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Cognitive symptoms in schizophrenic patients treated with risperidone compared to other neuroleptics
$296
P.2 Psychotic disorders andantipsychotics
likely to rate both physical (46% v. 18%, p < 0.001) and mental healthcare (39% v. 23%, p = 0.01) as fair or poor. Conclusion: Despite similar use of mental healthcare services, individuals receiving inadequate physical healthcare are more ill, both mentally and physically, than those who receive adequate physical healtheare. Supported by a grant from Pfizer Inc
References [1] Dixon L., Fostrado L., Delahanty J., Fischer P.J., Lehman A. (1999) The associationof medical comorbidity in schizophreniawith poor physical and mental health. J Nerv Ment Dis. 187 (8), 496-502. [2] Jeste D.V., Gladsjo J.A., Lindamer LA., Lacro J.P. (1996) Medical comorbidity in schizophrenia. Schizophr Bull. 22 (3), 413-30.
•
Risperidone oral solution versus intramuscular haloperidol for control of psychotic agitation
G.W. Currier 1, G.A. Simpson2. ~University of Rochester Medical
Center, 300 Crittenden Boulevards, Rochester, NY 14642, USA This study compared treatment with 2 mg oral risperidone solution plus 2 mg oral lorazepam with 5 mg intramuscular haloperidol plus 2 mg intramuscular lorazepam in 61 agitated patients. Agitation was rated on five subscales of the PANSS (excitement, hostility, hallucinations, uncooperativeness, and impulsivity) at baseline and 30 and 60 minutes after treatment. Each item was rated on a scale from 0-6, allowing a maximum total score of 30. Also evaluated were the need for repeat doses and the emergence of adverse effects for up to 24 hours after the initial dose. Both groups had similar mean (+SD) agitation scores at baseline (22.7 4- 5.5). Scores in both treatment groups declined significantly at 30 (mean 10.0 + 9.3) and 60 (mean 3.5 + 6.7) minutes (p < .0001) with no significant between-group differences. Of the 30 patients receiving haloperidol, 15 (50%) refused oral medications, 8 (27%) were unable to follow verbal instructions, 6 (20%) specifically requested intramuscular medications, and 1 (3%) described a n allergy to risperidone. No patient required a repeat dose of any medication. The majority of patients were sedated to the point of somnolence: at 2 hours, 2/30 (7%) of the haloperidol group and 5/31 (16%) of the risperidone group remained awake. The mean time to somnolence was 43.0 4- 25.1 minutes for patients receiving risperidone and 44.3 4- 25.7 minutes for those receiving haloperidol. The only adverse event was an episode of acute dystonia in a patient receiving haloperidol. In conclusion, risperidone oral solution plus lorazepam may be an effective and safe alternative to intramuscular haloperidol plus lorazepam in many patients with acute psychotic agitation.
References [1] Battaglia J, Moss S, Rosh J, Kang J, Mendoza R, Leedom L. et al. Haloperidol, lorazepam, or both for psychotic agitation? A multicenter, prospective, double-blind, emergency department study. Am J Emerg Med 1997; 15: 335-340. [2] Buckley PE The role of typical and atypical antipsychotic medications in the managementof agitation and aggression.J Clin Psychiatry 1997; 60: 52-60.
[R2.041[ Risperidone Olanzapine Drug Outcomes
Study in schizophrenia (RODOS) pooled results from German centers
M. Albus. German RODOS Study Group; District Hospital, Haar, Germany Methods: Retrospective chart review in 9 German centers to
compare drug usage patterns, costs and outcomes associated with treatment of schizophrenia with either Risperidone (R/S) or Olanzapine (OLA) within a single hospital setting. Main parameters are utilization and costs of drugs during inpatient treatment including neuroleptics and other relevant and concomittant medications. Secondary parameters are average daily dose and costs of treatments under study, proportions of patients discharged before 120 days and treatment efficacy. Results: 684 inpatients from 9 centers in Germany are included (ITT analysis R/S N = 324, OLA N = 357). Age at first symptoms RIS 31.1 year; OLA 29.9 year; age at admission RIS 39.8; OLA 38.1 without statistical significant differences. There are no differences concerning efficacy in both groups concerning number of patients with effective treatment, number of patients discharged before or at day 120; number of patients who discontinued treatment and average time to discharge. Average daily dose was 4.6 mg for RIS and 13.5 mg for OLA. 65% of R/S versus 60% of OLA patients took other neuroleptics during the treatment period (p 0.15). Comedikation was reduced to 38% in both groups at discharge. Daily costs of Risperidone were 3.14 DM versus OLA 6.71 DM (p > 0.0001). Daily costs of all treatment drugs were 5.51 DM R/S versus 9.15 OLA (p 0.0001). The two treatments were equally well tolerated. Conclusion: Because drug costs are only a minor part of total costs of schizophrenia and since atypical neuroleptics show clear advantages over conventional ones, atypical neuroleptics should be used first line. Comparing Risperidone and Olanzapine, our data indicate that treatment with Risperidone is more cost-effective than treatment with Olanzapine.
Cognitive symptoms in schizophrenic patients treated with Risperidone compared to other neuroleptics A. Klauder, K. Rettig. Janssen-Cilag GmbH, Neuss; G.E.M.,
Meerbusch, Germany Methods: Drug utilization observation study (DUOS) in chronic
schizophrenic patients comparing Risperidone to other neuroleptics. Efficacy: CGI, modified PANSS, standard progressive matrices (SPM) patient test, short version; tolerability: questionaire (EPS, sedation, weight gain) free adverse event AE-rating Results: 587 patients (485 R/S, 102 other neuroleptics) were analysed. 55% are male, 45% female. Mean age was 40 +/12 years RIS, versus 39 +/- 12 other neuroleptics. Most patients were diagnosed as paranoied (RIS 53.4%; others 49%) or residual (16% versus 20.6%). Mean Risperidone dose was 4 mg, Olanzapine (N = 34) mean dose was 12 mg. PANSS total score and PANSS subscores reduced significantly versus baseline. Compared to Olanzapine patients and to patients on conventional neuroleptics Risperidone patients improved significantly more on total PANSS, PANSS negative subscale and also on positive
P2 Psychotic disorders andantipsychotics subsacle for conventional neuroleptics only. Concerning the SPM Risperidone was numerically in favour OfOlanazapine and sign& cantly better than conventional neuroleptics. As EPS and sedation was concerned Risperidone was comparable to Olanzapine and in favour of conventional neuroleptics. More patients experienced weight gain while taking Olanzapine. Over all tolerability was rated significantly better with Risperidone and Olanzapine. Conclusion: This DUOS underlines the good efficacy and tolerability of Risperidene with special respect to cognitive symptoms in comparison to conventional neuroleptics and even Olanzapine.
m]
An intematianal survey on information needs of patients with schlzophrenla and their carers and management issues most frequent& entountered by professioiral care team members
T. W-r, M. Bassi, J. Dubuis, W.W. Fleischhacker, W. Kissling, D. Linszen, G. Remington, T. Turner, M. Wallaoe. Psykiatrin, Sektorsklinik Centrum Rundelenmottagningen Baltzarsgatan I, Malmii, Sweden
Aim: To identify the most frequently encountered management issues among professional aare team men@ers and the information needs of patients with schizophrenia and their carers (family and friends) and the preferred formats for information delivery used in schizophrenia management programs. Methods: A postal questionnaire, comprising 28 questions and developed in five languages (English, French, German, Italian and Spanish) was distributed to senior psychiatrists and other care team members in Canada, France, Germany, Italy, The Netherlands, Spain, Sweden and the UK, identified using mailing lists. Another questionnaire, comprising 21 questions and designed in two versions (for patients and carers) was developed in the same languages and distributed to patients and carers via professional care teams in the target countries. Results: There were 1358 responses from professional care team members, 212 from patients and 184 from carers. The patient management problems most frequently encountered by professional care team members were poor self-care (identified by 80% of respondents), non-compliance (79%), unemployment (71%), low self-image (67%), disruptive family stress (63%) and depression (63%). The care team members considered the following topics the most important for patients: information about schizophrenia (86%), managing symptoms (76%), advice on dealing with families (75%), advice on problems caused by substance and alcohol abuse (74%) and self-care (70%). The topics considered as most useful for carers were: information about schizophrenia (93%), medication (91%), coping with crisis (87%), advice on family issues (87%) and information about nondrug treatment (87%). Seventy-three percent of patients wanted to know more about a range of topics: drug treatment (55%), causes of schizophrenia (5 l%), self-management of symptoms (500/o), the nature of the illness (42%) and how to cope if unwell (34%). Patients identified physicians (67%) and other care team members (20%) as their main information sources. Their preferred formats for providing information were regular magazines (71%), personal sessions (70%), booklets (59%) and videos (53%). Almost all carers (93%) wanted to know more about the subj’ects such as the latest developments in schizophrenia (64%), drugs in schizophrenia (62%),, causes of schizophrenia (57%), how to cope in general (54%) and how to cope in crisis
s297
(53%). The main information sources for carers were physicians (58%), booklets/leaflets (29%) and nurses (21%). The preferred formats were personal sessions (85%), regular magazines (74%), booklets (63%) and videos (53%). Conclusions: Despite the methodological limitations of surveys, the results suggest that patients, carers and professional care team members require continuous information on a variety of different topics. In addition to information provided by a physician or other care team memb&s, patients and carers both rated highly the usefblness of regular magazines and videos. Appropriate, userfriendly information sources addressing the relevant topics and provided on a regular basis to patients and carers may enhance the alliance between professional teams, patients and carers and reinforce the information input provided in personal psychoeducational sessions.
lP.2.0441 A 3-week, double-blind, randomlzed’trial of ziprasidone in the acute treatment of mania I?E. Keck Jr.‘, K. Ice*. The Ziprasidone ‘Mania Study Group; ‘Biological Psychiat?y Progmm, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio; ‘Cent& Research Division, @er Inc. New York, New York, USA This randomized, double-blind study compared flexible-dose oral ziprasidone 80-160 mg/day (n = 13 1) with placebo (n = 64) over 3 weeks in inpatients with acute mania. Bipolar patients with acute mania and a baseline SADS-C Mania Rating Scale Score (MRS) > 14 were assessed using the SAD&C, PANSS, CGI-severity, GAF, Simpson-Angus and Barnes Akathisia scales. The SADS-C was rated on days 2,4,7,14 and 21. The primary efficacy analysis was mean change from baseline to endpoint (LOCF) on the SADSC MRS (ANCOVA, controlling for baseline and center). Groups were similar at baseline. Robust improvements in the MRS score were observed with ziprasidone which were statistically significantly greater than placebo by day 2 and at all time points until endpoint (p 5 0.05). Ziprasidone was significantly more effective than placebo in reducing the mean manic syndrome subscale score, the mean behavior and ideation subscale score and the mean CGI-severity score over the course of the study (all p < 0.05). Ziprasidone was associated with a statistically significantly greater mean improvement than placebo in overall psychopathology at endpoint, as measured by the PANSS total score, as well as significantly greater improvements in the positive and negative symptom subscales of the PANSS (all p < 0.05). Improvements in mania and psychopathology ratings scales with ziprasidone were accompanied by a statistically significantly greater improvement in global diction at endpoint compared with placebo, as measured by the GAF (p < 0.05). Ziprasidone was well tolerated. There was no significant difference between the ziprasidone and.placebo groups in mean changes in Simpson-Angus and Barnes akathisia rating scale scores at endpoint. Ziprasidone was well tolerated and appears to offer a rapidly effective treament for bipolar mania, improving manic symptoms, overall psychopathology and global functioning.
P.2 Psychotic disorders andantipsychotics
likely to rate both physical (46% v. 18%, p < 0.001) and mental healthcare (39% v. 23%, p = 0.01) as fair or poor. Conclusion: Despite similar use of mental healthcare services, individuals receiving inadequate physical healthcare are more ill, both mentally and physically, than those who receive adequate physical healtheare. Supported by a grant from Pfizer Inc
References [1] Dixon L., Fostrado L., Delahanty J., Fischer P.J., Lehman A. (1999) The associationof medical comorbidity in schizophreniawith poor physical and mental health. J Nerv Ment Dis. 187 (8), 496-502. [2] Jeste D.V., Gladsjo J.A., Lindamer LA., Lacro J.P. (1996) Medical comorbidity in schizophrenia. Schizophr Bull. 22 (3), 413-30.
•
Risperidone oral solution versus intramuscular haloperidol for control of psychotic agitation
G.W. Currier 1, G.A. Simpson2. ~University of Rochester Medical
Center, 300 Crittenden Boulevards, Rochester, NY 14642, USA This study compared treatment with 2 mg oral risperidone solution plus 2 mg oral lorazepam with 5 mg intramuscular haloperidol plus 2 mg intramuscular lorazepam in 61 agitated patients. Agitation was rated on five subscales of the PANSS (excitement, hostility, hallucinations, uncooperativeness, and impulsivity) at baseline and 30 and 60 minutes after treatment. Each item was rated on a scale from 0-6, allowing a maximum total score of 30. Also evaluated were the need for repeat doses and the emergence of adverse effects for up to 24 hours after the initial dose. Both groups had similar mean (+SD) agitation scores at baseline (22.7 4- 5.5). Scores in both treatment groups declined significantly at 30 (mean 10.0 + 9.3) and 60 (mean 3.5 + 6.7) minutes (p < .0001) with no significant between-group differences. Of the 30 patients receiving haloperidol, 15 (50%) refused oral medications, 8 (27%) were unable to follow verbal instructions, 6 (20%) specifically requested intramuscular medications, and 1 (3%) described a n allergy to risperidone. No patient required a repeat dose of any medication. The majority of patients were sedated to the point of somnolence: at 2 hours, 2/30 (7%) of the haloperidol group and 5/31 (16%) of the risperidone group remained awake. The mean time to somnolence was 43.0 4- 25.1 minutes for patients receiving risperidone and 44.3 4- 25.7 minutes for those receiving haloperidol. The only adverse event was an episode of acute dystonia in a patient receiving haloperidol. In conclusion, risperidone oral solution plus lorazepam may be an effective and safe alternative to intramuscular haloperidol plus lorazepam in many patients with acute psychotic agitation.
References [1] Battaglia J, Moss S, Rosh J, Kang J, Mendoza R, Leedom L. et al. Haloperidol, lorazepam, or both for psychotic agitation? A multicenter, prospective, double-blind, emergency department study. Am J Emerg Med 1997; 15: 335-340. [2] Buckley PE The role of typical and atypical antipsychotic medications in the managementof agitation and aggression.J Clin Psychiatry 1997; 60: 52-60.
[R2.041[ Risperidone Olanzapine Drug Outcomes
Study in schizophrenia (RODOS) pooled results from German centers
M. Albus. German RODOS Study Group; District Hospital, Haar, Germany Methods: Retrospective chart review in 9 German centers to
compare drug usage patterns, costs and outcomes associated with treatment of schizophrenia with either Risperidone (R/S) or Olanzapine (OLA) within a single hospital setting. Main parameters are utilization and costs of drugs during inpatient treatment including neuroleptics and other relevant and concomittant medications. Secondary parameters are average daily dose and costs of treatments under study, proportions of patients discharged before 120 days and treatment efficacy. Results: 684 inpatients from 9 centers in Germany are included (ITT analysis R/S N = 324, OLA N = 357). Age at first symptoms RIS 31.1 year; OLA 29.9 year; age at admission RIS 39.8; OLA 38.1 without statistical significant differences. There are no differences concerning efficacy in both groups concerning number of patients with effective treatment, number of patients discharged before or at day 120; number of patients who discontinued treatment and average time to discharge. Average daily dose was 4.6 mg for RIS and 13.5 mg for OLA. 65% of R/S versus 60% of OLA patients took other neuroleptics during the treatment period (p 0.15). Comedikation was reduced to 38% in both groups at discharge. Daily costs of Risperidone were 3.14 DM versus OLA 6.71 DM (p > 0.0001). Daily costs of all treatment drugs were 5.51 DM R/S versus 9.15 OLA (p 0.0001). The two treatments were equally well tolerated. Conclusion: Because drug costs are only a minor part of total costs of schizophrenia and since atypical neuroleptics show clear advantages over conventional ones, atypical neuroleptics should be used first line. Comparing Risperidone and Olanzapine, our data indicate that treatment with Risperidone is more cost-effective than treatment with Olanzapine.
Cognitive symptoms in schizophrenic patients treated with Risperidone compared to other neuroleptics A. Klauder, K. Rettig. Janssen-Cilag GmbH, Neuss; G.E.M.,
Meerbusch, Germany Methods: Drug utilization observation study (DUOS) in chronic
schizophrenic patients comparing Risperidone to other neuroleptics. Efficacy: CGI, modified PANSS, standard progressive matrices (SPM) patient test, short version; tolerability: questionaire (EPS, sedation, weight gain) free adverse event AE-rating Results: 587 patients (485 R/S, 102 other neuroleptics) were analysed. 55% are male, 45% female. Mean age was 40 +/12 years RIS, versus 39 +/- 12 other neuroleptics. Most patients were diagnosed as paranoied (RIS 53.4%; others 49%) or residual (16% versus 20.6%). Mean Risperidone dose was 4 mg, Olanzapine (N = 34) mean dose was 12 mg. PANSS total score and PANSS subscores reduced significantly versus baseline. Compared to Olanzapine patients and to patients on conventional neuroleptics Risperidone patients improved significantly more on total PANSS, PANSS negative subscale and also on positive
P2 Psychotic disorders andantipsychotics subsacle for conventional neuroleptics only. Concerning the SPM Risperidone was numerically in favour OfOlanazapine and sign& cantly better than conventional neuroleptics. As EPS and sedation was concerned Risperidone was comparable to Olanzapine and in favour of conventional neuroleptics. More patients experienced weight gain while taking Olanzapine. Over all tolerability was rated significantly better with Risperidone and Olanzapine. Conclusion: This DUOS underlines the good efficacy and tolerability of Risperidene with special respect to cognitive symptoms in comparison to conventional neuroleptics and even Olanzapine.
m]
An intematianal survey on information needs of patients with schlzophrenla and their carers and management issues most frequent& entountered by professioiral care team members
T. W-r, M. Bassi, J. Dubuis, W.W. Fleischhacker, W. Kissling, D. Linszen, G. Remington, T. Turner, M. Wallaoe. Psykiatrin, Sektorsklinik Centrum Rundelenmottagningen Baltzarsgatan I, Malmii, Sweden
Aim: To identify the most frequently encountered management issues among professional aare team men@ers and the information needs of patients with schizophrenia and their carers (family and friends) and the preferred formats for information delivery used in schizophrenia management programs. Methods: A postal questionnaire, comprising 28 questions and developed in five languages (English, French, German, Italian and Spanish) was distributed to senior psychiatrists and other care team members in Canada, France, Germany, Italy, The Netherlands, Spain, Sweden and the UK, identified using mailing lists. Another questionnaire, comprising 21 questions and designed in two versions (for patients and carers) was developed in the same languages and distributed to patients and carers via professional care teams in the target countries. Results: There were 1358 responses from professional care team members, 212 from patients and 184 from carers. The patient management problems most frequently encountered by professional care team members were poor self-care (identified by 80% of respondents), non-compliance (79%), unemployment (71%), low self-image (67%), disruptive family stress (63%) and depression (63%). The care team members considered the following topics the most important for patients: information about schizophrenia (86%), managing symptoms (76%), advice on dealing with families (75%), advice on problems caused by substance and alcohol abuse (74%) and self-care (70%). The topics considered as most useful for carers were: information about schizophrenia (93%), medication (91%), coping with crisis (87%), advice on family issues (87%) and information about nondrug treatment (87%). Seventy-three percent of patients wanted to know more about a range of topics: drug treatment (55%), causes of schizophrenia (5 l%), self-management of symptoms (500/o), the nature of the illness (42%) and how to cope if unwell (34%). Patients identified physicians (67%) and other care team members (20%) as their main information sources. Their preferred formats for providing information were regular magazines (71%), personal sessions (70%), booklets (59%) and videos (53%). Almost all carers (93%) wanted to know more about the subj’ects such as the latest developments in schizophrenia (64%), drugs in schizophrenia (62%),, causes of schizophrenia (57%), how to cope in general (54%) and how to cope in crisis
s297
(53%). The main information sources for carers were physicians (58%), booklets/leaflets (29%) and nurses (21%). The preferred formats were personal sessions (85%), regular magazines (74%), booklets (63%) and videos (53%). Conclusions: Despite the methodological limitations of surveys, the results suggest that patients, carers and professional care team members require continuous information on a variety of different topics. In addition to information provided by a physician or other care team memb&s, patients and carers both rated highly the usefblness of regular magazines and videos. Appropriate, userfriendly information sources addressing the relevant topics and provided on a regular basis to patients and carers may enhance the alliance between professional teams, patients and carers and reinforce the information input provided in personal psychoeducational sessions.
lP.2.0441 A 3-week, double-blind, randomlzed’trial of ziprasidone in the acute treatment of mania I?E. Keck Jr.‘, K. Ice*. The Ziprasidone ‘Mania Study Group; ‘Biological Psychiat?y Progmm, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio; ‘Cent& Research Division, @er Inc. New York, New York, USA This randomized, double-blind study compared flexible-dose oral ziprasidone 80-160 mg/day (n = 13 1) with placebo (n = 64) over 3 weeks in inpatients with acute mania. Bipolar patients with acute mania and a baseline SADS-C Mania Rating Scale Score (MRS) > 14 were assessed using the SAD&C, PANSS, CGI-severity, GAF, Simpson-Angus and Barnes Akathisia scales. The SADS-C was rated on days 2,4,7,14 and 21. The primary efficacy analysis was mean change from baseline to endpoint (LOCF) on the SADSC MRS (ANCOVA, controlling for baseline and center). Groups were similar at baseline. Robust improvements in the MRS score were observed with ziprasidone which were statistically significantly greater than placebo by day 2 and at all time points until endpoint (p 5 0.05). Ziprasidone was significantly more effective than placebo in reducing the mean manic syndrome subscale score, the mean behavior and ideation subscale score and the mean CGI-severity score over the course of the study (all p < 0.05). Ziprasidone was associated with a statistically significantly greater mean improvement than placebo in overall psychopathology at endpoint, as measured by the PANSS total score, as well as significantly greater improvements in the positive and negative symptom subscales of the PANSS (all p < 0.05). Improvements in mania and psychopathology ratings scales with ziprasidone were accompanied by a statistically significantly greater improvement in global diction at endpoint compared with placebo, as measured by the GAF (p < 0.05). Ziprasidone was well tolerated. There was no significant difference between the ziprasidone and.placebo groups in mean changes in Simpson-Angus and Barnes akathisia rating scale scores at endpoint. Ziprasidone was well tolerated and appears to offer a rapidly effective treament for bipolar mania, improving manic symptoms, overall psychopathology and global functioning.