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| |  Fewer Side Effects With Depakote (Divalproex) Than With Olanzapine For Acute Mania ABBOTT PARK, IL -- December 12, 2000 -- Data from a head-to-head study showed fewer patients reported side effects with the mood stabilizer, Depakote® (divalproex sodium delayed-release tablets), compared to patients taking the antipsychotic olanzapine (Zyprexa®, Eli Lilly), according to a study released at the annual meeting of the American College of Neuropsychopharmacology. In bipolar patients with acute mania, the data also show there was no difference in efficacy between the two drugs. Moreover, total outpatient costs for Depakote-treated patients were about half that of the olanzapine-treated group, primarily due to the lower cost of Depakote tablets. "This study further supports the safety and efficacy of Depakote, which continues to be the treatment indicated for acute mania in bipolar disorder most prescribed by psychiatrists," said John Zajecka, M.D., associate professor of psychiatry at Rush-Presbyterian-St. Luke's Medical Center, and an investigator in the study. The 12-week clinical trial evaluated the two compounds in 120 patients who were randomized to receive either Depakote (n=63) or olanzapine (n=57) during the double-blind treatment period. Treatment with Depakote was initiated at 20 mg/kg/day and olanzapine was initiated at 10 mg/day. If symptoms persisted, Depakote could be increased by an additional 500mg/day on days three and six. For olanzapine, if symptoms persisted, doses could be increased by 5 mg/day on days three and six. Fewer Depakote patients in the study had side effects than the patients taking olanzapine. The following adverse events showed a statistically significant difference: edema (0 percent vs. 14 percent), somnolence (29 percent vs. 47 percent), speech disorder (0 percent vs. 7 percent), rhinitis (3 percent vs. 14 percent) and weight gain (10 percent vs. 25 percent), in the Depakote- and olanzapine-treated groups respectively. Depakote patients had significantly less weight gain than olanzapine patients. The mean weight gain from baseline to final evaluation in patients treated with olanzapine was 8.8 lbs. vs. 5.5 lbs. for Depakote over the 12-week period. "Patients often times are concerned about cosmetic side effects and other health issues of their medications, such as weight gain," said Alan Swann, M.D., Pat R. Rutherford Junior Professor and vice chair, research, Department of Psychiatry and Behavior Sciences, University of Texas Medical School, Houston and an investigator in the study. "In this study there was a statistically significant difference in weight gain between the divalproex- and olanzapine-treated groups." Efficacy (baseline to day 21) was similar in both treatment groups. There was no statistically significant difference seen in efficacy measured by the Mania Rating Scale (MRS) between the two groups. The mean change in MRS score from baseline was -14.8 for the Depakote group and -17.2 for the olanzapine group (p=0.210) after three weeks of treatment. The MRS is an 11-item measure of the core symptoms of mania, which include elevated mood, increased activity, less need for sleep, more energy, pressured speech, grandiosity, racing thoughts, overt anger, poor judgment and lack of insight. Results between the two treatment groups were similar in the Hamilton Depression Scale (HAM-D), Clinical Global Improvement (CGI) Scale and the Brief Psychiatric Rating Scale (BPRS). Depakote produced significantly lower total outpatient costs than olanzapine. The approximate mean 12-week cost for Depakote-treated patients was US$550 compared to $1,100 for olanzapine-treated patients. "In this study, the outpatient costs associated with use of olanzapine were about double the costs of the Depakote treatment group," adds Dr. Swann. "With similar efficacy, the difference in cost, coupled with the potential incidence of side effects, could be important factors to consider when evaluating treatment options for bipolar patients experiencing mania." Depakote is indicated for the treatment of acute mania associated with bipolar disorder based upon results of two 21-day clinical trials. Depakote should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment. Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia may be dose-related. Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Depakote (divalproex sodium) is a derivative of valproic acid. In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation. In elderly patients, dosage should be increased more slowly, with regular monitoring. In two 21-day, well-controlled clinical trials, common adverse events were nausea (22 percent vs. 15 percent for placebo), somnolence (19 percent vs. 12 percent for placebo), dizziness (12 percent vs. 4 percent for placebo) and vomiting (12 percent vs. 3 percent for placebo). The rate of discontinuation due to intolerance was not statistically different between placebo, Depakote or the active control (lithium). Depakote is a versatile medication. Since its approval in 1983, several indications have been received, making Depakote a valued option to physicians and patients. More than three million people in the United States have been diagnosed with bipolar disorder (also known as manic-depressive illness). Symptoms and severity vary, but the disorder is marked by mood changes that cycle over time. Over the course of the illness, the person experiences periods of elevated mood, periods of depressed mood, and times when mood is normal. Related Links: Depakote® (divalproex sodium) and Zyprexa® (olanzapine).
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