Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia: Efficacy and Safety Outcomes of the CATIE

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Question. What to take away from CATIE. Message. One piece of a puzzle. Disclosures. Subcontracted site PIIndustryNIMHColleagues. Strengths. DesignSampleNon-industry sponsoredEfficacyEffectiveness. . . EPS TD. . Weight Gain. . Insulin Resistance. . Hyper-glycemia. . CVD. . Hyper-lipidemia.
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1. Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia: Efficacy and Safety Outcomes of the CATIE Trial Ira D. Glick, MD Stanford University School of Medicine For Jeffrey Lieberman, MD and the CATIE Investigators

2. Question What to take away from CATIE

3. Message One piece of a puzzle

4. Disclosures Subcontracted site PI Industry NIMH Colleagues

5. Strengths Design Sample Non-industry sponsored Efficacy Effectiveness

6. Side Effects of Atypical Antipsychotics: Shift in Risk Perception Side Effects of Atypical Antipsychotics: Shift in Risk PerceptionSide Effects of Atypical Antipsychotics: Shift in Risk Perception

8. Primary Questions Addressed by CATIE Schizophrenia Trial

10. CATIE: Broad Inclusion & Minimal Exclusion Criteria DSM-IV schizophrenia, 18-65 years old Not first-episode or treatment resistant Concomitant medications, medical illnesses, substance use disorders allowed No adjunctive antipsychotic after randomization In order to enroll a broad array of patients representing those who are actually seen in clinics, we developed minimal inclusion and exclusion criteria: In order to enroll a broad array of patients representing those who are actually seen in clinics, we developed minimal inclusion and exclusion criteria:

11. CATIE Schizophrenia Trial Design

12. Primary Outcome Measure: All-Cause Treatment Discontinuation

13. Phase I Results

14. CATIE Phase 1: Double-Blinded and Randomized

15. Highlights of Phase I High rate of discontinuation (switching) %74 Hypothesized 60% Consistent with practice and clinical trials OLZ most effective Best efficacy, worst side effects PER comparably effective to SGAs Very slightly higher EPS No differential effects of SGAs on Sxs including negative Sxs Cognition, substance abuse, violence ? Differences in types and severity of side effects Consistent results across multiple measures within domains

16. Phase II-E & T Results

17. CATIE Phase 2: Preference Pathways (for people who discontinue Phase 1)

18. Highlights of Phase 2E High rate of discontinuation (switching) %65 CLZ most effective and OLZ next most effective Best efficacy, worst side effects (1 agranulocytosis) Differences in types and severity of side effects Consistent results across multiple measures within domains

19. Highlights of Phase 2T High rates of discontinuation (switching) %70 Overall RIS and OLZ more effective than QUET and ZIP RIS most effective in patients Phase 1 who switched for tolerability OLZ most effective in patients Phase 1 who switched for efficacy Differences in types and severity of side effects Consistent results across multiple measures within domains

20. Neurocog improved for all treatments Second generation not better than older drug May want to drop neurocog results entirelyNeurocog improved for all treatments Second generation not better than older drug May want to drop neurocog results entirely

21. Difficulties in Interpretation Design Sample Dosing Stratification Statistical analysis

22. All APDs are generally effective but have various limitations as reflected by high rates of discontinuation, intolerable side effects and failure to adequately control symptoms. In non-refractory patients olanzapine is more efficacious than the other SGAs (other than clozapine) but also was associated with significant weight gain and metabolic changes. Intermediate potency FGAs (e.g. perphenazine, loxapine, molindone, thiothixene) are likely comparably effective to the SGAs and, in moderate doses, as well tolerated as the newer drugs.

23. There is variation in the side effects of the antipsychotic drugs which for individual patients can be substantial. Clozapine and olanzapine produced the most weight and metabolic effects followed by quetiapine and risperidone. Ziprasidone has the least weight and metabolic effects.

24. Treatments for persons with schizophrenia must be individualized. Doctors and patients must carefully evaluate the tradeoffs between efficacy and side effects in choosing an appropriate medication.

25. For patients whose symptoms don?t improve with initial treatment clozapine is most effective followed by olanzapine. For patients who must switch medications due to side effects the best alternative depends on the individual side effects.

26. Summary Findings Perphenazine is significantly less costly than other medications and not significantly or substantially less effective.

27. Summary Findings The superiority of the SGAs may be most evident in the refractory end of the schizophrenia spectrum.

28. Findings Cloz: good O and R>Q Z:? FGA=SGA:?

29. Message Schizophrenia difficult to treat Pts/family/MDs switch often Each med has differential efficacy and side effects

30. Pearls Monotherapy Adequate dose and duration Don?t do polypharmacy Always combine with individual and family psychosocial intervention

31. HIGHLIGHTS All antipsychotic medications are effective but have substantial limitations reflected by high discontinuation rates Olanzapine and Clozapine best efficacy but worst side effects Perphenazine surprisingly comparable to atypicals Differences in types & severity of side effects Ziprasidone has least weight and metabolic side effects What drug you should switch to depends on what treatment you have received and why you stopped it. The superiority of the SGAs may be most evident in the refractory end of the schizophrenia spectrum.

32. Principles from CATIE Results 1. Antipsychotic medications are not equivalent or interchangeable 2. Individual history, symptoms, side effects and circumstances must guide medication choices 3. Choice of medication is vital given the complexity and heterogeneity of schizophrenia 4. CATIE does not support a blanket "fail first" policy 5. CATIE does not support severe restrictions in formularies; algorithms may be helpful, based on individual needs 6. CATIE does not mean people doing well on newer medications should be switched on older drugs 7. CATIE does not mean it is always best for the patient to stay with the current treatment

33. Collaborators Principal Investigators Joe McEvoy Scott Stroup Diana Perkins Marvin Swartz Richard Keefe Ed Davis Bob Rosenheck Sonia Davis John Hsaio Jeffrey Lieberman 57 Site Investigators


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