Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Reagila

Reagila 1.5 mg orodispersible tablets Reagila 3 mg orodispersible tablets Reagila 4.5 mg orodispersible tablets Reagila 6 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 29

HOS-129608 · Präparat HOS-096751

Weight changes In the short-term studies, there were slightly greater mean increases in body weight in the cariprazine group compared to the placebo group; 1 kg and 0.3 kg, respectively. In the long-term maintenance of effect study, there was no clinically relevant difference in change of body weight from baseline to end of treatment (1.1 kg for cariprazine and 0.9 kg for placebo). In the open-label phase of the study during 20 weeks cariprazine treatment 9.0% of patients developed potentially clinically significant (PCS) weight gain (defined as increase ≥ 7%) while during the double-blind phase, 9.8 % of the patients who continued with cariprazine treatment had PCS weight gain versus 7.1% of the patients who were randomized to placebo after the 20 week open-label cariprazine treatment. In the negative symptom study, the mean change of body weight was -0.3 kg for cariprazine and +0.6 kg for risperidone and PCS weight gain was observed in 6% of the cariprazine group while 7.4% of the risperidone group.

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