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| |  Cabergoline Shows Significant Advantages Over Pergolide In Parkinson's LONDON, UK -- March 8, 2000 -- Cabaser/Cabaseril tablets (cabergoline) has been shown to be an effective and acceptable treatment in combination with levodopa for patients with advanced Parkinson's disease, offering significant advantages over pergolide. Cabaser/Cabaseril was shown to significantly reduce motor function complications compared to baseline, such as dyskinesias (uncontrollable jerking movements of the arms and legs), in a new study published in Aktuelle Neurologie. (German medical publication for neurologists and other doctors). The MODAC study, (Modern Dopamine Agonists in Comparison), in which patients trialed both cabergoline and pergolide, (both dopamine agonist* medications), revealed clear advantages for cabergoline over pergolide when each was added to patients' existing levodopa therapy to reduce the physical problems caused by levodopa. These include fluctuations** between mobility and immobility in addition to dyskinesias. The results of the study demonstrated a trend towards better control of symptoms known as 'off phases'** with cabergoline. Cabergoline was also better tolerated by patients, more successful in reducing the frequency and severity of dyskinesias, and more convenient to use than pergolide (once-a-day dosing compared to three times-a-day). At the conclusion of the study, 63 percent of patients chose to continue treatment with cabergoline, compared to 37 percent for pergolide. Dr Gudrun Ulm, Medical Director of the Paracelsus-Elena Clinic, Kassel, Germany and study leader of the German-based trial explained, "These are important clinical results for people with advanced Parkinson's disease. They provide clear evidence to support the use of cabergoline in patients with late-onset motor complications due to its overall effectiveness and its ability to smooth the motor fluctuations** caused by levodopa. It seems particularly suited to patients with dyskinesias." The study also provides support for cabergoline's effectiveness in improving the threshold for dyskinesias. "We believe that cabergoline's wider therapeutic window relative to other dopamine agonists improves the threshold for dyskinesias and provides smooth and even stimulation of dopamine receptors in the brain," added Dr Ulm "We believe that this even receptor stimulation is responsible for a desensitisation of the dopamine (D2) receptors thus reducing the frequency and severity of dyskinesias even after years of levodopa therapy." Cabergoline is currently the only dopamine agonist which is recommended for once-a-day dosing. It has a longer duration of action than any other treatment for Parkinson's disease, giving proven effectiveness over 24 hours. This is believed to be the reason for cabergoline's effectiveness in helping to manage night-time symptoms, as well as its ability to reduce the frequency and severity of dyskinesias. This is particularly important to many Parkinson's disease patients, (of which there are an estimated four million world-wide), who may find themselves with a range of nocturnal symptoms from jerking and cramps to total immobility as the effect of their medication wears off over the night-time period.
*Dopamine agonists are among the most promising newer treatment approaches for Parkinson's disease. They mimic the action of dopamine by directly stimulating dopamine receptors in the brain. There are five main dopamine receptor sub-types: D1, D2, D3, D4, D5. D2 appears to play the most significant role in movement control. **Motor fluctuations - also known as on/off phases, this phenomenon is characterised by abrupt, unpredictable fluctuations in mobility. Within minutes or even seconds, patients can find themselves profoundly immobile and rigid (off-phase) after being mobile or going through a period of dyskinetic mobility (mobile, but with disabling involuntary jerking). These fluctuations are believed to be linked to a growing inability to store and regulate the release of synthesised dopamine, after several years of levodopa therapy. Levodopa is traditionally regarded as the gold-standard treatment for Parkinson's disease. But after several years of use it is associated with a number of different problems, reducing both its usefulness and effectiveness. Over time, patients have to increase the dosage of levodopa to maintain control of their Parkinson's disease symptoms such as tremor and rigidity. Levodopa also causes 'on-off' episodes, where patients find they suddenly fluctuate between mobility (an 'on-phase') and immobility (an 'off-phase'). There is also the problem of dyskinesias with long-term levodopa therapy, which itself can be disabling. Study design - Cabergoline was compared to pergolide in a video-blinded, randomized, crossover study, examining effectiveness and tolerability. Patients were filmed undergoing a series of motor function tests (UPDRS III). The videos were randomised chronologically and evaluated blind. (UPDRS - the Unified Parkinson's Disease Rating Scale - is one of a number of rating scales that have been developed to assess the severity of the disease. The UPDRS system is very comprehensive and is generally regarded as being the most useful in measuring response to therapy.) The study was conducted through seven German clinics, and involved a total of 48 patients with advanced Parkinson's syndrome (with eight years average length of time from diagnosis), and existing late-onset motor function complications after several years of levodopa therapy. Patients were randomized to receive either pergolide (titrated up to 2-5mg per day) or cabergoline (titrated up to 2-6mg per day). Following an initial titration period of four weeks, a treatment period of eight weeks was commenced. Patients were then crossed over, so that those started on cabergoline were switched to pergolide and those started on pergolide were switched to cabergoline for a second eight week treatment period. Patients maintained symptom and side effect diaries. Cabergoline can be used for the treatment of Parkinson disease (PD), either as monotherapy in newly diagnosed patients or as adjunctive therapy to levodopa. The licence varies from country to country. In Denmark, Japan and Sweden, cabergoline is licensed for use in Parkinson's disease with or without the addition of levodopa. In Finland, Germany, Norway, Switzerland and the UK, it is indicated as adjunctive therapy to levodopa to control motor fluctuations. Cabergoline is marketed under the brand name Cabaser in Denmark, Finland, Japan, Norway, Sweden, Switzerland and the UK and as Cabaseril in Germany. Related Link: Pharmacia & Upjohn.
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