Superior consistency of ambulatory blood pressure monitoring in children: implications for clinical trials

被引:32
作者
Gimpel, Charlotte [1 ]
Wuehl, Elke [1 ]
Arbeiter, Klaus [2 ]
Drozdz, Dorota [3 ]
Trivelli, Antonella [4 ]
Charbit, Marina [5 ]
Gellermann, Jutta [6 ]
Dusek, Jiri [7 ]
Jankauskiene, Augustina [8 ]
Emre, Sevinc [9 ]
Schaefer, Franz [1 ]
机构
[1] Univ Heidelberg Hosp, Div Pediat Nephrol, Ctr Pediat & Adolescent Med, D-69120 Heidelberg, Germany
[2] Univ Childrens Hosp, Vienna, Austria
[3] Jagiellonian Univ, Dialysis Unit, Polish Amer Childrens Hosp, Coll Med, Krakow, Poland
[4] G Gaslini Inst Children, Genoa, Italy
[5] Hop Necker Enfants Malad, Paris, France
[6] Univ Childrens Hosp, Charite, Berlin, Germany
[7] Univ Hosp Motol, Dept Pediat, Prague, Czech Republic
[8] Vilnius State Univ, Childrens Hosp, Vilnius, Lithuania
[9] Istanbul Univ, Istanbul Fac Med, Istanbul, Turkey
关键词
adolescents; ambulatory blood pressure measurement; antihypertensive drugs; children; clinical trial; hypertension; MASKED HYPERTENSION; MASS INDEX; HOME; OFFICE; REPRODUCIBILITY; ADOLESCENTS; EFFICACY; INFANTS; HEALTHY;
D O I
10.1097/HJH.0b013e32832cb2a8
中图分类号
R6 [外科学];
学科分类号
1002 ; 100210 ;
摘要
Background Casual office blood pressure (CBP) measurements are still standard in antihypertensive drug trials. In pediatric hypertensive trials, ethical considerations, very low disease prevalence and the marked impact of white-coat hypertension create the need for very sensitive and reproducible techniques of BP assessment. We hypothesized that ambulatory BP monitoring (ABPM) may identify treatment effects more sensitively than CBP and thereby reduce sample sizes required in pediatric antihypertensive trials. Methods Standard deviations (SDs) were used to assess population variability of CBP and ABPM at baseline and after 6 months standardized antihypertensive treatment from a trial investigating the BP-lowering effect of ramipril in children with chronic kidney disease. Results In 157 hypertensive children, ramipril had a similar mean BP-lowering effect on clinic and ambulatory 24-h BP for systolic (-10 vs. -11 mm Hg, P = NS) and diastolic values (-9 vs. -11 mm Hg, P = NS). However, the SDs of the CBP responses were up to 39% larger than those of ABPM (SBP 15.5 vs. 9.4; DBP 13.8 vs. 8.8; both P< 0.0001). Using power analysis, we demonstrate that, depending on the magnitude of the expected antihypertensive effect and trial design, the utilization of ABPM in antihypertensive drug efficacy studies allows reduction of sample sizes by 57-75%. This reduction of cohort size with ABPM is substantially greater than previously observed for adults. Conclusion The primary use of ABPM can substantially reduce the number of children put at potential risk in blinded antihypertensive drug trials by up to three quarters. J Hypertens 27:1568-1574 (C) 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins.
引用
收藏
页码:1568 / 1574
页数:7
相关论文
共 33 条
[1]   Prognostic accuracy of day versus night ambulatory blood pressure:: a cohort study [J].
Boggia, Jose ;
Li, Yan ;
Thijs, Lutgarde ;
Hansen, Tine W. ;
Kikuya, Masahiro ;
Bjorklund-Bodegard, Kristina ;
Richart, Tom ;
Ohkuba, Tkayashi ;
Kuznetsova, Tatiana ;
Torp-Pedersen, Christian ;
Lind, Lars ;
Ibsen, Hans ;
Imaiji, Yutaka ;
Wang, Jiguang ;
Sandoya, Edgardp ;
O'Brien, Eoin ;
Staessen, Jan A. .
LANCET, 2007, 370 (9594) :1219-1229
[2]   Ambulatory blood pressure is a better marker than clinic blood pressure in predicting cardiovascular events in patients with/without type 2 diabetes [J].
Eguchi, Kazuo ;
Pickering, Thomas G. ;
Hoshide, Satoshi ;
Ishikawa, Joji ;
Ishikawa, Shizukiyo ;
Schwartz, Joseph E. ;
Shimada, Kazuyuki ;
Kario, Kazuomi .
AMERICAN JOURNAL OF HYPERTENSION, 2008, 21 (04) :443-450
[3]   Effect of allopurinol on blood pressure of adolescents with newly diagnosed essential hypertension - A randomized trial [J].
Feig, Daniel I. ;
Soletsky, Beth ;
Johnson, Richard J. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 300 (08) :924-932
[4]   ABPM vs. office blood pressure to define blood pressure control in treated hypertensive paediatric renal transplant recipients [J].
Ferraris, Jorge R. ;
Ghezzi, Lidia ;
Waisman, Gabriel ;
Krmar, Rafael T. .
PEDIATRIC TRANSPLANTATION, 2007, 11 (01) :24-30
[5]   A randomized, placebo-controlled trial of amlodipine in children with hypertension [J].
Flynn, JT ;
Newburger, JW ;
Daniels, SR ;
Sanders, SP ;
Portman, RJ ;
Hogg, RJ ;
Saul, JP .
JOURNAL OF PEDIATRICS, 2004, 145 (03) :353-359
[6]   Twenty-four-hour ambulatory blood pressure monitoring in young children [J].
Gellermann, J ;
Kraft, S ;
Ehrich, JHH .
PEDIATRIC NEPHROLOGY, 1997, 11 (06) :707-710
[7]  
Gueyffier F, 1999, ARCH MAL COEUR VAISS, V92, P1151
[8]   Prognostic superiority of daytime ambulatory over conventional blood pressure in four populations:: a meta-analysis of 7030 individuals [J].
Hansen, Tine W. ;
Kikuya, Masahiro ;
Thijs, Lutgarde ;
Bjorklund-Bodegard, Kristina ;
Kuznetsova, Tatiana ;
Ohkubo, Takayoshi ;
Richart, Tom ;
Torp-Pedersen, Christian ;
Lind, Lars ;
Jeppesen, Jorgen ;
Ibsen, Hans ;
Imai, Yutaka ;
Staessen, Jan A. .
JOURNAL OF HYPERTENSION, 2007, 25 (08) :1554-1564
[9]   White coat hypertension in childhood: Evidence for end-organ effect [J].
Kavey, Rae-Ellen W. ;
Kveselis, Daniel A. ;
Atallah, Nader ;
Smith, Frank C. .
JOURNAL OF PEDIATRICS, 2007, 150 (05) :491-497
[10]   Prognostic significance of blood pressure and heart rate variabilities - The Ohasama study [J].
Kikuya, M ;
Hozawa, A ;
Ohokubo, T ;
Tsuji, I ;
Michimata, M ;
Matsubara, M ;
Ota, M ;
Nagai, K ;
Araki, T ;
Satoh, H ;
Ito, S ;
Hisamichi, S ;
Imai, Y .
HYPERTENSION, 2000, 36 (05) :901-906