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Abstract
Background Attention-deficit/hyperactivity disorder (ADHD) is a common behavioural disorder in childhood. The psychostimulant methylphenidate hydrochloride (MPH) is one of the major pharmacological options for ADHD. MPH is known to result, on average, in a small increase in arterial blood pressure (BP). However, there are few clinical data regarding the individual influences of MPH on BP among children and adolescents with ADHD. According to the European Union-wide standardised patient information sheet for MPH, BP changes >10 mm Hg compared with baseline values are ‘common’ (ie, ≥1% to <10%) in children and adolescents with ADHD during MPH therapy.
Aim To investigate the frequency and individual severity of BP changes in children and adolescents with ADHD during the first 6 months of new MPH therapy.
Methods In this study, 44 (77% male) children and adolescents (mean age (SD) 9.13 (1.86) years) with a diagnosis of ADHD according to the International Classification of Diseases, tenth revision, underwent ambulatory BP monitoring before and during the first 6 months of routine MPH therapy. Exclusion criteria were pre-existing MPH therapy and other medications that potentially influence BP or interfere with MPH. The non-interventional study was conducted prospectively at 10 paediatric cardiology centres in Germany and Austria.
Results After beginning MPH therapy, 34% of participants (99% CI 15.52% to 52.66%) had BP increases/decreases >10 mm Hg. The mean changes in systolic BP and diastolic BP were 0.87 mm Hg (95% CI -1.75 mm Hg to 3.48 mm Hg) and 1.96 mm Hg (95% CI 0.21 mm Hg to 3.7 mm Hg), respectively. The proportion of participants with initial prehypertension/hypertension was 54.55% .
Conclusions In our sample with a high baseline rate of prehypertension/hypertension, BP changes >10 mm Hg during MPH therapy were more frequent than those indicated by the patient information sheet. Moreover, individual BP changes, including increases and decreases >10 mm Hg, resulted in a small average BP increase in the sample, thus reflecting neither the severity nor the direction of individual BP changes. Therefore, the frequency and, due to the common use of the arithmetic mean, the individual severity of BP changes during MPH therapy may be underestimated. Further studies without averaging and with larger samples including patients in primary care settings are warranted.
- attention deficit disorder with hyperactivity
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Footnotes
Presented at This work was previously presented as a work-in-progress with preliminary findings at a conference and was published as a conference abstract: Hulpke-Wette M, Hagenbeck D, Irtel von Brenndorff C. Anwendungsbeobachtung zur Erfassung möglicher Blutdruckveränderungen bei Kindern und Jugendlichen mit Aufmerksamkeitsdefizit-Hyperaktivitäts-Syndrom (ADHS) unter Methylphenidat-Therapie mit Hilfe von 24-Stunden Langzeitblutdruckmessungen. Thorac Cardiovasc Surg 2016;64(S02):ePP13. doi:10.1055/s-0036–1571915.
Contributors DB-H, MH-W, RH and CIvB contributed to study conception and design and data acquisition. DB-H performed the statistical analysis. JE and RH contributed to the statistical analysis plan and the data analysis. DB-H wrote the manuscript. JE contributed to writing the manuscript. All authors contributed to interpreting the analysis and critically revising the article, approved the final draft and agreed to be accountable for all aspects of the work. All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. MH-W is the guarantor.
Funding The study was partly funded by the German Working Group of Paediatric Cardiologists in Private Practice (ANKK e. V.), which funded governmental registration fees and office supplies. The provision of the ABPM devices at the time of the observational process by the manufacturer IEM GmbH included the devices itself and the patient management software.
Competing interests DB-H, MH-W and CIvB report grants from the German Working Group of Paediatric Cardiologists in Private Practice (ANKK e. V.) and non-financial support from IEM GmbH during the conduct of the study (see the ‘Funding’ section above).
Patient consent for publication Written informed consent for publication was obtained from the participants’ parents and from the participants themselves depending on their age.
Ethics approval The study was conducted in accordance with the ethical principles of World Medical Association’s Declaration of Helsinki and was approved by the ethical committee of the University of Göttingen (ID: 15/7/12).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.