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Re: Edronax - anyone on it? » nutsy

Posted by SalArmy4me on August 28, 2001, at 20:41:31

In reply to Edronax - anyone on it?, posted by nutsy on August 28, 2001, at 19:07:01

I used 12 mg for a week and stopped to go on moclobemide. But it was extremely tolerable.

Journal of Clinical Psychopharmacology
Volume 20(1) February 2000 pp 28-34
"Double-Blind, Placebo-Controlled Study With Reboxetine in Inpatients With Severe Major Depressive Disorder":

Efficacy
"The mean HAM-D total score at baseline was similarly high in the patients randomly assigned to receive reboxetine (35.7) and placebo (35.1), thus indicating that the majority of patients in both groups were severely ill. The mean total scores at last assessment were 12.6 for the reboxetine-treated group and 30.6 for the placebo-treated group. The absolute reduction in the mean HAM-D total score at the last assessment compared with that at baseline was significantly greater in the reboxetine group than in the placebo group (23.1 vs. 4.5; p < 0.001). Furthermore, the response rate (i.e., patients achieving a >=50% reduction in HAM-D total score) at the last assessment was 74% of patients in the reboxetine group compared with only 20% in the placebo group (p < 0.001).

Analysis of the change in mean HAM-D total scores over time (Fig. 1) showed that reboxetine was associated with a significantly greater response than was placebo from as early as day 10 of treatment (p = 0.006). Furthermore, the mean HAM-D score continued to improve throughout the study period for patients in the reboxetine group, but not for those in the placebo group (Fig. 1).

When the individual symptoms and symptom clusters on the HAM-D were assessed, significant differences in favor of reboxetine were observed in depressed mood (p = 0.044) by day 10; early/middle/late insomnia (p = 0.006) and work and activity/retardation (p = 0.003) by day 14; anxiety-psychic/hypochondriasis (p < 0.001), anxiety-somatic/somatic symptoms-gastrointestinal (p < 0.001), and general genital symptoms (p < 0.001) by day 21.

The superiority of reboxetine over placebo was confirmed by changes in the mean Zung total scores and the mean scores on the CGI Severity of Illness and Global Improvement subscales. The improvement in the mean Zung total scores from baseline to the last assessment was significantly greater in the reboxetine group (from 66.3 to 42.8) than in the placebo group (from 65.2 to 58.6) (p = 0.001). Significant differences between the two groups in terms of Zung total scores were first apparent at day 14 (54.7 vs. 60.8; p = 0.035), confirming the early onset of action demonstrated by the reduction in the mean HAM-D total scores. Improvements in mean CGI Severity of Illness and Global Improvement scores from baseline to last assessment were significantly greater in the reboxetine group than in the placebo group (p < 0.001). At the last assessment, 82% of patients receiving reboxetine compared with only 28% of those receiving placebo were judged "much improved" to "very much improved." Similarly, the mean CGI Severity of Illness score was only 2.07 in the reboxetine group compared with 4.24 in the placebo group at last assessment. Significant differences between the two groups in terms of mean CGI Severity of Illness and Global Improvement scores were first apparent at day 14 (p = 0.025 for CGI Severity of Illness and p < 0.001 for CGI Global Improvement), again confirming an early onset of action. None of the changes in the efficacy assessments showed age or gender effect.

Tolerability
The overall incidence of newly observed signs and symptoms was 86% (N = 24 of 28 patients) in the reboxetine group and 46% (N = 13 of 28) in the placebo group. The most frequently reported adverse events in the reboxetine group were dry mouth (57% of patients) and insomnia (25%). As shown in Table 2, other newly observed signs and symptoms reported in 10% or more of patients in the reboxetine group included blurred vision, sweating, constipation, vomiting, tremor, hypotension, decreased appetite, and sexual disturbance, whereas those occurring in the placebo group were dry mouth, headache, and tremor.

The majority of newly observed signs and symptoms began in the first 10 days of treatment, and the mean duration was 10.2 days in the reboxetine group and 2.7 days in the placebo group (p < 0.001). Most were mild to moderate in intensity (94% in the reboxetine group and 98% in the placebo group), and only a small proportion were considered to be severe (6% and 2%, respectively; p = 0.038). A total of 67% of the newly observed signs and symptoms were considered definitely related to treatment in the reboxetine group compared with 38% in the placebo group (p < 0.01). However, the incidence of discontinuations because of newly observed signs and symptoms was equally low in both groups (one patient per group).

The mean decrease in standing systolic blood pressure over the period of the trial was significantly greater in the reboxetine group than in the placebo group (-4.5 vs. -0.7 mmHg; p = 0.036). Hypotension was reported as an adverse event in three patients treated with reboxetine, of which one case was rated as "severe." There were no differences between the groups with respect to diastolic blood pressure, heart rate, or supine systolic blood pressure. Moreover, there were no clinically significant changes in laboratory or ECG parameters in either group.

Concomitant medication to treat insomnia, agitation, or headache was administered to 3 of the 32 patients completing the trial: chloral hydrate was administered to 2 patients and acetaminophen and diazepam were each administered to 1 patient. No withdrawal effects were observed on abrupt withdrawal of reboxetine.


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poster:SalArmy4me thread:76755
URL: http://www.dr-bob.org/babble/20010828/msgs/76761.html