Effect of statin therapy on disease progression in pediatric ADPKD: Design and baseline characteristics of participants

Contemporary Clinical Trials

Volumn 32, Issue 3, 2011, Pages 437-445

  Cadnapaphornchai, Melissa A ^a,b   George, Diana M ^a   Masoumi, Amirali ^a   McFann, Kim ^a   Strain, John D ^c   Schrier, Robert W ^a  

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

^b Children's Hospital Colorado   (United States)

^c CHILDREN S HOSPITAL COLORADO   (United States)

Author keywords

Autosomal dominant polycystic kidney disease; Pediatric; Renal volume; Statin

Indexed keywords

DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LISINOPRIL; PLACEBO; PRAVASTATIN;

ADOLESCENT; ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CHILD; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; KIDNEY DISEASE; KIDNEY FAILURE; KIDNEY POLYCYSTIC DISEASE; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; ALBUMINURIA; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CHILD; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERTENSION; HYPERTROPHY, LEFT VENTRICULAR; KIDNEY; LISINOPRIL; MALE; POLYCYSTIC KIDNEY, AUTOSOMAL DOMINANT; PRAVASTATIN; RENIN-ANGIOTENSIN SYSTEM; YOUNG ADULT;

EID: 79953032543     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2011.01.008     Document Type: Article

References (77)

1. Ecder T., Fick-Brosnahan G., Schrier R.W. Polycystic kidney disease. Diseases of the kidney and urinary tract 2007, 502-539. Lippincott Williams & Wilkins, Philadelphia. 8th ed. R.W. Schrier (Ed.).
2. Pazour G.J. Intraflagellar transport and cilia-dependent renal disease: the ciliary hypothesis of polycystic kidney disease. J Am Soc Nephrol Oct. 2004, 15(10):2528-2536.
3. Yoder B.K., Hou X., Guay-Woodford L.M. The polycystic kidney disease proteins, polycystin-1, polycystin-2, polaris, and cystin, are co-localized in renal cilia. J Am Soc Nephrol Oct. 2002, 13(10):2508-2516.
4. Nauli S.M., Alenghat F.J., Luo Y., Williams E., Vassilev P., Li X., et al. Polycystins 1 and 2 mediate mechanosensation in the primary cilium of kidney cells. Nat Genet Feb. 2003, 33(2):129-137.
5. Praetorius H.A., Frokiaer J., Nielsen S., Spring K.R. Bending the primary cilium opens Ca2+-sensitive intermediate-conductance K+ channels in MDCK cells. J Membr Biol Feb. 2003, 191(3):193-200.
6. Torres V.E., Harris P.C. Mechanisms of disease: autosomal dominant and recessive polycystic kidney diseases. Nat Clin Pract Nephrol Jan. 2006, 2(1):40-55.
7. Ecder T., Schrier R.W. Hypertension in autosomal-dominant polycystic kidney disease: early occurrence and unique aspects. J Am Soc Nephrol Jan. 2001, 12(1):194-200.
8. Schrier R.W., Mcfann K.K., Johnson A.M. Epidemiological study of kidney survival in autosomal dominant polycystic kidney disease. Kidney Int Feb. 2003, 63(2):678-685.
9. Fick G.M., Johnson A.M., Hammond W.S., Gabow P.A. Causes of death in autosomal dominant polycystic kidney disease. J Am Soc Nephrol 1995, 5:2048-2056.
10. Schrier R.W. Renal volume, renin-angiotensin-aldosterone system, hypertension, and left ventricular hypertrophy in patients with autosomal dominant polycystic kidney disease. J Am Soc Nephrol Sep. 2009, 20(9):1888-1893.
11. Dechend R., Fiebler A., Lindschau C., Bischoff H., Muller D., Park J.K., et al. Modulating angiotensin II-induced inflammation by HMG Co-A reductase inhibition. Am J Hypertens Jun. 2001, 14(6 Pt 2):55S-61S.
12. Chapman A.B., Johnson A., Gabow P.A., Schrier R.W. The renin-angiotensin aldosterone system and autosomal dominant polycystic kidney disease. N Engl J Med Oct. 1990, 323(16):1091-1096.
13. Barrett B.J., Foley R., Morgan J., Hefferton D., Parfrey P. Differences in hormonal and renal vascular responses between normotensive patients with autosomal dominant polycystic kidney disease and unaffected family members. Kidney Int 1994, 46(4):1118-1123.
14. Harrap S.B., Davies D.L., Macnicol A.M., Dominiczak A.F., Fraser R., Wright A.F., et al. Renal, cardiovascular and hormonal characteristics of young adults with autosomal dominant polycystic kidney disease. Kidney Int 1991, 40(3):501-508.
15. Bell P.E., Hossack K.F., Gabow P.A., Durr J.A., Johnson A.M., Schrier R.W. Hypertension in autosomal dominant polycystic kidney disease. Kidney Int Nov. 1988, 34(5):683-690.
16. Brunner H.R. Experimental and clinical evidence that angiotensin II is an independent risk factor for cardiovascular disease. Am J Cardiol 2001, 87:3C-9C.
17. Hirsch A.T., Pinto Y.M., Schunkert H., Dzau V.J. Potential role of the tissue renin-angiotensin system in the pathophysiology of congestive heart failure. Am J Cardiol 1990, 66:22D-30D.
18. Wolf G. Angiotensin II: a pivotal factor in the progression of renal diseases. Nephrol Dial Transplant 1999, 14(Suppl 1):S42-S44.
19. Laursen J.B., Rajagopalan S., Galis Z., Tarpey M., Freeman B.A., Harrison D.G. Role of superoxide in angiotensin II-induced but not catecholamine-induced hypertension. Circulation 1997, 95:588-593.
20. Ushio-Fukai M., Zafari A.M., Fukui T., Ishizaka N., Griendling K.K. P22phox is a critical component of the superoxide-generating NADH/NADPH system and regulates angiotensin II-induced hypertrophy in vascular smooth muscle cells. J Biol Chem 1996, 271:23317-23321.
21. Griendling K.K., Ushio-Fukai M., Lassegue B., Alexander R.W. Angiotensin II signaling in vascular smooth muscle: new concepts. Hypertension 1997, 29:366-373.
22. Chatterjee P.K., Weerackody R.P., Mistry S.K., Hawksworth G.M., McLay J.S. Selective antagonism of the AT1 receptor inhibits angiotensin II stimulated DNA and protein synthesis in primary cultures of human proximal tubular cells. Kidney Int 1997, 3:699-705.
23. Ruiz-Ortega M., Egido J. Angiotensin II modulates cell growth-related events and synthesis of matrix proteins in renal interstitial fibroblasts. Kidney Int 1997, 6:1497-1510.
24. Bernstein J., Evan A.P., Gardner K.D. Epithelial hyperplasia in human polycystic kidney diseases. Its role in pathogenesis and risk of neoplasia. Am J Pathol 1987, 1:92-101.
25. Grantham J.J. Mechanisms of progression in autosomal dominant polycystic kidney disease. Kidney Int Suppl 1997, 63:S93-S97.
26. Cadnapaphornchai M.A., McFann K., Strain J.D., Masoumi A., Schrier R.W. Prospective change in renal volume and function in children with ADPKD. Clin J Am Soc Nephrol Apr. 2009, 4(4):820-829.
27. Hafez K.S., Inman S.R., Stowe N.T., Novick A.C. Renal hemodynamic effects of lovastatin in a renal ablation model. Urology Dec. 1996, 48(6):862-867.
28. Glazer A.A., Inman S.R., Stowe N.T., Novick A.C. Renal microcirculatory effects of lovastatin in a rat model of reduced renal mass. Urology Nov. 1997, 50(5):812-817.
29. Inman S.R., Stowe N.T., Cressman M.D., Brouhard B.H., Nally J.V., Satoh S., et al. Lovastatin preserves renal function in experimental diabetes. Am J Med Sci Apr. 1999, 317(4):215-221.
30. Joyce M., Kelly C., Winter D., Chen G., Leahy A., Bouchier-Hayes D. Pravastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, attenuates renal injury in an experimental model of ischemia-reperfusion. J Surg Res Nov. 2001, 101(1):79-84.
31. Bianchi S., Bigazzi R., Caiazza A., Campese V.M. A controlled, prospective study of the effects of atorvastatin on proteinuria and progression of kidney disease. Am J Kidney Dis Mar. 2003, 41(3):565-570.
32. van Dijk M.A., Kamper A.M., van Veen S., Souverijn J.H., Blauw G.J. Effect of simvastatin on renal function in autosomal dominant polycystic kidney disease. Nephrol Dial Transplant Nov. 2001, 16(11):2152-2157.
33. Stowe N.T., Inman S.R., Tapolyai M., Brouhard B.H., Hodge E.E., Novick A.C. Lovastatin has direct renal hemodynamic effects in a rodent model. J Urol Jul. 1996, 156(1):249-252.
34. McFarlane S.I., Muniyappa R., Francisco R., Sowers J.R. Pleiotropic effects of statins: lipid reduction and beyond. J Clin Endocrinol Metab 2002, 87:1451-1458.
35. Park J.K., Muller D.N., Mervaala E.M., Dechend R., Fiebeler A., Schmidt F., et al. Cerivastatin prevents angiotensin II-induced renal injury independent of blood pressure- and cholesterol-lowering effects. Kidney Int Oct. 2000, 58(4):1420-1430.
36. Gile R.D., Cowley B.D., Gattone V.H., O'Donnell M.P., Swan S.K., Grantham J.J. Effect of lovastatin on the development of polycystic kidney disease in the Han:SPRD rat. Am J Kidney Dis 1995, 26:501-507.
37. Zafar I., Tao Y., Falk S., McFann K., Schrier R.W., Edelstein C.L. Effect of statin and angiotensin-converting enzyme inhibition on structural and hemodynamic alterations in autosomal dominant polycystic kidney disease model. Am J Physiol Ren Physiol Sep. 2007, 293(3):F854-F859.
38. Franz K.A., Reubi F.C. Rate of functional deterioration in polycystic kidney disease. Kidney Int Mar. 1983, 23(3):526-529.
39. Gabow P.A., Chapman A.B., Johnson A.M., Tangel D.J., Duley I.T., Kaehny W.D., et al. Renal structure and hypertension in autosomal dominant polycystic kidney disease. Kidney Int Dec. 1990, 38(6):1177-1180.
40. Gabow P.A., Johnson A.M., Kaehny W.D., Kimberling W.J., Lezotte D.C., Duley I.T., et al. Factors affecting the progression of renal disease in autosomal-dominant polycystic kidney disease. Kidney Int 1992, 41(5):1311-1319.
41. Fick G.M., Duley I.T., Johnson A.M., Strain J.D., Manco-Johnson M.L., Gabow P.A. The spectrum of autosomal dominant polycystic kidney disease in children. J Am Soc Nephrol 1994, 4(9):1654-1660.
42. Gabow P.A., Duley I.T., Johnson A.M. Clinical profiles of gross hematuria in autosomal dominant polycystic kidney disease. Am J Kidney Dis 1992, 20(2):140-143.
43. Gabow P.A., Kaehny W.D., Johnson A.M., Duley I.T., Manco-Johnson M.L., Lezotte D.C., et al. The clinical utility of renal concentrating capacity in polycystic kidney disease. Kidney Int Feb. 1989, 35(2):675-680.
44. Chapman A.B., Johnson A.M., Gabow P.A., Schrier R.W. Overt proteinuria and microalbuminuria in autosomal-dominant polycystic kidney disease. J Am Soc Nephrol Dec. 1994, 5(6):1349-1354.
45. Fick-Brosnahan G.M., Belz M.M., McFann K., Johnson A.M., Schrier R.W. Relationship between renal volume growth and renal function in autosomal dominant polycystic kidney disease: a longitudinal study. Am J Kidney Dis Jun. 2002, 39(6):1127-1134.
46. King B.F., Reed J.E., Bergstralh E.J., Sheedy P.F., Torres V.E. Quantification and longitudinal trends of kidney, renal cyst, and renal parenchyma volumes in autosomal dominant polycystic kidney disease. J Am Soc Nephrol Aug. 2000, 11(8):1505-1511.
47. Chapman A.B., Torres V.E., Perrone R.D., Steinman T.I., Bae K.T., Miller J.P., et al. The HALT polycystic kidney disease trials: design and implementation. Clin J Am Soc Nephrol Jan. 2010, 5(1):102-109.
48. Walz G., Budde K., Mannaa M., Nurnberger J., Wanner C., Sommerer C., et al. Everolimus in patients with autosomal dominant polycystic kidney disease. N Engl J Med Aug. 2010, 363(9):830-840.
49. Serra A.L., Poster D., Kistler A.D., Krauer F., Raina S., Young J., et al. Sirolimus and kidney growth in autosomal dominant polycystic kidney disease. N Engl J Med Aug. 2010, 363(9):820-829.
50. Chapman A.B., Guay-Woodford L.M., Grantham J.J., Torres V.E., Bae K.T., Baumgarten D.A., et al. Renal structure in early autosomal-dominant polycystic kidney disease (ADPKD): The Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) cohort. Kidney Int Sep. 2003, 64(3):1035-1045.
51. Iglesias C.G., Torres V.E., Offord K.P., Holley K.E., Beard C.M., Kurland L.T. Epidemiology of adult polycystic kidney disease, Olmsted County, Minnesota: 1935-1980. Am J Kidney Dis May. 1983, 2(6):630-639.
52. Roscoe J.M., Brissenden J.E., Williams E.A., Chery A.L., Silverman M. Autosomal dominant polycystic kidney disease in Toronto. Kidney Int Nov. 1993, 44(5):1101-1108.
53. Hateboer N., van Dijk M.A., Bogdanova N., Coto E., Saggar-Malik A.K., San Millan J.L., Torra R., Breuning M., Ravine D. Comparison of phenotypes of polycystic kidney disease types 1 and 2. European PKD1-PKD2 Study Group. Lancet Jan. 1999, 353(9147):103-107.
54. Chapman A.B., Johnson A.M., Rainguet S., Hossack K., Gabow P., Schrier R.W. Left ventricular hypertrophy in autosomal dominant polycystic kidney disease. J Am Soc Nephrol Aug. 1997, 8(8):1292-1297.
55. Cadnapaphornchai M.A., McFann K., Strain J.D., Masoumi A., Schrier R.W. Increased left ventricular mass in children with autosomal dominant polycystic kidney disease and borderline hypertension. Kidney Int Nov. 2008, 74(9):1192-1196.
56. Ivy D.D., Shaffer E.M., Johnson A.M., Kimberling W.J., Dobin A., Gabow P.A. Cardiovascular abnormalities in children with autosomal dominant polycystic kidney disease. J Am Soc Nephrol 1995, 5(12):2032-2036.
57. Schunkert H., Jackson B., Tang S.S., Schoen F.J., Smits J.F., Apstein C.S., et al. Distribution and functional significance of cardiac angiotensin converting enzyme in hypertrophied rat hearts. Circulation Apr. 1993, 87(4):1328-1339.
58. Morgan H.E., Baker K.M. Cardiac hypertrophy. Mechanical, neural, and endocrine dependence. Circulation Jan. 1991, 83(1):13-25.
59. Schrier R., McFann K., Johnson A., Chapman A., Edelstein C., Brosnahan G., et al. Cardiac and renal effects of standard versus rigorous blood pressure control in autosomal-dominant polycystic kidney disease: results of a seven-year prospective randomized study. J Am Soc Nephrol Jul. 2002, 13(7):1733-1739.
60. Luo J.D., Zhang W.W., Zhang G.P., Guan J.X., Chen X. Simvastatin inhibits cardiac hypertrophy and angiotensin-converting enzyme activity in rats with aortic stenosis. Clin Exp Pharmacol Physiol Nov. 1999, 26(11):903-908.
61. Cadnapaphornchai M.A., Fick-Brosnahan G.M., Duley I., Johnson A.M., Strain J.D., DeGroff C.G., et al. Design and baseline characteristics of participants in the study of antihypertensive therapy in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD). Contemp Clin Trials Apr. 2005, 26(2):211-222.
62. Grothues F., Smith G.C., Moon J.C., Bellenger N.G., Collins P., Klein H.U., et al. Comparison of interstudy reproducibility of cardiovascular magnetic resonance with two-dimensional echocardiography in normal subjects and in patients with heart failure or left ventricular hypertrophy. Am J Cardiol Jul. 2002, 90(1):29-34.
63. Rajappan K., Bellenger N.G., Melina G., Di Terlizzi M., Yacoub M.H., Sheridan D.J., et al. Assessment of left ventricular mass regression after aortic valve replacement-cardiovascular magnetic resonance versus M-mode echocardiography. Eur J Cardiothorac Surg Jul. 2003, 24(1):59-65.
64. Martinez-Vea A., Gutierrez C., Bardaji A., Pastor R., Garcia C., Peralta C., et al. Microalbuminuria in normotensive patients with autosomal-dominant polycystic kidney disease. Scand J Urol Nephrol Sep. 1998, 32(5):356-359.
65. Sharp C., Johnson A., Gabow P. Factors relating to urinary protein excretion in children with autosomal dominant polycystic kidney disease. J Am Soc Nephrol 1998, 9:1908-1914.
66. Nakamura T., Ushiyama C., Hirokawa K., Osada S., Shimada N., Koide H. Effect of cerivastatin on urinary albumin excretion and plasma endothelin-1 concentrations in type 2 diabetes patients with microalbuminuria and dyslipidemia. Am J Nephrol Nov. 2001, 21(6):449-454.
67. Schwartz G.J., Haycock G.B., CMJr Edelmann, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976, 2:259-263.
68. Marshall W.A., Tanner J.M. Growth and physiological development during adolescence. Annu Rev Med 1968, 19:283-300.
69. Marshall W.A., Tanner J.M. Variations in pattern of pubertal changes in girls. Arch Dis Child 1969, 44(235):291-303.
70. Marshall W.A., Tanner J.M. Variations in the pattern of pubertal changes in boys. Arch Dis Child Feb. 1970, 45(239):13-23.
71. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics 2004, 114:555-576. National high blood pressure education program working group on high blood pressure in children and adolescents.
72. Artigao L.M., Llavador J.J., Puras A., Lopez Abril J., Rubio M.M., Torres C., et al. Evaluation and validation of Omron Hem 705CP and Hem 706/711 monitors for self-measurement of blood pressure. Aten Primaria 2000, 25(2):96-102.
73. O'Brien E., Waeber B., Parati G., Staessen J., Myers M.G. Blood pressure measuring devices: recommendations of the European Society of Hypertension. BMJ 2001, 322(3 March):531-536.
74. Bae K.T., Commean P.K., Lee J. Volumetric measurement of renal cysts and parenchyma using MRI: phantoms and patients with polycystic kidney disease. J Comput Assist Tomogr Jul. 2000, 24(4):614-619.
75. O'Neill W.C., Robbin M.L., Bae K.T., Grantham J.J., Chapman A.B., Guay-Woodford L.M., et al. Sonographic assessment of the severity and progression of autosomal dominant polycystic kidney disease: the Consortium of Renal Imaging Studies in Polycystic Kidney Disease (CRISP). Am J Kidney Dis Dec. 2005, 46(6):1058-1064.
76. Torres V.E., King B.F., Chapman A.B., Brummer M.E., Bae K.T., Glockner J.F., et al. Magnetic resonance measurements of renal blood flow and disease progression in autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol Jan. 2007, 2(1):112-120.
77. Cadnapaphornchai MA, Masoumi A, Strain JD, McFann K, Schrier RW. Magnetic resonance imaging of kidney and cyst volume in children with ADPKD. Clin J Am Soc Nephrol. 2010 Nov 29.