New Treatment for Patients with Alzheimer's Disease
(13th Annual Meeting of the American Association for Geriatric Psychiatry) Results of three prospective studies demonstrated significant benefits from treatment with rivastigmine tartrate, a cholinesterase inhibitor, in patients with Alzheimer's disease who were also at high risk for developing vascular dementia (VaD). Improvement was noted in activities of daily living, behavior, cognition, memory, self-care and overall disease severity. In addition, treatment with rivastigmine had a greater effect on patients with vascular risk factors. A total of 2,126 patients were enrolled in three, 26-week prospective, randomized, double-blind, placebo-controlled studies. The results of these studies were pooled for analysis and evaluated according to presence or absence of vascular risk factors. The Modified Hachinski Ischemic Score was used to evaluate patients for vascular risk factors, with a score of zero representing “pure Alzheimer's disease” and scores greater than zero representing increasing vascular risks. Patients with and without vascular risk factors receiving rivastigmine (6 to 12 mg per day) demonstrated statistically significant improvement in global changes in cognitive abilities, behavior and functioning as well as significant clinically meaningful improvement (10 percent) in ability to perform activities of daily living (i.e., eating, dressing, bathing), compared with patients receiving placebo. Among patients receiving rivastigmine, those with vascular risk factors demonstrated less overall decline than patients without vascular risks. Adverse events were mild to moderate and were primarily gastrointestinal. Rivastigmine has recently been labeled by the U.S. Food and Drug Administration for the treatment of Alzheimer's disease. VaD is considered the second most common form of dementia in the United States after Alzheimer's disease. Patients with Alzheimer's disease who possess vascular risk factors are at an increased risk for further deterioration associated with VaD.—vinod kumar, m.d., Florida Institute of Neurosciences and Clinical Research, Venice, Florida.
Study Shows Effectiveness of Injectable Contraceptive
(47th Annual Meeting of the American College of Obstetrics and Gynecology) Lunelle (formerly known as Cyclo-Provera), a once-a-month injectable contraceptive, proved more effective than Ortho-Novum 7/7/7, an oral contraceptive, in preventing unintended pregnancies as well as decreasing total cholesterol and triglyceride levels. This is according to the results of a 60-week, phase IIIb, open-label, nonrandomized, parallel study conducted at 42 clinical sites throughout the United States. A total of 1,103 women 18 to 49 years of age were included in the study. The trial compared 782 women who received Lunelle once every 28 days (plus or minus five days) by intramuscular injection with 321 women who received the oral tablets once daily. No unintended pregnancies were reported among women receiving Lunelle, compared with two reported unintended pregnancies among women receiving Ortho-Novum 7/7/7. A subset of 112 women who completed the study was evaluated to determine the potential impact of both contraceptive options on blood lipid levels. After 60 weeks, median total cholesterol levels decreased 11 mg per dL (0.28 mmol per L) and 10 mg per dL (0.25 mmol per L) in women receiving Lunelle and women receiving Ortho-Novum 7/7/7, respectively. Median triglycerides levels decreased by 19 mg per dL (0.21 mmol per L) and 15 mg per dL (0.17 mmol per L) in women receiving Lunelle and women receiving Ortho-Novum 7/7/7, respectively. The side effects profile, including a disruption of menstrual bleeding patterns with initial therapy, was similar to those experienced in patients receiving a combined hormonal contraceptive. As with other hormonal contraceptives, Lunelle is not an appropriate contraceptive option for women with the following conditions: known or suspected pregnancies; thrombophlebitis or thromboembolic disorders; a past history of deep-vein thrombophlebitis or thromboembolic disorders, cerebral vascular or coronary artery disease; and undiagnosed abnormal genital bleeding. Lunelle is currently awaiting approval by the U.S. Food and Drug Administration.—andrew kaunitz, m.d., University of Florida Health Science Center, Jacksonville, Florida.
Azelastine Nasal Spray Reduces Symptoms of Vasomotor Rhinitis
(56th Annual Meeting of the American Academy of Allergy, Asthma and Immunology) Results of a randomized, double-blind, placebo-controlled, clinical trial demonstrated that azelastine hydrochloride (Astelin) nasal spray significantly reduced the total vasomotor rhinitis symptoms scores compared with placebo over a 21-day treatment period in patients with perennial nonallergy (vasomotor) rhinitis (VMR). All of the 203 patients included in the study had a diagnosis of VMR, had been symptomatic for at least one year, and had a negative skin test for common seasonal and perennial allergens and a nasal cytology examination negative for eosinophils, prior to beginning treatment. Patients who met these baseline criteria were randomized to receive treatment with Astelin nasal spray or placebo. The primary efficacy variable was the overall reduction from baseline in the total vasomotor rhinitis symptoms scores, which consists of symptoms including rhinorrhea, sneezing, postnasal drip and nasal congestion. Patients recorded the intensity of their VMR symptoms on diary cards. The most commonly reported adverse events were bitter taste, headache and dysesthesia. Definitive diagnosis of VMR is difficult because symptoms of VMR (including runny nose, sneezing, postnasal drip and nasal congestion) are similar to those of allergic rhinitis and the common cold. Symptoms of VMR are typically triggered or exacerbated by such things as perfumes, hair sprays, paint fumes, spicy food, alcohol and weather changes such as cold air and humidity.—charles banov, m.d., Roper Hospital, Columbia Trident Regional Medical Center, Charleston, South Carolina.
Mylotarg Produces Remission in Patients with Leukemia
(36th Annual Meeting of the American Society of Clinical Oncology) According to results compiled from three phase II clinical trials, Mylotarg (an antibody-targeted chemotherapy) induced remission in 31 percent of patients with relapsed acute myeloid leukemia (AML) and produced fewer side effects than standard combination chemotherapy regimens. Mylotarg's highly specific antibody recognizes CD33, a cell-surface molecule that is abundant on AML cells but absent from normal blood stem cells. A total of 104 patients who had CD33-positive AML in first relapse received two intravenous infusions 14 days apart. Unlike standard chemotherapy regimens that involve multiple medications, Mylotarg was given alone. Remission was achieved in 34 percent of patients younger than 60 years and 28 percent of patients older than 60 years. There were no clinically significant differences in side effects between the age groups. Mylotarg did not produce significant major organ damage or sores in the mouth or intestinal tract, as is common with standard combination chemotherapy treatment. Patients receiving Mylotarg also experienced shorter hospitalizations compared with patients receiving standard chemotherapy, with one sixth of patients receiving Mylotarg being hospitalized for less than one week. Mylotarg is associated with a relatively low treatment-related mortality.—eric sievers, m.d., Fred Hutchinson Cancer Research Center, Seattle, Washington.