Seroquel

[Quetiapine]

(3) use of anticholinergic medications to treat emergent EPS.
SEROQUEL Dose Groups Placebo 75 mg 150 mg 300 mg 600 mg 750 mg
Parkinsonism 0.6 -1.0 -1.2 -1.6 -1.8 -1.8
EPS incidence 16% 6% 6% 4% 8% 6%
Anticholinergic medications 14% 11% 10% 8% 12% 11%

In three additional placebo-controlled clinical trials using variable doses of SEROQUEL, there were no differences between the SEROQUEL and placebo treatment groups in the incidence of EPS, as assessed by Simpson-Angus total scores, spontaneous complaints of EPS and the use of concomitant anticholinergic medications to treat EPS.

Vital Sign Changes: SEROQUEL is associated with orthostatic hypotension (see PRECAUTIONS).

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Weight Gain

The proportions of patients meeting a weight gain criterion of >7% of body weight were compared in a pool of four 3-to 6-week placebo-controlled clinical trials, revealing a statistically significantly greater incidence of weight gain for SEROQUEL (23%) compared to placebo (6%).

Laboratory Changes:

An assessment of the premarketing experience for SEROQUEL suggested that it is associated with asymptomatic increases in SGPT and increases in both total cholesterol and triglycerides (see PRECAUTIONS). An assessment of hematological parameters in short-term, placebo-controlled trials revealed no clinically important differences between SEROQUEL and placebo.

ECG Changes

Between group comparisons for pooled placebo-controlled trials revealed no statistically significant SEROQUEL/ placebo differences in the proportions of patients experiencing potentially important changes in ECG parameters, including QT, QTc, and PR intervals. However, the proportions of patients meeting the criteria for tachycardia were compared in four 3-to 6-week placebo-controlled clinical trials revealing a 1% (4/ 399) incidence for SEROQUEL compared to 0.6% (1/ 156) incidence for placebo. SEROQUEL use was associated with a mean increase in heart rate, assessed by ECG, of 7 beats per minute compared to a mean increase of 1 beat per minute among placebo patients. This slight tendency to tachycardia may be related to SEROQUEL's potential for inducing orthostatic changes (see PRECAUTIONS).

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