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| |  Exelon (Rivastigmine Tartrate) Now Available In US For Alzheimer's Disease EAST HANOVER, NJ -- June 21, 2000 -- Novartis Pharmaceuticals Corporation announced today that Exelon® (rivastigmine tartrate) capsules -- the first new Alzheimer's disease medication in three years -- is now on pharmacy shelves and available by prescription. Exelon is a cholinesterase inhibitor for the treatment of mild to moderate Alzheimer's disease (AD). The safety and efficacy of Exelon were demonstrated in the largest phase III clinical program to date of any Alzheimer's disease medication. Patients treated with Exelon demonstrated a significant benefit in global functioning based on evaluation of activities of daily living (ADLs), behavior and cognition. "Before the introduction of Exelon there were only two Alzheimer's treatments available, which meant very limited options for those suffering with this devastating illness," said George T. Grossberg, MD, Director, Division of Geriatric Psychiatry, Saint Louis University School of Medicine. "What makes the introduction of Exelon so exciting is that it has demonstrated efficacy across all key critical domains of the disease - and that's extremely important to Alzheimer's patients and their caregivers." The phase III clinical program involved more than 3,900 patients worldwide. Nearly 5,300 patients in total have received Exelon in clinical trials. The six-month clinical trials with Exelon involved patients with mild to moderate AD, 94 percent of whom also suffered from a variety of medical illnesses common in the elderly, including hypertension, type 2 diabetes and arthritis. Virtually all patients in the studies used concomitant medications, allowing researchers to assess the efficacy and safety of Exelon in a patient population similar to a "real world" population. "My husband participated in the Exelon clinical trials, and I'm thankful for the time I believe it's given us together," said Trudy Brennan, caregiver of an Alzheimer's patient who received treatment with Exelon during the clinical trials and continues taking the medication today. "Before he started taking this medication his symptoms were progressively deteriorating; now he's been basically stable since being on Exelon. We're a very close family and I can't imagine what the past few years would have been like if he had continued to get worse as he had been before he started this treatment." Global Functioning (including activities of daily living, behavior and cognition) Patients treated with 6-12 mg/day Exelon demonstrated a significant benefit in global functioning as measured by the CIBIC-Plus. The CIBIC-Plus is a structured instrument based on a comprehensive evaluation of patient cognition, behavior and functioning, including assessment of activities of daily living. Significantly more patients treated with Exelon were rated improved at week 26 on the CIBIC-Plus as compared to patients given placebo. In a U.S. pivotal trial, patients treated with 6-12 mg/day Exelon demonstrated a highly significant 4.94 point drug versus placebo difference in cognitive scores at 26 weeks as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), a clinically relevant cognitive assessment scale extensively validated in AD patients. In a multi-national pivotal trial, the mean difference in the ADAS-Cog score for patients treated with Exelon (6-12 mg/day) compared to patients treated with placebo at 26 weeks was 2.6 points. Typical deterioration for patients with mild to moderate AD is six to 12 points per year on the ADAS-Cog. In an effort to evaluate the safety and efficacy of Exelon in all its potential applications, investigations with the medication continue. Clinical programs are ongoing to examine the effect of Exelon in patients with mild cognitive impairment (MCI) and in more severely ill out-patients, as well as patients in nursing homes with moderate to severe Alzheimer's disease. In addition, a study of Exelon in patients with Lewy-body dementia has been recently completed and clinical trials in vascular dementia are planned. Exelon should not be used in patients with known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation. In controlled clinical trials, the most common adverse events were nausea, vomiting, anorexia, dyspepsia and asthenia. Exelon use is associated with significant gastrointestinal adverse reactions, including nausea and vomiting anorexia and weight loss. In the controlled studies, these side effects occurred more frequently as doses were increased. The weight loss associated with Exelon occurred more frequently among women receiving high doses in clinical trials. Exelon should be used with caution in patients with peptic ulcers, gastrointestinal bleeding, and "sick sinus syndrome" or other supraventricular cardiac conduction conditions. In clinical studies, 3 percent of Exelon-treated patients experienced syncope compared to 2 percent of placebo-treated patients. (Please see important WARNINGS in complete prescribing information.) Exelon has been cleared for marketing in nearly 70 countries worldwide, including all 15 member states of the European Union, Switzerland, New Zealand, Australia, Canada and Mexico. Alzheimer's disease is a neurodegenerative disease involving deterioration of the brain. Alzheimer's disease is the fourth leading cause of death behind cardiovascular disease, cancer and stroke. It affects up to 4 million adults in the United States and 10 million worldwide. This fatal disease causes memory loss and the inability to perform daily activities. Annually the US price tag is approximately US$100 billion in direct (healthcare and related) and indirect (income) costs. It is estimated that delaying the onset of the disease by five years could save the nation's healthcare system as much as $50 billion. Related Link: Exelon (rivastigmine tartrate) and Novartis Pharmaceuticals Corporation.
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