Clinical comparison of extended-release divalproex versus delayed-release divalproex: pooled data analyses from nine trials

2004 ◽  
Vol 5 (5) ◽  
pp. 746-751 ◽  
Author(s):  
Michael C. Smith ◽  
Franca Centorrino ◽  
Jeffrey A. Welge ◽  
Michelle A. Collins
Author(s):  
Ann Catherine Childress ◽  
Victor Otcheretko ◽  
Lewis E. Warrington ◽  
Justin A. Barnes ◽  
Ryan A. Gregg ◽  
...  

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
J. Newcomer ◽  
R. Ratner ◽  
M. Åström ◽  
H. Eriksson

Background:Data pertaining to changes in weight during long-term treatment with quetiapine (QTP) have been published previously (1).Methods:Pooled data are presented from 26 short-term clinical studies (up to 12 weeks) of QTP or quetiapine extended-release (QTP XR)-as monotherapy or adjunct therapy-conducted by AstraZeneca up to November 2007. Studies were conducted in adult patients (18-65 years) across a number of psychiatric diagnoses. Variables were analyzed irrespective of fasting status with similar analyses planned in the fasting subset. LSM changes from baseline for the difference between QTP and placebo are presented.Results:Approximately 10000 patients were included in the analyses, 70% of whom were treated with QTP or QTP XR. Across the entire short-term dataset, the difference in LSM change in weight for QTP vs. placebo was 1.07 kg. Corresponding differences in glucose regulation parameters were 1.39 mg/dL for glucose and 0.04% units for HbA1C. the overall difference in total cholesterol was 5.48 mg/dL, with differences in HDL and LDL cholesterol of -0.62 mg/dL and 1.69 mg/dL. the difference in LSM change in triglycerides was 22.62 mg/dL.Discussion:Within the context of balancing potential risks against the acknowledged benefits of atypical antipsychotics, the degree and significance of variations in metabolic parameters is an area of continued interest. This analysis helps clinicians to better understand changes in important metabolic parameters across trials with QTP and QTP XR, and the size and uniqueness of the dataset permits further analyses within this important area.Supported by funding from AstraZeneca Pharmaceuticals LP.


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