Journal: Clinical drug investigation

Article Title: Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

doi: 10.1007/s40261-016-0439-2

Figure Lengend Snippet: Assessment of liver injury markers during the study period. a ALT assessment. #Elevated group patients showed robust differences R2 = 0.442 in ALT levels during the medication time-course at p = 0.001. *Significant contrast in the treatment course between the baseline elevated and non-elevated groups of the quetiapine arm F(3,82) = 10.437, p < 0.01 (F statistics). **There was a significant Time × Treatment × Liver-injury group interaction. b AST assessment. There was no significant elevation in association determined between AST levels through the treatment course of the quetiapine arm. Time by Treatment repeated analysis of variance statistical test was used. Data are presented as mean ± standard error. *Statistical significance was set at p ≤ 0.05. Non-elevated group from baseline. Gr.2 elevated group from baseline. Q in Quetiapine treatment group. P in Placebo treatment group. ALT normal range 6–40 IU/L; AST normal range 10–34 IU/L

Article Snippet: 2.2 Procedures and Assessments The active drug, quetiapine XR (Seroquel XR® AstraZeneca, Wilmington, DE, USA), was provided to the participants for 3 months in 50- and 200-mg tablets with identical matching non-active pills for the placebo group titrated with a full dose of 400 mg/day [ 28 ] (in a dose-escalating manner reaching a plateau phase during week 4).

Techniques:

Journal: Clinical drug investigation

Article Title: Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

doi: 10.1007/s40261-016-0439-2

Figure Lengend Snippet: Patient demographics and timeline for last 90 days for drinking history collected at baseline by treatment arm and sex

Article Snippet: 2.2 Procedures and Assessments The active drug, quetiapine XR (Seroquel XR® AstraZeneca, Wilmington, DE, USA), was provided to the participants for 3 months in 50- and 200-mg tablets with identical matching non-active pills for the placebo group titrated with a full dose of 400 mg/day [ 28 ] (in a dose-escalating manner reaching a plateau phase during week 4).

Techniques:

Journal: Clinical drug investigation

Article Title: Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

doi: 10.1007/s40261-016-0439-2

Figure Lengend Snippet: Serum triglyceride and fasting blood glucose evaluation of study participants by Time and Treatment. Within the quetiapine arm, triglyceride levels were higher in patients with baseline liver injury, and showed significant between-subjects effects at each time-point, p = 0.041, when TD90 was co-varied. *Significant time × treatment effect in observed in glucose level in quetiapine arm, p = 0.054, post hoc test showed an effect at 13 W. Time by Treatment repeated analysis of variance statistical test was used. Data are presented as mean ± standard error. *Statistical significance was set at p ≤ 0.05. Gr.1 Non-elevated group from baseline. Gr.2 Elevated group from baseline. Q in Quetiapine treatment group. P in Placebo treatment group. Triglycerides: normal <150, borderline-high range 150–199, high triglycerides range 200–499, and very high triglycerides ≥500. Normal fasting blood glucose (FBG) range was 60–115 mg/dl

Article Snippet: 2.2 Procedures and Assessments The active drug, quetiapine XR (Seroquel XR® AstraZeneca, Wilmington, DE, USA), was provided to the participants for 3 months in 50- and 200-mg tablets with identical matching non-active pills for the placebo group titrated with a full dose of 400 mg/day [ 28 ] (in a dose-escalating manner reaching a plateau phase during week 4).

Techniques:

Journal: Clinical drug investigation

Article Title: Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

doi: 10.1007/s40261-016-0439-2

Figure Lengend Snippet: Hepatotoxicity report from published articles of second-generation antipsychotic drugs in human subjects. Our study was conducted in patients who were actively drinking and had a heavy drinking profile

Article Snippet: 2.2 Procedures and Assessments The active drug, quetiapine XR (Seroquel XR® AstraZeneca, Wilmington, DE, USA), was provided to the participants for 3 months in 50- and 200-mg tablets with identical matching non-active pills for the placebo group titrated with a full dose of 400 mg/day [ 28 ] (in a dose-escalating manner reaching a plateau phase during week 4).

Techniques: