On April 17, 2012, Abbott announced the results of a phase 3 trial investigating the safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) for advanced Parkinson?s disease. Researchers found that the intestinal gel is more effective than the standard levodopa-carbidopa pill regimen in reducing ?off? time (the time in which symptoms, such as poor mobility, slowness and stiffness, return in patients taking medication for Parkinson?s disease) in patients with advanced Parkinson?s disease.
LCIG is administered directly into the small intestine through an implanted tube with a portable pump. This route of administration provides a continuous delivery of medication during the 16 hours a day of pump use.
The study duration was 12 weeks. Mean ?off? time at 12 weeks for patients with advanced Parkinson?s disease decreased by 4.0 hours per day with LCIG, which was an average of 1.91 hours less ?off? time compared to patients treated with the standard levodopa-carbidopa pill regimen. Also, the ?on? time (time without troublesome dyskinesias) improved by 4.1 hours for patients treated with LCIG, an average increase of 1.86 hours compared to patients treated with the standard pill regimen.
Dr. C.W. Olanow, M.D., Professor of Neurology and Neuroscience at the Mount Sinai School of Medicine in New York City, said, ?These results demonstrate that continuous delivery of levodopa-carbidopa intestinal gel produces statistically meaningful improvements in advanced PD patients by decreasing ‘off’ time and increasing ‘on’ time without troublesome dyskinetic symptoms.? The study results will be presented this week at the American Academy of Neurology?s annual meeting in New Orleans.
Analysis:
The most common adverse events reported with the LCIG were complications of device insertion, abdominal pain, procedural pain, and nausea.
Oral levodopa-carbidopa treatments include the brands Sinemet, Sinemet CR, and Parcopa.
Sinemet (carbidopa/levodopa) is indicated in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Sinemet was FDA approved on May 2, 1975 and is marketed by Merck & Co., Inc.
Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 6,506 patients who experienced a serious adverse event where Sinemet was identified as a suspect drug causing the event and 1,251 patients who experienced a serious adverse event where Sinemet was identified as the primary suspect. The most commonly reported side effects were drug ineffective, dyskinesia (involuntary tics and movements), and tremor. We identified 379 hospitalizations and 90 deaths where Sinemet was identified as the primary suspect.
Note: AdverseEvents aggregates the brand names ?Sinemet?, ?Sinemet CR?, and ?Parcopa?, along with generic equivalents, under the brand name ?Sinemet?. Thus, the analysis above for “Sinemet”?includes all AERS case reports in which the drug is oral levodopa-carbidopa.
