WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 1ĪDT=antidepressant therapy MADRS=Montgomery-Asberg Depression Rating Scale MDD=major depressive disorder. In the 8-week study, the shifts in fasting glucose were similar among the VRAYLAR and placebo + ADT groups. The proportion of patients with shifts in fasting glucose from normal to borderline (≥100 and <126 mg/dL) or from borderline to high was similar in patients treated with VRAYLAR and placebo. ¶In 6-week studies, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL): VRAYLAR 1.5 mg per day + ADT = 2% VRAYLAR 3 mg per day + ADT = 3.2% placebo-treated = 1.3%.
Shift defined as: total cholesterol: normal/borderline (<240 mg/dL) to high (≥240 mg/dL) fasting triglycerides: normal/borderline (<200 mg/dL) to high (≥200 mg/dL).
||In the 6- and 8-week MDD studies, proportion of patients with metabolic shifts was similar to placebo.
Monitor weight at baseline and frequently thereafter. The mean weight changes reported in this study were VRAYLAR 1-2 mg/day + ADT (n=273) = +1.98 lb VRAYLAR 2 -4.5 mg/day + ADT (n=273) = +1.98 lb placebo + ADT (n=266) = 0 lbs. In the 8-week MDD study, 2.5% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 2% of those taking placebo. The mean weight changes reported in these studies were VRAYLAR 1.5 mg/day + ADT (n=502) = +1.54 lb VRAYLAR 3 mg/day + ADT (n=503) = +1.54 lb placebo + ADT (n=503) = +0.44 lb. In two 6-week MDD studies, 2% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 1% of those taking placebo + ADT. In the 6-week studies, 4% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 2% of placebo-treated patients in these trials. ‡The most common adverse reactions observed in the two 6-week MDD studies (≥5% and at least twice the rate of placebo) were akathisia, nausea, and insomnia.
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