In: Main4 Apr 2010
Rotigotine Patch in Parkinson’s Disease
Speaker: Peter LeWitt, MD, Professor of Neurology and Psychiatry, Wayne State University School of Medicine, Detroit, Michigan, and Clinical Neuroscience Center, South-field, Michigan
The rotigotine transdermal system (Neupro, Schwarz Pharma), a non-ergolinic dopamine receptor agonist, when administered once daily, has been shown to be safe, well tolerated, and effective in patients with late-stage Parkinson’s disease who have not responded to levodopa. The patch provided statistically significant reductions in “off” time as an adjunct to levodopa without an increase in “on” time in patients with troublesome dyskinesias. (After a number of years of treatment with levodopa, about 80% of patients begin to experience fluctuations in their response—the “on-off” effect.)
A total of 351 patients with late-stage Parkinson’s disease were enrolled in a double-blind, placebo-controlled, multi-center trial. The patients were randomly assigned to wear the patch (delivering 18 or 27 mg/day) or to take placebo. The trial included a four-week pre-treatment phase, a five-week titration phase, a 24-week maintenance phase, a de-escalation period, and an unspecified open-label extension.
The primary efficacy outcome was reduction in “off” time in all-day hourly home assessment and responder rates.
Of the 351 randomly selected patients—111 receiving rotigotine doses of 18 mg/day, 120 receiving doses of 27 mg/day, and 120 taking placebo—260 individuals (74%) completed the
maintenance phase. A data analysis of these patients was performed. Ninety-nine percent of those who completed the study then entered the open-label extension.
Compared with their baseline measures, those who wore the patch at a dose of 27 mg had an adjusted mean daily decrease of 2.1 hours in “off” time. Patients who received the 18-mg dose had a mean reduction of 2.7 hours in “off” time. For the placebo group, the adjusted mean daily reduction was 0.9 hours. The differences between both rotigotine doses and placebo were significant in favor of rotigotine (18 mg/day, P < .001; 27 mg/day, P < .003). Responder rates were 57% with 18 mg/day, 55% with 27 mg/day, and 34% with placebo, respectively.
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There were no increases in “on time” for patients in either active-dose group who had troublesome dyskinesias. Common adverse events with the patch were application-site reactions, somnolence, nausea, and dizziness.
Levetiracetam Beneficial against Partial-Onset or Generalized Tonic-Clonic Seizures
Speaker: Elinor Ben Menachem, MD, PhD, Professor, Department of Clinical Neuroscience, Sahlgrenska Academy at Gothenburg University, and Sahlgren University Hospital, Gothenburg, Sweden
Results from a phase 3, randomized, non-inferiority comparison trial indicated that levetiracetam (Keppra, UCB) was effective as monotherapy in the first-line treatment of newly diagnosed epilepsy in patients with partial-onset or generalized tonic-clonic seizures. Its efficacy was similar to that of controlled-release (CR) (Tegretol canadian, Novartis) and was much more tolerable when optimal doses of both drugs were used.
Adults with newly or recently diagnosed epilepsy (but excluding idiopathic generalized epilepsy) were selected to receive levetiracetam 1,000 mg/day or carbamazepine 400 mg/day after a three-week period of upward dose titration. This dose was maintained for a six-month evaluation period or until the next seizure. When a seizure occurred, doses were increased to levetiracetam 200 mg/day plus carbamazepine CR 800 mg/day or to levetiracetam 3,000 mg/day plus carbamazepine CR 1,200 mg/day. After patients remained free of seizures for six months, they entered a six-month maintenance phase.
Of the 472 patients who adhered to the treatment protocol, 73% of those using levetiracetam and 72.8% of those using carbamazepine CR were seizure-free for 12 months. Among patients completing the maintenance phase, 56.6% of the levetiracetam patients and 58.5% of the CR group were seizure-free for 12 months.
It is significant that fewer patients taking levetiracetam (16.1%) needed to stop treatment or change their dose because of an adverse event, compared with 23% of those taking carbamazepine CR (P= .046).
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