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Financial.de, Germany (Press Release) Sept. 01, 2003 Updated 08:04 Novartis: First results of three multicenter open-label clinical trials with ... 01.09.2003 (08:04) First results of three multicenter open-label clinical trials with StalevoTM show improved symptomatic benefits and enhanced convenience for patients with Parkinsonīs disease. Basel, 1 September 2003 - Results from new clinical studies with Stalevo(TM) presented today at the 7th Congress of the European Federation of Neurological Societies in Helsinki, Finland confirm clear patient benefits. Data from these first-ever studies in patients with Parkinson's disease (PD) taking Stalevo - the new levodopa combination product containing levodopa, carbidopa and entacapone - show enhanced symptomatic benefits resulting in greater control of PD symptoms, as well as convenience of administration compared to traditional levodopa therapy. While levodopa therapy remains the cornerstone of PD treatment, its long term utility is limited by the occurrence of motor complications. Stalevo was therefore developed to optimize the pharmacokinetic profile of levodopa and enhance its clinical benefits. The individual components of Stalevo have a well-established efficacy record supported by numerous clinical trials1,2,3,4,5,6, which provided the basis for regulatory agency approval of Stalevo7. These first-ever clinical studies provide valuable data regarding dosing, tolerability and efficacy of Stalevo. Commenting on the clinical relevance of the TC-INIT study8, one of the lead investigators, Professor David Brooks, of the Medical Research Council Clinical Sciences Centre and Imperial College London, UK said: "These interim data show that levodopa treated PD patients may be switched to Stalevo and experience enhanced benefits of their levodopa therapy. In addition, this real-life experience is significant as it demonstrates that the switch can be achieved easily and conveniently". The TC-INIT study compares the switch from traditional levodopa/dopa decarboxylase inhibitor (DDCI) therapy to either Stalevo or levodopa/DDCI plus entacapone (Comtess/Comtan) tablets taken separately in 200 PD patients experiencing wearing-off symptoms. Interim results of 111 patients show that patients taking Stalevo experience improved symptom control comparable to levodopa/DDCI plus entacapone taken separately. At the end of week two, a majority of patients saw their condition improve when their levodopa therapy was optimized. When switched to Stalevo, 82% (investigator assessment) and 81% (patient assessment) of patients reported improved symptom control versus 76% (investigator assessment) and 73% (patient assessment) when switched to levodopa/DDCI plus entacapone taken separately. In addition, treatment with Stalevo as a single tablet was easy to initiate and provided simplicity and convenience of administration for patients. Interim data from a second study (SELECT-TC) assessing the switch to Stalevo in 160 PD patients currently being treated with levodopa/carbidopa and experiencing wearing-off symptoms, indicate that the majority of patients can easily be transferred to Stalevo with few, or no levodopa dose adjustments.9 "These data show that dose modifications are rarely needed when switching from levodopa treatment to Stalevo and can be accomplished with ease and convenience, and most importantly with the patient's acceptance. There are a number of complicated regimens that currently exist in PD treatment. Many patients often have to take medications for other co- existing conditions. Stalevo clearly has everyday practical benefits for patients and for physicians prescribing the treatment by combining three medicines in one", added Professor David Brooks. In a third, four-week completed study (SIMCOM) more than two-thirds of the patients preferred taking Stalevo to levodopa/DDCI and entacapone taken separately. Furthermore, the vast majority of patients reported that Stalevo was easier to dose, use, handle and swallow.10 In all studies, Stalevo was generally well tolerated. The most common side effects were dopaminergic in nature (e.g. dyskinesia or involuntary movements, nausea). These side effects are mild and moderate in nature, and when they occur, they can usually be managed with dose modifications. Side effects seldom lead to treatment discontinuation. In addition, the components of Stalevo have a well-established safety and tolerability profile supported by numerous clinical trials1,2,3,4,5,6 and over 300 000 patient years of experience with levodopa/DDCI plus entacapone.11 Novartis and Orion Pharma received US Food and Drug Administration (FDA) approval for Stalevo in June 2003 and have recently [26 June 2003] received a positive opinion from the European Committee for Proprietary Medicinal Products (CPMP). SOURCE: Financial.de, Germany (Press Release) http://www.financial.de:8065/newsroom/schweiz/2150.html * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn