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Prescription relevant diagnosis and responder rates in the use of venlafaxine in psychiatry care settings
Sl37
l?l Afectioe disorders and antidepressants
Ip.1.012)
Double-blind randomised trial assessing the efficacy of citalopram in controlling subjective phobic symptoms in patients with panic disorder
E. Leinonen’, U. Lepola’, A. Wade3, H. Lehto4, V Pedersen4 *. I Tampere University Hospital: 2Psychiatric Research Clinic of Kuopio and Universities of Helsinki and Oalu, Finland 3Clydebank Health Centre, Clydebank, UK 4H. Lundbeck A/S, Copenhagen, Denmark Panic disorder is a chronic disorder with disabling symptoms that can last a lifetime. Patients are fearful of the onset of a panic attack, and this results in severe avoidance behaviour and anxiety. These phobic symptoms often hinder the activities of the patient more than the panic attacks themselves. Recent open and double-blind trials have shown citalopram, a highly selective serotonin re-uptake inhibitor @SRI) with established antidepressant activity, to be effective in the treatment of panic disorder [ 1, 21. Methods: This randomised, double-blind trial assessed the efficacy of citalopram in controlling the subjective phobic symptoms associated with panic disorder. Patients (aged 18 to 65 years)_ with a DSM-IIIR diagnosis of panic disorder and a Montgomery-Asberg Depression Rating Scale score of 122 were randomised to one of five treatment groups: citalopram 10 or 15 mg (Group 1, n = 97), citalopram 20 or 30 mg (Group 2, n = 95), citalopram 40 or 60 mg (Group 3, n = 89), clomipramine 60 or 90 mg (n = 98) or placebo (n = 96), initially for 8 weeks; patients could elect to continue treatment for a l-year follow-up period. Patients rated their overall improvement on the Patient’s Global Improvement Scale at the end of each phase of the trial, and were classed as responders if they scored 9 or 10. Phobia symptoms were assessed on the phobia scale (patients indicate how often they would avoid each of 17 potentially phobic situations, and how troubled they are by 6 types of feeling) and the XL-90 symptom checklist. Results: Of the 475 patients who entered the trial, 279 agreed to continue into the long-term phase. At both Week 8 and Month 12, the response rate was significantly greater in citalopram Group 2 (40% and 88%, p = 0.001 and 0.107) and Group 3 (27% and 86%, p = 0.020 and 0.019), and in the clomipramine group (38% and 83%, p = 0.001 and 0.046), than with placebo. Citalopram was also superior to placebo with respect to phobia scale ratings: the reduction in mean total phobia score was significantly greater for Group 2 (p = 0.010) at Week 8, and for all citalopram groups at Month 12 (p = 0.003, 0.001 and 0.001). Citalopram Groups 2 and 3 showed significantly greater reductions in mean global phobia score than placebo at both Week 8 (p < 0.001 and p = 0.007) and Month 12 (p = 0.0035 and 0.015). Similar results were observed for reductions in main phobia score. All doses of citalopram caused significant improvements on the SCL-90, including reduction of anxiety and phobic anxiety scores, compared with placebo. Treatment beyond 8 weeks increased treatment response, and maximum effectiveness was achieved after about 3 months. All doses of citalopram were well tolerated in the short and long term. Increased sweating, a known effect of SSRIs, was significantly more common for citalopram than for placebo. Dry mouth and tremor were experienced less frequently with citalopram than with clomipramine. Conclusions: Citalopram 20 to 60 mg/day is a safe and effective treatment for controlling phobic symptoms and improving well-being in patients with panic disorder. Treatment beyond 8 weeks is required to reach maximal efficacy. References
[l] Lepola, U., Leinonen, E., Turtonen, I., et al. (1994) The effect of citalopram in panic disorder and agoraphobia: a pilot study. Nord. J. Psychiatry 48, 13-17. [2] Wade, A.G., Lepola, U., Kuponen, H.J., et al. (1997) The effect of citalopram in panic disorder. Br. J. Psychiatry 170, 549-553.
m(
Prescription relevant diagposis and responder rates in the use of venlafaxine in psychiatry care settings
R. Sprenger, Department, Germany
A. Ripkens-Reinhard, T. Munz, G. Lorkowski. Medical Wyeth-Lederle, Schleebriiggenkamp 1.5. 48159 Miinstec
Objectives: Assessment of prescription and efficacy profile of venlafaxine in routine treatment by primary care psychiatrists and psychiatry hospitals in the early postmarketing phase. Design: Phase IV case observation study, open-label, noncomparative, multicenter Intervention: Non-interventiv, Routine treatment Patients: 5376 outpatients, 1330 inpatients Observation Variables: Indications, dosage, duration, adverse drug reactions, drop out reasons, co-medication, efficacy (CGI, MADRS, Patients subjective assessment) Coding of Prescription Relevant Diagnosis: The prescription relevant tentative diagnose was coded according to ICD-10 by a physician based on diagnosis (description), course of disease, delusional symptoms, and degree of severity. All patients with a first episode of a depressive disorder were coded as F32. Patients with a CGI of 2 or 3 were coded as F32.0, CGI of 4 and 5 as F32.1 and CGI of 6 and 7 as F32.2. All Patients with psychotic symptoms were coded F32.3. Patients with recurrent depressive disorders are coded as F33 with the identical method. Other disorders (including bipolar affective disorders) were coded according ICD-10 Chapt. V (F), if sufficient information from the text was available. Distribution of Diagnosis: 54.0% of the patients had recurrent depressive disorders (F33), 20.9% a depressive episode (F32). Persistant mood (affective) disorders (F34) [(420 patients (6.3%) with dysthymic and 113 patients (1.7%) with cyclothymic disorders)] were seen in 8. I % patients. Bipolar affective disorders were presented in 2.6%. 1.9% with anxiety disorders (incl. panic) (F40, F41) were treated with venlafaxine. 3.2% patients had more than one diagnosis. 6.4% patients had other diagnoses. In 2.9% a coding was not possible.
Responder INPATIENT based on CGI
F33 F32 F34 F31
OUTPATIENl
N all
N
%
N all
N
%
709 296 72 59
456 215 48 47
64.3 12.6 66.7 79.7
2909 1104 472 117
I793 744 258 58
61.6 61.4 54.7 13.2
Conclusion: In the early postmarketing phase psychiatrists treat their patients with venlafaxine mainly in the approved indication. To our knowledge this is the first postmarketing observation study in Germany that characterised the treated patients according ICD-IO Chap. V (F). Detailed results of the efficacy and safety data are published elsewhere.
I]
Efficacy of venlafaxine (Efexoti) in patients with bipolar affective disorder. Results of a pharmacoepidemiological investigation in usual psychiatry care setting
M. Gastpar’,E. Quentin, G. Lorkowski’. ‘Rheinische Landes- und Hochschulklinik Essen, Virchowstr: 174, D-45147 Essen; 2Medical Department, Wyeth-Lederle, Schleebriiggenkamp IS, D-48159 Miinster, Germany introduction: This large pharmacoepidemiological investigation was performed according to the German Drug Law! 4 67 (6) and the
l?l Afectioe disorders and antidepressants
Ip.1.012)
Double-blind randomised trial assessing the efficacy of citalopram in controlling subjective phobic symptoms in patients with panic disorder
E. Leinonen’, U. Lepola’, A. Wade3, H. Lehto4, V Pedersen4 *. I Tampere University Hospital: 2Psychiatric Research Clinic of Kuopio and Universities of Helsinki and Oalu, Finland 3Clydebank Health Centre, Clydebank, UK 4H. Lundbeck A/S, Copenhagen, Denmark Panic disorder is a chronic disorder with disabling symptoms that can last a lifetime. Patients are fearful of the onset of a panic attack, and this results in severe avoidance behaviour and anxiety. These phobic symptoms often hinder the activities of the patient more than the panic attacks themselves. Recent open and double-blind trials have shown citalopram, a highly selective serotonin re-uptake inhibitor @SRI) with established antidepressant activity, to be effective in the treatment of panic disorder [ 1, 21. Methods: This randomised, double-blind trial assessed the efficacy of citalopram in controlling the subjective phobic symptoms associated with panic disorder. Patients (aged 18 to 65 years)_ with a DSM-IIIR diagnosis of panic disorder and a Montgomery-Asberg Depression Rating Scale score of 122 were randomised to one of five treatment groups: citalopram 10 or 15 mg (Group 1, n = 97), citalopram 20 or 30 mg (Group 2, n = 95), citalopram 40 or 60 mg (Group 3, n = 89), clomipramine 60 or 90 mg (n = 98) or placebo (n = 96), initially for 8 weeks; patients could elect to continue treatment for a l-year follow-up period. Patients rated their overall improvement on the Patient’s Global Improvement Scale at the end of each phase of the trial, and were classed as responders if they scored 9 or 10. Phobia symptoms were assessed on the phobia scale (patients indicate how often they would avoid each of 17 potentially phobic situations, and how troubled they are by 6 types of feeling) and the XL-90 symptom checklist. Results: Of the 475 patients who entered the trial, 279 agreed to continue into the long-term phase. At both Week 8 and Month 12, the response rate was significantly greater in citalopram Group 2 (40% and 88%, p = 0.001 and 0.107) and Group 3 (27% and 86%, p = 0.020 and 0.019), and in the clomipramine group (38% and 83%, p = 0.001 and 0.046), than with placebo. Citalopram was also superior to placebo with respect to phobia scale ratings: the reduction in mean total phobia score was significantly greater for Group 2 (p = 0.010) at Week 8, and for all citalopram groups at Month 12 (p = 0.003, 0.001 and 0.001). Citalopram Groups 2 and 3 showed significantly greater reductions in mean global phobia score than placebo at both Week 8 (p < 0.001 and p = 0.007) and Month 12 (p = 0.0035 and 0.015). Similar results were observed for reductions in main phobia score. All doses of citalopram caused significant improvements on the SCL-90, including reduction of anxiety and phobic anxiety scores, compared with placebo. Treatment beyond 8 weeks increased treatment response, and maximum effectiveness was achieved after about 3 months. All doses of citalopram were well tolerated in the short and long term. Increased sweating, a known effect of SSRIs, was significantly more common for citalopram than for placebo. Dry mouth and tremor were experienced less frequently with citalopram than with clomipramine. Conclusions: Citalopram 20 to 60 mg/day is a safe and effective treatment for controlling phobic symptoms and improving well-being in patients with panic disorder. Treatment beyond 8 weeks is required to reach maximal efficacy. References
[l] Lepola, U., Leinonen, E., Turtonen, I., et al. (1994) The effect of citalopram in panic disorder and agoraphobia: a pilot study. Nord. J. Psychiatry 48, 13-17. [2] Wade, A.G., Lepola, U., Kuponen, H.J., et al. (1997) The effect of citalopram in panic disorder. Br. J. Psychiatry 170, 549-553.
m(
Prescription relevant diagposis and responder rates in the use of venlafaxine in psychiatry care settings
R. Sprenger, Department, Germany
A. Ripkens-Reinhard, T. Munz, G. Lorkowski. Medical Wyeth-Lederle, Schleebriiggenkamp 1.5. 48159 Miinstec
Objectives: Assessment of prescription and efficacy profile of venlafaxine in routine treatment by primary care psychiatrists and psychiatry hospitals in the early postmarketing phase. Design: Phase IV case observation study, open-label, noncomparative, multicenter Intervention: Non-interventiv, Routine treatment Patients: 5376 outpatients, 1330 inpatients Observation Variables: Indications, dosage, duration, adverse drug reactions, drop out reasons, co-medication, efficacy (CGI, MADRS, Patients subjective assessment) Coding of Prescription Relevant Diagnosis: The prescription relevant tentative diagnose was coded according to ICD-10 by a physician based on diagnosis (description), course of disease, delusional symptoms, and degree of severity. All patients with a first episode of a depressive disorder were coded as F32. Patients with a CGI of 2 or 3 were coded as F32.0, CGI of 4 and 5 as F32.1 and CGI of 6 and 7 as F32.2. All Patients with psychotic symptoms were coded F32.3. Patients with recurrent depressive disorders are coded as F33 with the identical method. Other disorders (including bipolar affective disorders) were coded according ICD-10 Chapt. V (F), if sufficient information from the text was available. Distribution of Diagnosis: 54.0% of the patients had recurrent depressive disorders (F33), 20.9% a depressive episode (F32). Persistant mood (affective) disorders (F34) [(420 patients (6.3%) with dysthymic and 113 patients (1.7%) with cyclothymic disorders)] were seen in 8. I % patients. Bipolar affective disorders were presented in 2.6%. 1.9% with anxiety disorders (incl. panic) (F40, F41) were treated with venlafaxine. 3.2% patients had more than one diagnosis. 6.4% patients had other diagnoses. In 2.9% a coding was not possible.
Responder INPATIENT based on CGI
F33 F32 F34 F31
OUTPATIENl
N all
N
%
N all
N
%
709 296 72 59
456 215 48 47
64.3 12.6 66.7 79.7
2909 1104 472 117
I793 744 258 58
61.6 61.4 54.7 13.2
Conclusion: In the early postmarketing phase psychiatrists treat their patients with venlafaxine mainly in the approved indication. To our knowledge this is the first postmarketing observation study in Germany that characterised the treated patients according ICD-IO Chap. V (F). Detailed results of the efficacy and safety data are published elsewhere.
I]
Efficacy of venlafaxine (Efexoti) in patients with bipolar affective disorder. Results of a pharmacoepidemiological investigation in usual psychiatry care setting
M. Gastpar’,E. Quentin, G. Lorkowski’. ‘Rheinische Landes- und Hochschulklinik Essen, Virchowstr: 174, D-45147 Essen; 2Medical Department, Wyeth-Lederle, Schleebriiggenkamp IS, D-48159 Miinster, Germany introduction: This large pharmacoepidemiological investigation was performed according to the German Drug Law! 4 67 (6) and the