The Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study aimed to fill this gap by investigating the long-term safety of methylphenidate in children and adolescents aged 6–17 years from 27 European mental health centers using a two-year prospective pharmacovigilance design. The study recruited three cohorts: (1) individuals with formal ADHD diagnosis naive to any previous ADHD medication but about to start methylphenidate treatment; (2) individuals with ADHD diagnosis naive to any ADHD medication and not planning to start any ADHD medication; and (3) individuals screened negative for ADHD at study enrolment as a control group. The primary outcome was height velocity and secondary outcomes were weight, BMI, cardiovascular health, mental health symptoms and neurological symptoms. “Unique aspects of the ADDUCE study include the comprehensive two-year follow-up that addressed all aspects identified by the EMA, the inclusion of only stimulant-naive participants, the use of structured and validated outcome measures, and the inclusion of a non-medicated ADHD control group,” emphasizes David Coghill, the study coordinator.
The authors reported some baseline differences in age, sex ratio and mean systolic blood pressure between the groups but those differences did not affect the main investigation. They concluded that long-term treatment with methylphenidate did not result in any negative effects on the study outcome measures compared with the non-methylphenidate cohort, and therefore, the treatment is safe to use for at least 2 years. Although no serious adverse events were reported, treatment with methylphenidate increased the pulse rate and diastolic blood pressure, meaning that those outcomes should be monitored over the course of the treatment.
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