Company Press Release SOURCE: National Parkinson Foundation Parkinson's Cases in 21st Century Likely to Increase as Baby Boomers Age and Diagnosis Improves; Increasing Functional Time is a Critical Goal of Parkinson's Therapy NEW YORK, April 26 /PRNewswire/ -- Parkinson's disease, a debilitating neurological disorder affecting an estimated 1.5 million Americans, will be on the increase in the next century. While this disease is most common among people over 60, many are also diagnosed in their 50s and 40s. In support of Parkinson's Awareness Month in April, leading neurologists are alerting Americans that the aging of the baby boomer generation, an increase in life expectancy, and more precise diagnosis will cause the number of Parkinson's patients to grow substantially. Parkinson Population to Grow in the Next Century Currently, 60,000 new cases of this progressive movement disorder are diagnosed each year. One of every 100 Americans over the age of 60 has PD. By 2020, when the over-60 population grows to 54 million, another half million people are expected to be affected by this potentially debilitating disease. ``In addition to the growing 60-plus population, more patients are being diagnosed in their 50s and even 40s,'' says Lisa Shulman, MD, assistant professor of neurology at the University of Miami and co-director of the National Parkinson Foundation Center of Excellence in Miami. ``This is because we now have a better understanding of Parkinson's disease and its early signs and symptoms.'' According to the National Parkinson Foundation, one third of patients develop symptoms before age 50 and 10 percent are diagnosed before age 40. Originally described as the ``shaking palsy'' by James Parkinson (whose birthday, April 14, has become World PD Day) in 1817, Parkinson's disease symptoms tend to emerge gradually over several years. At first, patients may find they are becoming clumsy or slow. Sometimes, people attribute their symptoms to ``arthritis'' or simply getting older. Eventually, however, most Parkinson's disease patients find that their balance becomes impaired or that it becomes increasingly difficult to accomplish simple movements like standing up from a chair. Common symptoms of this debilitating condition include: tremors, generally in the hands and feet; rigidity; stooped posture; bradykinesia (slow movement) and loss of balance. Other symptoms may include a mask-like facial expression, shuffling gait, decrease in arm swing, difficulty swallowing, slurred speech and difficulty with hand movements. Extending ``On-Time'' Key in Today's Parkinson's Therapy Extending ``on-time'' -- periods of relatively good functioning -- is the critical goal of today's Parkinson's therapy as symptoms advance. ``Off-time,'' marked by periods of relatively poor functioning, can have dramatic consequences for patients, especially if they mean loss of mobility or speech. ``New medications that provide more functional time may enable patients to continue doing what they want and need to do for themselves and with loved ones,'' says Dr. Shulman. Current Drug Treatments: How They Work Parkinson's disease may be one of the most baffling and complex of the neurological disorders. Although researchers continue to explore the causes of the disease, a cure has yet to be found. Currently, there are medications available that can extend the functional time of Parkinson's patients. Since its introduction in 1968, levodopa has been the gold standard in Parkinson's therapy. Parkinson's symptoms correlate with a decrease in dopamine in the substantia nigra portion of the brain. Levodopa, the chemical precursor to dopamine, works because it is effectively converted to dopamine in the brain. Today, levodopa is almost always given in combination with carbidopa, which makes levodopa more effective. Approximately 80 percent of all Parkinson's patients now take levodopa/carbidopa therapy. However, over time, as Parkinson's disease progresses, higher or more frequent doses of levodopa are needed to relieve symptoms, which can lead to an increase in side effects, such as nausea, vomiting, involuntary movements and hallucinations in some patients. The newest class of therapy to emerge to relieve Parkinson's symptoms, C.O.M.T.- inhibitors, work in conjunction with levodopa/carbidopa to enhance and extend the benefits of levodopa. C.O.M.T.-Inhibitors TASMAR®, the first C.O.M.T.-inhibitor introduced last year, provides smoother and more sustained levels of levodopa to the brain. Although the precise mechanism of action is unknown, this is believed to translate into more consistent and greater effects on the symptoms of Parkinson's disease. In clinical trials, patients with fluctuating symptoms who were given 100 mg. of TASMAR three times a day gained a daily average of approximately 1.7-2 hours of ``on-time,'' periods of relatively good functioning. In addition, patients experienced significant improvements as measured in clinical investigators' global assessments. ``Advanced patients with Parkinson's disease fluctuate between periods when they are nearly immobile and periods when they are able to function well,'' says Dr. Shulman. ``Medications such as Tasmar help to extend their functional time, which can mean the difference between independence and dependency on a caregiver.'' TASMAR ordinarily should be used as adjunctive therapy in patients on levodopa/carbidopa who are experiencing symptom fluctuations and who are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies, because of the risk of potentially fatal acute fulminant liver failure. TASMAR should not be initiated in patients with clinical evidence of liver disease or elevated liver enzymes and should be discontinued if substantial clinical benefit is not seen within three weeks. Patients with severe dyskinesia or dystonia should be treated with caution. Patients should have baseline liver monitoring with follow-up monitoring every two weeks for the first year, every four weeks for the next six months and every eight weeks thereafter. Liver monitoring may not prevent liver failure; however, early detection and immediate drug withdrawal are believed to enhance the likelihood of recovery. Patients should be advised to self- monitor for signs of liver disease. TASMAR should be discontinued in patients whose liver enzyme levels exceed the upper limit of normal or who exhibit signs and symptoms suggesting onset of hepatic (liver) failure. In clinical trials, adverse events reported when TASMAR was administered in combination with levodopa/carbidopa were dyskinesia, nausea, sleep disorders, dystonia, anorexia, diarrhea, somnolence, excessive dreaming, muscle cramps, orthostatic complaints, dizziness, headache, and hallucination and confusion. Diarrhea was the adverse event that most commonly led to discontinuation of therapy. TASMAR may potentiate the dopaminergic side effects of levodopa and may require decreasing the dose of levodopa. However, some of these side effects may persist despite levodopa dose adjustment. TASMAR should not be used by patients taking nonselective MAO-A inhibitors, but may be used by patients on MAO-B inhibitors. Other important prescribing information is printed on the product labeling. For more detail, see prescribing materials. There is still a long way to go to finding a cure for this devastating illness. However, until a cure is found, experts believe that early diagnosis, improved medications and rehabilitation strategies will help Parkinson's patients live a full and more enjoyable and productive life. Copyright © 1999 PRNewswire. -- Judith Richards, London, Ontario, Canada <[log in to unmask]> ^^^ \ / \ | / Today’s Research \\ | // ...Tomorrow’s Cure \ | / \|/ ```````