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| |  APA: Olanzapine Reduces Behavioral and Psychotic Symptoms in Alzheimer's Patients INDIANAPOLIS, IN -- May 16, 2000 -- Olanzapine (Lilly) significantly improves behavioral and psychotic symptoms in patients with Alzheimer's disease, according to a new study presented at the 153rd Annual Meeting of the American Psychiatric Association in Chicago, IL. Alzheimer's disease is a chronic, degenerative illness that affects nearly four million people in the United States. "The behavioral disturbances associated with Alzheimer's disease are the leading cause of caregiver distress and patient institutionalization. Patients may not be able to sleep, may lash out at family members, or may withdraw from social activity," said Jamie Street, M.D., clinical research physician, Lilly Research Laboratories, and leader of the multicenter study. "Reducing these symptoms may help families care for their elderly relatives longer." The trial, which was designed to analyze the safety and efficacy of olanzapine, examined 137 nursing home patients (mean age: 81.3 years) who met the National Institute of Neurological and Communicative Disorders and Stroke- Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for possible or probable Alzheimer's disease. Subjects received olanzapine in a flexible dose range of 5, 10 or 15 mg/day for up to 18 weeks. Key Findings The efficacy of olanzapine was evaluated with the Neuropsychiatric Inventory/Nursing Home Version (NPI/NH) scale, which assesses psychopathology in dementia by measuring a patient's level of agitation, delusions, and hallucinations (Core Total). Use of olanzapine led to significant reduction in behavioral disturbances, as reflected in patients' improved scores on the Core Total (mean +/- SD: -7.55 +/- 8.53, p<.001) and nine of the 12 behavioral item scores of the NPI/NH. In particular, olanzapine was shown to reduce the incidence of hallucinations and aggression/agitation, two particularly disturbing events for sufferers and caregivers. Extrapyramidal symptoms were measured using the Barnes-Akathisia Scale, the Abnormal Involuntary Movement Scale (AIMS) and the Simpson-Angus Scale. Barnes Akathisia scores were significantly improved from baseline (o.22 +/- 0.80, p=.002). Simpson-Angus and AIMS scores did not change significantly. Safety was measured by examining treatment-emergent adverse events, ECG parameters, weight, and vital signs. Treatment-emergent symptoms with incidence greater than or equal to 20 percent included somnolence (26 percent), accidental injury (26 percent), and rash (22 percent). No significant differences were found for mean changes in any vital sign. Approximately six to eight percent of the world's population over 65 years of age is diagnosed with Alzheimer's disease. Of these patients, it is estimated that more than 50 percent exhibit psychotic symptoms and between 50 and 75 percent exhibit behavioral symptoms such as agitation, hostility, or wandering. In an earlier fixed dose study of olanzapine and placebo in nursing home patients having various psychiatric symptoms in association with Alzheimer's disease, the following treatment-emergent adverse events were reported: somnolence, abnormal gait, fever, dehydration and back pain. Discontinuations in that study due to abnormal gait, accidental injury and somnolence were considered to be drug related. As with other CNS active drugs, olanzapine should be used with caution in elderly patients with dementia. Olanzapine is indicated in the United States for the management of the manifestations of psychotic disorders as demonstrated in short-term clinical trials with schizophrenia patients. It is also approved for the short-term treatment of acute manic episodes associated with bipolar disorder. Since olanzapine was introduced in 1996, it has been prescribed to more than 4 million people worldwide. In the original schizophrenia registration trials, olanzapine was generally well tolerated. However, as with all medications, olanzapine was associated with some side effects. In the original six-week, acute-phase schizophrenia trials, the most common treatment-emergent adverse event associated with olanzapine was somnolence. Other common events were dizziness, weight gain, constipation, akathisia (restlessness), and postural hypotension. Modest elevations of prolactin were also seen, although mean changes from baseline to endpoint were not statistically significantly different between olanzapine and placebo. A small number of patients experienced asymptomatic elevations of hepatic transaminase; none of these patients developed jaundice or drug-induced hepatitis. In short-term (three- and four-week) acute bipolar mania trials, the most common treatment-emergent adverse event associated with olanzapine was somnolence. Other common events were dry mouth, dizziness, asthenia, constipation, dyspepsia, increased appetite, and tremor. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Related Links: Olanzapine and Eli Lilly.
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