Steroid withdrawal improves blood pressure control and nocturnal dipping in pediatric renal transplant recipients: analysis of a prospective, randomized, controlled trial
Variable effects of steroid minimization strategies on blood pressure in pediatric renal transplant recipients have been reported, but data on the effect of steroid withdrawal on ambulatory blood pressure and circadian blood pressure rhythm have not been published so far.
In a prospective, randomized, multicenter study on steroid withdrawal in pediatric renal transplant recipients (n = 42) on cyclosporine, mycophenolate mofetil, and methylprednisolone, we performed a substudy in 28 patients, aged 11.2 ± 3.8 years, for whom ambulatory blood pressure monitoring (ABPM) data were available.
In the steroid-withdrawal group, the percentage of patients with arterial hypertension, defined as systolic and/or diastolic blood pressure values recorded by ABPM > 1.64 SDS and/or antihypertensive medication, at month 15 was significantly lower (35.7%, p = 0.002) than in controls (92.9%). The need of antihypertensive medication dropped significantly by 61.2% (p < 0.000 vs. control), while in controls, it even rose by 69.3%. One year after steroid withdrawal, no patient exhibited hypertensive blood pressure values above the 95th percentile, compared to 35.7% at baseline (p = 0.014) and to 14.3% of control (p = 0.142). The beneficial impact of steroid withdrawal was especially pronounced for nocturnal blood pressure, leading to a recovered circadian rhythm in 71.4% of patients vs. 14.3% at baseline (p = 0.002), while the percentage of controls with an abnormal circadian rhythm (35.7%) did not change.
Steroid withdrawal in pediatric renal transplant recipients with well-preserved allograft function is associated with less arterial hypertension recorded by ABPM and recovery of circadian blood pressure rhythm by restoration of nocturnal blood pressure dipping.
KeywordsPediatric renal transplantation Steroid withdrawal Ambulatory blood pressure Nocturnal blood pressure dipping Randomized controlled trial
Our special thanks are due to all patients for their readiness to participate in this study.
B.H. participated in recruiting patients for the study, data collection and analysis, and preparation of the manuscript. L.T.W. and B.T. participated in study design, recruiting patients for the study, data collection and analysis, and preparation of the manuscript. U.J., J.D., H.F., G.K., and M.P. participated in recruiting patients for the study and data collection. T.S. participated in statistical analysis of the study data. E.W. participated in the statistical analysis of the study data and manuscript preparation.
The study was sponsored by a grant from Roche, Grenzach-Wyhlen, Germany. Neither did the company influence the performance and analysis of the study nor its publication.
Compliance with ethical standards
The study was conducted in accordance with the Good Clinical Practice Guidelines and the 1983 Helsinki Declaration and approved by the ethics committee of each contributing center. Written informed consent from patients’ parents or guardians was obtained prior to initiation of any study-related procedure, with assent from patients when appropriate for their age.
Conflict of interest
This was an investigator-initiated trial undertaken by members of the “German Study Group on Renal Transplantation in Children and Adolescents” and members of the “German Society of Pediatric Nephrology (GPN)”. B.H., L.T.W., and B.T. have received travel grants from Roche. B.T. has also received research grants from Roche.
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