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Venlafaxine versus fluoxetine in the treatment of depressed patients with concomitant anxiety
s224
l?l Afectiue
IP.1 .&I71 Venlafaxine versus fluoxetine in the treatment depressed patients with concomitant anxiety
disorders and antidepressants
of
S. Geerts, I! Lacante, A. Mignon. The 6OOA-637-BE study group; St. Lucashospital, psychiatry, Assebroek, Belgium Objective: To compare the efficacy and tolerability venlafaxine to fluoxetine in the treatment of depressed outpatients with concomitant anxiety. Methods: 12-week, double-blind, comparative study in Belgian psychiatric practice. Patients: 146 depressed outpatients were enrolled (73 per group). They had a HAM-D between 18 and 25 and a minimum score of 8 on the Covi anxiety scale. No concomitant anxiolytics were allowed. Patients started at either 75 mg/day venlafaxine or 20 mg fluoxetine. If the HAM-D score did not decrease by 20% at week 2, the dose could be doubled in both treatment groups. Main outcomes measures: HAM-D 21 item, MADRS, CGI and Covi were assessed at baseline and days, 7, 14, 28, 56 and 84 as well as vital signs and side effects. Key findings: Results on all rating scales were significantly better for venlafaxine at week 2 (observed cases) and final visit (Last observation carried forward). The mean HAM-D score decreased from 23 at baseline to 15 at week 2 and 8.7 at the final visit for the venlafaxine group compared to 23.1 at baseline to 18.1 at week 2 and 12.7 at the final visit in the fluoxetine group (wee2 p = 0.0058, final visit p = 0.0048). Response rates (50% decrease in HAM-D) were 28.3% versus 12.3% at week 2 (p = 0.018) and 71.9% versus 49.3% at final visit (p = 0.008) for venlafaxine and fluoxetine respectively. The Covi anxiety scale decreased from 8 to 2.4 in the venlafaxine group compared to 4.4 in the fluoxetine group (p = 0.0004). These differences were statistically significant. 53% of fluoxetine patients had a dose increase at week 2 compared to only 37% in the venlafaxine treated patients. There were less discontinuations (33% versus 40%) and side effects (55.7% versus 67.1%) with venlafaxine compared to fluoxetine. There were no effects on vital signs but a marked difference in weight change was observed. On average fluoxetine patients lost 3 kg compared with 0.3 kg weight loss in the venlafaxine treated patients. Conclusion: Venlafaxine is more effective and better tolerated than fluoxetine in depressed patients with concomitant anxiety.
References [ 1] Horst WD, Preskom SH. The pharmacology and mode of action of venlafacine. Rev Contemp Pharmacother 1998; 9: 293-302 [2] Joffe R. T. et al. A Large Open-label study of Veniafaxine in depressed outpatients by community based physicians, J Clin Psychiatry; 1998; 59: 515520 IP.1.049]
Response and remission with venlafaxine in hospitalized patients and outpatients with major depression. An open-label study in Belgium and Luxembourg
P Lacante, A. Mignon. The 6OOA-636-BE study group; Wyeth Lederie Belgium, medical department, Louoain-la-Neuue, Belgium
References
[1] Burnett FE, Dinan TG. The clinical Efficacy of Venlafaxine in the Treatment of Depression. Rev Contemp Pharmacother 1998; 9: 303-320 [2] Rudolph RL, Entsuah R, Chitm R. A m&-analysis of the effects of venlafaxine on anxiety associated with depression. J Clin Psychophannacol 1998; 18: 136 144
I]
card on the day they felt better. Blood pressure, pulse and side effects were monitored for safety. Main Outcome: The data generated in this large study allows to analyze the efficacy of venlafaxine in various types of depressed patients. The overall results confirm the antidepressant efficacy of venlafaxine with a mean change on the HAM-D from 26.2 to 12.2 at week 6. The response rate, defined as 50% reduction versus baseline on the HAM-D, was 65.5% after 6 weeks. On average, the patients reported feeling better on day 17 of treatment. Thirty percent of patients had a HAM-D-score of less than 8 at week 6 of treatment. The mean dose of venlafaxine at week 6 was 169 mg!day. If patients are classified according to the severity of the depression, a response rate of 64.1% was obtained in moderately depressed patients (HAM-D 18-25) and 66.6% in severely depressed patients (HAMD > 25). The mean dose used at week 6 was 138 mg for moderately depressed patients and 196 mg for severely depressed patients. The majority of patients (67.3%) changed from a current antidepressant to venlafaxine and the main reason for switching was lack of efficacy (86.3%). Comparing the switchers with the nonswitchers, the response rate was 76% in non-switchers and 61% in switchers. In patients switching from an SSRI, the response rate was 68.8%. In the non-switchers 43% reached remission (HAM-D < 8) at week 6 compared to 24% in switchers. The high reponse rates in patients with SSRI-failure can be explained by the dual action of venlafaxine on 5-HT and NE reuptake. The side effects were not increased in the switchers. The tolerability in the different subpopulations is comparable, with transient nausea being the most frequently reported side effect. Conclusion: Venlafaxine is effective, safe, and well tolerated in a naturalistic setting across a broad range of depressed patients.
Large, open-label study of venlafaxine naturalistic psychiatric setting
in a
B. Gribomont, P Lacante, A. Mignon. 6OOA-GAP-BE study group; psychiatric pmctice,
Brussels, Belgium
Objective: To assess the clinical utility of venlafaxine in depressed patients in usual psychiatric practice in Belgium and Luxembourg Method: This was a 6 week open-label study. Admission criteria were based on patients seen in daily psychiatric practice and allowed outpatients and hospitalized patients and patients switching from current antidepressant treatment. Venlafaxine was used according to approved labeling. Patients: Of 1010 patients enrolled, 797 completed the study. Eighteen percent of the patients started the study as inpatients. Fifty five percent of patients were rated as severely depressed (HAM-D 21 item > 25). Patients had a mean of 3 prior depressive episodes, 84.7% had received prior antidepressants. Sixty seven percent of the patients switched from a prior antidepressent to venlafaxine at the start of the study. Measures: HAM-D, MADRS and CGI was assessed at baseline and days, 7, 14, 28 and 42 of treatment. Patients were asked to complete a
Objective: To assess the response and remission rates in two groups of depressed patients. Methods: Open-label, non-comparative, parallel group study. Admission criteria required a minimum HAM-D score of 25 for inpatients and a score between 18 and 25 for outpatients. Venlafaxine treatment was started at 75 mg/day in both groups and could be increased to a maximum of 375 mg/day for inpatients and 225 mg/day for outpatients. HAM-D, MADRS and CGI scales were administered at baseline and days 7, 14, 28 and 42 and 56 of treatment. Inpatients were also assessed on days 4 and 21. Blood pressure, pulse and side effects were recorded for safety Patients: 149 patients were enrolled: 61 inpatients and 88 outpatients Main outcomes: Response (50% reduction from baseline in HAM-D scores) was obtained in 71.l% of inpatients and 71.4% of outpatients. Remission (HAM-D < 8) was achieved in more than 50% of outpatients and 39% of inpatients. A suicidal ideation score of 0 (HAM-D) was obtained by 73.3% and 85.7% of inpatients and outpatients respectively. The mean dose at week 8 of treatment was 148 mg for outpatients and 194 for inpatients. The most frequent side effects were nausea, headache and sweating. Conclusion: Venlafaxine is a highly effective antidepressant in both inpatients and outpatients with a meaningful proportion of patients achieving remission.
References
[1] Horst WD, Preskorn SH. The pharmacology and mode of action of venlafaxine. Rev Contemp Phannacotber 1998; 9: 293-302
l?l Afectiue
IP.1 .&I71 Venlafaxine versus fluoxetine in the treatment depressed patients with concomitant anxiety
disorders and antidepressants
of
S. Geerts, I! Lacante, A. Mignon. The 6OOA-637-BE study group; St. Lucashospital, psychiatry, Assebroek, Belgium Objective: To compare the efficacy and tolerability venlafaxine to fluoxetine in the treatment of depressed outpatients with concomitant anxiety. Methods: 12-week, double-blind, comparative study in Belgian psychiatric practice. Patients: 146 depressed outpatients were enrolled (73 per group). They had a HAM-D between 18 and 25 and a minimum score of 8 on the Covi anxiety scale. No concomitant anxiolytics were allowed. Patients started at either 75 mg/day venlafaxine or 20 mg fluoxetine. If the HAM-D score did not decrease by 20% at week 2, the dose could be doubled in both treatment groups. Main outcomes measures: HAM-D 21 item, MADRS, CGI and Covi were assessed at baseline and days, 7, 14, 28, 56 and 84 as well as vital signs and side effects. Key findings: Results on all rating scales were significantly better for venlafaxine at week 2 (observed cases) and final visit (Last observation carried forward). The mean HAM-D score decreased from 23 at baseline to 15 at week 2 and 8.7 at the final visit for the venlafaxine group compared to 23.1 at baseline to 18.1 at week 2 and 12.7 at the final visit in the fluoxetine group (wee2 p = 0.0058, final visit p = 0.0048). Response rates (50% decrease in HAM-D) were 28.3% versus 12.3% at week 2 (p = 0.018) and 71.9% versus 49.3% at final visit (p = 0.008) for venlafaxine and fluoxetine respectively. The Covi anxiety scale decreased from 8 to 2.4 in the venlafaxine group compared to 4.4 in the fluoxetine group (p = 0.0004). These differences were statistically significant. 53% of fluoxetine patients had a dose increase at week 2 compared to only 37% in the venlafaxine treated patients. There were less discontinuations (33% versus 40%) and side effects (55.7% versus 67.1%) with venlafaxine compared to fluoxetine. There were no effects on vital signs but a marked difference in weight change was observed. On average fluoxetine patients lost 3 kg compared with 0.3 kg weight loss in the venlafaxine treated patients. Conclusion: Venlafaxine is more effective and better tolerated than fluoxetine in depressed patients with concomitant anxiety.
References [ 1] Horst WD, Preskom SH. The pharmacology and mode of action of venlafacine. Rev Contemp Pharmacother 1998; 9: 293-302 [2] Joffe R. T. et al. A Large Open-label study of Veniafaxine in depressed outpatients by community based physicians, J Clin Psychiatry; 1998; 59: 515520 IP.1.049]
Response and remission with venlafaxine in hospitalized patients and outpatients with major depression. An open-label study in Belgium and Luxembourg
P Lacante, A. Mignon. The 6OOA-636-BE study group; Wyeth Lederie Belgium, medical department, Louoain-la-Neuue, Belgium
References
[1] Burnett FE, Dinan TG. The clinical Efficacy of Venlafaxine in the Treatment of Depression. Rev Contemp Pharmacother 1998; 9: 303-320 [2] Rudolph RL, Entsuah R, Chitm R. A m&-analysis of the effects of venlafaxine on anxiety associated with depression. J Clin Psychophannacol 1998; 18: 136 144
I]
card on the day they felt better. Blood pressure, pulse and side effects were monitored for safety. Main Outcome: The data generated in this large study allows to analyze the efficacy of venlafaxine in various types of depressed patients. The overall results confirm the antidepressant efficacy of venlafaxine with a mean change on the HAM-D from 26.2 to 12.2 at week 6. The response rate, defined as 50% reduction versus baseline on the HAM-D, was 65.5% after 6 weeks. On average, the patients reported feeling better on day 17 of treatment. Thirty percent of patients had a HAM-D-score of less than 8 at week 6 of treatment. The mean dose of venlafaxine at week 6 was 169 mg!day. If patients are classified according to the severity of the depression, a response rate of 64.1% was obtained in moderately depressed patients (HAM-D 18-25) and 66.6% in severely depressed patients (HAMD > 25). The mean dose used at week 6 was 138 mg for moderately depressed patients and 196 mg for severely depressed patients. The majority of patients (67.3%) changed from a current antidepressant to venlafaxine and the main reason for switching was lack of efficacy (86.3%). Comparing the switchers with the nonswitchers, the response rate was 76% in non-switchers and 61% in switchers. In patients switching from an SSRI, the response rate was 68.8%. In the non-switchers 43% reached remission (HAM-D < 8) at week 6 compared to 24% in switchers. The high reponse rates in patients with SSRI-failure can be explained by the dual action of venlafaxine on 5-HT and NE reuptake. The side effects were not increased in the switchers. The tolerability in the different subpopulations is comparable, with transient nausea being the most frequently reported side effect. Conclusion: Venlafaxine is effective, safe, and well tolerated in a naturalistic setting across a broad range of depressed patients.
Large, open-label study of venlafaxine naturalistic psychiatric setting
in a
B. Gribomont, P Lacante, A. Mignon. 6OOA-GAP-BE study group; psychiatric pmctice,
Brussels, Belgium
Objective: To assess the clinical utility of venlafaxine in depressed patients in usual psychiatric practice in Belgium and Luxembourg Method: This was a 6 week open-label study. Admission criteria were based on patients seen in daily psychiatric practice and allowed outpatients and hospitalized patients and patients switching from current antidepressant treatment. Venlafaxine was used according to approved labeling. Patients: Of 1010 patients enrolled, 797 completed the study. Eighteen percent of the patients started the study as inpatients. Fifty five percent of patients were rated as severely depressed (HAM-D 21 item > 25). Patients had a mean of 3 prior depressive episodes, 84.7% had received prior antidepressants. Sixty seven percent of the patients switched from a prior antidepressent to venlafaxine at the start of the study. Measures: HAM-D, MADRS and CGI was assessed at baseline and days, 7, 14, 28 and 42 of treatment. Patients were asked to complete a
Objective: To assess the response and remission rates in two groups of depressed patients. Methods: Open-label, non-comparative, parallel group study. Admission criteria required a minimum HAM-D score of 25 for inpatients and a score between 18 and 25 for outpatients. Venlafaxine treatment was started at 75 mg/day in both groups and could be increased to a maximum of 375 mg/day for inpatients and 225 mg/day for outpatients. HAM-D, MADRS and CGI scales were administered at baseline and days 7, 14, 28 and 42 and 56 of treatment. Inpatients were also assessed on days 4 and 21. Blood pressure, pulse and side effects were recorded for safety Patients: 149 patients were enrolled: 61 inpatients and 88 outpatients Main outcomes: Response (50% reduction from baseline in HAM-D scores) was obtained in 71.l% of inpatients and 71.4% of outpatients. Remission (HAM-D < 8) was achieved in more than 50% of outpatients and 39% of inpatients. A suicidal ideation score of 0 (HAM-D) was obtained by 73.3% and 85.7% of inpatients and outpatients respectively. The mean dose at week 8 of treatment was 148 mg for outpatients and 194 for inpatients. The most frequent side effects were nausea, headache and sweating. Conclusion: Venlafaxine is a highly effective antidepressant in both inpatients and outpatients with a meaningful proportion of patients achieving remission.
References
[1] Horst WD, Preskorn SH. The pharmacology and mode of action of venlafaxine. Rev Contemp Phannacotber 1998; 9: 293-302