Intestinal Gel Extends Benefits of Common Parkinson's Disease Drugs
Mount Sinai presented data on 2 commonly prescribed oral medications delivered as an intestinal gel at the Movement Disorders Society's annual meeting.
A new delivery method for levodopa/carbidopa, a common dual-drug Parkinson's disease (PD) regimen, significantly improved the duration of the drugs' effectiveness in people with advanced PD, according to research by Mount Sinai School of Medicine. The new method is continuous delivery of an intestinal gel formulation of the therapies, which are traditionally taken orally. The study found that the continuous gel delivery reduced "off" time—when the medicine's effectiveness wears off—by an average of nearly two extra hours per day. The gel also improved "on" time without involuntary movements when patients enjoyed a good response, compared to people taking standard levodopa/carbidopa.
The researchers are presenting their findings at the Movement Disorder Society's 16th International Congress of Parkinson's Disease and Movement Disorders being held from June 17-21 in Dublin.
Levodopa is the most effective drug for treating PD, reducing tremors, slowness, stiffness, and walking difficulty, and carbidopa helps prevent nausea and vomiting associated with levodopa. After five to 10 years, however, the duration of its treatment benefits wears off and PD-related symptoms return, representing a major source of disability for patients despite the benefits of the drug. This period of ineffectiveness, which can last six hours or more per day, is known as "off" time.
Researchers led by C. Warren Olanow, MD, Henry P. and Georgette Professor and Chairman Emeritus, Department of Neurology and Director of the Bendheim Parkinson Center at The Mount Sinai Medical Center, performed a double-blind study to explore whether continuous delivery of an intestinal gel form of levodopa/carbidopa could reduce "off" time in people with advanced PD. They found that the levodopa/carbidopa intestinal gel (LCIG) reduced "off" time by nearly four hours, two hours more than standard oral formulations of levodopa.
"Maintaining a response to oral therapy is a challenge in Parkinson's disease patients, and there is a significant unmet need for a treatment that provides the benefits of the drug without off time or dyskinesia," said Dr. Olanow. "Since it is administered continuously through a pump, LCIG is a promising development that improves outcomes and quality of life in patients with advanced disease."
The research team conducted a 12-week randomized, double-blind trial in 71 PD patients. At the start of the study, the average person had PD for about 11 years and experienced 6.6 hours of "off" time per day. Patients were randomized to receive a continuous infusion of LCIG, delivered through a portable pump connected to a tube implanted in the intestine, plus placebo pills; or placebo gel plus oral levodopa/carbidopa.
Treatment with LCIG was not associated with an increase in troublesome dyskinesia. The most common side effects associated with LCIG treatment involved complications due to inserting the device, abdominal pain, pain during the procedure and nausea.
Dr. Olanow has served as a consultant to Abbott, who manufactures LCIG and supports the study.
About The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Mount Sinai School of Medicine. Established in 1968, Mount Sinai School of Medicine is one of the leading medical schools in the United States. The Medical School is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News and World Report.
The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation's oldest, largest and most-respected voluntary hospitals. In 2011, U.S. News and World Report ranked The Mount Sinai Hospital 16th on its elite Honor Roll of the nation's top hospitals based on reputation, safety, and other patient-care factors. Of the top 20 hospitals in the United States, Mount Sinai is one of 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and U.S. News and World Report and whose hospital is on the U.S. News and World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.
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