title: Cataractogenic potential of quetiapine versus risperidone in the long-term treatment of patients with schizophrenia or schizoaffective disorder: a randomized, open-label, ophthalmologist-masked, flexible-dose, non-inferiority trial.
abstract: Clinical observations indicate no cataractogenic potential for quetiapine, in contrast to studies in laboratory animals. This randomized, non-inferiority study compared changes in lens opacity during long-term treatment with quetiapine versus risperidone. Patients with schizophrenia or schizoaffective disorder participated in the 2-year, randomized, multicentre, open-label, ophthalmologist-masked, flexible-dose, parallel-group study. Two ophthalmologists examined each patient 6-monthly for presence of nuclear opalescence (N) and cortical (C) or posterior subcapsular opacification (P), according to the lens opacities classification system II. 1098 patients were randomized to treatment. Mean doses were 386.3 mg/day quetiapine and 3.2 mg/day risperidone. Estimated absolute risk differences in cataractogenic events for quetiapine versus risperidone over 2 years were -0.035 (C), -0.012 (N) and -0.017 (P), with upper margins of confidence intervals within the non-inferiority margin of 10%. In post hoc analysis, risk of any lens opacification event was significantly lower for quetiapine than risperidone (6 and 16 events, respectively; risk difference: -0.058; P = 0.035). Efficacy and other safety assessments were in agreement with known profiles of these medications. Quetiapine was non-inferior to risperidone for changes in lens opacity grade in patients with schizophrenia or schizoaffective disorder, indicating that quetiapine does not have clinically significant cataractogenic potential during long-term treatment.
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA laties@mail.med.upenn.edu.
authors.forename: Alan M
authors.initials: AM
authors.lastname: Laties
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Allan J
authors.initials: AJ
authors.lastname: Flach
authors.affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA - former employee.
authors.forename: Irina
authors.initials: I
authors.lastname: Baldycheva
authors.affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA - former employee.
authors.forename: Ihor
authors.initials: I
authors.lastname: Rak
authors.affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA - former employee.
authors.forename: Willie
authors.initials: W
authors.lastname: Earley
authors.affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA - former employee.
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Pathak
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002386:Cataract / Q000139:chemically induced*; D003987:Dibenzothiazepines / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011618:Psychotic Disorders / Q000188:drug therapy*; D000069348:Quetiapine Fumarate; D018967:Risperidone / Q000009:adverse effects* / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate; D018967:Risperidone
keywords: Cataractogenic potential; non-inferiority trial; open-label; quetiapine; risperidone