OROS(R) Methylphenidate in Adults with ADHD: Ne...(the study population of 550 patients mea...),Health

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
'/>"/>

SOURCE McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine news :

1. Commonly used medications associated with impaired physical function in older adults
2. Pennsylvania Governor Rendell Says Enactment of PA ABC Would Help More Than 8,000 Uninsured Adults in Schuylkill County
3. New Book Helps Older Adults Manage Chronic Pain
4. Los Angeles Jewish Home Unveils Auerbach Behavioral Health Center Filling Community Void for Adults Over 55
5. FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD in adults
6. Social form of bullying linked to depression, anxiety in adults
7. Rat study suggests why teens get hooked on cocaine more easily than adults
8. Grocery Manufacturers Association: Canadian Risk Assessment Reaffirms Safety of Bisphenol A (BPA) for Adults and Children
9. Todays Working Adults Face Long Term Care Double Whammy, Says Denise Gott, Spokesperson for LTC Financial Partners, LLC
10. Youth and Adults Throughout Illinois Urge Governor Blagojevich and Congress: Invest Our Tax Dollars Wisely
11. AUDIO from Medialink and Apple Products Research and Education Council: New Research -- Adults Who Eat Apples, Apple Juice Have Healthier Diets and Lower Risk for Metabolic Syndrome