Abstrakt: |
Objective To assess ADHD symptoms after switching from Methylphenidate Immediate-release (MPH-IR) to Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS[TM]) in clinically stable patients with ADHD and to identify predictors of dissatisfaction with MPH-SODAS[TM]. Methods This is an 8-week open clinical trial. Patients were assigned to MPH-SODAS[TM] according to their pre-study dose of MPH-IR. Assessments at baseline were conducted using the Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV), and the Barkley's Side Effect Rating Scale (SERS). Potentials predictors of treatment response were evaluated. Results From 62 patients, 47 completed the protocol. There was no significant change in the total score at the SNAP-IV (F (1,51.26) = 0.01; P = 0.91) and its subscales scores during the trial. Although no significant effect on the SERS total score (F (1,111.49) = 0.75; P = 0.39) was found, one adult patient with a previous cardiovascular condition presented a hemorrhagic cerebral vascular accident resulting in her obit. Overall, 46 (74.2%) patients reported to be satisfied. No factor assessed predicted dissatisfaction in univariated analyses. Conclusion Results suggested that switching from MPH-IR to MPH-SODAS[TM] did not affect stabilization of ADHD symptoms in the majority of patients. MPH prescription in patients with previous cardiovascular conditions must be extremely careful. Further studies with long-acting MPH including larger samples and patients not responsive to MPH-IR are needed especially in countries outside the US. [ABSTRACT FROM AUTHOR] |