Data on Extended-Release Methylphenidate Grow. (Side Effects Related to Dose)

By Boschert, Sherry | Clinical Psychiatry News, December 2001 | Go to article overview

Data on Extended-Release Methylphenidate Grow. (Side Effects Related to Dose)


Boschert, Sherry, Clinical Psychiatry News


HONOLULU -- Two of the newer versions of extended-release methyiphenidate hydrochloride effectively treated attention-deficit hyperactivity disorder in separate studies reported in poster presentations at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

A third study found that side effects were dose related with one of the medications.

These newer versions of extended-release methylphenidate may fulfill the promise of earlier formulations that never caught on because their effects didn't last long enough.

A multicenter study of 137 children with attention-deficit hyperactivity disorder (ADHD) started with a week-long titration to optimal dosing of Ritalin LA followed by a 1-week placebo washout, with patients but not investigators blinded to the treatment. Patients then were randomized in a double-blind fashion to either once-daily Ritalin LA or placebo for 2 weeks, Dr. Joseph Biederman reported.

Parent, teacher, and investigator assessments found significantly greater improvements in ADHD symptoms in the Ritalin LA group compared with placebo. The two groups had a similar incidence of side effects (25% and 24%, respectively), including anorexia, insomnia, sore throat, headache, and vomiting, said Dr. Biederman, professor of psychiatry at Harvard Medical School, Boston, and chief of the joint program in pediatric psychopharmacology at Massachusetts General Hospital.

The study, which was funded by the maker of Ritalin LA, Novartis Pharmaceuticals Corp., East Hanover, N.J., did not compare Ritalin LA to other active treatments such as multiple doses of immediate-release Ritalin (which has a half-life of 2-3 hours) or to other extended-release stimulants. Ritalin LA, which has not yet been approved by the Food and Drug Administration, and Metadate CD, which is already on the market, are designed to replace twice-daily dosing of Ritalin to provide 8 hours of coverage. Metadate CD is produced by Celltech Pharmaceuticals, Slough, England. Two other extended-release stimulants are designed to provide patients with 10-12 hours of drug coverage equivalent to three "times" daily dosing of Ritalin: Concerta, a form of extended-release methylphenidate, and Adderall XR, an extended-release mix of amphetamine salts made by Shire Pharmaceuticals Group, Basingstoke, England. Both have been approved by the FDA.

A separate review of four studies found once-daily treatment with Concerta to be more effective than placebo and equivalent to thrice-daily doses of immediate-release methyiphenidate in treating children with ADHD, reported Dr. …

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