The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial of cardiovascular events in hypertension. Rationale and design

Blood Pressure

Volumn 7, Issue 3, 1998, Pages 176-183

  Mann, Jessica ^b   Julius, Stevo ^a  

^a UNIVERSITY OF MICHIGAN   (United States)

^b NONE

Author keywords

Amlodipine; Angiotensin II antagonist; Angiotensin receptor blocker; Cardiovascular; Cardiovascular risk; Hypertension; Intervention; Mortality morbidity; Valsartan

Indexed keywords

AMLODIPINE; ANGIOTENSIN; VALSARTAN;

ADULT; AGED; ANTIHYPERTENSIVE THERAPY; ARTICLE; CARDIOVASCULAR RISK; CIGARETTE SMOKING; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIABETES MELLITUS; DISEASE PREDISPOSITION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG MECHANISM; ESSENTIAL HYPERTENSION; FEMALE; HEART LEFT VENTRICLE HYPERTROPHY; HUMAN; HYPERCHOLESTEROLEMIA; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT;

AGED; AMLODIPINE; ANGIOTENSIN II; ANTIHYPERTENSIVE AGENTS; CALCIUM CHANNEL BLOCKERS; CARDIOVASCULAR DISEASES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPERTENSION; HYPERTROPHY, LEFT VENTRICULAR; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RESEARCH DESIGN; RISK FACTORS; TETRAZOLES; TREATMENT OUTCOME; VALINE;

EID: 0031690680     PISSN: 08037051     EISSN: None     Source Type: Journal    
DOI: 10.1080/080370598437394     Document Type: Article

References (55)

1. The Sixth Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. NIH Publication No 98-4080, 1997.
2. 1993 Guidelines for the management of mild hypertension: Memorandum from a WHO/ISH meeting. Bull WHO 1993; 71: 503-17.
3. Burt VL, Cutler JA, Higgins M, et al. Trends in the prevalence, awareness, treatment, and control of hypertension in the adult US population. Data from the Health examination surveys, 1960 to 1991. Hypertension 1995; 26: 60-9.
4. 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: 827-38.
5. Veterans' Administration Cooperative Study Group on Antihypertensive Agents. Effects of treatment on morbidity in hypertension. II. Results in patients with diastolic blood pressure averaging 90 through 114 mmHg. J Am Med Assoc 1970; 213: 1143-52.
6. Laragh JH, Sealey JE. The renin-angiotensin-aldosterone system in hypertensive disorders: a key to two forms of arteriolar vasoconstriction and a possible clue to risk of vascular injury (heart attack and stroke) and prognosis. In: Laragh JH, Brenner BM, eds. Hypertension: pathophysiology, diagnosis and management. New York: Raven Press, Ltd, 1990: 1329-8.
7. Brown MJ, Castaigne A, Ruilope LM, et al. INSIGHT: international nifedipine GITS study intervention as a goal in hypertension treatment. J Hum Hypertens 1996; 10 (Suppl 3): S157-160.
8. The Nordil Group. The Nordic Diltiazem Study (NORDIL). A prospective intervention trial of calcium antagonist therapy in hypertension. Blood Pressure 1993; 2: 312-21.
9. Wing LM, Reid CM, Ryan P, et al. Second Australian National Blood Pressure Study (ANBP2). Australian comparative outcome trial of ACE inhibitor- and diuretic-based treatment of hypertension in the elderly. Management Committee on behalf of the High Blood Pressure Research Council of Australia. Clin Exp Hypertens 1997; 19: 779-91.
10. The CAPPP Group. The Captopril Prevention Project: a prospective intervention trial of angiotensin converting enzyme inhibition in the treatment of hypertension. J Hypertens 1990; 8: 985-90.
11. Dahlöf B, Devereux R, de Faire U, et al. The Losartan Intervention for Endpoint reduction (LIFE) in hypertension study. Rationale, design and methods. Am J Hypertens 1997; 10: 705-13.
12. Furberg CD, Psaty BM, Meyer JV. Nifedipine: dose-related increase in mortality in patients with coronary heart disease. Circulation 1995; 92: 1326-31.
13. Estacio RO, Jeffers BW, Hiatt WR, et al. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin dependent diabetes and hypertension. N Engl J Med 1998; 338: 645-52.
14. Staessen JS, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. Lancet 1997; 350: 757-64.
15. SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. JAMA 1991; 265: 3255-64.
16. Braunwald E. Mechanism of action of calcium-channel blocking agents. N Engl J Med 1982; 307: 1618-27.
17. Tsuiki K, Ohata I, Oh-Hara N, Kaminishi T, Oguma M, Yasui S. Effect of diltiazem on coronary blood flow distribution in dog heart under ischemia. J Cardiovasc Pharmacol 1989; 14: 268-77.
18. McDonagh PF, Roberts DJ. Prevention of transcoronary macromolecular leakage after ischaemia - reperfusion by the calcium entry blocker, nisoldipine. Circ Res 1986; 58: 127-36.
19. Sullivan AT, Baker DJ, Drew GM. Effects of calcium channel blocking agents on infarct size after ischemia - reperfusion in anesthetized pigs: relationship between cardioprotection and cardiodepression. J Cardiovasc Pharmacol 1991; 17: 707-17.
20. Lichtlen PR, Hugenholtz PG, Rafflenbeul W, Heaber H, Jost S, Deckers JW. Retardation of angiographic progression of coronary artery disease by nifedipine. Lancet 1990; 335: 1009-13.
21. Kober G, Schneider W, Kaltenbach M. Can the progression of coronary sclerosis be influenced by calcium antagonists? J Cardiovasc Pharmacol 1989; 13 (Suppl 4): S2-S6.
22. Psaty BM, Heckbert SR, Koepsell TD, et al. The risk of myocardial infarction associated with antihypertensive drug therapies. JAMA 1995; 274: 620-5.
23. Schelling P, Fischer H, Ganten D. Angiotensin and cell growth: a link to cardiovascular hypertrophy? J Hypertens 1991; 9: 3-15.
24. Weber KT, Brilla CG. Factors associated with reactive and reparative fibrosis of the myocardium. Basic Res Cardiol 1992; 87 (Suppl 7): 291-301.
25. Dietz R, Waas W, Haberbosch W, et al. Modulation of coronary circulation and the cardiac matrix by the renin-angiotensin system. Eur Heart J 1991; 12(Suppl F): 107-11.
26. Naftilan AJ, Pratt RE, Dzau VJ. Induction of platelet-derived growth factor A-chain and c-myc gene expressions by angiotensin II in cultured rat vascular smooth muscle cells. J Clin Invest 1989; 83: 1419-24.
27. Folkow B. Physiological aspects of primary hypertension. Physiol Rev 1982; 62: 347-503.
28. Schiffrin EL, Deng L. Comparison of effects of angiotensin I-converting enzyme inhibition and beta-blockade for 2 years on function of small arteries from hypertensive patients. Hypertension 1995; 25 (part2): 699-703.
29. Ghali JK, Lias Y, Simmorts B, et al. The prognostic role of left ventricular hypertrophy in patients with or without coronary artery disease. Ann Intern Med 1992; 117: 831-6.
30. Levy D, Garrison RJ, Savage DD, Kannel WB, Castelli WP. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham study. N Engl J Med 1990; 322: 1561-6.
31. Linz W, Scholkens BA, Ganten D. Converting enzyme inhibition specifically prevents the development and induces regression of cardiac hypertrophy in rats. Clin Exp Hypertens 1989; 11: 1325-50.
32. Dahlöf B, Pennert K, Hansson L. Regression of left ventricular hypertrophy - a meta-analysis. Clin Exper Hypertens 1992; A14: 173-80.
33. Schmieder RE, Martus P, Klingbeil A. Reversal of left ventricular hypertrophy in essential hypertension. A meta-analysis of randomised, double-blind studies. JAMA 1996; 275: 1507-13.
34. Gottdiener JS, Reda DJ, Massie BM, et al. Effect of single-drug therapy on reduction of left ventricular mass in mild to moderate hypertension. Comparison of six antihypertensive agents. Circulation 1997; 95: 2007-14.
35. Liebson PR, Grandits GA, Dianzumba S, et al. Comparison of five antihypertensive monotherapies and placebo for change in left ventricular mass in patients receiving nutritional-hygienic therapy in the Treatment of Mild Hypertension Study (TOMHS). Circulation 1995; 91: 698-706.
36. Agabiti-Rosei E, Ambrosioni E, Dal Palu C, Muiesan ML, Zanchetti A. ACE inhibitor ramipril is more effective than the beta-blocker atenolol in reducing left ventricular mass in hypertension. Results of the RACE (ramipril cardioprotective evaluation) study. J Hypertens 1995; 13: 1325-34.
37. Thurmann P, Kenedi P, Schmidt A, Harder S, Rietbrock N. Influence of the angiotensin II antagonist valsartan on left ventricular hypertrophy in patients with essential hypertension (submitted).
38. Brush JE, Cannon RO, Schenke WH, et al. Angina due to coronary microvascular disease in hypertensive patients without left ventricular hypertrophy. N Engl J Med 1988; 319: 1302-7.
39. Lüscher TF, Boulanger CM, Dohi Y, Yang Z. Endothelium-derived contracting factors. Hypertension 1992; 19: 117-30.
40. Panza JA, Quyyumi AA, Brush JE, Epstein SE. Abnormal endothelium-dependent vascular relaxation in patients with essential hypertension. N Engl J Med 1990; 323: 22-7.
41. Mancini GBJ, Henry GC, Macaya C, et al. Angiotensin-converting enzyme inhibition with quinapril improves endothelial vasomotor dysfunction in patients with coronary artery disease. Circulation 1996; 94: 258-265.
42. Geisterfer AAT, Peach MJ, Owens G. Angiotensin II induces hypertrophy, not hyperplasia, of cultured rat aortic smooth muscle cells. Circ Res 1988; 62: 749-56.
43. Chobanian AV, Haudenschild CC, Nickerson C, Drago R. Antiatherogenic effect of captopril in the Watanabe heritable hyperlipidemic rabbit. Hypertension 1990; 15: 327-31.
44. Chobanian AV, Haudenschild CC, Nickerson C, Hope S. Trandolapril inhibits atherosclerosis in the Watanabe heritable hyperlipidemic rabbit. Hypertension 1992; 20: 473-7.
45. Chobanian AV, Hope S, Brecher P. Dissociation between the antiatherosclerotic effect of trandolapril and suppression of serum and aortic angiotensin-converting enzyme activity in the Watanabe heritable hyperlipidemic rabbit. Hypertension 1995; 25: 1306-10.
46. Pfeffer MA, Lamas GA, Vaughan DE, Parisi AF, Braunwald E. Effect of captopril on progressive ventricular dilatation after anterior myocardial infarction. N Engl J Med 1988; 319: 80-6.
47. Pfeffer MA, Braunwald E, Moyé LA, et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 1992; 327: 669-77.
48. The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators: effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure. Lancet 1993; 342: 821-8.
49. Pitt B, Segal R, Martinez FA, et al. Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet 1997; 349: 747-52.
50. Brunner HR, Laragh JH, Baer L, et al. Essential hypertension: renin and aldosterone, heart attack and stroke. N Engl J Med 1972; 286: 441-449.
51. Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26 year follow up of the Framingham population. Am Heart J 1986; 111: 383-91.
52. Kannel WB, Stampfer MJ, Castelli WP, Verter J. The prognostic significance of proteinuria. The Framingham study. Am Heart J 1984; 108: 1347-52.
53. Benhorin J, Moss AJ, Oakes D, et al. Prognostic significance of non fatal myocardial reinfarction. J Am Coll Cardiol 1990; 15: 253-34.
54. Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Controlled Clinical Trials 1991; 2: 93-113.
55. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-663.