Tolerability Of Reboxetine Research Articles

Adjunctive Reboxetine for Schizophrenia: Meta-analysis of Randomized Double-blind, Placebo-controlled Trials.

Results of previous studies on the safety and efficacy of adjunctive reboxetine for schizophrenia have been inconsistent. The aim of this study was to examine the efficacy and tolerability of reboxetine as an adjunct medication to antipsychotic treatment in a meta-analysis of randomized controlled trials (RCTs). Two independent investigators extracted data for a random effects meta-analysis and assessed the quality of studies using risk of bias and the Jadad scale. Weighted and standardized mean differences (WMDs/SMDs) and risk ratio (RR)±95% confidence intervals (CIs) were calculated. Nine RCTs (n=630) with double-blind design were identified. Reboxetine outperformed placebo in improving negative (9 RCTs, n=602, SMD: -0.47 [95% CI: -0.87, -0.07], p=0.02; I2=82%), but not the overall, positive, and general psychopathology scores. The significant therapeutic effect on negative symptoms disappeared in the sensitivity analysis after removing an outlying study and in 50% (6/12) of the subgroup analyses. Reboxetine outperformed placebo in reducing weight (3 RCTs, n=186, WMD: -3.83 kg, p=0.04; I2=92%) and body mass index (WMD: -2.23 kg/m2, p=0.04; I2=95%). Reboxetine caused dry mouth but was associated with less weight gain overall and weight gain of ≥7% of the initial weight. All-cause discontinuation and other adverse events were similar between reboxetine and placebo. Adjunctive reboxetine could be useful for attenuating antipsychotic-induced weight gain, but it was not effective in treating psychopathology including negative symptoms in schizophrenia.

Reboxetine versus methylphenidate in treatment of children and adolescents with attention deficit-hyperactivity disorder

Attention deficit-hyperactivity disorder (ADHD) is a common psychiatric diagnosis among children and adolescents. This study has been conducted to evaluate the efficacy and tolerability of reboxetine in comparison with methylphenidate in treatment of children and adolescents with ADHD. Thirty three children, 7-16 years of age, diagnosed with ADHD, participated in a 6-week, double-blind clinical trial with reboxetine (4-6 mg/d) and methylphenidate (20-50 mg/d) in two divided doses. The principal measure of the outcome was the Teacher and Parent ADHD Rating Scale. Patients were assessed by a child psychiatrist at baseline, 14, 28, and 42 days after the start of medication. No significant differences were observed between the two protocols on the Parent (P = 0.26) and Teacher (P = 0.97) ADHD Rating Scale scores and in treatment dropouts. A significant improvement in ADHD symptoms was observed over the 6 weeks of treatment for Parent ADHD Rating Scale (P < 0.001) and Teacher ADHD Rating Scale score in both groups (P < 0.001). The most common adverse effects reported with reboxetine were drowsiness and anorexia with mild to moderate severity. The study revealed that reboxetine may be beneficial in treatment of ADHD. Further studies are required to clarify the potential therapeutic effects on comorbid depression and anxiety and adverse effect profile.

An Open-Label Trial of Reboxetine in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

The main aim of this study was to assess the effectiveness and tolerability of reboxetine, a selective norepinephrine reuptake inhibitor, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Twenty children and adolescents, aged 6-16 (mean, 10.29; standard deviation, SD = 2.72) years, diagnosed with ADHD were enrolled in a 6-week open-label trial. Assessments included the ADHD Rating Scale (home version) and Conners' Parent Rating Scale-Revised, Short Version [CPRS-R (S)]. The dose of reboxetine was between 3 and 6 mg/day (mean, 4.41). A significant reduction in ADHD symptoms, as measured by CPRS-R (S), was observed. This reduction was significant after 2 weeks of treatment (p < 0.001). The oppositional symptoms were also reduced significantly (p < 0.05). Reboxetine was relatively well tolerated. The most common adverse effects were decreased appetite, constipation, sleep problems, and dry mouth. This open-label study suggests the efficacy of reboxetine in the treatment of ADHD in children and adolescents. Controlled studies in larger samples are needed to test the effectiveness of reboxetine in ADHD.

A comparison of the efficacy and tolerability of reboxetine and sertraline versus venlafaxine in major depressive disorder: A randomized, open-labeled clinical trial

The aim of the study was to compare the efficacy and tolerability of the combination of reboxetine and sertraline to venlafaxine XR (extended release) in major depressive disorder (MDD). The study consisted of 40 patients with MDD, aged 18–65 years. Patients were evaluated six times during a 10-week period. Treatment was started as venlafaxine XR 75 mg/day once a day (od) or reboxetine 4 mg/day twice a day (bid) + sertraline 50 mg/day od. In the second week, venlafaxine XR was increased to 150 mg/day od and reboxetine 8 mg/day bid while sertraline was kept at the same dose. The Hamilton Depression Rating Scale (HDRS), Montgomery and Asberg Depression Rating Scale, Clinical Global Impressions-Severity of Illness and Clinical Global Impressions-Global Improvement Scale were applied on each visit. Beginning from the second visit, both groups showed significant declines in each scale. There were no significant differences between treatment response rates. Remission rates defined as HDRS ≤ 10 were significantly higher in the venlafaxine XR group at visit 4 only. However, when remission was accepted as HDRS ≤ 7, no significant difference was observed. Side effect frequency was similar between the treatment groups. We may suggest that the reboxetine + sertraline combination is not superior to venlafaxine treatment.

Comparison of efficacy and tolerability of reboxetine and venlafaxine XR in major depression and major depression with anxiety features: an open label study

The aim of this study was to compare the efficacy and tolerability of reboxetine in the treatment of major depressive disorder (MDD) and MDD with anxiety features to venlafaxine XR. Patients with MDD, aging 18 between 65 years, were randomly allocated to two groups receiving either open-label venlafaxine XR capsules (n = 50) or reboxetine tablets (n = 43). Subjects were administered Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Scale (HAM-A) at baseline and 2, 4, 7, 10 weeks after the baseline visit. Response rates to antidepressant treatment were significantly higher in the venlafaxine XR group at 10th week. When patients having anxious depression were analysed separately; response rate for anxiety of reboxetine group was significantly higher at 7th week only. Mean number of side effects were significantly higher in reboxetine group. Only one subject in each group was dropped out due to side effect. We may suggest that reboxetine is as effective and tolerable as venlafaxine XR in the treatment of MDD and MDD with anxiety features, and it may be considered a treatment option to venlafaxine XR.

Efficacy and Tolerability of Reboxetine in Depressive Patients Treated in Routine Clinical Practice

Reboxetine, a potent and selective noradrenaline reuptake inhibitor, has been approved for treatment of major depression. The aim of this study was to investigate the efficacy and tolerability of reboxetine in depressive outpatients undergoing treatment in routine clinical practice. This post-marketing surveillance study was conducted to evaluate the therapeutic efficacy and tolerability of standard therapeutic doses of reboxetine in patients with depressive symptoms, particularly when administered in routine clinical practice. The 1835 patients (mean 54 years of age) evaluated showed demographic characteristics representative of the general depressive population. The majority of patients received the recommended dose of reboxetine 8 mg/day. Measures of efficacy showed improvement in depressive symptoms with reboxetine therapy over the mean observational period of 9.6 weeks. Response to therapy, defined as Hamilton depression scale 21-item version score reduction of > or =50%, was reported in 83% of patients. The effects of reboxetine were rated by physicians as 'good' or 'very good' in 86% of patients at the last visit. The tolerability of reboxetine was rated by physicians as 'good' or 'very good' in 92% of patients at all evaluations. No adverse events that were possibly related to reboxetine therapy occurred in >1% of patients. The results of this study suggest that reboxetine is safe and well tolerated and may improve symptoms in depressive patients treated in routine clinical practice.

P1.024 Venlafaxine XR for depression: Real-world remission data in primary careR. Mora S. Ros M. Garcia-Garcia

Seasonal affective disorder (SAD), winter type, is a condition characterized by the annual recurrence of depressive episodes during fall/winter, alternating with spring/summer euthymia or hypomania. Various neurotransmitters have been implicated in the etiology of SAD, the strongest evidence involving serotonin. Recently, increasing attention has been paid to the potential role of catecholaminergic pathways in the pathophysiology of SAD. We investigated the efficacy and tolerability of reboxetine, a selective noradrenaline inhibitor, in patients with SAD. Eleven out of sixteen patients who were included in a 6-week drug surveillance during winter season experienced full remission of depressive symptoms. Nine patients reported a rapid relief of preexistent severe atypical depressive symptoms within the first treatment week. Reboxetine might therefore be an effective and well-tolerated treatment option for SAD patients. In conclusion, our preliminary results are in line with evidence from recent studies suggesting that catecholaminergic systems might also be involved in the pathophysiology of SAD.

Reboxetine in seasonal affective disorder: an open trial

Seasonal affective disorder (SAD), winter type, is a condition characterized by the annual recurrence of depressive episodes during fall/winter, alternating with spring/summer euthymia or hypomania. Various neurotransmitters have been implicated in the etiology of SAD, the strongest evidence involving serotonin. Recently, increasing attention has been paid to the potential role of catecholaminergic pathways in the pathophysiology of SAD. We investigated the efficacy and tolerability of reboxetine, a selective noradrenaline inhibitor, in patients with SAD. Eleven out of sixteen patients who were included in a 6-week drug surveillance during winter season experienced full remission of depressive symptoms. Nine patients reported a rapid relief of preexistent severe atypical depressive symptoms within the first treatment week. Reboxetine might therefore be an effective and well-tolerated treatment option for SAD patients. In conclusion, our preliminary results are in line with evidence from recent studies suggesting that catecholaminergic systems might also be involved in the pathophysiology of SAD.

P02.265 Efficacy and tolerability of reboxetine used by elderly depressed patients

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Reboxetine, the first selective noradrenaline reuptake inhibitor antidepressant: Efficacy and tolerability in 2613 patients

INTRODUCTION: Reboxetine is the first available selective noradrenaline re-uptake inhibitor (selective NRI). This paper gives an overview of its antidepressant efficacy and tolerability in eight randomized double-blind, multicentre clinical trials. The clinical profile of reboxetine is also compared with that of the tricyclic antidepressants (TCAs) desipramine and imipramine and the selective serotonin re-uptake inhibitor (SSRI) fluoxetine. METHODS: Pooled data were analysed from seven short-term (4 - 8 weeks) and one long-term (up to 1 year) trials comparing reboxetine with placebo, imipramine, desipramine or fluoxetine. The tolerability of reboxetine was evaluated in 2613 patients with major depression or dysthymia. Data from 1959 patients with major depressive disorder were included to assess drug efficacy. Efficacy was principally assessed using the Hamilton Depression Rating Scale (HAM-D). RESULTS: Reboxetine was more effective than placebo in three of four short-term trials, and it was as effective as fluoxetine, imipramine and desipramine. In long-term treatment, reboxetine was more effective than placebo in preventing relapse ( S 50% increase in HAM-D) and recurrence (HAM-D total score h 10). In a subset of severely depressed patients, reboxetine was as effective as imipramine and significantly more effective than fluoxetine. Reboxetine was as effective as imipramine in the elderly, but better tolerated. The most common adverse events among the 1503 patients (adults and elderly) who received reboxetine were dry mouth (22%), constipation (15%), sweating (12%) and insomnia (11%). Overall, reboxetine was well tolerated, as well as the SSRI fluoxetine and better than the TCAs imipramine and desipramine. CONCLUSIONS: Reboxetine is effective and well tolerated in the short and long-term treatment of depression. It is as well tolerated as fluoxetine and better than imipramine and desipramine. ( Int J Psych Clin Pract 2000; 4: 201 - 208)

Reboxetine in the treatment of depression in the elderly: pilot study.

Elderly patients are particularly susceptible to the potential side effects of current antidepressants due to agerelated physiologic changes. We report a pilot study to examine the tolerability of increasing doses of reboxetine, a selective noradrenaline reuptake inhibitor (selective NRI), in elderly depressed patients. Twelve elderly female patients (75-87 years) with either major depression or dysthymia received reboxetine titrated to 8 mg/day over a 4-week period. Tolerability was assessed and included the measurement of vital signs. Electrocardiograms were recorded at baseline and on days 14 and 28. Newly emergent signs and symptoms were recorded throughout the study. Efficacy was assessed using four rating scales, including the Clinical Global Impression (CGI) scale and Hamilton Depression Rating Scale (HAM-D). Eleven patients completed the study, nine received the maximal dose of reboxetine 8 mg/day, and two received maximum doses of reboxetine 6 mg/day due to cardiac rhythm changes in week 3. A total of five patients experienced tachycardia (including two with cardiac rhythm changes in week 3). At the end of the study, seven patients were "much" to "very much" improved on the CGI scale with a concomitant decrease in HAM-D total score of 22% to 41%. Reboxetine was well tolerated by the majority of patients and efficacy outweighed side effects in 75% of patients. Reboxetine 4 mg/day, increasing to 6 mg/day on the basis of individual patient tolerability, may be considered as a safe dose range for testing the efficacy and tolerability of reboxetine in long-term controlled clinical trials in elderly patients with depression.