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Title: Fewer Side Effects With Mood Stabilizer Depakote (Divalproex Sodium) Than With Antipsychotic Zyprexa (Olanzapine)

"Fewer Side Effects With Mood Stabilizer Depakote (Divalproex Sodium) Than With Antipsychotic Zyprexa (Olanzapine)"

ABBOTT PARK, IL -- December 16, 2002 -- Fewer patients with bipolar disorder reported side effects with the mood stabilizer, Depakote® (divalproex sodium delayed-release tablets, Abbott Laboratories), compared to patients taking the antipsychotic, Zyprexa® (olanzapine, Eli Lilly), according to a head-to-head study of 120 patients published in the December issue of The Journal of Clinical Psychiatry. Depakote, approved by the FDA in 1995 for mania associated with bipolar disorder, is currently the most- prescribed treatment for mania. In bipolar patients with acute mania, a secondary analysis of the data also shows there were similar results between the two groups with respect to efficacy, as measured by the Mania Rating Scale (MRS). "This study further confirms the safety and efficacy of Depakote, which continues to be among the most-prescribed treatments for acute mania," said John M. Zajecka M.D., associate professor of psychiatry at Rush-Presbyterian- St. Luke's Medical Center. Study Results According to a head-to-head study of 120 patients, data showed that fewer Depakote patients reported certain side effects than the patients taking Zyprexa. A lower percentage of patients in the Depakote group than in the Zyprexa group reported the following adverse events: weight gain (10% vs. 25%), somnolence (drowsiness) (29% vs. 47%), rhinitis (runny nose) (3% vs. 14%), speech disorder (0% vs. 7%) and edema (swelling) (0% vs. 14%). A reduced platelet count was seen with Depakote-treated subjects. Depakote patients had less weight gain than Zyprexa patients. The mean weight gain in patients treated with Zyprexa was 8.8 lbs. vs. 5.5 lbs. for Depakote over the 12-week period. The difference in weight gain between groups emerged on day 14 of the trial and persisted through the end of the study. "Patients and physicians have become increasingly concerned about health issues related to side effects such as weight gain," said Zajecka. "In this study, there was a statistically significant difference in side effects, including weight gain and drowsiness, between the Depakote- and Zyprexa- treated patients. Gaining weight and excessive sleepiness may discourage patients from staying on their medicine. Sticking with treatment is particularly important for people with bipolar disorder." About Bipolar Disorder Bipolar disorder (also known as manic-depressive illness) is a biochemically-based mood disorder that affects more than 2.5 million people in the United States. Symptoms and severity vary, but the disorder is marked by mood changes that cycle over time from periods of elevated mood (mania), to periods of depressed mood, to times when mood is normal. Often beginning in adolescence or early childhood, bipolar disorder can be dangerous if left untreated or undiagnosed. According to recent statistics, as many as 30 percent of people living with untreated bipolar disorder take their own lives. In addition, patients have high rates of substance abuse and participate in behaviors risky to themselves and others. However, bipolar disorder is a highly treatable and manageable illness. Medication is an essential part of successful treatment. Study Design The 12-week, double-blind trial evaluated the two compounds in 120 patients who were randomized to receive either Depakote (n=63) or Zyprexa (n=57). Treatment with Depakote was initiated at 20 mg/kg/day and Zyprexa was initiated at 10 mg/day. If symptoms persisted, Depakote could be increased by an additional 500 mg/day on days three and six. For Zyprexa, if symptoms persisted, doses could be increased by 5 mg/day on days three and six. A secondary analysis of the data showed there were similar results with respect to efficacy, as measured by the MRS between two groups. The mean change in MRS score from baseline was -14.8 for the Depakote group and -17.2 for the Zyprexa group. Depakote is indicated for the treatment of acute mania associated with bipolar disorder based upon results of two 21-day clinical trials. "Depakote is a versatile and trusted medication that has been an important part of the bipolar treatment paradigm for acute mania in bipolar disorder for the past eight years," said Bruce McCarthy, M.D., global project head, Neuroscience, Abbott Laboratories. "We are pleased that it continues to show exciting results such as the data appearing in The Journal of Clinical Psychiatry." Important Product Safety Information About Depakote 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. Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. Valproate is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes fatal cases of hyperammonemic encephalopathy. 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. Depakote is a derivative of valproic acid. About Abbott Laboratories For more than 50 years Abbott Laboratories (NYSE: ABT) has been committed to the research and development of treatment for neurological disorders, including bipolar disorder. However, Abbott's commitment extends beyond research and development into the community to partner with advocacy organizations committed to helping people with bipolar disorder. Through an unrestricted educational grant with the Depression and Bipolar Support Alliance, Abbott has supported the Taking On and (Talking On) Bipolar Disorder Kit for families and their loved ones who may have bipolar disorder. Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com . More information on Depakote can be found at http://www.depakote.com . SOURCE: Abbott Laboratories

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