If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Olanzapine More Tolerable, As Effective As Clozaril For Treatment-Resistant Patients INDIANAPOLIS, IN -- Oct. 30, 1998 -- Results of clinical studies of Eli Lilly and Co.’s antipsychotic medication Zyprexa(R) (olanzapine) show that the drug is more tolerable and at least as effective as Clozaril (clozapine) in managing treatment-resistant patients. Results from an international, multi-centre, 18-week trial demonstrating the superior tolerability and at least comparable antipsychotic efficacy of Zyprexa compared to clozapine in managing treatment-resistant patients, were presented at the 11th European College of Neuropsychopharmacology annual congress in Paris, France. In a double-blind trial, the efficacy and safety of Zyprexa were compared with clozapine among treatment-resistant patients with schizophrenia. In this study, 180 patients who had not responded adequately to two previous conventional treatment courses were randomised to either Zyprexa or Clozaril for 18 weeks of treatment. Similar percentages of patients from each treatment group finished the 18-week trial period (60 percent Zyprexa; 58.9 percent clozapine). Dosing for Zyprexa was 15 to 25 mg/day and the dosing range for Clozaril was 25 to 200 mg/day (Day 1 to 8) and 200 to 600 mg/day (Day 8 through Week 18). Dosing was adjusted within each range at the discretion of the clinical investigator to maximise clinical response and mitigate any tolerability issues. Efficacy for positive and negative symptoms was evaluated by mean change from baseline to final visit (LOCF) on several standard efficacy measurements including the PANSS total, positive and negative scores; BPRS total score; and CGI Severity score. Data from the primary endpoint PANSS total score were assessed using a standard non-inferiority analysis. Adverse event information was gathered through spontaneous reporting as well as questions directly solicited from patients on a well-accepted side effect inventory (AMDP-5). Patients characterised as treatment-resistant who were treated with Zyprexa achieved an improvement in psychosis comparable to that seen with clozapine through the use of a statistical non-inferiority test. Further, while there was no statistically significant differences between the two treatment groups on the primary efficacy scales, the magnitude of the treatment effect numerically favoured Zyprexa on each of the overall efficacy measures based on standard analysis of variance. A similar proportion of Zyprexa-treated patients and clozapine-treated patients achieved at least a 20 percent improvement in PANSS total score; however, a trend toward significantly more Zyprexa-treated patients achieving 30 percent and 40 percent improvements in PANSS total score was seen. Significantly fewer Zyprexa-treated patients discontinued therapy because of an adverse event than those receiving clozapine. Among spontaneously reported side effects, constipation, increased salivation, dizziness, nausea and tooth disorder were reported significantly more often among clozapine-treated patients; only dry mouth was reported significantly more often among Zyprexa-treated patients. Based on response to AMDP-5 questionnaires, male patients experienced hypersalivation, dizziness and hypotonia significantly more often among clozapine patients, and dry mouth, difficulty falling asleep, diarrhea and backache significantly more often among Zyprexa patients. For female patients, the adverse events reported significantly more often among clozapine patients included hypersalivation, excessive appetite, drowsiness and constipation, but no events were reported more significantly among Zyprexa patients. The incidence of extrapyramidal symptoms was low in both treatment groups, however, concomitant use of medication to treat such symptoms was more than twice that in the clozapine group than in the Zyprexa group. The low rate of adverse events seen with Zyprexa combined with the lack of need for blood monitoring with Zyprexa should play an important role in patient ease of use. Related Links: Zyprexa, Eli Lilly and Co.
|
