005 26 (suppl 401.
46. Malacco E, Omboni S. Antihypertensive efficacy of zofenopril plus hydrochlorothiazide fixed combination for treatment in metabolic syndrome. Adv Ther 2007 24 : 1006 1115.
47. Malacco E, Omboni S. Antihypertensive effect fo zofenopril plus hydrochlorothiazide versus zofenopril monotherapy in patients with essential hypertension according to their cardiovascular risk level: A post hoc analysis. Curr Ther Res 2008 69 : 232 242.
48. Rizzoni D, Muiesan ML, Salvetti M, et al. The smoothness index, but not the trough-to-peak ratio predicts changes in carotid artery wall thickness during antihypertensive treatment. J Hypertens 2001 19 : 703 711.
49. Parati G, Omboni S, Rizzoni D, Agabiti-Rosei E, Mancia G. The smoothness index: A new, reproducible and clinically relevant measure of the homogeneity of the blood pressure reduction with treatment for hypertension. J Hypertens 1998 16 : 1685 1691.
50. Omboni S, Parati G, Mancia G. The trough:peak ratio and the smoothness index in the evaluation of control of 24h blood pressure by treatment in hypertension. Blood Press Monit 1998 3 : 201 204. (Pubitemid 28479252)
51. Omboni S, Benemio G, Corradi L, et al. Antihjypertensive efficacy of lisinopril plus hydrochlorothiazide versus ramipril plus felodipine in essential hypertension. High Blood Press 1998 7 : 80 86.
52. Mallion JM, Chamontin B, Asmar R REASON Project. Twenty-four-hour ambulatory blood pressure monitoring efficacy of perindopril/indapamide first-line combination in hypertensive patients: The REASON Study. Am J Hypertens 2004 17 : 245 251.
53. 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.
54. Fogari R, Preti P, Zoppi A, Corradi L, Pasotti C, Rinaldi A, Mugellini A. Effect of telmisartan/hydrochlorothiazide combination versus nifedipine GITS on ambulatory blood pressure and sympathetic activation. Am J Hypertens 2005 18 (5 Pt 1 577 583.
55. Eckel RH, Grundy SM, Zimmet PZ. The metabolic syndrome. Lancet 2005 365 : 1415 1428.
56. Hunt KJ, Resendez RG, Williams K, Haffner SM, Stern MP San Antonio Heart Study. National cholesterol education program versus world health organization metabolic syndrome in relation to all-cause and cardiovascular mortality in the San Antonio Heart Study. Circulation 2004 110 : 1251 1257.
57. Lakka HM, Laaksonen DE, Lakka TA, Niskanen LK, Kumpusalo E, Tuomilehto J, Salonen JT. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA 2002 288 : 2709 2716.
58. Isomaa B, Almgren P, Tuomi T, et al. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care 2001 24 : 683 689.
59. Hu G, Qiao Q, Tuomilehto J, Balkau B, Borch-Johnsen K, Pyorala K DECODE Study Group. Prevalence of the metabolic syndrome and its relation to all-cause and cardiovascular mortality in nondiabetic European men and women. Arch Intern Med 2004 164 : 1066 1076.
60. Bonora E, Targher G, Formentini G, et al. The metabolic syndrome is an independent predictor of cardiovascular disease in Type 2 diabetic subjects. Prospective data from the Verona Diabetes Complications Study. Diabet Med 2004 21 : 52 58.
61. Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: Findings from the third National Health and Nutrition Examination Survey. JAMA 2002 287 : 356 359.
62. Deedwania PC, Volkova N. Current Treatment Options for the Metabolic Syndrome. Curr Treat Options Cardiovasc Med 2005 7 : 61 74.
63. Abuissa H, Jones PG, Marso SP, O'Keefe JH Jr. Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for prevention of type 2 diabetes: A meta-analysis of randomised clinical trials. J Am Coll Cardiol 2005 46 : 821 826.
64. Sharma AM. Is there a rationale for angiotensin blockade in the management of obesity hypertension? Hypertension 2004 44 : 12 19.
65. Singh BM, Mehta JL. Interactions between the renin-angiotensin system and dyslipidemia: Relevance in the therapy of hypertension and coronary heart disease. Arch Intern Med 2003 163 : 1296 1304.
66. Borghi C, Bacchelli S, Esposti DD, Ambrosioni E SMILE Study. Effects of the early ACE inhibition in diabetic nonthrombolyzed patients with anterior acute myocardial infarction. Diabetes Care 2003 26 : 1862 1868.
67. Grundy SM, Cleeman JI, Daniels SR, et al. American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: An American Heart Association/National Heart, Lung, and Blood Institute scientific statement. Circulation 2005 112 : 2735 2752.
68. Onat A, Avci GS, Barlan MM, Uyarel H, Uzunlar B, Sansoy V. Measures of abdominal obesity assessed for visceral adiposity and relation to coronary risk. Int J Obes Relat Metab Disord 2004 28 : 1018 1025.
69. Grundy SM. Hypertriglyceridemia, atherogenic dyslipidemia, and the metabolic syndrome. Am J Cardiol 1998 81 : 18B 25B.
70. Lamarche B, Tchernof A, Moorjani S, Cantin B, Dagenais GR, Lupien PJ, Despres JP. Small, dense low-density lipoprotein particles as predictor of the risk of ischemic heart disease in men: Prospective results from the Quebec Cardiovascular Study. Circulation 1997 94 : 69 75. (Pubitemid 27029945)
71. de Leeuw PW, Ruilope LM, Palmer CR, et al. Clinical significance of renal function in hypertensive patients at high risk: Results from the INSIGHT trial. Arch Intern Med 2004 164 : 2459 2464.
72. Ruilope LM, Salvetti A, Jamerson K, Hansson L, Warnold I, Wedel H, Zanchetti A. Renal function and intensive lowering of blood pressure in hypertensive participants of the hypertension optimal treatment (HOT) study. J Am Soc Nephrol 2001 12 : 218 225.
73. Rahman M, Pressel S, Davis BR, et al. ALLHAT Collaborative Research Group. Cardiovascular outcomes in high-risk hypertensive patients stratified by vaseline glomerular filtration rate. Ann Intern Med 2006 144 : 172 180.
74. Casas JP, Chua W, Loukogeorgakis S, Vallance P, Smeeth L, Hingorani AD, MacAllister RJ. Effect of inhibitors of the renin-angiotensin system and other antihypertensive drugs on renal outcomes: Systematic review and meta-analysis. Lancet 2005 366 : 2026 2033.
75. Kunz R, Friedrich C, Wolbers M, Mann JF. Meta-analysis: Effect of monotherapy and combination therapy with inhibitors of the renin-angiotensin system on proteinuria in renal disease. Ann Intern Med 2008 148 : 30 48.
76. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976 16 : 31 41.
77. National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification and stratification. Am J Kidney Dis 2002 39 (suppl 1 S1 S266.
78. Conroy RM, Pyöräläl K, Fitzgerald AP, et al. for the SCORE Project Group. Estimation of ten-year risk of fatal cardiovascular disease in Europe: The SCORE project. Eur Heart J 2003 24 : 987 1003.