Investigational Alzheimer's Drug Improves Memory Up to One Year
(6th International Springfield Symposium) According to the results of two studies, patients receiving galantamine (an investigational drug under review by the U.S. Food and Drug Administration for the treatment of Alzheimer's disease) improved in memory, behavior and ability to perform activities of daily living (ADL), and were able to sustain these cognitive and functional benefits for up to 12 months. The first study was a five-month, double-blind, placebo-controlled trial involving 978 patients with mild to moderate Alzheimer's disease. Patients were randomized to one of four treatment groups, including a placebo group and three groups who received daily dosages of galantamine (8, 16 and 24 mg, respectively). The researchers used a variety of measures to assess the efficacy of the treatment, including the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog); the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus); the version of the Alzheimer's Disease Cooperative Study Inventory that includes ADL; and the Neuropsychiatric Inventory. Overall, the patients who received 16 mg of galantamine scored higher on each efficacy measure than patients who received placebo. The scores that measure cognition and the frequency and severity of behavioral symptoms were improved in patients in the galantamine groups at the completion of the study, compared with the patients' scores at the beginning of the trial. In contrast, the scores of patients in the placebo group had worsened. In patients receiving 16- and 24-mg dosages of galantamine, there was virtually no change in the ability to perform ADL from the start of the trial, whereas ADL deteriorated among the patients who received placebo. Adverse effects were mainly gastrointestinal, transient and mild to moderate in intensity. The second study demonstrated that patients receiving galantamine were able to maintain or increase their levels of cognitive performance and ability to participate in ADL after one year of treatment. A total of 636 patients were randomized into three groups, receiving placebo or a maximum daily dosage of galantamine of 24 or 32 mg. Eighty-one percent of the patients who completed the first six months of the study continued treatment with an open-label, daily dosage of 24 mg of galantamine for an additional six months. Primary assessment tools included the ADAS-cog and CIBIC-plus scales. Side effects were similar to side effects in the five-month trial.—pierre tariot, m.d., et al., University of Rochester Medical Center, New York City; tom wessel, m.d., et al., Janssen Research Foundation.
Indoor Allergens Are Closely Linked with Allergic Disease and Asthma
(American Thoracic Society's 96th International Conference) A significant portion of homes in the United States have beds with dust mite and cockroach allergen levels that exceed levels previously associated with triggering asthma symptoms, and cumulative exposure to these indoor allergens has been found to be a risk factor for developing allergic disease and asthma, with high levels of these allergens causing asthma. These findings are from the National Allergen Survey, conducted by the U.S. National Institute of Environmental Health Sciences, that included 831 homes representative of regions, ethnicity, socioeconomic status and housing characteristics in the United States. Researchers collected vacuum dust from five or six sites throughout each home and questioned home owners about issues including frequency of home cleaning and whether occupants had allergies or asthma. By extrapolating the results to the entire United States, the researchers estimated that 44 million homes (more than 45 percent of occupied housing units) have beds with levels of dust mites associated with allergen sensitization and that 22 million homes (23 percent) have beds with levels of dust mites believed to be associated with symptomatic asthma. The findings also showed that less than 40 percent of American households have bedding that is washed at least weekly in hot water and that only 4 percent of homes have impermeable mattress/pillow covers on their beds. The researchers recommend a number of ways for people with asthma or allergies to reduce their exposure to indoor allergens, including the following: encase mattresses and pillows in dust-proof or allergen impermeable covers; wash all bedding and blankets once a week in hot water; replace wool or feathered bedding with bedding made of synthetic materials; replace wall-to-wall carpeting in bedrooms with bare floors, if possible; use a damp mop to remove dust, as a dry cloth stirs up mite allergens; use a dehumidifier or air conditioner to maintain relative humidity at about 50 percent or lower; use a vacuum cleaner with low emissions.—patrick j. vojta, ph.d., et al., National Institute of Environmental Health Sciences, Washington, D.C.
Paroxetine Is Effective Treatment For Anxiety in Patients with GAD
(153rd Annual Meeting of the American Psychiatric Association) Results from a double-blind, placebo-controlled multicenter study indicate that patients with generalized anxiety disorder (GAD) receiving paroxetine (Paxil) experience a 60 percent reduction in anxiety symptoms. The study included 566 patients with GAD between 18 and 80 years of age (average age: 40 years). Patients receiving paroxetine, a selective serotonin reuptake inhibitor, showed significant reductions in tension (measured by the Hamilton Anxiety Scale), severity of illness (measured by a global assessment by the physician) and disability (measured by the Sheehan Disability Scale). The most common side effects associated with paroxetine include asthenia, sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, yawn, and sexual side effects in men and women. These side effects are generally not severe enough to cause discontinuation of paroxetine. Patients taking monoamine oxidase inhibitors should not take paroxetine. Paroxetine is currently labeled by the U.S. Food and Drug Administration for the treatment of depression, panic disorder, obsessive-compulsive disorder and social anxiety disorder, but it is not labeled for the treatment of GAD.—jack gorman, m.d., Columbia University, New York City.
Treatment with Citalopram Prevents Recurrent Depressive Episodes
(American Psychiatric Association) Long-term treatment (daily dosage of 20 to 40 mg) with citalopram HBr (Celexa), a selective serotonin reuptake inhibitor, helped prevent the recurrence of major depression in patients 65 years and older for up to two years. This is according to a study of 230 depressed individuals who were initially treated for depression with citalopram for eight weeks. A total of 121 patients who responded to citalopram during the acute treatment phase and remained well during the continuation phase (16 weeks) were then randomized to receive citalopram or a placebo for a minimum of 48 weeks during the placebo-controlled phase of the study to evaluate the drug's effect on prevention of recurrence. About 72 percent of the participants in the placebo-controlled phase were diagnosed with physical health problems in addition to depression, and all participants lived in the community. Mean age was 74 years. Long-term maintenance treatment (in dosages of 20 to 40 mg per day) was significantly more effective than placebo in preventing recurrence of depressive episodes—barry d. lebowitz, m.d., National Institute of Mental Health, Bethesda, Maryland.