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OROS(R) Methylphenidate in Adults with ADHD: New Insights
Date:5/7/2008

the study population of 550 patients, mean increases in blood pressure (BP) and heart rate (HR) observed with OROS(R) MPH were consistent with those seen in other data from the methylphenidate class. Mean systolic and diastolic blood pressure increased by 2.6 mmHg and 1.9mmHg, respectively and mean heart rate increased by 4.1 beats per minute (bpm).

Overall, cardiovascular-related adverse events occurred in 23.3% of patients and mainly consisted of BP and HR increases. There was no evidence of a treatment effect in any ECG assessment aside from an increase in HR. No deaths, heart attacks or strokes were reported and no unexpected safety findings were noted.

The safety profile of OROS(R) MPH in the long-term, open-label study's dose range of 36 mg to 108 mg per day, was consistent with that seen in shorter-term trials in adults. Adverse events with an incidence greater than 10% included decreased appetite, headache, insomnia, dry mouth, anxiety, upper respiratory tract infection, nausea, increased heart rate and irritability.

Additionally, a cardiovascular sub-analysis from the short-term dose-titration study of OROS(R) MPH versus placebo showed no clinically significant mean changes from baseline in blood pressure, heart rate or ECG parameters. The cardiovascular effects noted in this sub-analysis were consistent with those previously documented in other data from the MPH class.

Data from this sub-analysis showed similar mean changes from baseline in systolic and diastolic BP for OROS(R) MPH and placebo groups. Systolic mean change from baseline was -1.2 mmHg for OROS(R) MPH vs. -0.5 mmHg for placebo; diastolic mean change from baseline was +1.1 mmHg for OROS(R) MPH vs. +0.4 mmHg for placebo. Mean change in pulse from baseline was greater for the OROS(R) MPH group, with +3.6 beats per minute (bpm) vs. -1.6 bpm in placebo. Increased BP was the only cardiovascular adverse event reported in greater than 10% of OROS(R) MPH patients (10% for O
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SOURCE McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen
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