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document
Comparison of olanzapine long-acting injection and oral olanzapine : a 2-year , randomized , open-label study in outpatients with schizophrenia . We compared long-term treatment effectiveness of monthly olanzapine long-acting injection ( LAI ) with that of oral olanzapine . Outpatients with 2 or more episodes of psychotic worsening in the past 24 months with Positive and Negative Syndrome Scale total score of lower than 70 were randomized to 405 mg/4 weeks of olanzapine LAI ( n = 264 ) or 10 mg/d of oral olanzapine ( n = 260 ) for 2 years of open-label treatment . Dosing thereafter was flexible ( 150-405 mg/4 weeks of LAI vs 5-20 mg/d of oral ) . Primary outcome was time to all-cause discontinuation . At baseline , patients were clinically stable ( mean Positive and Negative Syndrome Scale total score of 57 ) . Seventeen percent of patients had been psychiatrically hospitalized in the previous 6 months , and 4.6 % were rated nonadherent in the month before study entry . The groups did not differ significantly in median time to all-cause discontinuation ( 645 days for LAI , 678 days for oral ; P = 0.61 ) , discontinuation rate ( 53.8 % for LAI , 51.2 % for oral ; P = 0.60 ) , or relapse rate ( 20.1 % for LAI , 18.5 % for oral ; P = 0.66 ) . Postbaseline psychiatric hospitalization rate was low for both groups ( 7.6 % for LAI , 9.2 % for oral ) , but mean hospitalization duration was significantly longer for oral patients ( 1.80 days [ 20 for those hospitalized ] vs 0.43 days [ 6 for those hospitalized ] , P = 0.02 ) . There were no clinically significant group differences in adverse events or safety measures . No post-injection delirium/sedation syndrome events occurred . In conclusion , olanzapine LAI and oral olanzapine were similarly effective and well tolerated for up to 2 years of treatment in patients with schizophrenia . Treatment discontinuation for olanzapine LAI was similar to that of oral olanzapine , despite the 3-hour post-injection observation period and other precautionary procedures related to risk of post-injection delirium/sedation syndrome .
65402
Intervention_Pharmacological
olanzapine long-acting injection
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Intervention_Pharmacological
oral olanzapine
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Intervention_Pharmacological
olanzapine long-acting injection ( LAI )
65405
Intervention_Pharmacological
oral olanzapine .
65406
Intervention_Pharmacological
olanzapine LAI
65407
Intervention_Pharmacological
oral olanzapine
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Intervention_Pharmacological
LAI
65409
Intervention_Pharmacological
LAI
65410
Intervention_Pharmacological
LAI
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Intervention_Pharmacological
olanzapine LAI
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Intervention_Pharmacological
olanzapine
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Intervention_Pharmacological
olanzapine LAI
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Intervention_Pharmacological
olanzapine
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Outcome_Mental
schizophrenia .
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Outcome_Mental
psychiatric
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Outcome_Mental
delirium/sedation syndrome
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Outcome_Other
effective
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Outcome_Other
tolerated
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Outcome_Mental
schizophrenia .
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Outcome_Other
Treatment discontinuation