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P.2.e.014 A multinational assessment of quality of life and resource use by bipolar disorder patients in Europe and the US
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P.2.e Affective disorders and antidepressants – Bipolar disorders (clinical)
The overall evaluation by physician was rated as satisfied for all these patients. The most commonly reported side effects including dizziness (n = 3), nausea (n = 3), rigidity (n = 2), and akathisia (n = 1), were all mild and transit. After six weeks treatment, the average weight had increased by 3.17%; (2.86% for males, 3.87% for females). A decrease on sitting blood pressure and an increase on sitting pulse rate was noted. However, these changes were not clinically significant. Discussion: This study suggests that zotepine in combination with mood stabilizers in actual practice, to be effective for mania patients. Although a slightly weigh gain was noted, it is considered as tolerable as other antipsychotics. References [1] Benedikt A, Roland M, Sandra Di Michael O, Andrea S, 2005, Zotepine loading in acute and severely manic patients: a pilot study. Bipolar Disord 7, 471–476. [2] Harada T, Otsuki S, 1986, Antimanic effect of Zotepine. Clin Ther 8, 406–414. [3] Petit M, Raniwalla J, Tweed J, Leutenegger E, Dollfus S, Kelly F, 1996, A comparison of an atypical and typical antipsychotic, zotepine versus haloperidol in patients with acute exacerbation of schizophrenia: a parallel-group double-blind trial. Psychopharmacol Bull 32, 81−87.
scores were reported by French patients (70.1±28.6), and the lowest VAS scores were reported by Italian patients (59.1±18.5). Across all countries, EQ-5D utility scores were significantly lower in patients reporting a depressed health state (64.6±28.7) than in patients reporting manic (80.6±25.6, P < 0.001) or hypomanic (82.6±22.3, P < 0.0001) health states, but did not differ significantly from scores in patients reporting a mixed health state (68.8±27.6). The mean number of drugs prescribed in the overall study population was 2.13±1.02. The number of drugs was significantly higher in patients with EQ-5D utility scores in the lowest quartile versus the highest quartile (2.48±1.13 vs 1.82±0.85, P < 0.001). Patients in the lowest quartile of EQ-5D utility scores also tended to have the highest number of hospital visits (0.82 vs 0.49−0.58 for the other quartiles). Conclusions: In this large, multinational, cross-sectional survey of physicians and their patients with bipolar disorder, patientreported QOL varied substantially as a function of the phase of the illness. The depressed health state was associated with the lowest QOL scores, which in turn were associated with the highest number of prescribed drugs and hospital visits. Thus, successful treatment of the depressed state in patients with bipolar disorder may improve QOL and reduce resource use.
P.2.e.014 A multinational assessment of quality of life and resource use by bipolar disorder patients in Europe and the US
P.2.e.015 Early onset of antipsychotic action and time course in the treatment of acute bipolar mania
O. Leeuwenkamp1 ° , R. Morlock2 , G. Milligan3 , R. Perry3 . 1 NV Organon, Department of Global Health Economics & Strategic Pricing, Oss, The Netherlands; 2 Pfizer Inc, Worldwide Outcomes Research, New York, USA; 3 Adelphi, Adelphi Group Products, Chesire, United Kingdom
T. Ketter1 , L. Warrington2 , A. Loebel2 , S. Kolb3 ° , C. Siu4 . 1 Stanford University, Psychiatry, Stanford, USA; 2 Pfizer Inc., Medical Neuroscience, New York, USA; 3 Pfizer Inc., Global Pharmaceuticals, DEU, Karlsruhe, Germany; 4 Data Power (DP) Inc., Quantitative Methodology, Ringoes, USA
Objective: Bipolar disorder is a burden to patients and society. The objective of this research was to provide information on selfreported quality of life (QOL) and resource use in patients with bipolar disorder from the United States and Europe. Methods: Physicians from the United States and 5 European countries (France, Germany Italy, Spain, and the United Kingdom) completed a questionnaire concerning the clinical status and therapy of their patients. Patients completed the EuroQol EQ-5D, which assesses QOL in 5 key areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patient responses were used to generate EQ-5D utility scores. Current health state was also rated by each patient, using the EQ-5D visual analog scale (VAS), on which 0 = worst imaginable health and 100 = best imaginable health. In addition, patients reported their level of resource use (number of prescribed medications, number of hospital visits) during the preceding 12 months. Results are reported as mean ± standard deviation. Results: Data on self-reported QOL were collected from 1762 patients from the United States (n = 506), France (n = 270), Germany (n = 329), Italy (n = 259), Spain (n = 177), and the United Kingdom (n = 221) in 2006. Patients were predominantly female (57.6%), outpatients (90.7%), and between the ages of 25 and 64 (85.8%). Reasons for physician visits were classified as maintenance of treatment (49.7%) and depressed (20.4%), mixed (10.4%), manic (10.1%), or hypomanic (9.4%) health states. Across all countries, mean EQ-5D utility scores (76.8±24.8) were higher than EQ-5D VAS scores (64.0±20.6). The highest EQ5D utility and VAS scores were reported by German patients (82.8±20.3 and 67.1±22.4, respectively); the lowest EQ-5D utility
Background: Previous studies have demonstrated the efficacy of ziprasidone compared with placebo in improving symptoms of mania and global illness severity from Day 2 onward in subjects with a manic or mixed episode of bipolar I disorder, with or without psychotic features [1]. While the efficacy of antipsychotic medications for the treatment of psychosis is generally established, their mechanism of action and particularly the speed of “onset” of antipsychotic response remain controversial. In addition, it has usually been assumed that the acute or earlier effects on psychosis are nonspecific or “behavioral” with the antipsychotic effects thought to occur much later. Recent research have indicated that intramuscular ziprasidone produces a significant, early (within 24 hours) improvement in psychotic symptoms [2], distinct from drug-induced changes in non-specific behavior symptoms such as agitation, In this post-hoc analysis, we evaluated the potential for an early antipsychotic response to oral ziprasidone in subjects with acute bipolar mania, and to determine whether this early effect is distinct from a reduction in agitation symptoms associated with the treatment. Methods: We conducted a pooled analysis of two 3-week, randomized, double-blind, placebo-controlled studies of ziprasidone (40–160 mg/d) in hospitalized patients (N = 415) with bipolar I disorder and a current manic (N = 257) or mixed episode (N = 158), with (N = 167) or without (N = 248) psychotic features. Efficacy assessments included the Mania Rating Scale (MRS, derived from the SADS-C) and CGI-S which were administered at baseline and Days 2, 4, 7, 14, and 21 (or early termination). Improvement in psychosis was evaluated by the SADS-C psychosis subscale (delusions, hallucinations, and suspiciousness).
P.2.e Affective disorders and antidepressants – Bipolar disorders (clinical)
The overall evaluation by physician was rated as satisfied for all these patients. The most commonly reported side effects including dizziness (n = 3), nausea (n = 3), rigidity (n = 2), and akathisia (n = 1), were all mild and transit. After six weeks treatment, the average weight had increased by 3.17%; (2.86% for males, 3.87% for females). A decrease on sitting blood pressure and an increase on sitting pulse rate was noted. However, these changes were not clinically significant. Discussion: This study suggests that zotepine in combination with mood stabilizers in actual practice, to be effective for mania patients. Although a slightly weigh gain was noted, it is considered as tolerable as other antipsychotics. References [1] Benedikt A, Roland M, Sandra Di Michael O, Andrea S, 2005, Zotepine loading in acute and severely manic patients: a pilot study. Bipolar Disord 7, 471–476. [2] Harada T, Otsuki S, 1986, Antimanic effect of Zotepine. Clin Ther 8, 406–414. [3] Petit M, Raniwalla J, Tweed J, Leutenegger E, Dollfus S, Kelly F, 1996, A comparison of an atypical and typical antipsychotic, zotepine versus haloperidol in patients with acute exacerbation of schizophrenia: a parallel-group double-blind trial. Psychopharmacol Bull 32, 81−87.
scores were reported by French patients (70.1±28.6), and the lowest VAS scores were reported by Italian patients (59.1±18.5). Across all countries, EQ-5D utility scores were significantly lower in patients reporting a depressed health state (64.6±28.7) than in patients reporting manic (80.6±25.6, P < 0.001) or hypomanic (82.6±22.3, P < 0.0001) health states, but did not differ significantly from scores in patients reporting a mixed health state (68.8±27.6). The mean number of drugs prescribed in the overall study population was 2.13±1.02. The number of drugs was significantly higher in patients with EQ-5D utility scores in the lowest quartile versus the highest quartile (2.48±1.13 vs 1.82±0.85, P < 0.001). Patients in the lowest quartile of EQ-5D utility scores also tended to have the highest number of hospital visits (0.82 vs 0.49−0.58 for the other quartiles). Conclusions: In this large, multinational, cross-sectional survey of physicians and their patients with bipolar disorder, patientreported QOL varied substantially as a function of the phase of the illness. The depressed health state was associated with the lowest QOL scores, which in turn were associated with the highest number of prescribed drugs and hospital visits. Thus, successful treatment of the depressed state in patients with bipolar disorder may improve QOL and reduce resource use.
P.2.e.014 A multinational assessment of quality of life and resource use by bipolar disorder patients in Europe and the US
P.2.e.015 Early onset of antipsychotic action and time course in the treatment of acute bipolar mania
O. Leeuwenkamp1 ° , R. Morlock2 , G. Milligan3 , R. Perry3 . 1 NV Organon, Department of Global Health Economics & Strategic Pricing, Oss, The Netherlands; 2 Pfizer Inc, Worldwide Outcomes Research, New York, USA; 3 Adelphi, Adelphi Group Products, Chesire, United Kingdom
T. Ketter1 , L. Warrington2 , A. Loebel2 , S. Kolb3 ° , C. Siu4 . 1 Stanford University, Psychiatry, Stanford, USA; 2 Pfizer Inc., Medical Neuroscience, New York, USA; 3 Pfizer Inc., Global Pharmaceuticals, DEU, Karlsruhe, Germany; 4 Data Power (DP) Inc., Quantitative Methodology, Ringoes, USA
Objective: Bipolar disorder is a burden to patients and society. The objective of this research was to provide information on selfreported quality of life (QOL) and resource use in patients with bipolar disorder from the United States and Europe. Methods: Physicians from the United States and 5 European countries (France, Germany Italy, Spain, and the United Kingdom) completed a questionnaire concerning the clinical status and therapy of their patients. Patients completed the EuroQol EQ-5D, which assesses QOL in 5 key areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patient responses were used to generate EQ-5D utility scores. Current health state was also rated by each patient, using the EQ-5D visual analog scale (VAS), on which 0 = worst imaginable health and 100 = best imaginable health. In addition, patients reported their level of resource use (number of prescribed medications, number of hospital visits) during the preceding 12 months. Results are reported as mean ± standard deviation. Results: Data on self-reported QOL were collected from 1762 patients from the United States (n = 506), France (n = 270), Germany (n = 329), Italy (n = 259), Spain (n = 177), and the United Kingdom (n = 221) in 2006. Patients were predominantly female (57.6%), outpatients (90.7%), and between the ages of 25 and 64 (85.8%). Reasons for physician visits were classified as maintenance of treatment (49.7%) and depressed (20.4%), mixed (10.4%), manic (10.1%), or hypomanic (9.4%) health states. Across all countries, mean EQ-5D utility scores (76.8±24.8) were higher than EQ-5D VAS scores (64.0±20.6). The highest EQ5D utility and VAS scores were reported by German patients (82.8±20.3 and 67.1±22.4, respectively); the lowest EQ-5D utility
Background: Previous studies have demonstrated the efficacy of ziprasidone compared with placebo in improving symptoms of mania and global illness severity from Day 2 onward in subjects with a manic or mixed episode of bipolar I disorder, with or without psychotic features [1]. While the efficacy of antipsychotic medications for the treatment of psychosis is generally established, their mechanism of action and particularly the speed of “onset” of antipsychotic response remain controversial. In addition, it has usually been assumed that the acute or earlier effects on psychosis are nonspecific or “behavioral” with the antipsychotic effects thought to occur much later. Recent research have indicated that intramuscular ziprasidone produces a significant, early (within 24 hours) improvement in psychotic symptoms [2], distinct from drug-induced changes in non-specific behavior symptoms such as agitation, In this post-hoc analysis, we evaluated the potential for an early antipsychotic response to oral ziprasidone in subjects with acute bipolar mania, and to determine whether this early effect is distinct from a reduction in agitation symptoms associated with the treatment. Methods: We conducted a pooled analysis of two 3-week, randomized, double-blind, placebo-controlled studies of ziprasidone (40–160 mg/d) in hospitalized patients (N = 415) with bipolar I disorder and a current manic (N = 257) or mixed episode (N = 158), with (N = 167) or without (N = 248) psychotic features. Efficacy assessments included the Mania Rating Scale (MRS, derived from the SADS-C) and CGI-S which were administered at baseline and Days 2, 4, 7, 14, and 21 (or early termination). Improvement in psychosis was evaluated by the SADS-C psychosis subscale (delusions, hallucinations, and suspiciousness).