Seroquel Bipolar Data Published
Patients Taking Seroquel in Combination with Lithium or Divalproex
Achieved Significantly Greater Remission and Response Rates than Patients Taking Lithium or
Divalproex Alone
(June 1, 2004) -- Patients with
mania associated with bipolar disorder
receiving
Seroquel (quetiapine fumarate) adjunct therapy in combination with
lithium or
divalproex
(Depakote) achieved significantly greater rates of response and remission
from manic episodes than patients receiving lithium or divalproex alone, according
to a study published today in Bipolar Disorders.
Results from this randomized, double-blind, placebo-controlled study showed that at three weeks, 54.3% of
bipolar patients treated with Seroquel in combination with lithium or divalproex achieved a response [defined as >50% YMRS (Young Mania Rating Scale) improvement], compared with 32.6% treated with lithium or divalproex alone. In addition, 45.7% of patients treated with Seroquel in combination with lithium or
Depakote (divalproex) achieved clinical remission (defined as YMRS<12) at three weeks, compared with 25.8% treated with lithium or divalproex alone.1
“Achieving remission of symptoms of mania can be difficult,” said Gary S. Sachs, M.D., Director of the Bipolar Treatment Center, Harvard University. “These data suggest combining Seroquel with a mood stabilizer may improve patients’ symptoms of mania, and could increase the likelihood of achieving clinical remission.”
Seroquel currently is indicated by the U.S. Food and Drug Administration for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. Since its launch, 24.6 million Seroquel prescriptions have been written for 6.2 million patients.2
STUDY INFORMATION
The study was designed to evaluate the efficacy of quetiapine as combination therapy with lithium or divalproex in manic episodes associated with bipolar disorder. One hundred ninety-one patients were randomly assigned to quetiapine plus mood stabilizer (n = 91) or placebo plus mood stabilizer (n = 100) in the 3-week, double-blind, randomized, parallel-group, placebo-controlled study, conducted at 27 sites in the United States.1
- The primary endpoint was change from baseline in YMRS score at Day 21 of treatment. At day 21, patients treated with Seroquel adjunct therapy with lithium or divalproex achieved a significantly greater mean reduction in total YMRS score than patients receiving placebo with lithium or divalproex (-13.76 versus -9.93; p=0.021).1
- At day 21, the proportion of patients treated with Seroquel adjunct therapy with lithium or divalproex achieving clinical remission (YMRS < 12) was significantly greater than that of patients treated with placebo plus lithium or divalproex (45.7% versus 25.8%; p = 0.007).1
- Patients treated with Seroquel adjunct therapy with lithium or divalproex also had a significantly greater improvement in CGI-BP Severity of Illness scores (-1.38 versus -0.78; p = 0.001).
- Most adverse events were mild, with withdrawal due to adverse events being only 5% for patients receiving Seroquel adjunct therapy with lithium or divalproex versus 6% for those receiving placebo with lithium or divalproex.1
“The results of this study, in conjunction with other bipolar data from our clinical trial program, support the role of Seroquel in controlling symptoms of bipolar mania,” said Jamie Mullen, MD, Senior Director of Clinical Research, AstraZeneca. “AstraZeneca has a clear commitment to the development of new treatments for mental illness, and is proud of how successful Seroquel has been in treating patients since its launch in 1997.”
IMPORTANT SAFETY INFORMATION
Seroquel is indicated for the treatment of schizophrenia and the short-term treatment of acute manic episodes associated with bipolar I disorder. The physician who elects to use Seroquel for extended periods of time should periodically re-evaluate the long-term usefulness of the drug for individual patients.
Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia, seizures, and orthostatic hypotension. A rare condition referred to as neuroleptic malignant syndrome (NMS) has been reported with this class of medications, including Seroquel.
There have been reports of diabetes mellitus and hyperglycemia related adverse events associated with the use of atypical antipsychotics, including Seroquel.
The most commonly observed adverse events associated with the use of Seroquel in clinical trials were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia and weight gain.
For Seroquel full prescribing information, please visit:
the Seroquel website.
Source: AstraZeneca Press Release (manufacturer of Seroquel)
References
- Sachs G, Chengappa K.N.R, Suppes T, Mullen JA, Brecher M, Devine NA, Sweitzer DE. Quetiapine with Lithium or Divalproex for the Treatment of Bipolar Mania: A Randomized, Double-Blind, Placebo-Controlled Study. Bipolar Disorders, June 2004 (publication/edition number TBD)
- Data on File
- NIMH Publication No. 01-4584, Printed January 2001; Revised May 2003
- NIH Publication No. 02-3679, Printed 2001, Reprinted September 2002
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