Design of combination angiotensin receptor blocker and angiotensin- converting enzyme inhibitor for treatment of diabetic nephropathy (VA NEPHRON-D)

Clinical Journal of the American Society of Nephrology

Volumn 4, Issue 2, 2009, Pages 361-368

  Fried, Linda F ^a   Duckworth, William ^b   Zhang, Jane Hongyuan ^c   O'Connor, Theresa ^c   Brophy, Mary ^d   Emanuele, Nicholas ^e   Huang, Grant D ^f   McCullough, Peter A ^g   Palevsky, Paul M ^a   Seliger, Stephen ^h   Warren, Stuart R ⁱ   Peduzzi, Peter ^c  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

^c VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^d BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^f US Department of Housing   (United States)

^g WILLIAM BEAUMONT HOSPITAL   (United States)

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

ⁱ UNIVERSITY OF NEW MEXICO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; ALDOSTERONE; ANGIOTENSIN; ANGIOTENSIN RECEPTOR ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; LISINOPRIL; LOSARTAN; PLACEBO; RENIN;

ALBUMINURIA; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIABETIC NEPHROPATHY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG SAFETY; EMERGENCY WARD; GLOMERULUS FILTRATION RATE; HEMODIALYSIS; HOSPITAL ADMISSION; HUMAN; HYPERKALEMIA; KIDNEY TRANSPLANTATION; METHODOLOGY; MORTALITY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PERITONEAL DIALYSIS; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; RENIN ANGIOTENSIN ALDOSTERONE SYSTEM; SAMPLE SIZE; TREATMENT OUTCOME; CHEMICALLY INDUCED DISORDER; CHRONIC KIDNEY FAILURE; DRUG COMBINATION; DRUG EFFECT; GOVERNMENT; PATHOPHYSIOLOGY; PROSPECTIVE STUDY; RENAL REPLACEMENT THERAPY; TIME; UNITED STATES;

ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; GLOMERULAR FILTRATION RATE; HUMANS; HYPERKALEMIA; KIDNEY FAILURE, CHRONIC; KIDNEY TRANSPLANTATION; LISINOPRIL; LOSARTAN; PROSPECTIVE STUDIES; PROTEINURIA; RENAL DIALYSIS; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES DEPARTMENT OF VETERANS AFFAIRS;

EID: 66849128220     PISSN: 15559041     EISSN: 1555905X     Source Type: Journal    
DOI: 10.2215/CJN.03350708     Document Type: Article

References (32)

1. United States Renal Data System: USRDS 2003 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, in, edited by National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2003
2. Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar S: Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 345: 861-869, 2001 (Pubitemid 34940825)
3. Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz I: Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 345: 851-860, 2001 (Pubitemid 34940824)
4. Azizi M, Menard J: Combined blockade of the renin-angio-tensin system with angiotensin-converting enzyme inhibitors and angiotensin II type 1 receptor antagonists. Circulation 109: 2492-2499, 2004 (Pubitemid 38720545)
5. 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 361: 117-124, 2003 (Pubitemid 36092015)
6. Bidani A: Controversy about COOPERATE ABPM trial data. Am J Nephrol 26: 629, 632, 2006 (Pubitemid 46143889)
7. Kunz R, Wolbers M, Glass T, Mann JF: The COOPERATE trial: A letter of concern. Lancet 371: 1575-1576, 2008
8. Mann JF, Schmieder RE, McQueen M, Dyal L, Schumacher H, Pogue J, Wang X, Maggioni A, Budaj A, Chaithiraphan S, Dickstein K, Keltai M, Metsarinne K, Oto A, Parkhomenko A, Piegas LS, Svendsen TL, Teo KK, Yusuf S: 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
9. Cetinkaya R, Odabas AR, Selcuk Y: Anti-proteinuric effects of combination therapy with enalapril and losartan in patients with nephropathy due to type 2 diabetes. Int J Clin Pract 58: 432-435, 2004 (Pubitemid 38786561)
10. Jacobsen P, Andersen S, Rossing K, Hansen BV, Parving HH: Dual blockade of the renin-angiotensin system in type 1 patients with diabetic nephropathy. Nephrol Dial Transplant 17: 1019-1024, 2002 (Pubitemid 34746204)
11. Rossing K, Jacobsen P, Pietraszek L, Parving HH: Reno-protective effects of adding angiotensin II receptor blocker to maximal recommended doses of ACE inhibitor in diabetic nephropathy: A randomized double-blind crossover trial. Diabetes Care 26: 2268-2274, 2003 (Pubitemid 36993311)
12. Rossing K, Christensen PK, Jensen BR, Parving HH: Dual blockade of the renin-angiotensin system in diabetic nephropathy: A randomized double-blind crossover study. Diabetes Care 25: 95-100, 2002 (Pubitemid 41070790)
13. Jacobsen P, Andersen S, Rossing K, Jensen BR, Parving HH: Dual blockade of the renin-angiotensin system versus maximal recommended dose of ACE inhibition in diabetic nephropathy. Kidney Int 63: 1874-1880, 2003
14. Agarwal R: Add-on angiotensin receptor blockade with maximized ACE inhibition. Kidney Int 59: 2282-2289, 2001 (Pubitemid 32467622)
15. Tutuncu NB, Gurlek A, Gedik O: Efficacy of ACE inhibitors and ATII receptor blockers in patients with microalbuminuria: A prospective study. Acta Diabetol 38: 157-161, 2001 (Pubitemid 34145694)
16. Palmer BF: Managing hyperkalemia caused by inhibitors of the renin-angiotensin-aldosterone system. N Engl J Med 351: 585-592, 2004
17. 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 329: 1456-1462, 1993
18. Lachin JM, Foulkes MA: Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. Biometrics 42: 507-519, 1986
19. Pfeffer MA, McMurray JJ, Velazquez EJ, Rouleau JL, Kober L, Maggioni AP, Solomon SD, Swedberg K, Van de Werf F, White H, Leimberger JD, Henis M, Edwards S, Zelenkofske S, Sellers MA, Califf RM: Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 349: 1893-1906, 2003
20. Pitt B, Poole-Wilson PA, Segal R, Martinez FA, Dickstein K, Camm AJ, Konstam MA, Riegger G, Klinger GH, Neaton J, Sharma D, Thiyagarajan B: 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 (Pubitemid 30240502)
21. Emanuel EJ, Miller FG: The ethics of placebo-controlled trials-A middle ground. N Engl J Med 345: 915-919, 2001
22. 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 366: 2026-2033, 2005 (Pubitemid 41773378)
23. Lewis J, Greene T, Appel L, Contreras G, Douglas J, Lash J, Toto R, Van Lente F, Wang X, Wright JT, Jr.: A comparison of iothalamate-GFR and serum creatinine-based outcomes: Acceleration in the rate of GFR decline in the African American Study of Kidney Disease and Hypertension. J Am Soc Nephrol 15: 3175-3183, 2004 (Pubitemid 39578850)
24. Stevens LA, Greene T, Levey AS: Surrogate end points for clinical trials of kidney disease progression. Clin J Am Soc Nephrol 1: 874-884, 2006
25. Beck GJ, Berg RL, Coggins CH, Gassman JJ, Hunsicker LG, Schluchter MD, Williams GW: Design and statistical issues of the Modification of Diet in Renal Disease Trial. The Modification of Diet in Renal Disease Study Group. Control Clin Trials 12: 566-586, 1991
26. Collins AJ, Li S, Gilbertson DT, Liu J, Chen SC, Herzog CA: Chronic kidney disease and cardiovascular disease in the Medicare population. Kidney Int Suppl S24-31, 2003 (Pubitemid 37315504)
27. Maschio G, Alberti D, Janin G, Locatelli F, Mann JF, Motolese M, Ponticelli C, Ritz E, Zucchelli P: Effect of the angiotensin-converting-enzyme inhibitor benazepril on the progression of chronic renal insufficiency. The Angiotensin- Converting-Enzyme Inhibition in Progressive Renal Insufficiency Study Group. N Engl J Med 334: 939-945, 1996
28. Ruggenenti P, Perna A, Gherardi G, Garini G, Zoccali C, Salvadori M, Scolari F, Schena FP, Remuzzi G: Renoprotective properties of ACE-inhibition in non-diabetic nephropathies with non-nephrotic proteinuria. Lancet 354: 359-364, 1999 (Pubitemid 29355751)
29. The GISEN Group: 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 349:1857-1863, 1997
30. Cohn JN, Tognoni G: A randomized trial of the angiotensin- receptor blocker valsartan in chronic heart failure. N Engl J Med 345: 1667-1675, 2001 (Pubitemid 33126822)
31. McMurray JJ, Ostergren J, Swedberg K, Granger CB, Held P, Michelson EL, Olofsson B, Yusuf S, Pfeffer MA: Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin- converting-enzyme inhibitors: The CHARM-Added trial. Lancet 362: 767-771, 2003 (Pubitemid 37093916)
32. ONTARGET Investigators: Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med 358: 1547-1559, 2008